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the previous claim objections set forth in the Office action mailed 09/17/2025, the previous claim objections are withdrawn.
Applicant amendments do not overcome each and every 112(b) rejection set forth in the Office Action mailed 09/17/2025, please see 112 section below.
Status of Claims
Claims 1-8, 10-21, 23-24, 26-29 remain pending in the application, with claims 1-8, 10-16, 21, 23-24, 26-29 being examined and claims 17-20 being withdrawn pursuant to the election filed 05/08/2023.
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 1-8, 10-16, 21, 23-24, 26-29 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 “the sample” on line 13, there is insufficient antecedent basis for this limitation, as no sample has been recited prior.
Claims 2-8, 10-13, 21, 23-24, 26-29 are rejected by virtue of being dependent on a rejected claim.
Claim 14 recites “a testing device” on line 7, where it is unclear if this testing device is referring to the testing device recited on line 1 of claim 14, or if it is “a testing device interface zone configured to receive the test card” recited on line 15.
For examination, it will be interpreted that line 7 is referring to a testing device interface zone.
Line 17 recites “the sample” where there is insufficient antecedent basis for this limitation as no sample has been recited prior.
Claims 15-16 are rejected by virtue of being dependent on a rejected claim.
Claim 23 recites “configured to connect to the pneumatic system of the testing device to enable the pneumatic system to direct fluid through the microfluidic chip” on lines 2-3, where due to the amendments to claim 1, it is unclear if the fluid is the same or different from the sample because the sample is described in claim 1 to moved via pneumatic actuation.
Claim 24 recites “wherein the pneumatic port enables pneumatic actuation of fluids through the microfluidic chip.” on lines 1-2, where due to amendments to claim 1, it is unclear if the pneumatic actuation of fluids is the same or different from the pneumatic actuation to move the sample as described on lines 12-13 of claim 1.
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) 1-8, 13, 21, 23-24, 26 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 ([0148] see one branch that undergoes PCR reaction and then sample is transported to a lateral flow strip for visualization. The PCR reaction test zone is a first test zone and lateral flow strip is a second test zone. See Figure 17 which shows a chamber for PCR and a chamber for a lateral flow strip); and
wherein the at least two test zones are configured to perform at least two different tests ([0148] where the PCR test and lateral flow strips are different tests, Figure 17); and
wherein at least two of the at least two different tests each utilize a different modality ([0148] where PCR and lateral flow strips are two different modalities, Figure 17);
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 cassette is seen in Figure 18e. The cassette seen in Figure 17 will similarly be placed in an actuator, where the slot for cassette is the testing device interface zone); and
The limitation “a testing device interface zone configured to receive the microfluidic chip” 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 Chen and the slot for cassette is capable of receiving the cassette. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Chen (see MPEP §2114).
Chen does teach where there are valves located in Figure 17. [0075] 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 pneumatic 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.
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 (Figure 17) 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 there 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) between the PCR chamber and lateral flow strip 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) between the PCR chamber and lateral flow strip 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 wherein the at least two of the at least two test zones 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 sample 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 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 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 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 13, modified Chen teaches the testing device of claim 1. Chen further teaches wherein each test zone in the at least two test zones is individually configured to perform a test selected from the group consisting of a polymerase chain reaction (PCR) test, a lateral flow assay test, and combinations thereof (Chen; [0148], Figure 17).
Regarding claim 21, 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 a test selected from the group consisting of a lateral flow assay test (Chen; [0148], Figure 17).
Regarding claim 23, modified Chen teaches the testing device of claim 1. Chen has been modified with Adamant Valves so that the valves seen in Figure 17 are pneumatic ball valves, where further the actuator of Chen is now a pneumatic system to control the pneumatic ball valves.
The limitation “wherein the pneumatic port is configured to connect to the pneumatic system of the testing device to enable the pneumatic system to direct fluid through the microfluidic chip by applying a vacuum to the microfluidic chip via the pneumatic port.” 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 having the pneumatic ports be connected to a pneumatic system, which allows the pneumatic system to direct fluid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Regarding claim 24, modified Chen teaches the testing device of claim 1. Chen has been modified with Adamant Valves so that the valves seen in Figure 17 are pneumatic ball valves, where further the actuator of Chen is now a pneumatic system to control the pneumatic ball valves.
The limitation “wherein the pneumatic port enables pneumatic actuation of fluids through the microfluidic chip.” 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 enabling pneumatic actuation of fluids through the cassette. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Regarding claim 26, modified Chen teaches the testing device of claim 1. Chen further teaches wherein at least one of the at least two different tests utilizes a modality of a lateral flow assay test (Chen; [0148], Figure 17).
Claim(s) 2-4 is/are alternatively rejected and claim(s) 10-11 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 testing device 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 is 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 is 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 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.
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 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 modified Chen teaches an additional input port, see claim 2 supra.
Regarding claim 4, modified Chen teaches the testing device 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 is 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 is 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 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.
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 10, 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 is 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 is 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 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.
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 11, modified Chen teaches the testing device of claim 10. Chen has been modified with Pulitzer such that there are now two sample ports, therefore 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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US-2010/0304986-A1), “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 12, modified Chen teaches the testing device of claim 10. 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 at least one input port of the at least two input ports is fluidically connected to at least two test zones configured to perform the same testing modality.
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) 14-16 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 14, 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 ([0148] see one branch that undergoes PCR reaction and then sample is transported to a lateral flow strip for visualization. The PCR reaction test zone is a first test zone and lateral flow strip is a second test zone. See Figure 17 which shows a chamber for PCR and a chamber for a lateral flow strip); and
wherein the at least two test zones are configured to perform at least two different tests ([0148] where the PCR test and lateral flow strips are different tests, Figure 17); and
wherein at least two of the at least two different tests each utilize a different modality ([0148] where PCR and lateral flow strips are two different modalities, Figure 17); 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);
Chen does teach where there are valves located in Figure 17. [0075] 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 pneumatic 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.
The limitation “the 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 15, modified Chen teaches the testing device of claim 14. 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 16, modified Chen teaches the testing device of claim 14. 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).
Claim(s) 27-29 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 Phadke (US-2007/0259348-A1).
Regarding claim 27, modified Chen teaches the testing device of claim 1. Chen further teaches further comprising at least one rehydration port (Chen; [0148] which describes the branch that undergoes a PCR reaction and a lateral flow strip, where it is seen in Figure 17 that there is a port labeled for reagent).
Chen does describe where the cassette can be pre-loaded with one or more reagents in fluid form or dried form (Chen; [0055]), Chen does not teach a lyophilized bead.
In the analogous art of lyophilized pellets for use in a microfluidic device, Phadke teaches a method of making the pellet (Phadke; abstract, [0006]).
Specifically, Phadke teaches where lyophilization (freeze-drying) is an effective process for converting a biological reagent into a form that is convenient to handle but does not result in a concomitant loss of activity of the biological reagent (Phadke; [0003]). Phadke further teaches where the present invention includes a microfluidic cartridge that comprises: a reagent inlet, wherein are situated one or more lyophilized pellets that each contain one or more reagents (Phadke; [0015]).
It would have been obvious to one skilled in the art to modify the dried reagents of Chen such that they are instead lyophilized pellets as taught by Phadke because Phadke teaches that lyophilization is an effective process for converting a biological reagent into a form that is convenient to handle but does not result in a concomitant loss of activity of the biological reagent (Phadke; [0003]).
Regarding claim 28, modified Chen teaches the testing device of claim 27.
The limitation “wherein the microfluidic chip is configured to be stored at room temperature.” 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 being stored at room temperature. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Regarding claim 29, modified Chen teaches the testing device of claim 27.
The limitation “wherein the at least one rehydration port is configured to mix the lyophilized bead with a liquid-phase fluid.” 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 mixing the lyophilized bead with a liquid-phase fluid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Chen (see MPEP §2114).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Due to applicant amendments to the claims, claims 1-8, 10-16, 21, 24, 26-27, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-12, 14-17 of copending Application No. 18/482,228 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 1 and reference claim 1 are both directed to a testing device comprising a microfluidic chip that comprises at least one input port fluidically connected to at least two test zones by at least one microfluidic guide, and a pneumatic port. The reference application teaches that one test zone performs a lateral flow assay test and at least one test zones performs a PCR test or cytometry test, which reads on the instant claims of at least two of the at least two different tests each utilize a different modality. Both instant and reference claim 1 describe a testing device interface zone, and a pneumatic system configured to connect to the pneumatic port and is configured to control pneumatic actuation to move sample from the at least one input port through the microfluidic guide to at least one of the at least two test zones.
Reference claims 2-8 read on instant claims 2-8, 27, and 29. Reference claim 10 reads on instant claims 21 and 26. Reference claim 1 reads on instant claim 24. Reference claims 11-12 reads on instant claims 10-11, and reference claim 14 reads on instant claim 13.
Instant claim 14 and reference claim 15 are both directed to a testing device comprising a test card comprising a microfluidic chip comprising at least one input port fluidically connected to at least two zones by at leas tone microfluidic guide, and a pneumatic port. The reference application teaches that the test zones perform a lateral flow assay test and either a PCR test or cytometry test, which read on instant claim 14 of at least two of the at least two different tests each utilize a different modality. Reference claim 14 and instant claim 14 both describe a chip carrier coupled to the microfluidic chip, a testing device interface zone, and a pneumatic system that connects to the pneumatic port and the pneumatic system configured to control pneumatic actuation to move 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Due to amendments to the claims, adding limitations regarding the pneumatic system, the rejections in view of Chen and Adamant Valves, and the rejections in view of Chen, Adamant Valves, and Arlett under 35 USC 103 have been modified to address this amendment.
Applicant arguments filed 03/02/2026 have been fully considered but are not persuasive.
Applicant argues on page 8 that the present claims positively recite a pneumatic system that is separate from the microfluidic chip as well as the functionality of the pneumatic system, which is distinct from Chen which recites on-chip actuation by mechanical motion. Therefore, it would not be obvious to one skilled in the art to modify Chen by substituting the mechanically actuated diagnostic device of Chen with a testing device having a pneumatic system as claimed, and that there is no teaching, suggestion, or motivation or other reason in Chen.
Firstly, it is respectfully noted that currently neither claim 1 nor 14 requires that the pneumatic system be separate. The claims recite “a pneumatic system configured to connect to the pneumatic port”. Further, it is understood from Figure 18a of Chen that the chip seen in Figure 17 (the microfluidic chip) is loaded into the device that actuates the chip. Therefore, the chip seen in Figure 17 will be separate from the pneumatic system (in view of Adamant valves), but the pneumatic system will still connect to the chip.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to modify the ball valves of Chen is found in Adamant Valves, which teaches that pneumatic ball valves have the advantage of having quick opening and closing (Adamant Valves; point 4).
On page 9, applicant argues that modifying Chen with Adamant Valves would alter the principle of operation of Chen, that is the actuation of 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
Prosecution Insights