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 on 23 June 2026.
Claims 1, 4-6, 8-11, 13-16, and 18-23 are pending.
Claims 2-3, 7, 12, and 17 are canceled.
No claims are withdrawn from consideration.
Claims 21-23 are newly added.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 11 is 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.
Regarding Claim 11, the claim requires a “branch point” of the mixing channel, mixing connection channel, and/or pneumatic channel, wherein it is unclear at what position the branch point is located.
Further, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The discussion of branch points in Claim 11, are contrary to the conventional meaning of branching channels, wherein one channel branches into two separate channels (forming a splitting or offshooting arrangement). Instead, as seen through Applicant’s instant Fig. 7, such branching appears to refer to a mere narrowing of the channel 123 into the channel 127 contrary to the typical meaning of branching. Applicant may wish to amend the claim to instead recite a constriction point if in accordance with the instant disclosure.
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, 4-6, 8-11, 13-16, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ririe et al. (US 2021/0095330 A1), hereinafter “Ririe”, in view of Veres et al. (US 2017/0036208 A1), hereinafter “Veres”.
Regarding Claim 1, Ririe teaches a cartridge 10 for detecting a target analyte (Fig. 1 and [0006]), comprising:
A plate-shaped base 217 comprising a first surface, a second surface opposite to the first surface, and side surfaces connecting between the first surface and the second surface (The annotated Fig. 1 below shows the surfaces of the cartridge 10 arranged commensurately as claimed. – Further, regarding the base being “plate-shaped”, see Ririe Figs. 6 and 8 showing the bladder assembly and fitment 210 (and flat plastic film portion 210 thereof) as being a planar assortment of channels and chambers, thereby forming a flat “plate” structure in shape. The term “plate shaped” is interpreted broadly herein to encompass any substantially flat arrangement of the relevant elements of the device including the channel assembly herein. Further, merely changing the shape of the base is an obvious matter of design choice when the result achieves the same desired function and structural arrangement of channels and chambers – see MPEP 2144.04(IV)(B).);
wherein at least one of the chambers and at least one of the channels are formed as recessed portions on the base and sealed by a cover 804 (See Fig. 6 showing the channels and chambers formed as recesses in the plastic base portion 217. See also Fig. 8 showing the sealing cover 804 which mounts on the opposite side of the bladder assembly 810 as the base. See also [0101] discussing the support cover 804 as compressing and thereby sealing onto the base/bladder assembly such that pressure may be actuated to actuate fluid.),
a sample chamber into which a sample is introduced (See Fig. 1 showing the sample injection port 12 and the chamber 22 for receiving the sample. See also paras. [0039, 0047].);
a first mixing chamber 58 connected to the sample chamber and containing a magnetic bead 56 (Fig. 1 and [0053]: “The magnetic beads 56 are captured in blister 58 by a retractable magnet 50...”);
a second mixing chamber 61 connected to the first mixing chamber 58 and containing a dry reagent (Fig. 1 and [0057]: “dried reagents may be spotted onto the location of blister 61”);
a detection chamber 82 connected to the second mixing chamber 61 and in which the target analyte is detected (Fig. 1 and [0066]: “The optics provided may be configured to capture images of all blisters 82 at once, or individual optics may be provided for each individual blister.”);
a detection channel 78 connecting the second mixing chamber 61 and the detection chamber 82 (See the annotated Fig. 1 below.); and
a first pneumatic channel (Fig. 8 shows hoses 878 (the pneumatic channels) connecting the pressure source 895 to the pneumatic fittings (843a, for example) to provide gaseous communication therebetween for pressure actuation.) communicated with a first pneumatic port (Fig. 2a and [0045]: “...but individual blisters in the bladder assembly 710 include pneumatic fittings (illustratively fitting 724 a) allowing individual bladders within the bladder assembly 710 to be pressurized by a compressed gas source.”) through which pneumatic pressure is supplied and connected to the second mixing chamber 61 ([0046]: “When pouch 10 is placed within the instrument, the pneumatic bladder assembly 710 is pressed against one face of the pouch 10, so that if a particular bladder is inflated, the pressure will force the liquid out of the corresponding blister in the pouch 10.” – See also para. [0057] regarding pressure actuation involving the mixing chamber 61.),
wherein the second mixing chamber includes an upper space communicating with the first pneumatic channel and a lower space containing the dry reagent, the lower space being deeper than the upper space (See Fig. 8 showing the second mixing chamber formed as a recessed space of the fitment 290 wherein the chamber thereby comprises a lower space and an upper space, and the pneumatic bladder assembly and ports thereof connecting to the pneumatic hoses 878. As discussed above, the second mixing chamber comprises a dry reagent. When the fitment is oriented with the pneumatic points pointing upward, the reagent falls to the bottom lower space while the pneumatic hose connects with the upper space, such as is the case even when the fitment is oriented on its side as shown through Fig. 8 wherein the dry reagent would remain as falling to a lower point by way of gravity.),
as in Claim 1.
Further regarding Claim 1, Ririe does not specifically teach the cartridge device discussed above further comprising a shuttle chamber connected to the first mixing chamber and providing a dissolution space, a mixing connection channel connecting the first mixing chamber and the second mixing chamber, a shuttle channel connecting the second mixing chamber and the shuttle chamber, wherein the shuttle chamber is configured to dissolve the dry reagent provided from the second mixing chamber into the solution provided from the first mixing chamber, wherein the mixing connection channel is connected to a first port of the shuttle chamber, and the shuttle channel is connected to a second port of the shuttle chamber, where the first port is positioned higher than the second port in a direction of gravity when the cartridge is in an upright state, and wherein a fluid in the second mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from the first pneumatic port, or the fluid in the shuttle chamber is movable to the second mixing chamber through the shuttle channel by negative pressure provided from the first pneumatic port, as in Claim 1.
However, Veres teaches a respective microfluidic device comprising a shuttle chamber and a mixing chamber connected by a siphon-shaped channel (See Fig. 12b where the upper chamber is the shuttle chamber and the lower chamber is the mixing chamber), therein providing a dissolution space within its volume where a dry reagent may be dissolved in a liquid. Therebetween the mixing chamber and the shuttle chamber is a shuttle channel which siphons liquid to the mixing chamber. The shuttle channel is connected to a port of the shuttle chamber, where the port is positioned higher than the sample-introduction port in a direction of gravity when the cartridge is in an upright state, given that the shuttle channel port extends downward into the chamber to aspirate the liquid shown therein Fig. 12b. And wherein a fluid in the mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from a pneumatic port, or the fluid in the shuttle chamber is movable to the second mixing chamber through the shuttle channel by negative pressure provided from a pneumatic port ([0079]: “A positive pressure at the vent is equivalent to a negative pressure at the port, and accordingly all of the processes described can be implemented by alternating couplings to the supply lines and ambient, and reversing the pressurization relative to ambient, and further advantages may be provided by coupling both the port and vent to respective, independently controlled (or oppositely pressurized) channels.”). Therein, this arrangement provides a dedicated mixing chamber for sample fluid received by the device, the shuttle chamber, for mixing reagent via bubble mixing before transferring the mixture to the mixing chamber (See [0100-0108] and Figs. 12c and 14.), and for transferring back and forth through the shuttle channel as discussed above.
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 cartridge of Ririe further comprising a shuttle chamber connected to the first mixing chamber and providing a dissolution space, a shuttle channel connecting the second mixing chamber and the shuttle chamber, wherein the shuttle chamber is configured to dissolve the dry reagent provided from the second mixing chamber into the solution provided from the first mixing chamber, wherein the mixing connection channel is connected to a first port of the shuttle chamber, and the shuttle channel is connected to a second port of the shuttle chamber, where the first port is positioned higher than the second port in a direction of gravity when the cartridge is in an upright state, and wherein a fluid in the second mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from the first pneumatic port, or the fluid in the shuttle chamber is movable to the second mixing chamber through the shuttle channel by negative pressure provided from the first pneumatic port, such as suggested by Veres, so as to provide a dedicated mixing chamber for sample fluid received by the device, the shuttle chamber, for mixing reagent via bubble mixing before transferring the mixture to the mixing chamber, thereby ensuring adequate mixing before and during fluid advancement back and forth among the chambers.
Further, when such modification is implemented in Ririe, it would be necessary to connect the sample inlet channel of Veres to the first mixing chamber of Ririe, so as to obtain the first mixed mixture. Thereby, the “a mixing connection channel connecting the first mixing chamber and the second mixing chamber” corresponds to the inlet channel of Veres and is maintained in the modification of Ririe.
Further, Examiner generally notes that the variously designated channels, chambers, and ports of the device (mixing channel, pneumatic port, etc.) are mere nominal designations not afforded particular patentable weight with regard to the function implied through the nominal designation. For example, the first/second mixing chambers are effectively claimed as mere chambers. Applicant must particularly point out and claim the specific structure which affords the sought function, such as a stirring mechanism within the mixing chambers for example.
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Regarding Claim 4, the prior art meets the limitations of Claim 2 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein the shuttle chamber is disposed below the first mixing chamber and the second mixing chamber in a direction of gravity when the cartridge is in an upright state (See Veres Fig. 12c showing another arrangement of the shuttle chamber and the mixing chamber, wherein when the device is oriented on its side, and the first mixing chamber of Ririe is considered to be positioned at the sample inlet, the shuttle chamber would be below both mixing chambers. Examiner further notes that the claim is predicated on the conditional “when the cartridge is in an upright state” which is not necessitated by the claim and is thereby not afforded patentable weight. The cartridge may be positioned and viewed from any particular orientation, not merely Applicant’s desired viewpoint. Applicant may wish to structurally distinguish the chamber locations functionally by way of the desired flow by gravity instead of using relative above/below terms.), as in Claim 4.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Ririe in view of Veres, to maintain the chamber placement positions of Veres so as to maintain the desired siphon-driven flow and liquid distribution as in Veres.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein the shuttle channel comprises an inverted U-shaped portion configured to provide siphon flow (See Veres Fig. 12b and [0094].), as in Claim 5.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Ririe in view of Veres, to maintain the inverted-U-shaped siphon channel as the shuttle channel so as to maintain the gravity driven flow desired by Veres allowing flow from the shuttle chamber to the mixing chamber by way of gravity alone.
Regarding Claim 6, the prior art meets the limitations of Claim 4 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein the shuttle channel extends upward from a bottom of the second mixing chamber and then extends downward through a U- shaped portion to be connected to the shuttle chamber (See Veres Fig. 12b and [0094].), as in Claim 6.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Ririe in view of Veres, to maintain the shuttle channel extending upward from a bottom of the second mixing chamber and then extending downward through a U-shaped portion to be connected to the shuttle chamber so as to maintain the gravity driven flow desired by Veres allowing flow from the shuttle chamber to the mixing chamber by way of gravity alone.
Regarding Claim 7, the prior art meets the limitations of Claim 2 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein a portion of the shuttle chamber connected to the shuttle channel is located lower than a portion of the shuttle chamber connected to the mixing connection channel (See Veres Fig. 12b and [0094] where the inlet channel, corresponding to the mixing connection channel, attaches at an upper portion of the shuttle chamber, and where the shuttle channel extends into the shuttle chamber to open and connect at a lower portion than the mixing connection channel, thereby avoiding backflow through the mixing connection channel.), as in Claim 7.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Ririe in view of Veres, to maintain the portion of the shuttle chamber connected to the shuttle channel as located lower than a portion of the shuttle chamber connected to the mixing connection channel so as to maintain the gravity driven flow desired by Veres allowing flow from the shuttle chamber to the mixing chamber by way of gravity alone, and so as to avoid backflow through the mixing connection channel.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe teaches the cartridge discussed above further comprising a metering chamber connected to the sample chamber for quantifying the sample; a waste chamber connected to the metering chamber; and a waste channel connecting the metering chamber and the waste chamber (See the annotated Fig. 1 above.), as in Claim 8.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Ririe teaches the cartridge discussed above wherein the first pneumatic channel is branched into a first branch channel and a second branch channel (Fig. 1 shows branching of the pneumatic channel 878 through the pneumatic valve assembly 808. – See also para. [0101].), and wherein the first branch channel is connected to the second mixing chamber (Fig. 8 shows the piston 858 corresponding to a second mixing chamber, and Fig. 1 shows the pneumatic bladder 848 corresponding to the second mixing chamber. – Note that Ririe maintains a second mixing chamber downstream of the first mixing chamber, Veres is relied on for the shuttle chamber and its connection to the first/second mixing chambers.), and the second branch channel is connected to the waste channel (Fig. 2a shows gas bladder 726 connected to the waste channel, and Fig. 8 shows the piston 862 corresponding to the waste channel.), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 9 as discussed above. Further, Ririe teaches the cartridge discussed above wherein the metering chamber is connected to a junction where the first pneumatic channel is connected to the waste channel (See the annotated Fig. 1 above.); and wherein an angle between the first pneumatic channel and the waste channel is greater than an angle between the first pneumatic channel and a channel connected to the metering chamber at the junction (When viewed in the top-down view as in Fig. 1, the channel 38 fluidically connected to the channel junction has a lesser angle between itself and the pneumatic channels of the valve assembly 808 compared with that of the waste channel. Further, different orientations of the device may afford different angles further satisfying the claim requirements.), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 8 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above further comprising a mixing channel connecting a lower portion of the metering chamber and a lower portion of the first mixing chamber 58 (See the annotated Fig. 1 above.),
wherein the mixing channel extends upward from the lower portion of the first mixing chamber to a first branch point (See the annotated Fig, 1A above showing the mixing channel extending upward to the branch point, the first mixing chamber.),
wherein the mixing connection channel extends from the first branch point toward the shuttle chamber (When implemented with Veres as discussed above regarding Claim 1, the mixing connection channel extends from the first branch point of the first mixing chamber towards the shuttle chamber – see Veres Fig. 12b.), and
wherein valves are respectively provided between the first branch point and the metering chamber, and between the first branch point and the shuttle chamber (See the blister valve arrangement shown in Fig. 9 corresponding to the channel between the first branch point and the metering chamber, and [0046] discussing such pinch valve arrangements as sealing off the channels. See further Fig. 9 where the valve leading from the first mixing chamber would be for control over the shuttle chamber when implemented from Veres.),
as in Claim 11.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe teaches the cartridge discussed above wherein the second mixing chamber comprises an ultrasonic receiving area configured to receive ultrasonic waves through a surface of the cartridge (As the second mixing chamber 61 of Ririe is commensurately structured as a “chamber”, it is commensurately fully capable of serving as an ultrasonic receiving area, given such ultrasonic receiving is provided as a mere “area” wherein the area in Ririe meets this limitation. Applicant may wish to claim the specific structure which corresponds/allows for ultrasonic receiving. -- Note that Ririe maintains a second mixing chamber downstream of the first mixing chamber, Veres is relied on for the shuttle chamber and its connection to the first/second mixing chambers.), as in Claim 13.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe teaches the cartridge discussed above wherein the second mixing chamber 61 comprises a heat receiving area configured to receive heat through a surface of the cartridge (Similarly as above regarding Claim 13, as the second mixing chamber 61 of Ririe is commensurately structured as a “chamber”, it is commensurately fully capable of serving as a heat receiving area, given such heat receiving is provided as a mere “area” wherein the area in Ririe meets this limitation. Applicant may wish to claim the specific structure which corresponds/allows for heat receiving. -- Note that Ririe maintains a second mixing chamber downstream of the first mixing chamber, Veres is relied on for the shuttle chamber and its connection to the first/second mixing chambers.), as in Claim 14.
Regarding Claim 15, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein the shuttle chamber is located below the second mixing chamber (See Veres Fig. 12b and 12c where reorienting the device shows the shuttle chamber below the second mixing chamber. – Note that such an orientation of the device is not necessarily the state in which it is operated, merely the orientation in which it is viewed, given that the term “below” is a relative term that is accounted for by different viewing angles. Applicant may wish to instead specify the chamber locations functionally by the desired gravity-driven sequence of flow.), the mixing connection channel is connected to one side of the shuttle chamber, and the shuttle channel is connected to an other side opposite to the one side of the shuttle chamber (See Veres Fig. 12c showing an embodiment where the inlet channel, corresponding to the mixing connection channel, is connected to one side and the shuttle channel connecting to the second mixing chamber is connected at the opposite side as the inlet channel. – Therein, this arrangement prevents backflow through the inlet channel.), as in Claim 15.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Ririe in view of Veres, to maintain the shuttle chamber is located below the second mixing chamber, the mixing connection channel as connected to one side of the shuttle chamber, and the shuttle channel is connected to an other side opposite to the one side of the shuttle chamber so as to maintain the gravity driven flow desired by Veres allowing flow from the shuttle chamber to the mixing chamber by way of gravity alone, and so as to avoid backflow through the mixing connection channel.
Regarding Claim 16, the prior art meets the limitations of Claim 15 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein the shuttle chamber is provided with a width in a horizontal direction larger than a height in a vertical direction (See Veres Fig. 13 showing the chambers as being larger in a horizontal, in-the-plane of the chip, direction than the vertical, perpendicular-to-the-chip, direction.), as in Claim 16.
Therein, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide such a chamber sizing in Ririe given that Ririe commensurately provides a flat card-like flow structure where the chambers are also greater in width than height, thereby maintaining the laminated/layered microfluidic arrangement desired by both references.
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above further comprising a second pneumatic channel communicated with a second pneumatic port through which pneumatic pressure is supplied and connected to the first mixing chamber 58 (Fig. 9 and [0053]: “...applying pressure to blister 58...”), and wherein a fluid in the second mixing chamber 61 is moved to the shuttle chamber 62 by positive pressure provided from the first pneumatic port, and a fluid in the shuttle chamber 62 is moved to the second mixing chamber 61 by positive pressure provided from the second pneumatic port (Para. [0060] discusses increasing and decreasing the pressure in the second mixing chamber 61 and the shuttle chamber 62 to actuate a fluid contained therewithin between said second mixing chamber 61 and said shuttle chamber 62 to cause mixing. -- Examiner further notes that this recitation is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). – Further, when implemented with Ririe, the shuttle chamber fluidically between the first and second mixing chambers would commensurately receive and discharge the fluid as claimed given the same arrangement of channels and chambers is present. Applicant may wish to claim a controller configured to perform the desired pressure operations), as in Claim 18.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when the shuttle chamber of Veres is implemented with the first and second mixing chambers of Ririe, that the resulting arrangement would commensurately be fully capable of performing the claimed back and forth fluid actuation, given the commensurate arrangement of channels and chambers.
Regarding Claim 19, Ririe teaches a cartridge 10 for detecting a target analyte (Fig. 1 and [0006]), comprising:
A plate-shaped base comprising a first surface, a second surface opposite the first surface, and side surfaces connecting between the first surface and the second surface (The annotated Fig. 1 above shows the surfaces of the cartridge 10 arranged commensurately as claimed. – Further, regarding the base being “plate-shaped”, see Ririe Figs. 6 and 8 showing the bladder assembly and fitment 210 (and flat plastic film portion 210 thereof) as being a planar assortment of channels and chambers, thereby forming a flat “plate” structure in shape. The term “plate shaped” is interpreted broadly herein to encompass any substantially flat arrangement of the relevant elements of the device including the channel assembly herein. Further, merely changing the shape of the base is an obvious matter of design choice when the result achieves the same desired function and structural arrangement of channels and chambers – see MPEP 2144.04(IV)(B).);
wherein at least one of the chambers and at least one of the channels are formed as recessed portions on the base and sealed by a cover 804 (See Fig. 6 showing the channels and chambers formed as recesses in the plastic base portion 217. See also Fig. 8 showing the sealing cover 804 which mounts on the opposite side of the bladder assembly 810 as the base. See also [0101] discussing the support cover 804 as compressing and thereby sealing onto the base/bladder assembly such that pressure may be actuated to actuate fluid.),
a sample chamber into which a sample is introduced (See Fig. 1 showing the sample injection port 12 and the chamber 22 for receiving the sample. See also paras. [0039, 0047].);
a metering chamber connected to the sample chamber configured to quantify the sample (See the annotated Fig. 1 above.);
a first mixing chamber 58 connected to the metering chamber and containing a magnetic bead 56 (Fig. 1 and [0053]: “The magnetic beads 56 are captured in blister 58 by a retractable magnet 50...”);
a liquid storage chamber 48 connected to the first mixing chamber 58 and storing a liquid (Fig. 1 and [0053]: “The individual components needed for nucleic acid extraction illustratively reside in blisters 44, 46, 48...”);
a second mixing chamber 61 connected to the first mixing chamber 58 and containing a dry reagent (Fig. 1 and [0057]: “dried reagents may be spotted onto the location of blister 61”);
a detection chamber 82 connected to the second mixing chamber and in which the target analyte is detected (Fig. 1 and [0066]: “The optics provided may be configured to capture images of all blisters 82 at once, or individual optics may be provided for each individual blister.”);
a metering channel connecting the sample chamber and the metering chamber (See the annotated Fig. 1 above.);
a mixing channel connecting the metering chamber and the first mixing chamber 58 (See the annotated Fig. 1 above.);
a liquid transport channel connecting the liquid storage chamber 48 and the first mixing chamber 58 (See the annotated Fig. 1 above.);
a detection channel connecting the second mixing chamber 61 and the detection chamber 82 (See the annotated Fig. 1 above.); and
a first pneumatic channel communicated with a first pneumatic port through which pneumatic pressure is supplied and connected to the second mixing chamber; and a second pneumatic channel communicated with a second pneumatic port through which pneumatic pressure is supplied and connected to the first mixing chamber (See Fig. 7 showing pneumatic bladder 844 corresponding to the first mixing chamber, and pneumatic bladder 848 corresponding to the second mixing chamber, each respective bladder comprising a pneumatic fitting/port 844a/848a to which a pneumatic channel is connected.),
wherein the first mixing chamber comprises an upper space communicating with the second pneumatic channel and a lower space containing the magnetic bead, the lower space being deeper than the upper space (See Fig. 8 showing the first mixing chamber formed as a recessed space of the fitment 290 wherein the chamber thereby comprises a lower space and an upper space, and the pneumatic bladder assembly and ports thereof connecting to the pneumatic hoses 878. As discussed above, the first mixing chamber comprises a magnetic bead. When the fitment is oriented with the pneumatic points pointing upward, the bead falls to the bottom lower space while the pneumatic hose connects with the upper space, such as is the case even when the fitment is oriented on its side as shown through Fig. 8 wherein the bead would remain as falling to a lower point by way of gravity.),
wherein the second mixing chamber comprises an upper space communicating with the first pneumatic channel and a lower space containing the dry reagent, the lower space being deeper than the upper space (See Fig. 8 showing the second mixing chamber formed as a recessed space of the fitment 290 wherein the chamber thereby comprises a lower space and an upper space, and the pneumatic bladder assembly and ports thereof connecting to the pneumatic hoses 878. As discussed above, the second mixing chamber comprises a dry reagent. When the fitment is oriented with the pneumatic points pointing upward, the reagent falls to the bottom lower space while the pneumatic hose connects with the upper space, such as is the case even when the fitment is oriented on its side as shown through Fig. 8 wherein the dry reagent would remain as falling to a lower point by way of gravity.),
as in Claim 19.
Further regarding Claim 19, Ririe does not specifically teach the cartridge device discussed above further comprising a shuttle chamber connected to the first mixing chamber and providing a dissolution space, a mixing connection channel connecting the first mixing chamber and the second mixing chamber, a shuttle channel connecting the second mixing chamber and the shuttle chamber, wherein the shuttle chamber is configured to dissolve the dry reagent provided from the second mixing chamber into the solution provided from the first mixing chamber, wherein the mixing connection channel is connected to a first port of the shuttle chamber, and the shuttle channel is connected to a second port of the shuttle chamber, where the first port is positioned higher than the second port in a direction of gravity when the cartridge is in an upright state, and wherein the shuttle chamber and the second mixing chamber are configured to dissolve the dry reagent by reciprocating a fluid through the shuttle channel between the second mixing chamber and the shuttle chamber via the first and second pneumatic ports, as in Claim 19.
However, Veres teaches a respective microfluidic device comprising a shuttle chamber and a mixing chamber connected by a siphon-shaped channel (See Fig. 12b where the upper chamber is the shuttle chamber and the lower chamber is the mixing chamber), therein providing a dissolution space within its volume where a dry reagent may be dissolved in a liquid. Therebetween the mixing chamber and the shuttle chamber is a shuttle channel which siphons liquid to the mixing chamber. The shuttle channel is connected to a port of the shuttle chamber, where the port is positioned higher than the sample-introduction port in a direction of gravity when the cartridge is in an upright state, given that the shuttle channel port extends downward into the chamber to aspirate the liquid shown therein Fig. 12b. And wherein a fluid in the mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from a pneumatic port, or the fluid in the shuttle chamber is movable to the second mixing chamber through the shuttle channel by negative pressure provided from a pneumatic port ([0079]: “A positive pressure at the vent is equivalent to a negative pressure at the port, and accordingly all of the processes described can be implemented by alternating couplings to the supply lines and ambient, and reversing the pressurization relative to ambient, and further advantages may be provided by coupling both the port and vent to respective, independently controlled (or oppositely pressurized) channels.”). Therein, this arrangement provides a dedicated mixing chamber for sample fluid received by the device, the shuttle chamber, for mixing reagent via bubble mixing before transferring the mixture to the mixing chamber (See [0100-0108] and Figs. 12c and 14.), and for transferring back and forth through the shuttle channel as discussed above.
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 cartridge of Ririe further comprising a shuttle chamber connected to the first mixing chamber and providing a dissolution space, a shuttle channel connecting the second mixing chamber and the shuttle chamber, wherein the shuttle chamber is configured to dissolve the dry reagent provided from the second mixing chamber into the solution provided from the first mixing chamber, wherein the mixing connection channel is connected to a first port of the shuttle chamber, and the shuttle channel is connected to a second port of the shuttle chamber, where the first port is positioned higher than the second port in a direction of gravity when the cartridge is in an upright state, and wherein a fluid in the second mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from the first pneumatic port, or the fluid in the shuttle chamber is movable to the second mixing chamber through the shuttle channel by negative pressure provided from the first pneumatic port, such as suggested by Veres, so as to provide a dedicated mixing chamber for sample fluid received by the device, the shuttle chamber, for mixing reagent via bubble mixing before transferring the mixture to the mixing chamber, thereby ensuring adequate mixing before and during fluid advancement back and forth among the chambers.
Further, when such modification is implemented in Ririe, it would be necessary to connect the sample inlet channel of Veres to the first mixing chamber of Ririe, so as to obtain the first mixed mixture. Thereby, the “a mixing connection channel connecting the first mixing chamber and the second mixing chamber” corresponds to the inlet channel of Veres and is maintained in the modification of Ririe.
Further, regarding the “wherein the shuttle chamber and the second mixing chamber are configured to dissolve the dry reagent by reciprocating a fluid through the shuttle channel between the second mixing chamber and the shuttle chamber via the first and second pneumatic ports”, the combination of Ririe and Veres having a shuttle chamber between the first and second mixing chambers is fully capable of performing the claimed reciprocating process by pneumatic control through the pneumatic lines of Ririe. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).
Regarding Claim 20, the prior art meets the limitations of Claim 19 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein a fluid in the second mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from the first pneumatic port, and a fluid in the shuttle chamber is movable to the second mixing chamber by positive pressure provided from the second pneumatic port (Given the commensurate arrangement of channels and chambers as in Ririe in view of Veres, the resulting device is commensurately capable of performing the claimed positive and negative pressure fluid actuation functions through the pneumatic hoses of Ririe.), and
wherein the shuttle chamber is disposed below the first mixing chamber and the second mixing chamber in a direction of gravity when the cartridge is in an upright state (See Veres Fig. 12c showing another arrangement of the shuttle chamber and the mixing chamber, wherein when the device is oriented on its side, and the first mixing chamber of Ririe is considered to be positioned at the sample inlet, the shuttle chamber would be below both mixing chambers. Examiner further notes that the claim is predicated on the conditional “when the cartridge is in an upright state” which is not necessitated by the claim and is thereby not afforded patentable weight. The cartridge may be positioned and viewed from any particular orientation, not merely Applicant’s desired viewpoint. Applicant may wish to structurally distinguish the chamber locations functionally by way of the desired flow by gravity instead of using relative above/below terms.), as in Claim 20.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when modifying Ririe in view of Veres, to maintain the chamber placement positions of Veres so as to maintain the desired siphon-driven flow and liquid distribution as in Veres.
Regarding Claim 21, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein the shuttle chamber, the shuttle channel, the second mixing chamber, and the first pneumatic channel are arranged such that a fluid containing the dry reagent reciprocates between the second mixing chamber and the shuttle chamber through the shuttle channel by alternating pneumatic pressure from the first pneumatic port to dissolve the dry reagent in the shuttle chamber and the second mixing chamber (The combination of Ririe and Veres having a shuttle chamber between the first and second mixing chambers is fully capable of performing the claimed reciprocating process by pneumatic control through the pneumatic lines of Ririe. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).), as in Claim 21.
Regarding Claim 22, the prior art meets the limitations of Claim 1 as discussed above. Further, Ririe teaches the cartridge discussed above wherein the dry reagent is a master mix comprising lyophilized reagents for a nucleic acid amplification reaction ([0007, 0078, 0124]), as in Claim 22.
Regarding Claim 23, the prior art meets the limitations of Claim 21 as discussed above. Further, Ririe in view of Veres teaches the cartridge discussed above wherein a fluid in the second mixing chamber is movable to the shuttle chamber through the shuttle channel by positive pressure provided from the first pneumatic port and a fluid in the shuttle chamber is movable to the second mixing chamber through the shuttle channel by positive pressure provided from the second pneumatic port (The combination of Ririe and Veres having a shuttle chamber between the first and second mixing chambers is fully capable of performing the claimed reciprocating process by pneumatic control through the pneumatic lines of Ririe. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II).), as in Claim 23.
Response to Arguments
37 CFR 1.105
Applicant’s submission of the IDS filed 06/23/2026 is acknowledged. The requirement under 37 CFR 1.105 is now satisfied, and the request for information set forth by the previous office action is withdrawn.
Drawings
Examiner appreciates Applicant’s submission of replacement drawing sheets and clarification over the position of the shuttle chamber being in terms of fluid flow rather than positional arrangement. The drawings objection is thereby withdrawn herein.
Claim Objections
Applicant’s amendment of Claim 13 sufficiently overcomes the claim objection set forth by the prior office action. As such, the claim rejection over Claim 13 is withdrawn herein.
35 USC 112
Applicant’s amendments partially overcome the indefiniteness rejections set forth under 35 USC 112 by the prior office action; however, Applicant did not address Examiner’s concern over the “branch point” language incorporated with Claim 11. Thus, all other rejections under 35 USC 112 are rendered moot by Applicant’s amendments and are withdrawn herein, but examiner sets forth the rejection of Claim 11 for similar reasons as the previously rejected, now canceled, Claim 12 discussing those branch points as now incorporated into Claim 11.
35 USC 102 and 103
Applicant argues that the amendments of independent Claims 1 and 19 render the rejection under 35 USC 102 moot. Examiner agrees, and the rejections under 35 USC 102 set forth by the previous office action are withdrawn. Examiner sets forth a new grounds of rejection over the pending claims under 35 USC 103, discussed below, as necessitated by Applicant’s amendments.
1. Applicant argues on the alleged grounds that Ririe does not provide the plate-shaped base, rather providing a flexible pouch for receiving air from a pneumatic system.
Applicant’s argument is not persuasive because the base of Ririe is not the pneumatic blister pouch assembly such as seen through Fig. 7, but rather the flat, plat-shaped fitment 210 having the recesses in the plastic film portion 217 forming the channels and chambers. Further, [0043] discusses regions of the pouch 10 as being flexible such that the blisters are readily deformable, but describes other regions of the pouch as being of a rigid material or reinforced with a rigid material. Finally, Applicant’s “plate-shaped” terminology only requires the structure to be substantially flat, not necessarily inflexible as argued by Applicant. Applicant may wish to specify specific materials forming the base or additional structural limitations thereof if a particular rigidity property is desired.
Thus, Examiner sets forth in the 35 USC 103 section over Claims 1 and 19 above that the base of Ririe satisfies Applicant’s added plate-shaped limitation.
2. Applicant further argues on the alleged grounds that Ririe does not discuss a shuttle chamber placed fluidically between the first and second mixing chambers such as to provide a three-node mixing architecture.
Applicant’s argument is not persuasive because the additional reference of Veres is newly added herein, as necessitated by Applicant’s amendments, to provide the amended connectivity of the shuttle chamber, shuttle channel, and mixing connection channel – see above in the body of the action. Therein, the additional shuttle channel provides an additional mixing area for bubble mixing by actuating a pneumatic system and siphons the mixed solution to the second mixing chamber by way of gravity.
Thus, Examiner sets forth the rejection of Claims 1 and 19, and dependents thereof, as being unpatentable under 35 USC 103 over Ririe in view of Veres, wherein this new grounds of rejection was necessitated by Applicant’s amendments rearranging the connectivity of the first/second mixing chambers and the shuttle chamber.
3. Applicant further argues on the alleged grounds that Ririe does not satisfy the vertical port geometry of the amended claims requiring the first port of the shuttle chamber to be higher than the second port.
Applicant’s argument is not persuasive because the vertical port geometry is accounted for by Veres such as seen through Figs. 12b and 12c, arranged as such so as to permit gravity-driven flow while avoiding backflow through a sample-introduction channel leading to an improper flow direction. Therein, one skilled in the art would have found it obvious to maintain this port arrangement in Veres when modifying Ririe so as to maintain the backflow prevention, ensuring fluid flows through the device in a desired direction.
Thus, Examiner sets forth that Ririe in view of Veres accounts for the claimed vertical port geometry of the shuttle chamber, wherein this new grounds of rejection was necessitated by Applicant’s amendments specifying such geometry in the claims.
4. Applicant further argues on the alleged grounds that Ririe fails to teach a chamber having an upper region in communication with the pneumatic channel, and a lower region containing the reagent/bead.
Applicant’s arguments are not persuasive because while Applicant is correct in asserting that the pneumatic channels correspond to blisters, the blisters are in communication with the channels and chambers of the device to seal such channels and chambers and/or actuate fluid therethrough – see para. [0046]. Therein, as Fig. 8 shows that the blisters communicate with only one side of each chamber, the side where the blister is adjacent constitutes the upper region, and the base of the depression forming the channels/chambers where reagent falls by force of gravity constitutes the lower region.
Thus, Examiner sets forth that Ririe in view of Veres accounts for the claimed upper and lower chamber regions, wherein this new grounds of rejection was necessitated by Applicant’s amendments specifying such geometry in the claims.
New Claims
Newly added Claims 21-23 are rejected under 35 USC 103 as being unpatentable over Ririe in view of Veres, as necessitated by Applicant’s addition of the new claims, and as 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.
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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