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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/07/2025 has been entered.
Response to Amendment
Applicant amendments filed 10/07/2025 have been entered. Applicant amendments overcomes the previous provisional nonstatutory double patenting rejection set forth in the Office Action mailed 04/07/2025, the provisional nonstatutory double patenting rejection is withdrawn.
Status of Claims
Claims 1-2, 4, 6-21 remain pending in the application, with claims 1-2, 4, 6-17, 19-21 being examined and claim 18 being withdrawn pursuant to the election filed 06/14/2024.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 it appears that the semicolon at the end of line 32 was not deleted. As the lines after have been deleted, this is the end of the claim and the semicolon should be removed.
Appropriate correction is required.
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) 1-2, 4, 6, 9, 16-17, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1) in view of Schultze (US-2013/0171685-A1), Fiering (US-2018/0313816-A1), and as evidenced by Olde (US-2014/0231319-A1).
Regarding claim 1, Durack teaches an aphaeretic portable biological fluid filtration system, comprising:
a housing (substrate 402) including an inlet (port 410) and an outlet (well/chamber 414), wherein the inlet (410) of the housing (402) is adapted to be fluidly connected to a patient to receive a biological fluid from the patient ([0054] see cells from an external cell supply are introduced into the microfluidic device via port 410, Figure 4);
a fluid filtration device (flow diverter 418) including an inlet, a first outlet, and a second outlet, wherein the inlet of the fluid filtration device (418) is fluidly connected to the inlet (410) of the housing (402), wherein the fluid filtration device (418) is adapted to receive the biological fluid, and wherein the second outlet of the fluid filtration device (418) is fluidly connected to the outlet (414) of the housing (402) ([0056], Figure 4 where flow diverter 418 is connected to flow channel 411 and will therefore have an inlet. The outlets of the flow diverter 418 lead to the two branching channels seen in Figure 4, where a first outlet will lead to the channel that goes to the sterile collection bag and a second outlet will lead to the channel that goes to the well/chamber 414);
a cartridge (sterile collection bag 416) removably attached to the housing (402), wherein the cartridge (416) is fluidly connected to the first outlet of the fluid filtration device (418), wherein the cartridge (416) is adapted to receive the biological fluid if the fluid filtration device determines that the biological fluid includes the tumor cell or pathogen ([0055]);.
The limitations “the housing adapted to be fluidly connected to a patient to receive a biological fluid from the patient”, “wherein the fluid filtration device is adapted to receive the biological fluid”, and “the cartridge is adapted to receive the biological fluid if the fluid filtration device determines that the biological fluid includes the tumor cell or pathogen;.” 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 Durack and the apparatus of Durack is capable of having the port 410 be connected to a patient, adapted to receive the biological fluid, and the cartridge is capable of receiving biological fluid if the device determines it includes the tumor cell or pathogen. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
Further, the biological fluid has not been positively recited in the claim and is therefore not a part of the claimed system.
While Durack does teach an analysis section 412 ([0054]) Durack is not specific as to the components that make up the analysis section.
In the analogous art of characterizing biological objects and sorting, Schutze teaches where a stimulus applied to a biological object and measuring the response is done using Raman scattering and digital holographic microinterferometry (DHMI, also known as digital holographic microscopy) (Schutze; abstract, [0011]).
Specifically, Schultze teaches a system comprising an apparatus 2 for characterizing biological objects and a computing device 3 coupled to the apparatus 2 (Schultze; [0058], Figure 1). The apparatus 2 performs Raman spectroscopy and DHMI on a biological object to quantitatively determine its response to a stimulus, where the computing device 3 has a data base 4 that has information regarding the behavior of different biological objects for various types of cells such as healthy cells or tumor cells (Schultze; [0058], Figure 1). The apparatus 2 has a microfluidic system 11 that has a fluid channel 13 where cells 8, 9 are positioned in the channel 13 (Schultze; [0059], Figure 1). [0071] of Schultze further describes where a signal is provided by the computing device 3 according to which cell 8, 9 is selectively sorted into one of plural output channels 14, 15. [0046] describes where the characteristics of Raman spectroscopy and DHMI allow the characterization of biological objects to be automated to a large degree, where in particular the spectra obtained by Raman spectroscopy and information on shape, volume and/or refractive index obtained from DHMI can be compared with a data base to automatically sort cells where in this manner healthy cells may be discriminated from tumor cells and are directed to different collection vessels. [0063] describes a device 22 for performing Raman spectroscopy and device 24a, 24b, 24c for performing DHMI.
Durack is silent with regards to specific components of an analysis section, therefore, it would have been necessary and thus obvious to look to the prior art for conventional analysis sections. Schultze provides this conventional teaching showing that it is known in the art to use Raman spectroscopy and DHMI with a computing device to sort cells. Therefore, it would have been obvious to one having ordinary skill in the art to have the analysis section include the devices for performing Raman spectroscopy and DHMI and the computing device because it is taught by Schultze that these two components are effective for discriminating healthy cells from tumor cells.
From [0058] of Schultze, the data base 4 of computing device 3 will comprise one or more characteristics of a healthy cell. [0055] of Durack describes where flow diverter 418 physically diverts cells into chamber 414 or sterile collection bag 416 from the analysis section, where [0056] describes where the flow diverter is a piezoelectric device that can be actuated with an electrical signal. The computing device 3 of Schultze will be connected to the flow diverter 418 to sort cells (Schultze; [0071] see a signal provided by computing device 3 according to which cell is selectively sorted into one of plural output channels). Therefore, when the cell matches the characteristics of the healthy cell in the reference data, the cell will be sorted to the well/chamber 414 (connected to the second outlet). Otherwise, the cells are sorted into the sterile collection bag 416 (Durack; [0054] see cells collected may be stored and preserved for later viewing, imaging or testing).
Please note that the limitation “wherein the fluid filtration device is adapted to (a) direct the biological fluid through the first outlet when the control unit identifies the presence of a tumor cell or a pathogen when the one or more characteristics of the healthy cell are not recognized in the scanned data” is not required due to recitation of “or”.
Additionally, the limitation “wherein the fluid filtration device is adapted to (a) direct the biological fluid through the first outlet when the control unit identifies the presence of a tumor cell or a pathogen when the one or more characteristics of the healthy cell are not recognized in the scanned data or (b) direct the biological fluid through the second outlet if the control unit recognizes the one or more characteristics of the healthy cell in the scanned data;” 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 Durack and the apparatus of modified Durack is capable of directing the biological fluid through the second outlet if the control unit recognizes the one or more characteristics of the healthy cell in the scanned data. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
If it is determined that the port of Durack is not capable of being fluidly connected to a patient, Durack does not teach:
wherein the inlet of the housing is adapted to be fluidly connected to a patient to receive a biological fluid from the patient;
a return channel fluidly connected to the outlet of the housing, wherein the return channel is adapted to be fluidly connected to the patient, and wherein the return channel is adapted to return the biological fluid to the patient if the fluid filtration device determines that the biological fluid does not include the tumor cell or pathogen; and
In the analogous art of separating particles in a biofluid, Fiering teaches a system for microfluidic particle separation that is connectable to intraluminal lines that extract biofluid from a donor and deliver an output suspension to a recipient (Fiering; abstract, [0012], [0017]).
Specifically, Fiering teaches where biofluid is collected from a donor subject through an intraluminal line, where the intraluminal line may be connectable to a body cavity, tubular structure, or organ in the body and the line includes catheters (Fiering; [0052]). [0094] of Fiering describes where the system may be configured to separate target particles from non-target particles in a biofluid. [0120] of Fiering describes where intraluminal line extracts biofluid from a donor to deliver it to the source of the biofluid for processing, where the system is also connected to an intraluminal line that delivers output suspension to the recipient subject may be the same as the donor subject.
Durack is silent with regards to specific cell supply and how the port is connected to the cell supply, therefore, it would have been necessary and thus obvious to look to the prior art for conventional cell sources and means for connection. Fiering provides this conventional teaching showing that it is known in the art for a system that separates target particles from non-target particles to be connected to a donor subject via an intraluminal line. Therefore, it would have been obvious to one having ordinary skill in the art to connect the port that introduces cells from an external cell supply with an intraluminal line because it is taught by Fiering that an intraluminal line is effective to connect a donor to a system that separates target particles from non-target particles.
Because sample is being drawn directly from a donor subject, this will make Durack an extracorporeal process. Therefore it would have been obvious to one skilled in the art to modify the well/chamber of Durack such that it has an intraluminal line that returns fluid as taught by Fiering because Fiering teaches that the intraluminal line can deliver either a target particle enriched fluid or target particle depleted fluid to the recipient subject (Fiering; [0120]). As evidenced by Olde, in extracorporeal blood flow circuits blood is taken from the systemic blood circuit of a patient to have a process applied to it and it is then returned to the patient (Olde; [0151]).
Please see [0055] of Durack that describes where the chamber/well 414 may have an output port that isn’t shown that allows for withdrawing of its contents, where the intraluminal line of Fiering will be attached to this output port.
Regarding claim 2, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Durack further teaches wherein the fluid filtration device (418) includes a valve, wherein the valve is comprised of an inlet, a first outlet, and a second outlet, wherein the inlet of the valve is fluidly connected to the inlet of the fluid filtration device (418), wherein the first outlet of the valve is fluidly connected to the first outlet of the fluid filtration device (418), and wherein the second outlet of the valve is fluidly connected to the second outlet of the fluid filtration device (418) (Durack; the flow diverter is understood to be a valve, [0056] see flow diverter 218 is a piezoelectric device that is actuated with an electric command signal to mechanically divert flow into either well 214 or bag 216).
Regarding claim 4, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 2. Durack has been modified by Schultze so the analysis section 412 includes the devices for performing Raman spectroscopy and DHMI as well as the computing unit. It is understood that the computing unit 3 of Schultze will be connected to the flow diverter 418 of Durack to sort the cells, please see claim 1 supra for further explanation.
Regarding claim 6, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Durack further teaches wherein the fluid filtration device (418) includes an anti-coagulant insert (input port 413), wherein the anti-coagulant insert (413) is configured to apply an anti-coagulant to the biological fluid within the fluid filtration device (418) (Durack; [0054], Figure 4).
It is noted that the limitation of “the anti-coagulant insert is configured to apply an anti-coagulant to the biological fluid within the fluid filtration device.” 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 Durack and the input port 413 of Durack is capable of applying an anti-coagulant to the flow diverter. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
[0054] of Durack describes where the input port 413 introduces a supply of sheath fluid, where therefore the input port 413 is understood to be capable of applying an anti-coagulant to the biological fluid within the flow diverter 418 (fluid filtration device).
Further, please note that the anti-coagulant has not been positively recited and is therefore not a part of the claimed system.
Regarding claim 9, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Durack further teaches wherein the fluid filtration device (418) includes a buffer fluid insert (input port 413), wherein the buffer fluid insert (413) is adapted to apply a buffer fluid to the biological fluid within the fluid filtration device (418) (Durack; [0054], Figure 4).
It is noted that the limitation of “wherein the buffer fluid insert is adapted to apply a buffer fluid to the biological fluid within the fluid filtration device.” 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 Durack and the input port 413 of Durack is capable of applying a buffer fluid to the flow diverter. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
[0054] of Durack describes where the input port 413 introduces a supply of sheath fluid, where therefore the input port 413 is understood to be capable of applying a buffer fluid to the biological fluid within the flow diverter 418 (fluid filtration device).
Further, please note that the buffer fluid has not been positively recited in the claim and is therefore not a part of the claimed system.
Regarding claim 16, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Durack has been modified by Fiering such that it is now an extracorporeal process. Durack does not teach further comprising a drug infuser device fluidly connected between the second outlet of the fluid filtration device and the outlet of the housing.
In the analogous art of separating particles in a biofluid, Fiering teaches a system for microfluidic particle separation and where fluid may be post-treated before being delivered back to the subject (Fiering; abstract, [0012], [0007]).
Specifically, Fiering teaches where post-treating a fluid includes a process such as washing, separating, concentrating, diluting, heating, purifying, or filtering capable of removing toxins, contaminants, or harmful chemical compounds from the fluid, in addition to viral transduction, gene transfer, or gene editing of the target particles to produce a therapeutic, physiologically acceptable fluid for delivery to the recipient subject (Fiering; [0083], [0084]). Further, [0118] of Fiering describes where the system comprises a post-treatment chamber that may be configured to post-treat output suspension.
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes the post-treatment chamber as taught by Fiering because Fiering teaches that post-treating the fluid produces a physiologically acceptable fluid that may be directly delivered to a recipient subject (Fiering; [0083]).
It is understood that the post-treatment chamber of Fiering would occur after the cells have been sorted by the flow diverter 418 of Durack, and will thus be between the second outlet of the flow diverter 418 (fluid filtration device) and the well/chamber 414 (outlet of the substrate 402).
Regarding claim 17, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Fiering further teaches wherein the return channel is comprised of a catheter (Fiering; [0052]).
Regarding claim 19, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1.
The limitations of claim 19 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 modified Durack and the apparatus of modified Durack is capable of being worn on a body of the patient. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
As Figure 4 of Durack is showing a microfluidic device 400, it is understood that a microfluidic device would be capable of being worn on a body of a patient.
Regarding claim 21, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Schultze further teaches wherein the scanner comprises a digital holographic microscope (please see claim 1 supra).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1), Schultze (US-2013/0171685-A1), and Fiering (US-2018/0313816-A1), and in further view of Tirapu Azpiroz (US-2016/0231274-A1) herein Tirapu.
Regarding claim 7, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. While Durack does teach a flow diverter 418 on the substrate 402 that is actuated with an electric command signal to divert flow through the sorting channel 411, Durack does not teach how the flow diverter is powered (Durack; [0055], [0056]).
In the analogous art of particle manipulation devices, Tirapu teaches a monolithic device (Tirapu; [0002], [0083]).
Specifically, Tirapu teaches where a device 600 includes a chip 610 with microfluidic channel 630, biasing structures 620, and detection sensor 622, where the device 600 further includes a microcontroller and memory 658, display unit 660, and battery 652 to power device 600 (Tirapu; [0082], [0083], Figure 7). As described by [0036] of Tirapu in reference to Figure 1, the biasing structures 44 can be antennae 20 and 22 that are controlled by a voltage and antenna feed control circuit 28 that affect particles traveling through the microchannel 30 in different ways. The biasing includes changing direction imparted to particles to separate, distinguish, or alter the motion of the particles (Tirapu; [0035]).
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes a battery as taught by Tirapu because Tirapu teaches that the battery is effective for powering components of the device, which includes biasing structures (Durack; [0082], [0083]).
Regarding claim 8, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. The analysis section of Durack has been modified by Schultze so that it includes the devices for performing Raman spectroscopy and DHMI as well as the computing device. While the computing device 3 of Schultze outputs information on the object to display device 5 (Schultze; [0058], Figure 1), it is unclear if the computing device with display device will be on the substrate 402 (housing) of Durack.
In the analogous art of particle manipulation devices, Tirapu teaches a monolithic device (Tirapu; [0002], [0083]).
Specifically, Tirapu teaches where a device 600 includes a chip 610 with microfluidic channel 630, biasing structures 620, and detection sensor 622, where the device 600 further includes a microcontroller and memory 658, display unit 660, and battery 652 to power device 600 (Tirapu; [0082], [0083], Figure 7). In an alternative embodiment seen in Figure 6, Tirapu teaches a device 500 that includes a chip 510 with microfluidic channel 530, biasing structures 520, and detection sensor 522 where there is a reader device 550 that connects via electrical contact portion 524 (Tirapu; [0078], [0079]). The reader device 550 may include a computer with a processor or microcontroller and a display interface 560 (Tirapu; [0080], [0081], Figure 6).
It would have been obvious to one skilled in the art to modify the computing device, which includes the display device, of Schultze such that it is monolithic with the substrate of Durack because it is taught by Tirapu that it is effective to have a chip with a microfluidic channel, biasing structures, and detection sensor, as well as a microcontroller and display, for biasing movement of particles within the microchannel (Tirapu; [0009], [0082], [0083]).
Examiner further finds that the prior art contained a device/method/product (i.e., a computing device with display device) which differed from the claimed device by the substitution of component(s) (i.e., the computing device with display device being separate from the substrate) with other component(s) (i.e., the computing device with display device being formed monolithically with a chip), 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., having the computing device and display device be monolithic with the substrate rather than separate components), and the results of the substitution (i.e., control of the components and display of results) 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 placement of the computing device and display device such that instead of being separate from the substrate as taught by modified Durack they will be monolithic with the substrate as taught by Tirapu, since the result would have been predictable.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1), Schultze (US-2013/0171685-A1), and Fiering (US-2018/0313816-A1), and in further view of Hiruma (US-2009/0198168-A1).
Regarding claim 10, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1. Durack does not teach wherein the housing includes a presorting device fluidly connected between the inlet of the housing and the inlet of the fluid filtration device.
In the analogous art of cell sorting apparatuses, Hiruma teaches a cell sorting apparatus that sorts a specific type of cell from cells in a blood sample from a subject that includes a pre-sorting section (Hiruma; [0001], [0018], [0020]).
Specifically, Hiruma teaches where a cell sorting system includes an extracorporeal circulation system 10, a cell measuring section 20, a cell separating section 30, an image acquiring section 40, and a cell treating section 50 (Hiruma; [0018], Figure 1). [0020] describes where a pre-sorting section 13 classifies cells to be measured into a group containing erythrocytes and a group containing leukocytes, where [0021] of Hiruma describes where the method for pre-sorting cells can include centrifugal separation.
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes a connection that would allow sample to be centrifuged as taught by Hiruma because Hiruma teaches that pre-sorting is an effective and desirable step to separate out a specific cell type, in particular a cancer cell that gets sorted with the leukocytes (Hiruma; [0020]).
It is understood that there will be a connection that will allow sample to travel to the centrifuge of Hiruma after port 410 seen in Figure 4 of Durack, where after centrifuging sample will be returned such that the sample can be analyzed in analysis section 412.
Regarding claim 11, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 10. Hiruma further teaches wherein the presorting device is comprised of a centrifuge, please see claim 10 supra.
Claim(s) 10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1), Schultze (US-2013/0171685-A1), and Fiering (US-2018/0313816-A1), and in further view of Padmanabhan (US-2005/0255001-A1), Hiruma (US-2009/0198168-A1), and as evidenced by Carver (US-5316725-A).
Regarding claims 10 and 12, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1.
Durack does not teach:
wherein the housing includes a presorting device fluidly connected between the inlet of the housing and the inlet of the fluid filtration device.
Nor wherein the presorting device is adapted to apply a chemical agent to the biological fluid.
In the analogous art of fluidic cartridges that include one or more flow cytometry channels, Padmanabhan teaches a fluidic cartridge that includes one or more reagents including a lysing reagent (Padmanabhan; [0013]).
Specifically, Padmanabhan teaches a cartridge 14 where to count and classify white blood cells, a portion of the whole blood sample is partitioned to provide a white blood measurement in the channel in the cartridge 14 (Padmanabhan; [0042], Figures 1-2). The blood sample may also be diluted and lysed on the fly that results in sample being hydrodynamically focused for core formation and provided to a second cytometry channel (Padmanabhan; [0042]). It is seen in Figure 2 of Padmanabhan that the cartridge 14 has a sample collector port/lancet 32, where there are a number of reagents 49 that are then focused for core formation in one or more on board cytometry channels 50 (Padmanabhan; [0047], [0048]). Further, in Figure 3 of Padmanabhan a lyse reservoir 64 is depicted (Padmanabhan; [0052]).
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes a lysing reagent in a reservoir as taught by Padmanabhan because it is taught by Hiruma that in a cell sorting system for cancer cells, it is effective for there to be a pre-sorting section that separates cells into erythrocytes and leukocytes because the cancer cells are sorted into the group containing leukocytes (Hiruma; [0020]).
It is evidenced by Carver that a lysing reagent stromatolyzes and therefore eliminates a red blood cell population in whole blood, where it simultaneously modifies the cell membranes of white cell subpopulations so that the cytoplasm leeches out to cause differential shrinkage of the different cell types and enabling discrimination and sorting (Carver; column 1 lines 52-60).
It is understood that the lysing reagent of Padmanabhan will be introduced after the input port 414 and before the analysis section 412 of Durack seen in Figure 4.
The limitation “the presorting device is adapted to apply a chemical agent to the biological 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 Durack and the apparatus of modified Durack is capable of applying a chemical agent to the biological fluid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
Further, please note that the biological fluid nor the chemical agent have been positively recited, and are therefore not a part of the claimed system.
Regarding claim 13, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 12.
The chemical agent has not been positively recited in the claim, and is therefore not a part of the claimed system. Therefore the limitation “wherein the chemical agent is comprised of a red blood cell lysis buffer.” is considered to be met.
However, please note that Padmanabhan further teaches wherein the chemical agent is comprised of a red blood cell lysis buffer, please see claim 12 supra.
Claim(s) 10, 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1), Schultze (US-2013/0171685-A1), and Fiering (US-2018/0313816-A1), and in further view of Applegate (WO-2013/085797-A1) and Hiruma (US-2009/0198168-A1).
Regarding claims 10 and 14, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 1.
Durack does not teach:
wherein the housing includes a presorting device fluidly connected between the inlet of the housing and the inlet of the fluid filtration device.
Nor wherein the presorting device is comprised of a microfluidic separation device.
In the same problem solving area of separating cells or particles from a lysed solution, Applegate teaches a chip that receives stained cells that includes an inertial microfluidic microchannel passageway (Applegate; page 5 paragraphs 1-2, page 8 paragraph 1).
Specifically, Applegate teaches where a chip 20 has a passageway 80 and linear inlet passageway 80’ into which stained and lysed blood sample and clean buffer are pumped (Applegate; page 10 paragraph 3, Figure 7). It is further described by page 11 paragraph 1 of Applegate that at the outlet passageway after inertial microfluidic focusing and separation has been achieved, the washed cell stream containing only stained white cells or particles flow along the center channel of exit passageway 86, and the red-blood remnants and reagents flow along the wall surfaces in the outside microchannels for disposal.
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes an inertial microfluidic passageway as taught by Applegate because it is taught by Applegate that the chip takes less time than a conventional centrifuge to separate the components (Applegate; page 11 paragraph 1).
However, it is not taught by Durack or Applegate where the inertial microfluidic passageway would be placed in relation to the order of operations of the substrate of Durack.
In the analogous art of cell sorting apparatuses, Hiruma teaches a cell sorting apparatus that sorts a specific type of cell from cells in a blood sample from a subject that includes a pre-sorting section (Hiruma; [0001], [0018], [0020]).
Specifically, Hiruma teaches where a cell sorting system includes an extracorporeal circulation system 10, a cell measuring section 20, a cell separating section 30, an image acquiring section 40, and a cell treating section 50 (Hiruma; [0018], Figure 1). [0020] describes where a pre-sorting section 13 classifies cells to be measured into a group containing erythrocytes and a group containing leukocytes.
It would have been obvious to one skilled in the art to modify the substrate of Durack such the microfluidic passageway of Applegate is before the analysis section, because it is taught by Hiruma that it is desirable and effective to pre-sort blood into groups containing either erythrocytes or leukocytes, where a cell of interest (cancer cell) is sorted into the group of leukocytes for subsequent separating and imaging (Hiruma; [0022], Figure 1).
Regarding claim 15, modified Durack teaches the aphaeretic portable biological fluid filtration system of claim 14.
The limitation “wherein the microfluidic separation device is adapted to apply inertial focusing to the biological 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 Durack and the apparatus of modified Durack is capable of applying inertial focusing. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
Further, the biological fluid has not been positively recited, and is therefore not a part of the claimed system.
However, please note that Applegate further teaches wherein the microfluidic separation device is adapted to apply inertial focusing to the biological fluid, please see claim 14 supra.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1) in view of Fiering (US-2018/0313816-A1), as evidenced by Olde (US-2014/0231319-A1), Hiruma (US-2009/0198168-A1), Schultze (US-2013/0171685-A1), and Tirapu Azpiroz (US-2016/0231274-A1) herein Tirapu.
Regarding claim 20, Durack teaches an aphaeretic portable biological fluid filtration system, comprising:
a housing (substrate 402) including an inlet (port 410) and an outlet (well/chamber 414), wherein the inlet (410) of the housing (402) is adapted to be fluidly connected to a patient to receive a biological fluid from the patient, wherein the housing (402) is adapted to be worn on a body of the patient ([0054] see cells from an external cell supply are introduced into the microfluidic device via port 410, Figure 4),
a fluid filtration device (flow diverter 418) including an inlet, a first outlet, and a second outlet, wherein the inlet of the fluid filtration device (418) is fluidly connected to the inlet (410) of the housing (402), wherein the fluid filtration device (418) is adapted to receive the biological fluid, wherein the second outlet of the fluid filtration device (418) is fluidly connected to the outlet (414) of the housing (402), and wherein the fluid filtration device (418) includes a buffer fluid insert (input port 413), wherein the buffer fluid insert (413) is adapted to apply a buffer fluid to the biological fluid within the fluid filtration device (418) ([0054], [0056], Figure 4 where flow diverter 418 is connected to flow channel 411 and will therefore have an inlet. The outlets of the flow diverter 418 lead to the two branching channels seen in Figure 4, where a first outlet will lead to the channel that goes to the sterile collection bag and a second outlet will lead to the channel that goes to the well/chamber 414);
a cartridge (sterile collection bag 416) removably attached to the housing (402), wherein the cartridge (416) is fluidly connected to the first outlet of the fluid filtration device (418), wherein the cartridge (416) is adapted to receive the biological fluid if the fluid filtration device (418) determines that the biological fluid includes the tumor cell or pathogen ([0055]);
It is noted that the limitations regarding the inlet of the housing being adapted to be fluidly connected to a patient, the housing being adapted to be worn on a body of the patient, and a buffer fluid insert adapted to apply a buffer fluid to the biological fluid within the fluid filtration device 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 Durack and the apparatus of Durack is capable of being fluidly connected to a patient, worn on the body of the patient, and applying a buffer fluid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
As Figure 4 of Durack is showing a microfluidic device 400, it is understood that a microfluidic device would be capable of being worn on a body of a patient. [0054] of Durack describes where the input port 413 introduces a supply of sheath fluid, where therefore the input port 413 is understood to be capable of applying a buffer fluid to the biological fluid within the flow diverter 418 (fluid filtration device).
If it is determined that the input port of Durack is not capable of being fluidly connected to a patient, Durack does not teach:
wherein the inlet of the housing is adapted to be fluidly connected to a patient to receive a biological fluid from the patient;
a return channel fluidly connected to the outlet of the housing, wherein the return channel is adapted to be fluidly connected to the patient, and wherein the return channel is adapted to return the biological fluid to the patient if the fluid filtration device determines that the biological fluid does not include the tumor cell or pathogen; and
a drug infuser device fluidly connected between the second outlet of the fluid filtration device and the outlet of the housing;
In the analogous art of separating particles in a biofluid, Fiering teaches a system for microfluidic particle separation that is connectable to intraluminal lines that extract biofluid from a donor and deliver an output suspension to a recipient (Fiering; abstract, [0012], [0017]).
Specifically, Fiering teaches where biofluid is collected from a donor subject through an intraluminal line, where the intraluminal line may be connectable to a body cavity, tubular structure, or organ in the body and the line includes catheters (Fiering; [0052]). [0094] of Fiering describes where the system may be configured to separate target particles from non-target particles in a biofluid. [0120] of Fiering describes where intraluminal line extracts biofluid from a donor to deliver it to the source of the biofluid for processing, where the system is also connected to an intraluminal line that delivers output suspension to the recipient subject may be the same as the donor subject. Further, Fiering teaches where post-treating a fluid includes a process such as washing, separating, concentrating, diluting, heating, purifying, or filtering capable of removing toxins, contaminants, or harmful chemical compounds from the fluid, in addition to viral transduction, gene transfer, or gene editing of the target particles to produce a therapeutic, physiologically acceptable fluid for delivery to the recipient subject (Fiering; [0083], [0084]). Further, [0118] of Fiering describes where the system comprises a post-treatment chamber that may be configured to post-treat output suspension.
Durack is silent with regards to specific cell supply and how the port is connected to the cell supply, therefore, it would have been necessary and thus obvious to look to the prior art for conventional cell sources and means for connection. Fiering provides this conventional teaching showing that it is known in the art for a system that separates target particles from non-target particles to be connected to a donor subject via an intraluminal line. Therefore, it would have been obvious to one having ordinary skill in the art to connect the port that introduces cells from an external cell supply with an intraluminal line because it is taught by Fiering that an intraluminal line is known in the art to connect a donor to a system that separates target particles from non-target particles.
Because sample is being drawn directly from a donor subject, this will make Durack an extracorporeal process. Therefore it would have been obvious to one skilled in the art to modify the well/chamber of Durack such that it has an intraluminal line that returns fluid and such that the substrate of Durack includes the post-treatment chamber as taught by Fiering because Fiering teaches that the intraluminal line can deliver either a target particle enriched fluid or target particle depleted fluid to the recipient subject and because post-treating fluid produces a physiologically acceptable fluid that may be directly delivered to a recipient subject (Fiering; [0083], [0120]). As evidenced by Olde, in extracorporeal blood flow circuits blood is taken from the systemic blood circuit of a patient to have a process applied to it and it is then returned to the patient (Olde; [0151]).
Please see [0055] of Durack that describes where the chamber/well 414 may have an output port that isn’t shown that allows for withdrawing of its contents, where the intraluminal line of Fiering will be attached to this output port.
Durack does not teach a presorting device fluidly connected between the inlet of the housing and the inlet of the fluid filtration device, wherein the presorting device is adapted to remove a first constituent from the biological fluid;
In the analogous art of cell sorting apparatuses, Hiruma teaches a cell sorting apparatus that sorts a specific type of cell from cells in a blood sample from a subject that includes a pre-sorting section (Hiruma; [0001], [0018], [0020]).
Specifically, Hiruma teaches where a cell sorting system includes an extracorporeal circulation system 10, a cell measuring section 20, a cell separating section 30, an image acquiring section 40, and a cell treating section 50 (Hiruma; [0018], Figure 1). [0020] describes where a pre-sorting section 13 classifies cells to be measured into a group containing erythrocytes and a group containing leukocytes, where [0021] of Hiruma describes where the method for pre-sorting cells can include centrifugal separation.
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes a connection that would allow sample to be centrifuged as taught by Hiruma because Hiruma teaches that pre-sorting is an effective and desirable step to separate out a specific cell type, in particular a cancer cell that gets sorted with the leukocytes (Hiruma; [0020]).
It is understood that there will be a connection that will allow sample to travel to the centrifuge of Hiruma after port 410 seen in Figure 4 of Durack, where after centrifuging sample will be returned such that the sample can be analyzed in analysis section 412.
While Durack does teach an analysis section 412 ([0054]) Durack is not specific as to the components that make up the analysis section.
In the analogous art of characterizing biological objects and sorting, Schutze teaches where a stimulus applied to a biological object and measuring the response is done using Raman scattering and digital holographic microinterferometry (DHMI, also known as digital holographic microscopy) (Schutze; abstract, [0011]).
Specifically, Schultze teaches a system comprising an apparatus 2 for characterizing biological objects and a computing device 3 coupled to the apparatus 2 (Schultze; [0058], Figure 1). The apparatus 2 performs Raman spectroscopy and DHMI on a biological object to quantitatively determine its response to a stimulus, where the computing device 3 has a data base 4 that has information regarding the behavior of different biological objects for various types of cells such as healthy cells or tumor cells (Schultze; [0058], Figure 1). The apparatus 2 has a microfluidic system 11 that has a fluid channel 13 where cells 8, 9 are positioned in the channel 13 (Schultze; [0059], Figure 1). [0071] of Schultze further describes where a signal is provided by the computing device 3 according to which cell 8, 9 is selectively sorted into one of plural output channels 14, 15. [0046] describes where the characteristics of Raman spectroscopy and DHMI allow the characterization of biological objects to be automated to a large degree, where in particular the spectra obtained by Raman spectroscopy and information on shape, volume and/or refractive index obtained from DHMI can be compared with a data base to automatically sort cells where in this manner healthy cells may be discriminated from tumor cells and are directed to different collection vessels. [0063] describes a device 22 for performing Raman spectroscopy and device 24a, 24b, 24c for performing DHMI.
Durack is silent with regards to specific components of an analysis section, therefore, it would have been necessary and thus obvious to look to the prior art for conventional analysis sections. Schultze provides this conventional teaching showing that it is known in the art to use Raman spectroscopy and DHMI with a computing device to sort cells. Therefore, it would have been obvious to one having ordinary skill in the art to have the analysis section include the devices for performing Raman spectroscopy and DHMI and the computing device because it is taught by Schultze that these two components are effective for discriminating healthy cells from tumor cells.
From [0058] of Schultze, the data base 4 of computing device 3 will comprise one or more characteristics of a healthy cell. [0055] of Durack describes where flow diverter 418 physically diverts cells into chamber 414 or sterile collection bag 416 from the analysis section, where [0056] describes where the flow diverter is a piezoelectric device that can be actuated with an electrical signal. The computing device 3 of Schultze will be connected to the flow diverter 418 to sort cells (Schultze; [0071] see a signal provided by computing device 3 according to which cell is selectively sorted into one of plural output channels). Therefore, cells will be sorted depending on if the fluid filtration device determines that a tumor cell or pathogen are present.
Please note that only one of either (a) and (b) is required due to recitation of “or”.
The limitation “wherein the fluid filtration device is adapted to (a) direct the biological fluid through the first outlet if the fluid filtration device determines that the biological fluid includes a tumor cell or pathogen or (b) direct the biological fluid through the second outlet if the fluid filtration device determines that the biological fluid does not include the tumor cell or pathogen;” 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 Durack and the apparatus of modified Durack is capable of directing the biological fluid depending on if the tumor cell or pathogen are present. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
While Durack does teach a flow diverter 418 on the substrate 402 that is actuated with an electric command signal to divert flow through the sorting channel 411, Durack does not teach how the flow diverter is powered (Durack; [0055], [0056]). Additionally, the analysis section of Durack has been modified by Schultze so that it includes the devices for performing Raman spectroscopy and DHMI as well as the computing device. While the computing device 3 of Schultze outputs information on the object to display device 5 (Schultze; [0058], Figure 1), it is unclear if the computing device with display device will be on the substrate 402 (housing) of Durack.
In the analogous art of particle manipulation devices, Tirapu teaches a monolithic device (Tirapu; [0002], [0083]).
Specifically, Tirapu teaches where a device 600 includes a chip 610 with microfluidic channel 630, biasing structures 620, and detection sensor 622, where the device 600 further includes a microcontroller and memory 658, display unit 660, and battery 652 to power device 600 (Tirapu; [0082], [0083], Figure 7). As described by [0036] of Tirapu in reference to Figure 1, the biasing structures 44 can be antennae 20 and 22 that are controlled by a voltage and antenna feed control circuit 28 that affect particles traveling through the microchannel 30 in different ways. The biasing includes changing direction imparted to particles to separate, distinguish, or alter the motion of the particles (Tirapu; [0035]). In an alternative embodiment seen in Figure 6, Tirapu teaches a device 500 that includes a chip 510 with microfluidic channel 530, biasing structures 520, and detection sensor 522 where there is a reader device 550 that connects via electrical contact portion 524 (Tirapu; [0078], [0079]). The reader device 550 may include a computer with a processor or microcontroller and a display interface 560 (Tirapu; [0080], [0081], Figure 6).
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes a battery as taught by Tirapu because Tirapu teaches that the battery is effective for powering components of the device, which includes biasing structures (Durack; [0082], [0083]). Additionally, it would have been obvious to one skilled in the art to modify the computing device, which includes the display device, of Schultze such that it is monolithic with the substrate of Durack because it is taught by Tirapu that it is effective to have a chip with a microfluidic channel, biasing structures, and detection sensor, as well as a microcontroller and display, for biasing movement of particles within the microchannel (Tirapu; [0009], [0082], [0083]).
Examiner further finds that the prior art contained a device/method/product (i.e., a computing device with display device) which differed from the claimed device by the substitution of component(s) (i.e., the computing device with display device being separate from the substrate) with other component(s) (i.e., the computing device with display device being formed monolithically with a chip), 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., having the computing device and display device be monolithic with the substrate rather than separate components), and the results of the substitution (i.e., control of the components and display of results) 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 placement of the computing device and display device such that instead of being separate from the substrate as taught by modified Durack they will be monolithic with the substrate as taught by Tirapu, since the result would have been predictable.
Response to Arguments
Applicant’s arguments, see page 10 of 21, filed 10/07/2025, with respect to the rejection(s) of claim(s) 1-2, 4-6, 9, 16-17, 19, and 21 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Durack (US-2011/0003325-A1) in view of Schultze (US-2013/0171685-A1), Fiering (US-2018/0313816-A1), and as evidenced by Olde (US-2014/0231319-A1) for claim 1, and Durack (US-2011/0003325-A1), Fiering (US-2018/0313816-A1), as evidenced by Olde (US-2014/0231319-A1), Hiruma (US-2009/0198168-A1), Schultze (US-2013/0171685-A1), and Tirapu Azpiroz (US-2016/0231274-A1) for claim 21.
Please note that the references cited above, minus Olde, were previously used in the Office Action mailed 10/07/2025 where the rejections have been modified to address applicant amendments to the claims.
No Motivation to Combine Due to Different Modes of Operation argument on page 8 of 21, where applicant argues that it is imperative to Durack’s methods that the cells are maintained in a natural morphological state (citing to Durack; [0059], [0095], [0063], and [0079]), and that Schutze specifically alters the morphology of cells to visualize 2D and 3D changes in the cells.
Examiner respectfully disagrees. Firstly, [0059], [0095], [0063], and [0079] of Durack are directed to the sterile collection bag that contains the necessary nutrients, reagents, and/or other chemical to maintain the cells in a healthy, viable state and keep them alive and functional which occurs after sorting, it is not stating that it is imperative for the overall method of Durack to maintain the cells in a natural morphological state. From [0063] and [0079] specifically, “In such a way, the cells’ morphology remains substantially in the same state as when they were sorted. This procedure maintains the integrity of the sorted and isolated cells, substantially preventing the cells from breaking down and thus preventing the morphological characteristic(s) of the cells which may have dictated their sorting.”, from this cells could have their morphology altered during sorting and the reagents in the sterile collection bag would maintain them in whatever state the sorting leaves them in.
Additionally, [0022] of Schutze describes that with the invention it allows “a contactless and marker-free characterization of a biological objection is possible which does not destroy the biological object.” and [0069] recites “A minimally invasive dynamic detection of deformations and movements of living cells in three dimensions is also possible…” and [0076] recites “The stimulus may also be applied over a longer time period to induce a longer lasting deformation of the object”
From these sections of Schutze, it is understood that the deformation is not permanent and does not destroy the cell being measured. However, even if the deformation is permanent, it is understood that Durack would maintain the morphology of the cells in that state and would still be maintaining cells in that state.
No Motivation to Arrive at a System with Inlets and Return Channels Adapted to be Fluidly Connected to a Patient argument on page 10 of 21, where applicant argues the assertion that Durack is capable of having the port connected to a patient and that it this is insufficient to establish obviousness because it does not imply a motivation to pick out two references and combine them.
Please see page 5 of the Office Action, where “the housing adapted to be fluidly connected to a patient” is directed to the function of the apparatus and/or the manner of operating the apparatus, where the structural limitations of the claim have been met by Durack.
Additionally, please note that the intraluminal line of Fiering is being connected to the chamber/reservoir 414 of Durack (which is described to have an output port for withdrawing its contents (Durack; [0055]), the intraluminal line is not being connected to the sterile collection bag 416.
The Cited References Do Not Teach or Suggest All Elements of the Claims argument on page 12 of 21.
Applicant argues that Schutze identifies cells by correlating a pre-stored database of cells to the cell being investigated, whereas the instant system does not match a tumor cell to a tumor cell because there is a great deal of heterogenicity in tumor cells. Please note that the instant claims currently do not restrict there being other kinds of reference data present. Secondly, in both claim 1 and 21 only one of (a) and (b) is required to be met due to the use of “or”.
Additionally, it is noted that the features upon which applicant relies (i.e., the system identifies tumor cells or pathogens by identifying a mis-match with healthy cell reference data) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims 4, 5, 6, 9, 16, 17, 19, and 21 argument on page 13 of 21.
Applicant argues that for claim 6, an anticoagulation insert is a structure that is not present in the cited art.
Examiner does agree that an anticoagulation insert is a structure, however there is no additional structure provided for such an anticoagulation insert. Further, it is the limitation “wherein the anti-coagulation insert is configured to apply an anti-coagulant to the biological fluid within the fluid filtration device.” that is the function of such a structure, where the described function does not provide additional structure to the anticoagulation insert. Therefore, the input port 413 of Durack meets the limitation of an anticoagulation insert as it is capable of having an anticoagulant applied.
Applicant agues for claim 9 that a buffer fluid insert is a structure not present in the cited art. Similar to above, examiner does agree that a buffer fluid insert is a structure, however there is no additional structure provided for such a buffer fluid insert. And the limitation “wherein the buffer fluid insert is adapted to apply a buffer fluid to the biological fluid within the fluid filtration device.” is the function of such a structure, where the described function does not provide additional structure to the buffer fluid insert. Therefore, the input port 413 of Durack meets the limitation.
Durack, Schutze, and Fiering and in further view of Tirapu argument on page 14 of 21.
Applicant argues that the motivation to bring in Tirapu is not proper to establish a prima facie case of obviousness and that obviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Primary reference Durack does teach a flow diverter, but not how it is powered. Tirapu teaches a particle manipulation device that is powered by a battery. One skilled in the art would find it obvious that incorporating the battery of Tirapu would be reasonably successful in the device of Durack, as the battery similarly powers a biasing structure that affects particles moving through a microchannel.
Applicant argues for claim 8 that Figure 6 is clear that display interface element 560 is associated with a reader or smartphone, and not with the housing. Examiner respectfully notes that both Figure 6 and Figure 7 were referenced in the rejection, where both were referenced to show that Tirapu describes both where the chip and reader device are separate and monolithic. The monolithic embodiment being used to teach claim 8.
Durack, Schutze, Fiering, and in further view of Hiruma argument on page 15 of 21.
In response to applicant's argument that Hiruma teaches away from the instantly claimed device because Hiruma describes sorting a specific type of cell such as a cancer cell if a condition for a cancer cell is detected, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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, Hiruma teaches that it is desirable to pre-sort a fluid before it is more specifically sorted, and this provides the motivation to include the pre-sorter in the device of Durack which similarly sorts cells.
Further, the reference of Hiruma is being considered as a whole, where it is the specific teaching of the pre-sorter that is being brought into the device of Durack.
Durack and Fiering and in further view of Padmanabhan, Hiruma, as evidenced by Carver argument on page 16 of 21. Please see above arguments with regards to Hiruma.
Durack, Schutze, and Fiering and in further view of Applegate and Hiruma argument on page 17 of 21. Please see above arguments with regards to Hiruma.
Durack in view of Fiering, Schutze, Tirapu, and Hiruma argument on page 18 of 21. Please see above arguments.
Conclusion
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, Elizabeth Robinson can be reached at (571) 272-7129. 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
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796