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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2025 has been entered.
Response to Amendment
Applicant amendments filed 01/07/2025 have been entered.
Status of Claims
Claims 1-20 remain pending in the application.
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) 1-4, 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1) in view of Schutze (US-2013/0171685-A1).
Regarding claim 1, Durack teaches a portable biological fluid filtration system, comprising:
a housing (substrate 402) including an inlet (port 410), wherein the inlet (410) of the housing (402) is adapted to receive a biological fluid ([0054], Figure 4);
a fluid filtration device (flow diverter 418) fluidly connected to the inlet (410) of the housing (402), wherein the fluid filtration device (418) includes an inlet, a first outlet, and a second outlet, and wherein the fluid filtration device (418) is adapted to receive the biological fluid from the housing (402) ([0055], [0056], Figure 4); and
The flow diverter 418 (fluid filtration device) is disposed in flow channel 411, and will thus have an inlet. Further, in Figure 4 there are channels in a branch configuration that lead away from the flow diverter 418 that go to well/chamber 414 and sterile collection bag 416, thus the flow diverter 418 will have a first and second outlet.
a cartridge (sterile collection bag 416) removably connected to the housing (402), wherein the cartridge (416) is fluidly connected to the first outlet of the fluid filtration device (418), and wherein the cartridge (416) is adapted to receive the biological fluid including the undesirable constituent ([0054], [0055], [0057], [0058], Figure 4).
The limitation “the cartridge is adapted to receive the biological fluid including the undesirable constituent.” 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 apparatus of Durack is capable of receiving the biological fluid including the undesirable constituent. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
It is described by [0054] that cells within flow channel 411 are analyzed via cytometry in analysis section 412, where according to the results of the analysis performed the cells may be sorted into one or more different wells or chambers 414 and/or one or more different sterile collection bags 416.
However, Durack is not specific as to the specific operations that occur in analysis section 412.
In the analogous art of methods and apparatuses for characterizing biological objects, Schutze teaches the use of digital holographic microinterferometry (DHMI) to characterize biological objects, where DHMI is also known as digital holographic microscopy (Schutze; [0002], [0011]).
Specifically, Schutze teaches a system 1 for sorting biological objects that comprises an apparatus 2 for characterizing objects and a computing device 3 coupled to the apparatus 2 (Schutze; [0058], Figure 1). Further, the apparatus 2 performs DHMI on a biological object to quantitatively determine its response to a stimulus, where computing device 3 has a data base 4 which has information on the changes in shape or volume for various types of cells that includes healthy or tumor cells, and where the computing device may output a control command for sorting the biological object (Schutze; [0058]). [0071] of Schutze describes where a signal provided by the computing device 3 according to which the cell 8, 9 is selectively sorted into one of the plural output channels 14, 15 (Schutze; Figure 1).
It would have been obvious to one skilled in the art to modify the analysis section of Durack such that it evaluates cells using DHMI and has the computing device that includes information on healthy cells as taught by Schutze because Schutze teaches that DHMI is a contactless, marker-free process, where this prevents the destruction of the biological object (Schutze; [0021], [0022], [0069]).
The DHMI and computing device of Schutze will now be a part of the fluid filtration device of Durack where the analysis section 412 is, where the DHMI will generate scanned data, and the computing device will compare the scanned data to the data base that includes information on healthy cells, and then send instructions to the flow diverter 418 to sort cells.
Regarding claim 2, modified Durack teaches the portable biological fluid filtration system of claim 1. Durack further teaches wherein the housing (402) includes an outlet (well/chamber 414) fluidly connected to the second outlet of the fluid filtration device (418) (Durack; [0054], Figure 4).
Regarding claim 3, modified Durack teaches the portable biological fluid filtration system of claim 2.
Durack has been modified with Schutze such that the analysis section analyzes uses DHMI and that there is a computing device that provides signals to allow sorting of cells. As described by [0058] of Schutze the data base 4 can include information on changes in shape or changes in volume for various types of cells, healthy cells, where then depending on a comparison of acquired and processed data to a threshold value or a comparison of acquired data with data base 4, the computing device 3 may output a control command for sorting the biological object.
Regarding claim 4, modified Durack teaches the portable biological fluid filtration system of claim 2. Durack further teaches wherein the outlet (414) of the housing (402) is not fluidly connected to a source of the biological fluid (Durack; Figure 4).
It is seen in Figure 4 of Durack that the chamber/well 414 will not be fluidly connected to a source of biological fluid.
Regarding claim 7, modified Durack teaches the portable biological fluid filtration system of claim 1. Durack further teaches wherein the housing (402) includes a buffer fluid insert (input port 413), and 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 recitation that “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 apparatus of Durack is capable of applying a buffer fluid to the biological fluid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
The input port 413 of Durack supplies sheath fluid, where the input port 413 is understood to be capable of applying a buffer fluid to the biological fluid within the flow diverter 418.
Regarding claim 8, modified Durack teaches the portable biological fluid filtration system of claim 7. It is noted that the buffer fluid has not been positively recited, where the recitation that “wherein the buffer fluid is comprised of a red blood cell lysis buffer.” 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 apparatus of Durack is capable of receiving a red blood cell lysis buffer. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
Regarding claim 9, the limitation “wherein the fluid filtration device is adapted to apply an anti-coagulant 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 Durack and the apparatus of Durack is capable of applying an anti-coagulant to the biological fluid. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
It is understood that the input port 413 of Durack is capable of receiving an anti-coagulant that would be applied to the biological fluid as it reaches the flow diverter 418 where therefore the flow diverter 418 would apply the anti-coagulant to the biological fluid.
Further, it is noted that the anti-coagulant has not been positively recited, and is therefore not required.
Regarding claim 10, these limitations are directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by modified Durack and the apparatus of modified Durack is capable of working on blood. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2115).
Durack describes where the sample fluid is blood in [0102] in relation to an alternative embodiment seen in Figure 12, where it is understood the embodiment seen in Figure 4 will also be capable of receiving blood.
Regarding claim 11, modified Durack teaches the portable biological fluid filtration system of claim 1. The limitations of “wherein the undesirable constituent is comprised of a T-cell.” 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 sorting a T-cell. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
Durack has been modified with Schutze such that it now includes the computing device and data base, where the data base includes information on changes in the shape or volume for various cells, including healthy cells. As such, cells not determined to be healthy cells will be sorted out and are therefore undesirable. The device of modified Durack is capable of sorting out T-cells.
Regarding claim 12, modified Durack teaches the portable biological fluid filtration system of claim 1. The limitations of “wherein the undesirable constituent is comprised of a malignant cell.” 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 sorting a malignant cell. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
Durack has been modified with Schutze such that it now includes the computing device and data base, where the data base includes information on changes in the shape or volume for various cells, including healthy cells. As such, cells not determined to be healthy cells will be sorted out and are therefore undesirable. The device of modified Durack is capable of sorting out malignant cells.
Regarding claim 13, modified Durack teaches the portable biological fluid filtration system of claim 1. The limitations “wherein the undesirable constituent is comprised of a circulating tumor cell.” 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 sorting a circulating tumor cell. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
Durack has been modified with Schutze such that it now includes the computing device and data base, where the data base includes information on changes in the shape or volume for various cells, including healthy cells. As such, cells not determined to be healthy cells will be sorted out and are therefore undesirable. The device of modified Durack is capable of sorting out circulating tumor cells.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1) and Schutze (US-2013/0171685-A1) and in further view of Tirapu Azpiroz (US-2016/0231274-A1), herein Tirapu.
Regarding claim 5, modified Durack teaches the portable biological fluid filtration system of claim 1. While Durack does teach where the microfluidic device includes a flow diverter 218 (fluid filtration device) that can be a piezoelectric device, Durack does not teach how this piezoelectric device is powered.
In the analogous art of particle manipulation devices, Tirapu teaches a device that includes a substrate and a microchannel included in the substrate configured to receive a fluid including particles and a biasing structure formed on the substrate adjacent to but outside the microchannel (Tirapu; abstract).
Specifically, Tirapu teaches a device 10 that includes a substrate 12 upon which a microfluidic chamber or channel 30 is formed, where there are biasing structures 44 for producing radiating energy to bias particles in the channel 30 (Tirapu; [0034], Figures 1A-B). [0035] of Tirapu describes where the biasing elements are circuits, transducer elements, or other energy or radiation producing elements that change the movement of particles in the microchannel 30, where biasing can include speeding up, slowing down, changing direction, changing the energy, or any other change imparted to the particles to separate, distinguish, or otherwise alter the motion of the particles. [0036] of Tirapu describes where the biasing structures 44 are depicted as antennae 20 and 22 and are controlled by a voltage and antenna feed control circuit 28, where the circuit 28 is integrated on the substrate 12, and [0038] describes where the circuit 28 and structures 44 can be powered by a small battery.
Durack is silent with regards to specific ways of powering the flow diverter, therefore, it would have been necessary and thus obvious to look to the prior art for conventional ways of powering flow diverters. Tirapu provides this conventional teaching showing that it is known in the art to use a battery integrated in the substrate to power various components. Therefore, it would have been obvious to one having ordinary skill in the art to have battery integrated into the substrate to control the flow diverter because it is taught by Tirapu that it is effective to integrate a battery into a substrate in order to power elements that change the movement of particles in a solution.
Regarding claim 6, modified Durack teaches the portable biological fluid filtration system of claim 1. Durack does not teach wherein the housing includes at least one indicator configured to convey an operational status of the fluid filtration device.
In the analogous art of particle manipulation devices, Tirapu teaches a device that includes a substrate and a microchannel included in the substrate configured to receive a fluid including particles and a biasing structure formed on the substrate adjacent to but outside the microchannel (Tirapu; abstract).
Specifically, Tirapu teaches a device 600 that includes a chip 610 having a microfluidic channel 630, biasing structures 620, and detection sensor 622, where the biasing structures 620 are understood to be similar to the biasing structures described by [0035] of Tirapu. [0083] of Tirapu describes where the device 600 may be monolithic and include all elements in a single non-disposable chip, where this includes a display unit/interface 660 that shows results to a user in real-time.
It would have been obvious to one skilled in the art to modify the substrate of Durack such that it includes a display unit/interface 660 that is monolithic with the substrate as taught by Tirapu because Tirapu teaches that the display unit/interface shows results to a user in real-time (Tirapu; [0083]).
Claim(s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durack (US-2011/0003325-A1) in view of Schutze (US-2013/0171685-A1), Padmanabhan (US-2005/0255001-A1), Hiruma (US-2009/0198168-A1), and as evidenced by Carver (US-5316725-A).
Regarding claim 14, Durack teaches a portable biological fluid filtration system, comprising:
a housing (substrate 402) including an inlet (port 410), wherein the inlet (410) of the housing (402) is adapted to receive a biological fluid ([0054], Figure 4);
a fluid filtration device (flow diverter 418) 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 fluid filtration device includes a fluid receiving device, wherein the fluid filtration device includes an inlet, a first outlet, a second outlet ([0055], [0056], Figure 4);
The flow diverter 418 (fluid filtration device) is disposed in flow channel 411, and will thus have an inlet. Further, in Figure 4 there are channels in a branch configuration that lead away from the flow diverter 418 that go to well/chamber 414 and sterile collection bag 416, thus the flow diverter 418 will have a first and second outlet.
a cartridge (sterile collection bag 416) removably connected to the housing (402), wherein the cartridge (416) is fluidly connected to the first outlet of the fluid filtration device (418), and wherein the cartridge (416) is adapted to receive the biological fluid including the undesirable constituent ([0054], [0055], [0057], [0058], Figure 4).
The limitation “the cartridge is adapted to receive the biological fluid including the undesirable constituent.” 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 apparatus of Durack is capable of receiving the biological fluid including the undesirable constituent. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Durack (see MPEP §2114).
It is described by [0054] that cells within flow channel 411 are analyzed via cytometry in analysis section 412, where according to the results of the analysis performed the cells may be sorted into one or more different wells or chambers 414 and/or one or more different sterile collection bags 416.
However, Durack is not specific as to the specific operations that occur in analysis section 412.
In the analogous art of methods and apparatuses for characterizing biological objects, Schutze teaches the use of digital holographic microinterferometry (DHMI) to characterize biological objects, where DHMI is also known as digital holographic microscopy (Schutze; [0002], [0011]).
Specifically, Schutze teaches a system 1 for sorting biological objects that comprises an apparatus 2 for characterizing objects and a computing device 3 coupled to the apparatus 2 (Schutze; [0058], Figure 1). Further, the apparatus 2 performs DHMI on a biological object to quantitatively determine its response to a stimulus, where computing device 3 has a data base 4 which has information on the changes in shape or volume for various types of cells that includes healthy or tumor cells, and where the computing device may output a control command for sorting the biological object (Schutze; [0058]). [0071] of Schutze describes where a signal provided by the computing device 3 according to which the cell 8, 9 is selectively sorted into one of the plural output channels 14, 15 (Schutze; Figure 1).
It would have been obvious to one skilled in the art to modify the analysis section of Durack such that it evaluates cells using DHMI and has the computing device that includes information on healthy cells as taught by Schutze because Schutze teaches that DHMI is a contactless, marker-free process, where this prevents the destruction of the biological object (Schutze; [0021], [0022], [0069]).
The DHMI and computing device of Schutze will now be a part of the fluid filtration device of Durack where the analysis section 412 is, where the DHMI will generate scanned data, and the computing device will compare the scanned data to the data base that includes information on healthy cells, and then send instructions to the flow diverter 418 to sort cells.
Durack does not teach a presorting device fluidly connected to the inlet of the fluid filtration device, and wherein the presorting device is adapted to remove a first constituent from the biological fluid; and
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, there is 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.
Regarding claim 15, modified Durack teaches the portable biological fluid filtration system of claim 14. Padmanabhan further teaches wherein the presorting device is adapted to apply a chemical agent to the biological fluid to remove the first constituent from the biological fluid, see claim 14 supra.
Regarding claim 16, modified Durack teaches the portable biological fluid filtration system of claim 15. Modified Durack further teaches wherein the housing includes a buffer fluid inlet for receiving the chemical agent, and wherein the buffer fluid inlet is fluidly connected to the presorting device.
The substrate of Durack now has a lysing reagent introduced into the substrate of Durack as taught by Padmanabhan. It is seen in in Figure 3 of Padmanabhan that there is a fluidic circuit 86, where the removable cartridge 14 is seen to have five pressure receiving ports that control the pressures in the reservoirs (Padmanabhan; [0054]). It is therefore understood that the reservoir attached to the flow channel 411 of Durack will therefore have an inlet that receives the lysing reagent as it exits the reservoir.
Note: recitation that “the housing includes a buffer fluid inlet for receiving the chemical agent” 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 receiving a chemical agent. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
Regarding claim 17, modified Durack teaches the portable biological fluid filtration system of claim 16. Durack further teaches wherein the housing includes a waste fluid outlet for disposing of the chemical agent after the chemical agent has been applied to the biological fluid.
[0054] of Durack describes where there are one or more different wells/chambers 414 which are understood to make up the fluid receiving device, where an individual well/chamber 414 of the one or more different wells/chambers 414 is a waste fluid outlet.
Regarding claim 18, modified Durack teaches the portable biological fluid filtration system of claim 14. Durack further teaches wherein the fluid receiving device is comprised of a microfluidic channel.
It is understood that the chambers/wells 416 and the channel that leads to them from the flow diverter 418 (fluid filtration device) are a part of the fluid receiving device.
Regarding claim 19, modified Durack teaches the portable biological fluid filtration system of claim 14. Durack further teaches wherein the fluid receiving device is comprised of a microwell array.
[0054] of Durack describes where the cells may be sorted into one or more different wells or chambers 414 and/or one or more different sterile collection bags 416. Further, [0054] of Durack describes that Figure 4 is illustrating a microfluidic device 400. It is therefore understood that the one or more different wells 414 is a microwell array.
Regarding claim 20, modified Durack teaches the portable biological fluid filtration system of claim 14. The limitation “wherein the first constituent is comprised of a healthy cell selected from erythrocytes and platelets.” 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 removing erythrocytes and platelets. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Durack (see MPEP §2114).
Note: Durack has been modified by Padmanabhan to include a lysing reagent, where it is evidenced by Carver that a lysing reagent stromatolyzes and therefore eliminates a red blood cell population, which is removing erythrocytes.
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.
Claims 1, 5, 6, 7, 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 9, 10, 20 of copending Application No. 17/205,769 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and reference claims are directed to a housing with an inlet adapted to receive a biological fluid, where a fluid filtration device has an inlet, first outlet, second out, and an optical scanner being a digital holographic microscope, where a control unit compares scanned data to reference data and directs the biological fluid accordingly, and has a cartridge removably connected to the housing. The reference claims has the reference data comprising one or more images of a healthy cell, where images of a healthy cell are characteristics of a healthy cell. Further, both the instant and reference claims include a power source, an indicator to convey operational status, a buffer fluid insert, and a presorting device configured to apply a chemical agent to the biological fluid.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21 of copending Application No. 17/313,421 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and reference claims are directed to a housing including an inlet adapted to receive a biological fluid, a fluid filtration device including an inlet, first outlet, second outlet, a cartridge removably attached to the housing, and the fluid filtration device includes a scanner comprising, and where a control unit receives the scanned data and compares the scanned data to reference data that comprise one or more characteristics of a healthy cell and directs the biological fluid accordingly. Claim 21 of the reference application has the scanner being a digital holographic microscope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant arguments filed 01/07/2025 on page 5 of 7 with regards to the rejection of claim(s) 1-4 and 7-3 have been fully considered. Due to amendments to the claims, incorporating the limitations of a control unit and reference data the rejections in view of Durack (US-2011/0003325-A1) and Schutze (US-2013/0171685-A1) under 35 USC 103 have been modified to address this amendment.
Applicant arguments filed 01/07/2025 on page 6 of 7 with regards to the rejection of claim(s) 14-20 have been fully considered. Due to amendments to the claims, incorporating the limitations of a control unit and reference data the rejections in view of Durack (US-2011/0003325-A1), Schutze (US-2013/0171685-A1), Padmanabhan (US-2005/0255001-A1), and Hiruma (US-2009/0198168-A1) have been modified to address this amendment.
Applicant argues on page 7 of 7 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, where it is noted that Hiruma is being used for teaching a motivation to include a pre-sorting section.
Conclusion
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/SOPHIA Y LYLE/Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796