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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed 25 June 2026.
Claims 1-27 are pending.
Claims 13-21 and 23-25 are withdrawn.
No claims are canceled.
No claims are newly added.
Claims 1 and 22 are amended.
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 1-8, 22, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Yue et al. (US 2011/0020179 A1), hereinafter “Yue,” in view of Hintsche et al. (WO 2010040748 A1; see English translation attached through Google Patents), hereinafter “Hintsche”, and Park et al. (US 2005/0230767 A1), hereinafter “Park”.
Regarding Claim 1, Yue teaches a fluid handling apparatus for a bioprocessing system ([0005]: “a system for distribution of a biological sample”), comprising:
a first plate 30 having a first surface and a second surface (Fig. 2B);
and a sealing layer 20 disposed over the first surface (Fig. 2B shows film 20 disposed over the first surface of plate 30.);
wherein at least one fluid flow channel 70 is formed in one of the first surface of the first plate or the sealing layer or both (Fig. 2B shows main flow channels 70 formed in the first surface of the plate 30.),
at least one valve recess is formed in one of the first surface of the first plate or the sealing layer (Fig. 38 shows an embodiment wherein a dissolvable plug 3900 is positioned within a recess of the first plate 3910. [0152] states that a burst valve or Timavo valve can be used in place of the plug.),
wherein the at least one fluid flow channel 70 includes one or more fluid passageways 110 (The flow channels 70 as seen through Fig. 2B include fluid passageways 110 as the central bore through which the sample fluid flows as discussed in para. [0109], acting as a defined path, route, or conduit for fluid to be transported from the sample ports 60 to the sample chambers 80, also being part of the passageways. – Applicant’s Fig. 2 similarly shows the flow channel having a branching arrangement forming various passageways.),
wherein the at least one fluid flow channel 70 has an input port 60 and an output port 40 (Fig. 2B and [0109]: “Venting chamber 90 contains gas-permeable membranes 50 and aligns with vents 40.” – As the above recitation indicates the at least one fluid flow channel includes one or more fluid passageways, interpreted herein as the channels 110 and chambers 80 through which fluid travels from the channel 70, the vents 40 are interpreted as being of the at least one fluid flow channel 70.), and
wherein the at least one valve recess is formed in the at least one fluid flow channel 70 (Fig. 38 shows an embodiment wherein a dissolvable plug 3900 is positioned within a recess of the first plate 3910. [0152] states that a burst valve or Timavo valve can be used in place of the plug. Further, the channel 3970 of Fig. 38 corresponds to the main channel 70 of Fig. 2B as the channel 3970 is a main channel that feeds a plurality of the side channels 3975 to fill the analysis chambers 3980 commensurately as in Fig. 2B and merely provided as a different arrangement. Thus, the valve recess is formed in the at least one fluid flow channel commensurately as claimed.),
as in Claim 1.
Further regarding Claim 1, Yue does not teach the device discussed above wherein the at least one valve recess cooperates with an actuator to prevent a flow of fluid through the at least one fluid flow channel, as in Claim 1.
However, Hintsche teaches a fluidic valve mechanism for use in microfluidics systems wherein a valve recess 6 is configured to cooperate and cooperates with an actuator 7 (i.e. 7a, 7b, and/or 7c) to prevent a flow of fluid through at least one fluid flow channel 5 (see abstract, Figs. 2A and 2B and accompanying disclosure thereof). This arrangement allows the valves to be opened at specific times as defined by a user, allowing more control over the device as opposed to passive one-time operations, as well as promoting multiple uses of the device as opposed to the single-use cartridge of Yue which loses a functioning valve element after the dissolvable plug 3900 is dissolved.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the burst valve mechanism of Yue with an actuator valve recess assembly such as taught by Hintsche to provide a structure capable of user-programmed control over the valve, thus enabling complex fluidic functions, and allows multiple-use of the valve and overall device that houses it, wherein said modification would have a reasonable expectation of success in Yue.
Further regarding Claim 1, Yue does not teach the device discussed above wherein the first plate includes a ridge protruding above the first surface along substantially an entire periphery of the at least one fluid flow channel, as in Claim 1.
However, Park teaches a respective microfluidic device (abstract) wherein a first plate 202/206 is formed with ridges 210 protruding above the surface of the first plate 202/206 along the periphery of channel 216, the ridges 210 being configured to contact a sealing layer 218 to form a fluid-tight seal (Fig. 7 -- see also [0104-0105] and [0109].).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluid handling device of Yue with peripheral protruding ridges such as taught by Park to as to achieve a fluid tight seal with the sealing layer.
Further regarding Claim 1, Yue does not specifically teach the apparatus discussed above wherein the at least one fluid flow channel has across-sectional area of from about 2 square millimeters to about 35 square millimeters, as in Claim 1.
However, Yue establishes that cross-sectional flow channel size is a result-effective variable and would have been an obvious optimization objective to a person of ordinary skill in the art. Yue teaches selecting the cross-sectional dimensions of sample-introduction channels to facilitate rapid delivery while minimizing channel volume ([0081]); sizing channels to produce capillary force for transporting liquid ([0083]); and reducing channel cross-section to control the pressure gradient during filling ([0225]). Most directly, Yue teaches that decreasing a channel’s cross-sectional area increases the fluidic resistance or pressure encountered by the sample ([0242]). Accordingly, Yue expressly recognizes that changing channel width and depth—and thus cross-sectional area—predictably affects delivery or filling rate, fluidic resistance, pressure, capillary transport, and retained channel volume.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the cross-sectional flow channel size to achieve a desired channel resistance, capillary flow, and/or appropriate channel volume for the desired sample volume to be passed therethrough (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Yue teaches the fluid handling apparatus discussed above wherein:
the at least one fluid flow channel is in the first surface of the first plate (Fig. 2B shows main flow channels 70 as in the first surface of the first plate 30.),
the at least one valve recess is in the first surface along the at least one fluid flow channel (Fig. 38 shows the valve 3900 as formed in the first surface of the first plate 3910 and along the fluid supply channel 3970.),
and the at least one fluid passageway extends through the first plate from the at least one fluid flow channel to the second surface (Fig. 28 shows an embodiment wherein a passageway connects sample chamber 2880 to a venting chamber 2890 which opens to the second surface of the first plate via through hole 2800.);
and wherein the sealing layer encloses the at least one fluid flow channel (Fig. 13 demonstrates how the film layer 1320 completely covers the substrate 1330 and thus encloses the main flow channels 1370 and all accessory channels.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 2 as discussed above. Further, Yue/Hintsche does not teach the fluid handling apparatus discussed above wherein the ridge is configured to contact the sealing layer to form a seal and a groove that substantially mirrors the ridge, as in Claim 3.
However, Park teaches a respective microfluidic device (abstract) wherein a first plate 202/206 is formed with ridges 210 protruding above the surface of the first plate 202/206 along the periphery of channel 216, the ridges 210 being configured to contact a sealing layer 218 to form a fluid-tight seal (Fig. 7 -- see also [0104-0105] and [0109].). (By contacting the sealing layer, the ridge 210 further forms a groove that substantially mirrors the ridge by deforming the sealing layer around the ridge ([0109]: “When MEMS device 200 is placed under compression, sealing layer 218 is compressed against patterned structure 206, causing ridge 210 to apply stress to and deform sealing layer 218 at contact areas along ridge 210.”). As such, the ridge is configured to contact the sealing layer to form a groove that substantially mirrors the ridge as claimed.)
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluid handling device of Yue with peripheral protruding ridges which form a groove in a sealing layer, such as taught by Park, so as to achieve a fluid tight seal with the sealing layer.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Park teaches the sealing ridge protrusions discussed above wherein the ridge has an inverted v-shape or rounded profile (In this case, the ridge 210 has an inverted V-shape as shown in Fig. 7.), or comprises a plurality of spaced-apart ridges configured to contact the sealing layer to form a plurality of seals (Fig. 7 further demonstrates a plurality of ridges 210 to form a plurality of seals.), as in Claim 4. Park further teaches how this “knife’s edge” shape of the ridge provides the strongest contact with the flexible seal, resulting in a more reliable fluid-tight assembly ([0105]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize an inverted V-shaped ridge when modifying the fluid handling device of Yue with the ridge of Park so as to achieve the strongest fluid-tight seal with the sealing layer.
Regarding Claim 5, the prior art meets the limitations of Claim 2 as discussed above. Further, Hintsche teaches the valve mechanism discussed above wherein the valve recess includes a valve ridge extending across the valve recess perpendicular to a direction of fluid flow (Fig. 2A shows a valve ridge formed as the edge connecting the upper fluidic channel 4a with the valve recess 6.), the valve ridge being configured to cooperate with the sealing layer to prevent a flow of fluid past the valve recess (Fig. 2B shows when the actuator compresses the film 2a, the film 2a comes into contact with the valve ridge edge, providing a more effective fluid seal.).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to utilize a valve ridge when adding the valve of Hintsche to the fluid handling system of Yue so as to provide a more effective fluid seal.
Regarding Claim 6, the prior art meets the limitations of Claim 2 as discussed above. Further, Yue teaches the fluid handling apparatus discussed above wherein:
the first plate comprises a rigid material ([0084]: “the substrate that defines the sample-distribution network can be constructed from any solid material…including various plastic polymers and copolymers, such as polypropylenes, polystyrenes, polyimides, COP, COC, and polycarbonates. Inorganic materials such as glass and silicon are also useful.” – All of these are rigid materials.);
and the sealing layer comprises a flexible material ([0095]: “elastic properties of the film…” -- Fig. 3C further shows the film 320 as a flexible sheet.), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Yue teaches the fluid handling apparatus discussed above wherein:
the at least one fluid flow channel is a plurality of fluid flow channels (Fig. 2B shows a plurality of main flow channels 70 as well as sample introduction channels 110 which branch from the main channel.);
wherein at least one of the plurality of fluid flow channels intersects with at least another of the plurality of fluid flow channels (Fig. 2A shows that main flow channels 70 intersect with sample introduction channels 110.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Yue teaches the fluid handling apparatus discussed above further comprising:
a second plate sandwiching the sealing layer against the first plate (Fig. 4 shows sealing plate 120 which sandwiches the sealing layer 20 against the plate.), as in Claim 8.
Regarding Claim 22, Yue teaches a fluid handling apparatus for a bioprocessing system ([0005]: “a system for distribution of a biological sample”), comprising:
a first plate having a first surface and a second surface (Fig. 2B);
a sealing layer in registration with the first surface (Fig. 2B shows film 20 disposed over the first surface of plate 30.);
at least one fluid flow channel 70 formed in at least one of the first surface and the sealing layer (Fig. 2B shows main flow channels 70 formed in the first surface of the plate 30.);
at least one valve recess formed in at least one of the first surface and the sealing layer along the at least one fluid flow channel (Fig. 38 shows an embodiment wherein a dissolvable plug 3900 is positioned within a recess of the first plate 3910. [0152] states that a burst valve or Timavo valve can be used in place of the plug. – The valve is shown as positioned along the flow channel 3970.);
and at least one first fluid passageway extending through the first plate from the at least one fluid flow channel to the second surface (Fig. 28 shows an embodiment wherein a passageway connects sample chamber 2880 to a venting chamber 2890 which opens to the second surface of the first plate via through hole 2800.);
wherein the at least one fluid flow channel 70 includes one or more fluid passageways 110 (The flow channels 70 as seen through Fig. 2B include fluid passageways 110 as the central bore through which the sample fluid flows as discussed in para. [0109], acting as a defined path, route, or conduit for fluid to be transported from the sample ports 60 to the sample chambers 80, also being part of the passageways. – Applicant’s Fig. 2 similarly shows the flow channel having a branching arrangement forming various passageways.),
wherein the at least one fluid flow channel 70 has an input port 60 and an output port 40 (Fig. 2B and [0109]: “Venting chamber 90 contains gas-permeable membranes 50 and aligns with vents 40.” – As the above recitation indicates the at least one fluid flow channel includes one or more fluid passageways, interpreted herein as the channels 110 and chambers 80 through which fluid travels from the channel 70, the vents 40 are interpreted as being of the at least one fluid flow channel 70.), and
wherein the at least one valve recess is formed in the at least one fluid flow channel 70 (Fig. 38 shows an embodiment wherein a dissolvable plug 3900 is positioned within a recess of the first plate 3910. [0152] states that a burst valve or Timavo valve can be used in place of the plug. Further, the channel 3970 of Fig. 38 corresponds to the main channel 70 of Fig. 2B as the channel 3970 is a main channel that feeds a plurality of the side channels 3975 to fill the analysis chambers 3980 commensurately as in Fig. 2B and merely provided as a different arrangement. Thus, the valve recess is formed in the at least one fluid flow channel commensurately as claimed.),
as in Claim 22.
Further regarding Claim 22, Yue does not teach the device discussed above wherein the at least one valve recess cooperates with an actuator and the sealing layer to prevent a flow of fluid through the at least one fluid flow channel, as in Claim 22.
However, Hintsche teaches a fluidic valve mechanism for use in microfluidics systems wherein a valve recess 6 is configured to cooperate with and cooperates with an actuator 7 (i.e. 7a, 7b, and/or 7c) and a flexible membrane 2a to prevent a flow of fluid through at least one fluid flow channel 5 (see abstract, Figs. 2A and 2B and accompanying disclosure thereof). This arrangement allows the valves to be opened at specific times as defined by a user, allowing more control over the device as opposed to passive one-time operations, as well as promoting multiple uses of the device as opposed to the single-use cartridge of Yue which loses a functioning valve element after the dissolvable plug 3900 is dissolved.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the burst valve mechanism of Yue with an actuator valve recess assembly such as taught by Hintsche to provide a structure capable of user-programmed control over the valve, thus enabling complex fluidic functions, and allows multiple-use of the valve and overall device that houses it, wherein said modification would have a reasonable expectation of success in Yue.
Further regarding Claim 22, Yue does not teach the device discussed above wherein the first plate includes a ridge protruding above the first surface along substantially an entire periphery of the at least one fluid flow channel, as in Claim 22.
However, Park teaches a respective microfluidic device (abstract) wherein a first plate 202/206 is formed with ridges 210 protruding above the surface of the first plate 202/206 along the periphery of channel 216, the ridges 210 being configured to contact a sealing layer 218 to form a fluid-tight seal (Fig. 7 -- see also [0104-0105] and [0109].).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluid handling device of Yue with peripheral protruding ridges such as taught by Park to as to achieve a fluid tight seal with the sealing layer.
Further regarding Claim 22, Yue does not specifically teach the apparatus discussed above wherein the at least one fluid flow channel has across-sectional area of from about 2 square millimeters to about 35 square millimeters, as in Claim 22.
However, Yue establishes that cross-sectional flow channel size is a result-effective variable and would have been an obvious optimization objective to a person of ordinary skill in the art. Yue teaches selecting the cross-sectional dimensions of sample-introduction channels to facilitate rapid delivery while minimizing channel volume ([0081]); sizing channels to produce capillary force for transporting liquid ([0083]); and reducing channel cross-section to control the pressure gradient during filling ([0225]). Most directly, Yue teaches that decreasing a channel’s cross-sectional area increases the fluidic resistance or pressure encountered by the sample ([0242]). Accordingly, Yue expressly recognizes that changing channel width and depth—and thus cross-sectional area—predictably affects delivery or filling rate, fluidic resistance, pressure, capillary transport, and retained channel volume.
Thus, one of ordinary skill in the art would have optimized through routine experimentation the cross-sectional flow channel size to achieve a desired channel resistance, capillary flow, and/or appropriate channel volume for the desired sample volume to be passed therethrough (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding Claim 26, the prior art meets the limitations of Claim 1 as discussed above. Further, Yue teaches the microfluidic device discussed above wherein the first plate includes a plurality of protrusions extending above the first surface and configured to serve as an alignment feature ([0136]: “Providing the blades 1122 as part of the carrier 1120 (e.g., an integral part of the carrier 1120) may facilitate manufacturing and alignment of the blades 1122, as the appropriate alignment can be assured prior to sealing the substrate 1110 with the carrier 1120.”), as in Claim 26.
Regarding Claim 27, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the fluidic device of Yue with the peripheral ridge of Park so as to form a fluid tight seal surrounding the fluidic elements of the device. Therein, the ridges 210 of the substrate layer 202 form a complementary trough in the layer 218 into which they protrude, as can be seen through Fig. 7 and id discussed in para. [0109].
Thus, given that the valve recess of Yue comprises a fluid flow passageway, one skilled in the art would find it obvious that, when modifying Yue with the ridge/trough arrangement of Park, to include the valve recess as a structure having a trough formed opposite the ridge so as to maintain a fluid-tight seal as it is a fluid-handling element.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yue in view of Hintsche and Park, as applied to Claims 1-8, 22, and 26 above, and in further view of Webster et al. (US 2005/0180891 A1), hereinafter “Webster.”
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, Hintsche teaches the valve assembly discussed above wherein an actuator is extendable to bias the sealing layer into contact with a surface of the at least one valve recess to occlude or reduce fluid flow through the at least one fluid flow channel (Figs. 2A and 2B).
Hintsche does not teach a second plate having a through hole or aperture machined for an actuator to pass therethrough.
However, Webster teaches a respective microfluidic device wherein an actuator 24 is similarly configured to deform a flexible layer 23 against a recess 24 to act as a valve seal as in Hintsche. Webster additionally teaches a substrate 22 machined with a through hole/aperture 141 for the actuator 24 to pass therethrough and reach the flexible layer 23.
Thus, one of ordinary skill in the art would find it obvious to provide a through hole to the substrate of Yue when modifying Yue to include the actuator of Hintsche to allow said actuator to pass therethrough and reach the film 20 of Yue so as to enable its function of compressing said film 20 to form a valve seal.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yue in view of Hintsche and Park, as applied to Claims 1-8, 22, and 26 above, and in further view of Wang et al. (US 2013/0206597 A1), hereinafter “Wang.”
Regarding Claim 10, the prior art meets the limitations of Claim 9 as discussed above. Further, Yue/Hintsche does not specifically teach the fluid handling apparatus discussed above wherein the second plate is mechanically joined to the first plate and compressed against the first plate.
However, Wang teaches a respective microfluidic device for actuating and handling droplets wherein a second plate 112 is mechanically joined to a first plate 110 and compressed against the first plate 110 (Figs. 1B and 1C). ([0095]: “The production process may consist of compressing the top substrate into the PCB (with the rubber material in between) and then heat stamping the overhanging cylindrical pegs of the top substrate into the PCB. This process allows the rubber material to be pressure fit into the droplet actuator assembly and also allows the assembly to be liquid tight.”)
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to compress the layers of Yue/Hintsche together such as taught by Wang so as to achieve a liquid-tight seal.
Regarding Claim 11, the prior art meets the limitations of Claim 10 as discussed above. Further, Yue/Hintsche does not specifically teach the fluid handling apparatus discussed above wherein said mechanical joining comprises plural securing pegs extending between the first and second plates through the sealing layer, said pegs each including a head to maintain said compression.
However, Wang teaches cylindrical pegs extending between the first plate (the droplet operations substrate 116), the second plate (thermoplastic top substrate 112), and the sealing layer (gasket 130), as shown in Figs. 1B and 1C. Said pegs each include a head (“the overhanging cylindrical pegs of the top substrate”) to maintain compression. (“In another embodiment, the droplet actuator assemblies may be produced using a…thermoplastic top substrate that has cylindrical pegs that fit into holes located in the droplet operations substrate…This process allows the rubber material to be pressure fit into the droplet actuator assembly and also allows the assembly to be liquid tight.” ([0095]).)
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the fluidic device of Yue/Hintsche with securing pegs such as taught by Wang so as to provide a structure for compressing the layers of the device together so as to achieve a liquid-tight seal.
Regarding Claim 12, the prior art meets the limitations of Claim 11 as discussed above. Further, Yue/Hintsche does not specifically teach the fluid handling apparatus discussed above wherein said heads are formed during assembly of the apparatus by melting the head at the same time as compressing the first and second plates together.
However, Wang teaches heat stamping of the heads of the cylindrical pegs while compressing the plates together, “The production process may consist of compressing the top substrate into the PCB (with the rubber material in between) and then heat stamping the overhanging cylindrical pegs of the top substrate into the PCB. This process allows the rubber material to be pressure fit into the droplet actuator assembly and also allows the assembly to be liquid tight.” ([0095]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to produce the fluid handling apparatus of Yue/Hintsche using compression and heat stamping such as taught by Wang so as to achieve a liquid-tight seal.
Response to Arguments
35 USC 112
Applicant amendment of Claim 22 sufficiently overcomes the indefiniteness rejection under 35 USC 112(b) set forth by the previous office action. As such, the rejection of Claim 22 under 35 USC 112(b) is withdrawn herein.
35 USC 103
Applicant’s arguments are on the alleged grounds that Yue, Hintsche, and Park are limited to microfluidic devices having channel cross-sectional areas below 0.5 mm², whereas Claims 1 and 22 require a non-microfluidic channel having a cross-sectional area from about 2 mm² to about 35 mm² and operating at milliliter-per-minute flow rates.
Applicant’s arguments are not persuasive because Yue establishes that changing a channel cross-sectional area affects fluid-handling results. Yue expressly recognizes the relationship between channel cross-sectional area and delivery rate, contained volume, capillary force, pressure gradient, leakage, fluidic resistance, and filling behavior – see the bolded sections cited above in the body of the action. Cross-sectional area therefore was a recognized result-effective variable at the time the invention was made — see MPEP § 2144.05(III)(C). Thus, the disclosure of Yue accounts for Applicant’s claimed range.
Further, Hintsche specifically supplies the relevant scale and an expressly overlapping dimensional range. Hintsche [0062] states that the dimensions and structures of its channels are adapted to the application, that their dimensions are “freely selectable,” and that preferred structural dimensions are from 0.1 mm to 10 mm. Hintsche expressly states that these dimensions permit both microfluidic systems and “voluminous fluidic systems.” Hintsche’s disclosed dimensions include, for example, 1 mm × 2 mm and 4 mm × 2 mm channels, corresponding to cross-sectional areas of 2 mm² and 8 mm². This disclosure directly overlapping the claimed range of about 2 mm² to about 35 mm².
Thus, in view of the above, Applicant’s argument that Yue is in a different scale than the instant claims is not persuasive, the disclosure of Yue teaching obvious optimization of the channel scale/cross-sectional area as a result-effective variable directly affecting flow impedance through the channel, and Hintsche teaching a respective channel device having channels at Applicant’s scale. By this, examiner maintains the rejection of Claims 1 and 22 under 35 USC 103 as being unpatentable over Yue in view of Hintsche and Park, wherein the new grounds of rejection identifying Yue as providing the channel cross-sectional area as a result-effective variable was necessitated by Applicant’s amendments.
Applicant’s arguments are further on the alleged grounds that Yue’s vents 40 cannot constitute the claimed output ports because Yue’s gas-permeable membranes may be liquid-impermeable and prevent liquid from leaving the device.
Applicant’s argument is not persuasive because the claim does not require the output port to be fluid permeable. The term “output” is merely nominal, not having any particular structural meaning and merely serving as a naming identifier, and the “port” is satisfied by the vent opening provided by Yue. Further, Hintsche [0062, 0067] discusses fluid flowing from input port to outlet port wherein one would find this arrangement obvious in Yue for providing an entrance and exit point for fluid, as is similarly discussed by Yue [0152] discussing terminating the venting channel to a waste port.
Applicant’s arguments are further on the alleged grounds that replacing Yue’s dissolvable plug with Hintsche’s externally actuated valve would fundamentally alter Yue’s single-use operating principle, require a different architecture and control system, and render Yue inoperable under In re Gordon.
Applicant’s argument is not persuasive because Yue does not make use of the dissolvable plug an indispensable operating principle. Yue describes plug 3900 as temporarily blocking flow while dissolving at a controlled rate ([0148]). Yue further states that a burst valve or Timavo valve may be used instead of the dissolvable plug ([0152]). Yue therefore recognizes alternative valve mechanisms at that location. Hintsche teaches a predictable active-valve alternative. Hintsche [0025] discloses an external actuator pressing an elastic film into a recessed valve seat to interrupt liquid flow completely. Hintsche [0027] teaches an elastic film capable of repeated deformation, and [0036] teaches programmed sequences of valve opening and closing for automated liquid handling; [0080] further describes reversible, pressure-tight opening and closing, each of which being fully compatible with the commensurate chip of Yue having a layer patterned with channel recesses and a sealing layer.
The proposed modification therefore does not require making Yue’s entire cartridge “reusable”. The modification uses Hintsche’s known actuator-controlled valve at a flow-control location to provide selectable and repeatable valve operation during a processing run. Yue’s fundamental function of distributing a biological sample through channels to sample chambers remains unchanged. The modification provides more precise timing and control while preserving the intended flow-distribution function. This situation is unlike In re Gordon, where the proposed inversion of a gravity-operated separator destroyed the very separation mechanism required for operation. See MPEP § 2143.01(V). Here, both Yue’s plug and Hintsche’s actuated valve perform the same basic function of selectively blocking flow, and Hintsche expressly demonstrates successful operation of its valve in planar liquid-handling channels. The substitution consequently would have produced the predictable result of controllable flow interruption with a reasonable expectation of success. See MPEP §§ 2143.01(B) and 2143.02.
By this, examiner maintains the rejection of Claims 1 and 22 under 35 USC 103 as being unpatentable over Yue in view of Hintsche and Park.
Applicant’s arguments are further on the alleged grounds that Yue, Hintsche, and Park are non-analogous microfluidic or MEMS references directed to diagnostic cartridges, whereas the claimed apparatus is a macro-scale, reusable bioprocessing manifold for cell-therapy manufacturing, and that differences in materials, dimensions, pressures, and fabrication methods would have discouraged the combination.
Applicant’s argument is not persuasive because, under MPEP § 2141.01(a), a reference is analogous if it is either within the same field of endeavor or reasonably pertinent to the problem addressed by the inventor. A reference need satisfy only one test. Yue is within the same general field because it concerns planar apparatuses for distributing and processing biological samples through channels, ports, chambers, films, and flow-control structures. Hintsche likewise concerns planar liquid-handling apparatuses containing channels, ports. Further, Park likewise concerns planar microfluidic liquid handling in a layered device. Thus, the references lie within the same field of endeavor and address problems common in microfluidic devices: control over fluid flow, and reducing leakage and contamination.
Claim 1 does not require Applicant’s asserted silicone thickness, hardness, particular polymer, manufacturing method, cell-therapy use, or reuse capability. Applicant also has not submitted experimental evidence or a technical declaration showing that Hintsche’s valve or Park’s ridge-and-seal arrangement would fail at a channel area within Hintsche’s expressly disclosed 2-8 mm² overlap. Attorney argument cannot substitute for evidence where evidence is required to rebut a supported prima facie case. MPEP § 2145(I).
Accordingly, Yue, Hintsche, and Park are analogous or reasonably pertinent art, and their express structural and dimensional disclosures provide a reasonable expectation that the proposed combination would operate successfully.
Applicant’s arguments are further on the alleged grounds that Claims 2-8 and 26-27 are patentable because they depend from Claim 1 and because the alleged deficiencies concerning Claim 1 are not cured by the additional dependent-claim analysis.
Applicant’s argument is not persuasive because the asserted deficiencies concerning Claim 1 have not been established for the reasons discussed above. Applicant does not identify a specific error in the separate prior-art findings for any additional limitation of Claims 2-8 or 26-27.
Thus, Examiner maintains the rejection of Claims 2-8 and 26-27 as unpatentable under 35 USC 103 for the reasons discussed above in the body of the action.
Applicant’s arguments are further on the alleged grounds that Caim 9 is patentable for the same reasons asserted for Claim 1, and that Webster does not cure the alleged deficiencies in the rejection of Claim 1 over Yue, Hintsche, and Park.
Applicant’s argument is not persuasive because, as discussed above, the asserted deficiencies in the rejection of Claim 1 are refuted. Moreover, Webster is not relied upon to cure those alleged deficiencies, but only to teach the additional limitation recited by Claim 9. Accordingly, Applicant’s argument does not overcome the rejection of Claim 9.
Thus, Examiner maintains the rejection of Claim 9 as unpatentable under 35 USC 103 for the reasons discussed above in the body of the action.
Applicant’s arguments are further on the alleged grounds that Claims 10-12 are patentable for the same reasons asserted for Claim 1, and that Wang does not cure the alleged deficiencies in the rejection of Claim 1 over Yue, Hintsche, and Park.
The argument is not persuasive. As discussed above, the asserted deficiencies in the rejection of claim 1 have not been established. Moreover, Wang is not relied upon to cure those alleged deficiencies, but only to teach the additional limitations recited by claims 10-12. Accordingly, Applicant’s argument does not overcome the rejection of claims 10-12.
Thus, Examiner maintains the rejection of Claims 10-12 as unpatentable under 35 USC 103 for the reasons discussed above in the body of the action.
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 BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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