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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 October 2025 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 3 February 2026. Claims 1, 2, 4-18, 21-23, and 25-39 are currently pending. Claims 3 and 24 have been cancelled. Claims 21-23 and 25-39 have been withdrawn from consideration. Claims 1, 2, and 4-18 are being examined herein.
Status of Objections and Rejections
The interpretation of claims 1, 2, 12, and 13 under 35 U.S.C. § 112(f) are withdrawn in view of amendments.
The rejections of claims 1, 5-7, and 13-15 under 35 U.S.C. § 103 in view of Chun (KR 20160133812 A) in view of Schick (US 20060027500 A1) and Sheng, et. al. (WO 2012050420 A1) are withdrawn in view of amendments.
The rejections of claim 2 under 35 U.S.C. § 103 in view of Chun (KR 20160133812 A) in view of Schick (US 20060027500 A1), Sheng, et. al. (WO 2012050420 A1), and Kim (US 20170088807 A1) is withdrawn in view of amendments.
The rejections of claims 4, 8-12, and 16-18 under 35 U.S.C. § 103 in view of Chun (KR 20160133812 A) in view of Schick (US 20060027500 A1), Sheng, et. al. (WO 2012050420 A1), and Issadore, et. al. (US 20160158756 A1) are withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see Remarks, pages 2-4, filed 3 February 2026, with respect to the rejection(s) of claim 1 under Chun (KR 20160133812 A) in view of Schick (US 20060027500 A1) and Sheng, et. al. (WO 2012050420 A1) 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 Therefore, the rejection has been withdrawn.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 Chun (KR 20160133812 A) in view of Sheng, et. al. (WO 2012050420 A1), Van Reis ( US 20020108907 A1), and Gagnon (US 20170173537 A1).
Applicant argues Schick does not teach, disclose, or suggest a first pump and a second pump as now required by newly amended claim 1 (Remarks, pg. 2, par. 05). The other cited prior art sources also does not teach, disclose, or suggest a first pump and a second pump.
Applicant’s arguments with respect to claim 1 (see above) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant additionally argues that Examiner fails to establish a rational basis supporting the motivation of combing Schick with Chun and Sheng (Remarks, pg. 2; par. 08 – pg. 3, par. 04). Examiner notes Schick is not longer relied upon and therefore, without conceding to the argument, considers the argument moot.
Applicant makes no additional argument for dependent claims outside of their dependence to claim 1 (Remarks, pg. 3, par. 07 – pg. 4).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12-14 recites the limitation "the device configured for inducing tangential fluid flow" in lines 1-2 of each claim. There is insufficient antecedent basis for this limitation in the claim as claim 1 was previously amended to no longer recite the device configured for inducing tangential fluid flow. Examiner believes this is referring to the first pump of claim 1 and will be examined as such. Examiner recommends amending claim to recite “the first pump” or an equivalent thereof.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-7, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Chun (KR 20160133812 A; as previously cited in office action dated 16 June 2025) in view of Bien Chia Sheng, et. al. (WO 2012050420 A1; hereinafter Sheng; as previously cited in office action dated 14 August 2025), Van Reis ( US 20020108907 A1), and Gagnon (US 20170173537 A1).
Regarding Claim 1, Chun teaches an apparatus for separating biomolecules (system for isolating exosomes) (Abstract). Chun teaches a device comprising: A first space 120 (first chamber), second space 130 (second chamber), and a nanoporous membrane 110 separating the two spaces from one another (membrane positioned between the first and second chambers) (Fig. 3, 4). The nanoporous membrane has a top surface partially defining the first space 120 (first membrane surface facing and at least partially defining the first chamber) and a bottom surface partially defining second space 130 (second membrane surface facing and at least partially defining the second chamber) with pores that extend through the membrane (a plurality of asymmetrically shaped nanopores extending between the first and second membrane surfaces) (Fig. 3, 4). One embodiment of the nanoporous membrane comprises a first pore portion 111 that has a diameter that is smaller than a second pore portion 112 creating a conical shape. Chun specifically teaches one embodiment wherein first pore portion 111 is 200 nm (par. 0090, 0094) (each nanopore includes a first nanopore opening at the first membrane surface having a first diameter of between about 5 nm and about 300 nm) (and a second nanopore opening at the second membrane surface having a second diameter that is greater than the first diameter....) (Fig. 3-4; par. 0059).
Chun teaches the biological sample are introduced into the first space 120 and separate to the second space 130 (par. 0034) (a sample comprising exosomes positioned within the first chamber) (wherein the exosomes... are isolated from the sample in the second chamber). Chun teaches an electroosmotic pump that drives the flow of the sample from the first chamber to the second chamber (par. 0050). Chun teaches the biological sample can include microvesicles such as exosomes and can come from a cell culture medium such as derives from a body fluid sample (urine, mucus, lymphatic fluid, blood, etc.) (Par. 0035, 0039) (the sample comprising one or more of cell culture supernatants, a sample obtained from an animal subject). Chun teaches the diameter of the nanopore can be adjusted depending on the size biomolecule to be separated (par. 0044). Chun teaches the device can accommodate several sizes of biomolecules (exosomes) ranging from 30 nm to 1000 nm (par. 0005), with specific experiments testing exosomes of 50 nm, 75 nm, 100 nm, and 200 nm (par. 0127) (wherein the exosomes having a diameter of about 50 nm to about 200 nm are isolated from the sample in the second chamber).
Chun is silent to a second diameter that is less than about 5 µm.
Chun teaches the diameter of the second pore portion 112 follows the ratio for 1:1 up to 1:2000 when compared to the first pore portion 111 (par. 0022). For example, if the first pore portion 111 is 200 nm, as described by the embodiment above, the second pore portion can be 1.5 to 25 times larger and be less than or equal to 5 µm. Chun teaches the diameter of the pore can be adjusted based on the size of the biomolecules being separated (par. 0044, 0060) and prevent Brownian motion in the reverse direction (par. 0059).
Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention through routine optimization for the diameter of the second pore of the filter membrane to have a second diameter is less than about 5 µm to create nanopores to accommodate the size of the molecules in the sample and prevent reverse motion with a reasonable expectation of success.
It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the diameter of the second pore as taught by Chun because doing so would allow for the pore size to optimize biomolecule separation and prevent reverse motion with a reasonable expectation of success. MPEP § 2143(I)(G). Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Chun is silent to inducing fluid flow of the sample across the membrane in the first chamber driven by pressure driven flow, and wherein isolation occurs (by) flow of the sample across the membrane is induced by pressure driven flow.
Sheng teaches a multilayer microfluidic particle for filtering particle through funnel-shaped pores (Abstract). Sheng teaches a microfluidic filter that comprises a substrate 110 with a plurality of pores 130 (Fig. 1; pg. 5, lines 1-6). Sheng teaches the sample is introduced and directed towards the filtering area (the plurality of pores 130) by an internal or external pumping device (pg. 6; line 4-5). The pressure from the pumping and the shape of the pores 130 encourage particles to be filtered through the layer (pg. 6; line 4-13) (flow of the sample across the membrane is induced by pressure driven flow) (inducing fluid flow of the sample across the membrane in the first chamber driven by pressure driven flow). Sheng teaches the pressure gradient due to pore shape allows for easier separation of desired particles through the pores while blocking impurities (pg. 6, lines 4-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the isolation driving force of Chun to be pressure driven as taught by Sheng because the shapes of the pores are similar and therefore would apply similar driving forces on the sample and also because doing so would allow for easier separation of desired particles through the pores (as taught by Sheng). MPEP 2143(I)(G).
Modified Chun is silent to a first pump configured for inducing tangential fluid flow of a recirculating buffer solution through the first chamber, a second pump configured for inducing fluid flow of the sample across the membrane in the first chamber driven by pressure driven flow, and wherein isolation occurs after tangential fluid flow of the sample across the membrane.
Van Reis teaches a fluidic system for tangentially passing a solution over a porous membrane for separating select species in the solution (Abstract). Van Reis teaches the tangential flow filtration system 10' comprises a first channel 12 (first chamber) and a second channel 14 (second chamber) separated by a porous filtration membrane 30 (membrane), and a first feed pump 36 connected to the input 16 of first channel 12 and an output conduit 44. The sample containing solution flows to the first channel 12 through input 16 by tangential flow from the feed pump 36 where it encounters membrane 30 surface (par. 0027) (after tangential fluid flow of the sample across the membrane). Output conduit 44 allows for liquid and particles within the liquid that did not pass through the membrane 30 to reservoir 60 where the liquid is recirculated through first channel 12 (Fig. 3; par. 0033-0034) (a second pump configured for inducing fluid flow of the sample across the membrane in the first chamber) (inducing tangential fluid flow of a recirculating buffer solution). Examiner notes while the system 10' of Van Reis depicts two filtration devices, the recirculation of the same is capable of recirculating with just a single filtration system similarly to if valve 56 was closed. Van Reis teaches the introduction of the fluid tangentially to the membrane prevents solutes from settling on the membrane resulting in a clogged membrane with this particular tangential flow filtration system having enhanced ability to select between similarly size solutes due to recirculation (par. 0008-0010).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the pumping and fluidic flow of modified Chun to include a pump for inducing tangential flow and a fluidic pathway for recirculation of the liquid as taught by Van Reis because doing so would prevent clogging of the membrane and have enhance membrane selectivity. MPEP 2143(I)(G).
Modified Chun in view of Van Reis is silent to an additional pump (the first pump) pumping the recirculating buffer specifically through the first chamber.
Gagnon teaches an apparatus for the separation of biological molecules in part by tangential flow filtration (Abstract). Gagnon teaches an apparatus comprising a sample vessel 01 connected to pump 50 leading to tangential flow filtration subunit 100, wherein the sample flows through the interior of the filter and exits through a fluid conduit where it meets valves to direct the solution that did not pass through the membrane of the filter back to recirculation vessel 03 where the solution can be reintroduced to the membrane with pump 51 (Fig. 1; par. 0009) (a first pump configured for inducing tangential fluid flow of a recirculating buffer solution through the first chamber). Examiner notes the tangential flow filtration subunit 100 is additionally connected to adsorptive subunit 200, is not required for the operation of the tangential flow filtration subunit 100 as seen in Figure 6 (par. 0014). The addition of a second pump allows the sample and recirculated solution to function independent of one another and allows for the desired particle to be concentrated by the tangential flow filtration subunit (par. 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the recirculation line and reservoir of modified Chun in view of Van Reis to include a second pump solely for recirculating liquid as taught by Gagnon because doing so keeps the pumps independent in their function and allows for concentration of desired analyte. MPEP 2143(I)(G).
Regarding Claim 5, modified Chun teaches one embodiment wherein first pore portion 111 has a diameter of 200 nm (Chun, par. 0090, 0094) (wherein the first diameter is between about 10 nm and about 200 nm).
Regarding Claim 6, modified Chun teaches the diameter of the second pore portion 112 follows the ratio for 1:1 up to 1:2000 when compared to the first pore portion 111 (Chun, par. 0022). For example, if the first pore portion 111 is 200 nm, as described by the embodiment above, the second pore portion can be 1.5 to 10 times larger and be less than or equal to 2 µm. Chun teaches the diameter of the pore can be adjusted based on the size of the biomolecules being separated (Chun, par. 0044, 0060) and prevent Brownian motion in the reverse direction (Chun, par. 0059).
Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention through routine optimization for the diameter of the second pore of the filter membrane to have a second diameter is less than about 2 µm to create nanopores to accommodate the size of the molecules in the sample and prevent reverse motion.
It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the diameter of the second pore as taught by Chun because doing so would allow for the pore size to optimize biomolecule separation and prevent reverse motion with a reasonable expectation of success. MPEP § 2143(I)(G). Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding Claim 7, modified Chun teaches the nanoporous membrane is made of polycarbonate (the membrane is formed from one or more materials comprising one or more of... a polycarbonate (PC)) (Chun, par. 0066, 0076).
Regarding Claim 13, modified Chun in view of the limitations as applied to claim 1 (see above).
Modified Chun is silent to wherein the device configured for inducing tangential fluid flow generates a pressure less than about 1 atm.
Van Reis teaches wherein the flux within the tangential flow filtration (TFF) system is partially determined by transmembrane pressure. Van Reis teaches the goal of the TFF system as disclosed is to reduce and maintain the pressure to be significantly less than the transition point pressure (par. 0009). Van Reis teaches minimizing pressure in turn minimized flux of the system while being able to separate particles similar in size (par. 0009). Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention through routine optimization for the device configured for inducing tangential fluid flow generates a pressure less than about 1 atm because doing so would minimize flux and allow for better separation performance.
It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the generated pressure of modified Chun to be less than about 1 atm as suggested by Van Reis because doing so would minimize flux and allow for better separation performance with a reasonable expectation of success. MPEP 2143(I)(G).
Regarding Claim 14, modified Chun in view of Sheng teaches the sample is introduced and directed towards the filtering area (the plurality of pores 130) by an internal or external pumping device (pg. 6; line 4-5). Sheng specifically teaches an element like a micropump can be easily paired with a microfluidic device (pg. 1; lines 14-18) (wherein the device configured for inducing tangential fluid flow comprises... a micropump).
Regarding Claim 15, modified Chun in view of Van Reis teaches the sample containing solution flows to the first channel 12 through input 16 by tangential flow from the feed pump 36 where it encounters membrane 30 surface (par. 0027). Output conduit 44 allows for liquid and particles within the liquid that did not pass through the membrane 30 to reservoir 60 where the liquid is recirculated through first channel 12 (Fig. 3; par. 0033-0034) (wherein a first portion of the sample passes through the membrane or filter and a second portion of the sample passes parallel to the membrane and is recirculated).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chun (KR 20160133812 A) in view of Sheng, et. al. (WO 2012050420 A1), Van Reis ( US 20020108907 A1), and Gagnon (US 20170173537 A1) as applied to claim 1 above, and further in view of Kim (US 20170088807 A1; as previously cited in office action dated 16 June 2025).
Regarding Claim 2, modified Chun teaches all of the limitation as recited in Claim 1.
Modified Chun is silent to wherein the first chamber comprises a wall opposite of the first membrane surface that comprises one or more baffles.
Kim teaches a multichannel microfluidic device with membranes to mimic a biomolecular environment (par. 0006-0009). Kim teaches within the chambers there are baffles 425 along the wall of the channel 421 opposite to the porous membrane 430 (wherein the first chamber comprises a wall opposite of the first membrane surface that comprises one or more baffles) (Fig. 5; par. 0040). Kim teaches these baffles induce dynamic mixing of the sample (par. 0009) as well as provide structural integrity to the channel (par. 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wall opposite to the nanopore membrane of Chun to include baffles as taught by Kim because doing so would dynamically mix the sample and provide structural supported to the stacked layers with reasonable expectation of success. MPEP § 2143(I)(G).
Claims 4, 8-12, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chun (KR 20160133812 A) in view of Sheng, et. al. (WO 2012050420 A1), Van Reis ( US 20020108907 A1), and Gagnon (US 20170173537 A1) as applied to claim 1 above, and further in view of Issadore, et. al. (US 20160158756 A1; as previously cited in office action dated 16 June 2025).
Regarding Claim 4, modified Chun teaches all of the limitations as applied to claim 1 (see above).
Modified Chun is silent to wherein the first membrane surface is coated with a magnetic alloy.
Issadore teaches a magnetic separation device with a membrane with pores (Abstract). Issadore teaches a separation device comprising open layers (first chamber, second chamber) separated by a membrane with a plurality of pores embedded into the membrane (membrane positioned between the first and second chambers... plurality of nanopores). Issadore teaches a magnetic material layered along the top of the membrane surface (wherein the first membrane surface is coated with a magnetic alloy) (Fig. 1a, 4a; par. 0032). Issadore teaches the addition of a magnetic alloy to the surface of the membrane improves sorting efficiency and greater throughput while keeping costs low (par. 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the nanopore membrane of Chun to include a magnetic alloy as taught by Issadore because doing so would increase efficiency and throughput of the separation device with a reasonable expectation of success. MPEP § 2143(I)(G).
Regarding Claim 8, modified Chun teaches all of the limitations as applied to claim 1 (see above).
Modified Chun is silent to a third chamber and a filter positioned between the third chamber and the first chamber and the filter comprising a first filter surface facing and at least partially defining the third chamber, a second filter surface facing and at least partially defining the first chamber and a plurality of filter pores extending between the first and second filter surfaces.
Issadore teaches a magnetic separation device with a membrane with pores (Abstract). Issadore teaches a separation device comprising open layers (first chamber, second chamber) separated by a magnetic filter membrane with a plurality of pores embedded into the membrane (membrane positioned between the first and second chambers... plurality of nanopores) (Fig. 1a, 4a; par. 0032). Issadore teaches an embodiment that comprises up to 10 layers of the magnetic filter membrane with an open space between each layer (a third chamber and a filter positioned between the third chamber and the first chamber) (par. 0056). Each magnetic filter membrane helps define the open layers they separate (the filter comprising a first filter surface facing and at least partially defining the third chamber, a second filter surface facing and at least partially defining the first chamber and a plurality of filter pores extending between the first and second filter surfaces) (Fig. 4a). Issadore teaches adding more layers of filter membranes increases the enrichment of the sample after each additional layer (par. 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the two chambers and nanopore membrane of Chun in include a second filter membrane and third chamber, as taught by Issadore, to the first chamber because doing so would increase enrichment of the sample through each pass through of a filter with a reasonable expectation of success. MPEP § 2143(I)(G).
Regarding Claim 9, modified Chun in view of Issadore teaches the pores in the membrane filter range from 100 nm to 100 µm (Issadore, par. 0007; 0038). Issadore teaches the pore size selected based on sample (Issadore, par. 0038-0039). Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention through routine optimization for the diameter of the pores of the filter membrane to be between 200 nm to 5 microns to create nanopores to accommodate the size of the molecules in the sample.
It additionally would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the diameter of the second pore as taught by Issadore because doing so would allow for the pore size to be optimized for the biomolecules in the sample with a reasonable expectation of success. MPEP § 2143(I)(G). Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding Claim 10, modified Chun in view of Issadore teaches the filters are made of polycarbonate (Issadore, par. 0066) (wherein the filter is formed from one or more materials comprising... polycarbonate (PC)).
Regarding Claim 11, modified Chun teaches all of the limitations as applied to claim 1 (see above).
Modified Chun is silent a fourth chamber and a second membrane positioned between the fourth chamber and the second chamber; the second membrane comprising a first surface coated with a magnetic alloy facing and at least partially defining the second chamber and a second surface facing and at least partially defining the fourth chamber.
Issadore teaches a magnetic separation device with a membrane with pores (Abstract). Issadore teaches a separation device comprising open layers (first chamber, second chamber) separated by a magnetic filter membrane with a plurality of pores embedded into the membrane (membrane positioned between the first and second chambers... plurality of nanopores) (Fig. 1a, 4a; par. 0032). Issadore teaches an embodiment that comprises up to 10 layers of the magnetic filter membrane with an open space between each layer (a fourth chamber and a second membrane positioned between the fourth chamber and the second chamber) (par. 0056). Each magnetic filter membrane helps define the open layers they separate (the second membrane comprising a first surface... facing and at least partially defining the second chamber and a second surface facing and at least partially defining the fourth chamber) (Fig. 4a). Issadore teaches adding more layers of filter membranes increases the enrichment of the sample after each additional layer (par. 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the two chambers and nanopore membrane of Chun in include an additional filter membrane and fourth chamber, as taught by Issadore, to the second chamber because doing so would increase enrichment of the sample through each pass through of a filter with a reasonable expectation of success. MPEP § 2143(I)(G).
Regarding Claim 12, modified Chun in view of Sheng teaches the sample is introduced and directed towards the filtering area (the plurality of pores 130) by an internal or external pumping device (pg. 6; line 4-5). Sheng specifically teaches an element like a micropump can be easily paired with a microfluidic device (pg. 1; lines 14-18). Modified Chun is silent to wherein the device configured for inducing tangential fluid flow generates a flow rate of between about 0.01 mL/hour to about 1000 mL/hour.
Issadore teaches the sample is pumped through the filtration device (par. 0077). Issadore teaches the pump is capable of reaching flows from 1 mL/hr (par. 0082) and to 100 mL/hr (par. 0075) (wherein the device configured for inducing tangential fluid flow generates a flow rate of between about 0.01 mL/hour to about 1000 mL/hour). Issadore teaches the flow rate at which the sample is pumped through the filter directly contributes to the sorting efficiency of the filter (par. 0078).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the micropump of Chun in view of Sheng to achieve flow rates of between 0.01 mL/hr to 1000 mL/hr as taught by Issadore because doing so would allow for better control of the sorting efficiency of the filter with a reasonable expectation of success. MPEP § 2143(I)(G).
Regarding Claim 16, modified Chun in view of Issadore teaches the magnetic layer is a nickel and iron alloy (Issadore, par. 0045) (wherein the magnetic alloy is nickel- iron).
Regarding Claim 17, modified Chun teaches the biological sample can include microvesicles such as exosomes (Par. 0035).
Modified Chun is silent to wherein the exosomes are bound to a probe that is coupled to a magnetic bead.
Issadore teaches bacteria are tagged with a magnetic nanoparticle that will influence how the sample interacts with the magnetic filters. The magnetic nanoparticles used for tagging interact with antibodies (wherein the exosomes are bound to a probe that is coupled to a magnetic bead) (par. 0068). This allows the biological sample to interact with the magnetic filter membrane to separate the sample (0077-0082).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the exosome sample of modified Chun to include a probe (antibody) coupled with a magnetic bead (magnetic nanoparticle) as taught by Issadore because doing so allows the sample to interact with the magnetic filter membrane with a reasonable expectation of success. MPEP § 2143(1)(G).
Regarding Claim 18, modified Chun in view of Issadore teaches the magnetic nanoparticles used for tagging interact with antibodies (the probe is an antibody) (Issadore, par. 0068, 0077-0082).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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