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 .
Status of Claims
Claims 1-20 are currently pending. Claims 1, 11, and 17 are currently amended. No new subject matter is added.
Response to Arguments
Applicant’s arguments, see pg. 1-2, filed 04/09/2026, with respect to the rejection(s) of claim(s) 1, 11, and 17 under U.S.C. 102(a)(1) and 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 Therefore, the rejection has been withdrawn.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 Borenstein (US 20230091557 A1). Specifically, applicant argues that neither prior art of Nosrati or DiBiasio would teach a design of a vertical manifold to achieve equal resistance across layers external to the stack. Therefore, Figure 1A of Borenstein teaches a similar extracorporeal membrane oxygenation device that has a vertical manifold for introducing blood into device, wherein the manifold has a branching design that provides equal resistance to each layer (see below).
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Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nosrati (US 20170252701 A1) in view of Borenstein (US 20230091557 A1).
Regarding Claim 1, Nosrati teaches an extracorporeal membrane oxygenation (ECMO) device (biomimetic microfluidic modules emulating varieties of microvasculature in body, see Abstract), comprising:
a first layer (blood microfluidic chip 104, see Figure 4B; microfluidic units 102a-d fabricated from any inert and biocompatible polymer used as microfluidic substrate like polymeric organosilicon compound Paragraph [0224]) defining a plurality of banks of first channels each extending in a first direction (plurality of micro-channels 110a-b or carrying the blood 134, see Paragraph [0234]), the plurality of banks of first channels configured to receive blood via a trunk channel (12C illustrate top views of an micro-channels fabricated directly on a
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blood microfluidic chip; trunk channels supply blood into the first channels, see below);
a second layer (dialysate microfluidic chip 106) defining a bank of second channels (110c-d, see Paragraph [0224]; Figure 4B) extending in a second direction (the microchannels may take any shape, topology and configurations. Hence, any form of microchannel design could be used including but not limited to straight, crisscrossing, fractal, curvilinear channels or interrupted channels using pillar design and etc., see Paragraph [0042]), the bank of second channels configured to receive oxygen (microchannels configured for carrying dialysate, see Paragraph [0234]; it is understood that dialysate comprises oxygen), the first direction different from the second direction (the microchannels may take any shape, topology and configurations. Hence, any form of microchannel design could be used including but not limited to straight, crisscrossing, fractal, curvilinear channels or interrupted channels using pillar design and etc., see Paragraph [0042]); and
a membrane disposed between the first layer and the second layer (semipermeable membrane 108 disposed between the chips 104, 106, see Figure 4B) and configured to cause the oxygen to permeate from the second layer to the first layer to oxygenate the blood (each basic chipset module which utilizes a specific or various semipermeable membranes to allow manipulation gases, including the O Chipset (Oxygenation) in formation of this any type of ECMO membrane will be used, see Paragraph [0074]-[0075]).
However, Nosrati does not explicitly disclose a vertical manifold located external to and fluidly coupled with the first and second layers, the vertical manifold having an equal resistance branching design.
Borenstein teaches an extracorporeal membrane oxygenation (ECMO) device (see Paragraph [0041]) comprising: a first layer (a first polymer layer with a plurality of gas channels, see Abstract; Figure 1A), a second layer (a second polymer layer with a plurality of blood channel, see Abstract; Figure 1A), and a vertical manifold located external to and fluidly coupled with the first and second layers (blood inlet, see Figure 1A; Paragraph [0071]), the vertical manifold having an equal resistance branching design (the microfluidic device may comprise a distribution system for delivering gas to any gas channel in the device, and delivering blood to any blood channel in the device; the distribution system may comprise branching or bifurcating microchannels, biomimetic vascular-like channels, or a manifold structure, see Paragraph [0063]; Figure 1A; ).
Nosarti and Borenstein are analogous art because both disclose Extracorporeal Membrane Oxygenation (ECMO) device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the extracorporeal membrane oxygenation (ECMO) device of Nosrati and further include a vertical manifold located external to and fluidly coupled with the first and second layers, the vertical manifold having an equal resistance branching design, as taught by Borenstein. Borenstein teaches the vertical manifold having an equal resistance branching design is beneficial because the networks may feature smooth bifurcations and/or gradual changes in the cross-sectional channel dimensions, and may mimic the physiological properties of in-vivo vascular and/or micro-vascular networks (see Paragraph [0061]) and controllable access to the chambers may be provided by vascular-like channel structures, structures that provide a smooth path for fluid flow (see Paragraph [0063]).
Regarding Claim 9, Nosrati teaches all of the limitations as discussed above in claim 1. However, Nosrati does not explicitly disclose wherein the membrane comprises polydimethylsiloxane (PDMS).
Bornstein teaches an extracorporeal membrane oxygenation (ECMO) device (see Paragraph [0015]) comprising: a first micropatterned polymer layer defining a microvascular network for blood flow therethrough (see Paragraph [0015]) ; a second micropatterned polymer layer defining channels for gas supply (see Paragraph [0015]); a gas-permeable polymer membrane located between and bonding the first micropatterned polymer layer to the second micropatterned polymer layer (see Paragraph [0015]); and wherein the membrane comprises polydimethylsiloxane (PDMS) (the gas-permeable membrane is preferably made of PDMS, see Paragraph [0080]).
Nosrati and Bornstein are analogous art because both teach an extracorporeal membrane oxygenator device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the membrane of Nosrati and further include wherein the membrane comprises polydimethylsiloxane (PDMS).
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the membrane of Nosrati and further include wherein the membrane comprises polydimethylsiloxane (PDMS), as taught by Bornstein. Bornstein teaches the gas-permeable membrane is preferably made of a material that is gas-permeable, non-porous, has hemocompatibility (such as membrane materials used in ECMO devices) is compatible with the manufacturing procedures described herein, and is compatible with covalently-linked biological molecules (see Paragraph [0080]).
Regarding Claim 10, Nosrati and Borenstein teach all of the limitations as discussed above in claim 1 and Nosrati further teaches wherein the plurality of banks of first channels comprise four banks of first channels (see above), each receiving oxygen from the bank of second channels via the membrane (the micro-channels 110c-d follow a top down approach: The inflow into the chipset module is via a central inlet (or other approaches) which is divided in successive steps to provide a network of micro-channels 110a-d to distribute the oxygen, fluids and nutrients in a coordinated and uniform pattern, see Paragraph [0262]).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over DiBiasio et al. (US 20140061115 A1), hereinafter referred to as “DiBiasio” in view of Borenstein (US 20230091557 A1).
Regarding Claim 17, DiBiasio teaches a layer of an extracorporeal membrane oxygenation (ECMO) device (microfluidic device 100 having a blood substrate layer 200 suitable for use as the blood substrate layer 104, see Figure 1A-2), comprising:
an inlet configured to receive blood (blood inlet manifold 110),
a trunk channel in fluid communication with the inlet (blood inlet manifold 110 includes a trunk channel 302 a, see Figures 1B and 3);
a plurality of finger channels extending from the trunk channel (branch channels 304A-304C); and
a plurality of banks of blood channels (bifurcation channels 310A and 310B), each of the plurality of banks of blood channels in fluid communication with a respective one of the plurality of finger channels via a bifurcating manifold (the fluid flow through the branch channel 304A bifurcates into bifurcation channels 310A and 310B,, see Figure 3) configured to maintain shear stress on the blood within a predetermined range (the features of the channel network 300 can be selected to maintain a wall shear rate in a range, see Paragraph [0039]; it is understood that the shear rate is directly proportionate to a shear stress).
However, DiBiasio does not explicitly disclose the inlet being coupled to a vertical manifold having an equal resistance branching design.
Borenstein teaches an extracorporeal membrane oxygenation (ECMO) device (see Paragraph [0041]) comprising: a first layer (a first polymer layer with a plurality of gas channels, see Abstract; Figure 1A), a second layer (a second polymer layer with a plurality of blood channel, see Abstract; Figure 1A), and an inlet being coupled to a vertical manifold (blood inlet, see Figure 1A; Paragraph [0071]), having an equal resistance branching design (the microfluidic device may comprise a distribution system for delivering gas to any gas channel in the device, and delivering blood to any blood channel in the device; the distribution system may comprise branching or bifurcating microchannels, biomimetic vascular-like channels, or a manifold structure, see Paragraph [0063]; Figure 1A).
Nosarti and Borenstein are analogous art because both disclose Extracorporeal Membrane Oxygenation (ECMO) device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the inlet of DiBiasio and further include the inlet being coupled to a vertical manifold having an equal resistance branching design, as taught by Borenstein. Borenstein teaches a blood inlet with a vertical manifold having an equal resistance branching design is beneficial because the networks may feature smooth bifurcations and/or gradual changes in the cross-sectional channel dimensions, and may mimic the physiological properties of in-vivo vascular and/or micro-vascular networks (see Paragraph [0061]) and controllable access to the chambers may be provided by vascular-like channel structures, structures that provide a smooth path for fluid flow (see Paragraph [0063]).
Regarding Claim 18, DiBiasio and Borenstein teaches all of the limitations as discussed above and DiBiasio further teaches wherein a shape of one or more curves of the plurality of finger channels is configured to maintain the shear stress on the blood within the predetermined range (the curvature of the branches 304A-304C, and the bifurcation channels 310A-310F, are selected to maintain a wall shear rate within a specified range substantially throughout the entire channel network 300, see Paragraph [0039]).
Regarding Claim 19, DiBiasio and Borenstein teaches all of the limitations as discussed above and DiBiasio further teaches wherein each of the plurality of banks of blood channels (channels 310 can form bifurcation subnetwork 312) are in fluid communication with an outlet channel (blood outlet manifold 112) via a second bifurcating manifold (a bifurcation network of channels 400 for dividing and recombining fluid flow, similar to the bifurcation subnetwork 312, see Paragraph [0042]; wherein the bifurcation network of channels recombining the fluid flow from the bifurcation channels 404A-404B into the outlet channel 406, see Figure 4).
Regarding Claim 20, DiBiasio and Borenstein teaches all of the limitations as discussed above and DiBiasio further teaches wherein the outlet channel is parallel to the trunk channel (outlet channel 210 is parallel to trunk channel 202; the trunk 302 of FIG. 3 can correspond to the primary channel 202, see Paragraph [0030]; Figure 2).
Claims 2-8 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nosrati and Borenstein, as applied in claim 1 above and in further view of DiBiasio (US 20140061115 A1).
Regarding Claim 2, Nosrati and Borenstein teach all of the limitations as discussed above in claim 1 and Nosrati further teaches wherein at least one bank of the plurality of banks of first channels is configured to receive the blood via a finger channel in fluid communication with the trunk channel (see above).
However, Nosrati and Borenstein do not explicitly disclose the finger channel having a taper along a length of the at least one bank.
DiBiasio teaches a compact hybrid hydraulic manifold structure for shear sensitive fluids (see Abstract; Figures 1-5) comprising: a plurality of banks of first channel (310A-B), wherein at least one bank of the plurality of banks of first channels is configured to receive the blood via a finger channel (304A-C) in fluid communication with the trunk channel (in communication with trunk 302, see Figure 3), the finger channel having a taper along a length of the at least one bank (any other channel in the network 300 can also be tapered, including channels 304A-304C, see Paragraph [0039] and [0041]).
Nosrati, Borenstein, and DiBiasio are analogous art because all teach a microfluidic device having networks of channels.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the finger channel of Modified Nosrati and further include wherein the finger channel has a taper along a length of the at least one bank, as taught by DiBiasio. DiBiasio teaches the curvature of the branches are selected to maintain a wall shear rate within a specified range substantially throughout the entire channel network (see Paragraph [0039]).
Regarding Claim 3, Modified Nosrati teaches all of the limitations as discussed above in claim 2 and Nosrati further teaches wherein the at least one bank comprises a plurality of bifurcating channels in fluid communication with the finger channel (see Figure 12C; see above).
Regarding Claim 4, Modified Nosrati teaches all of the limitations as discussed above in claim 3 and Nosrati further teaches wherein each of the plurality of bifurcating channels bifurcate at least twice (the network of channels 300 can contain any number of bifurcations, see Figure 3; Paragraph [0038]).
Regarding Claim 5, Nosrati and Borenstein teaches all of the limitations as discussed above in claim 1. However, Nosrati and Borenstein do not explicitly disclose wherein the trunk channel comprises at least one trunk ramp configured to maintain shear stress on the blood within a predetermined range as the blood flows through the plurality of banks of first channels.
DiBiasio teaches a compact hybrid hydraulic manifold structure for shear sensitive fluids (see Abstract; Figures 1-5) comprising: a trunk channel (302) and a plurality of banks of first channel (310A-B), wherein the trunk channel comprises at least one trunk ramp configured to maintain shear stress on the blood within a predetermined range as the blood flows through the plurality of banks of first channels (trunk 302 has a tapered shape, see Figure 3; the curvature of the branches 304A-304C, the taper of the trunk is selected to maintain a wall shear rate within a specified range substantially throughout the entire channel network (see Paragraph [0039]).
Nosrati, Borenstein, and DiBiasio are analogous art because all teach a microfluidic device having networks of channels.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the trunk channel of Modified Nosrati and further include at least one trunk ramp configured to maintain shear stress on the blood within a predetermined range, as taught by DiBiasio. DiBiasio teaches its desirable to have a compact channel network architecture that is capable of safely transporting blood and other shear sensitive fluids (see Paragraph [0001]).
Regarding Claim 6, Nosrati and Borenstein teach all of the limitations as discussed above in claim 1 and Nosrati further teaches wherein the bank of second channels (110c-d) is configured to receive the oxygen via an oxygen channel (the inflow into the chipset module is via a central inlet (or other approaches) which is divided in successive steps to provide a network of micro-channels 110c-d to distribute the oxygen, fluids and nutrients in a coordinated and uniform pattern, see Paragraph [0262]).
However, Nosrati and Borenstein do not explicitly disclose an oxygen channel having a taper along a length of the bank of second channels.
DiBiasio teaches a compact hybrid hydraulic manifold structure for shear sensitive fluids (see Abstract; Figures 1-5) comprising: a bank of second channels (see Paragraph [0011]) having a taper along a length of the bank of second channels (a second network of channels having at least one Second Channel complementary to one or more of the First Channels. The microfluidic device includes a filtration membrane separating the one or more First Channels from the at least one Second Channel, see Paragraph [0003]), wherein there is a taper along a length of the bank of second channels (any other channel in the network 300 can also be tapered, see Paragraph [0041]).
Nosrati, Borenstein and DiBiasio are analogous art because all teach a microfluidic device having networks of channels.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the second channels of Modified Nosrati and further include a taper along a length of the bank of second channels, as taught by DiBiasio. DiBiasio teaches its desirable to have a compact channel network architecture that is capable of safely transporting blood and other shear sensitive fluids (see Paragraph [0001]).
Regarding Claim 7, Modified Nosrati teaches all of the limitations as discussed above in claim 6 and DiBiasio further teaches wherein the oxygen channel comprises one or more support structures (a filtrate inlet manifold 114, see Figure 1).
Regarding Claim 8, Nosrati and Borenstein teach all of the limitations as discussed above in claim 1. However, Nosrati and Borenstein do not explicitly disclose wherein the membrane has a thickness ranging from about 50 m to about 100 m.
DiBiasio teaches a compact hybrid hydraulic manifold structure for shear sensitive fluids (see Abstract; Figures 1-5) comprising: a membrane (108), wherein the membrane has a thickness ranging from about 50 micrometers to about 100 micrometers (the membrane 108 has thickness in the range of about 500 nanometers to about 1 millimeter, see Paragraph [0023]; therefore can be in range of 50 micrometers to about 100 micrometers).
Nosrati, Borenstein, and DiBiasio are analogous art because all teach a microfluidic device having networks of channels.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the membrane of Modified Nosrati and further include wherein the membrane has a thickness ranging from about 50 micrometers to about 100 micrometers, as taught by DiBiasio. DiBiasio teaches its beneficial for waste products and water to be removed from the blood via diffusion through the permeable membrane 108 into the filtrate substrate layer. Healthy blood remains in the blood substrate layer and can then be recirculated into the body of a patient (see Paragraph [0024]).
Regarding Claim 11, Nosrati teaches a system (biomimetic microfluidic modules emulating varieties of microvasculature in body, see Abstract), comprising:
a housing (a microfluidic housing 114, see Figure 7) comprising a plurality of oxygenator layers (microfluidic units 102a-d are combined into constructs and modules to operatively fit into a microfluidic housing 114, see Paragraph [0225]; each basic chipset module which utilizes a specific or various semipermeable membranes to allow manipulation gases, including the O Chipset (Oxygenation) in formation of this any type of ECMO membrane will be used, see Paragraph [0074]-[0075]), each of the plurality of oxygenator layers comprising:
a bank of first channels configured to receive blood (plurality of micro-channels 110a-b or carrying the blood 134, see Paragraph [0234]),
a bank of second channels configured to receive oxygen (plurality of microchannels 110c-d carrying dialysate, see Paragraph [0224]; Figure 4B; it is understood that dialysate comprises oxygen), and
a membrane (semipermeable membrane 108 disposed between the chips 104, 106, see Figure 4B) configured to cause the oxygen to permeate from the bank of second channels to the bank of first channels to oxygenate the blood (each basic chipset module which utilizes a specific or various semipermeable membranes to allow manipulation gases, including the O Chipset (Oxygenation) in formation of this any type of ECMO membrane will be used, see Paragraph [0074]-[0075]).
However, Nosrati does not explicitly disclose a vertical manifold configured to provide the blood to each of the plurality of oxygenator layers.
DiBiasio teaches a system (a microfluidic device 100 composed of eight bilayers, as exemplified by the bilayer 102; Figures 1A) comprising: a vertical manifold (manifolds 110, 112, 114, and 116; wherein manifold 110 is a blood inlet, see Paragraph [0023]) configured to provide the blood to each of the plurality of oxygenator layers (blood enters the blood substrate layer 104 through the blood inlet manifold 110 to supply blood to each bilayer 102, see Figure 1A).
Nosrati and DiBiasio are analogous art because both teach a microfluidic device having networks of channels.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the housing of Nosrati and further include a vertical manifold configured to provide the blood to each of the plurality of oxygenator layers, as taught by DiBiasio. DiBiasio teaches the vertical manifold is beneficial to provide a compact hydraulic manifold for transporting shear sensitive fluids and can be coupled to a series of microfluidic layers to construct a compact microfluidic device (see Abstract).
Nosrati and DiBiasio teach all of the limitations as discussed above. However, Nosrati and DiBiasio do not explicitly disclose the vertical manifold having an equal resistance branching design external to the plurality of oxygenator layers.
Borenstein teaches an extracorporeal membrane oxygenation (ECMO) device (see Paragraph [0041]) comprising: a first layer (a first polymer layer with a plurality of gas channels, see Abstract; Figure 1A), a second layer (a second polymer layer with a plurality of blood channel, see Abstract; Figure 1A), and a vertical manifold located external to and fluidly coupled with the first and second layers (blood inlet, see Figure 1A; Paragraph [0071]), the vertical manifold having an equal resistance branching design external to the plurality of oxygenator layers (the microfluidic device may comprise a distribution system for delivering gas to any gas channel in the device, and delivering blood to any blood channel in the device; the distribution system may comprise branching or bifurcating microchannels, biomimetic vascular-like channels, or a manifold structure, see Paragraph [0063]; Figure 1A).
Nosrati and Borenstein are analogous art because both disclose Extracorporeal Membrane Oxygenation (ECMO) device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the extracorporeal membrane oxygenation (ECMO) device of Nosrati and further include a vertical manifold located external to and fluidly coupled with the first and second layers, the vertical manifold having an equal resistance branching design, as taught by Borenstein. Borenstein teaches the vertical manifold having an equal resistance branching design is beneficial because the networks may feature smooth bifurcations and/or gradual changes in the cross-sectional channel dimensions, and may mimic the physiological properties of in-vivo vascular and/or micro-vascular networks (see Paragraph [0061]) and controllable access to the chambers may be provided by vascular-like channel structures, structures that provide a smooth path for fluid flow (see Paragraph [0063]).
Regarding Claim 12, Modified Nosrati teaches all of the limitations as discussed above in claim 11 and Nosrati further teaches wherein the vertical manifold is configured to maintain a range of shear stress in the blood (features of the blood manifolds 110 and 112, such as the curved shape of the channels, help to preserve blood health, see Paragraph [0025]; in a device that will be used to transport blood, such as the microfluidic device 100 of FIG. 1A or the blood substrate layer 200 of FIG. 2, the features of the channel network 300 can be selected to maintain a wall shear rate in the range, see Paragraph [0039]).
However, Modified Nosrati does not explicitly disclose maintaining the range of shear stress in the blood ranging from about 7 dynes/cm2 to about 35 dynes/cm2.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Modified Nosrati to have a range of shear stress in the blood ranging from about 7 dynes/cm2 to about 35 dynes/cm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative range of the claimed device and a device having the claimed range would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Nosrati would not operate differently with the claimed shear stress range and since the device is configured to maintain even flow and keeping the shear rate within a specified range for a shear sensitive fluid, such as blood, the device would function appropriately having the claimed shear range. Further, applicant places no criticality on the range claimed, indicating simply that the shear stress is “about” be within the claimed ranges (specification pp. [0008]).
Regarding Claim 13, Modified Nosrati teaches all of the limitations as discussed above in claim 11 and DiBiasio further teaches wherein the vertical manifold (manifold 114) is further configured to provide the oxygen to the plurality of oxygenator layers (filtrate inlet manifold 114; it is understood that filtrate comprises oxygen).
Regarding Claim 14, Modified Nosrati teaches all of the limitations as discussed above in claim 11 and Nosrati further teaches wherein the housing (114) comprises a plurality of trays each having a respective oxygenator layer of the plurality of oxygenator layers (multiple types of microfluidic chip units 102a-d may be used in parallel, see Figure 7). DiBiasio further teaches wherein the vertical manifold (manifold 118) is coupled to the plurality of trays (coupled to teach bilayers 102, see Figure 1; bilayers 102 are analogous to the microfluidic chip units 102a-d in Nosrati).
Regarding Claim 15, Modified Nosrati teaches all of the limitations as discussed above in claim 11 and Nosrati further teaches an oxygen source (dialysate 116 having oxygen) configured to provide the oxygen at a predetermined pressure (pressure and the type of dialysate 116 also dictate the position of the micro-valves 154a-c, see Paragraph [0233]).
Regarding Claim 16, Modified Nosrati teaches all of the limitations as discussed above in claim 11 and DiBiasio further teaches wherein the vertical manifold (manifold 110) comprises a plurality of tubes positioned within a casing (channels 118 and 120 are positioned within body of manifold 110, see Figure 1A).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (7/28/2026)Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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