DETAILED ACTION
The amendment filed on 08/04/2026 has been entered and fully considered. Claims 1-15 are pending, of which claim 1-2, 6 and 9 are amended.
Response to Amendment
In response to amendment, the examiner withdrawn rejection under 35 U.S.C. 112(b), and maintains rejection over the prior art established in the previous Office action.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 .
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oleksandrov et al. (US 2019/0329254, IDS) (Oleksandrov) in view of Oberhardt (US 5,658,723, IDS).
Regarding claim 1, Oleksandrov discloses a PCR module (abstract) comprising:
a microfluidic chamber (130) comprising an inlet unit (134d) formed for introducing a sample (Fig. 5B, par [0063]), and capable of being manufactured by injection molding (par [0063]);
a well array (140) comprising a plurality of micro-wells with upper and lower parts penetrated, and disposed on a lower surface of the microfluidic chamber (Fig. 6, par [0066]); and
a capillary member (134e) configured to provide a path so that the sample introduced through the inlet unit through the path to reach the micro-wells by capillary action (Fig. 5B, par [0077] [0079]).
Oleksandrov teaches that “[a] micro flow path 134e is formed in a region connecting the inlet 134d of the inlet portion 134c and a bottom edge region of the membrane switch 134b,” (par [0077]), and that “[t]he liquid samples injected into the inlet 134d of the inlet portion 134c reaches the bottom edge region of the membrane switch 134b through the micro flow path 134e.” (par [0077]). Oleksandrov further teaches that “the inlet 134d and the micro flow path 134e are connected to each other,” (par [0079]), that “the liquid sample falls through the micro flow path 134e into the space formed below the membrane switch 134b,” (par [0079]), and that “the liquid sample may be fully charged into each of the microwells of the well array 140 exposed through the micro channel 134e.” (par [0079]).
Oleksandrov further teaches that the sample reaches and fills the micro-wells by capillary action because Oleksandrov teaches that “a liquid sample pipetted into the inlet 134e is provided to the well array 140 along the micro flow path 134e,” (par [0099]), and further teaches that, after the vacuum device is turned off, “the liquid samples reaching the lower space of the well array 140 is gradually drawn up to the upper space of the well array 140 by the capillary force.” (par [0101]). Oleksandrov then teaches that “[t]hus, the liquid sample is filled in the space between the well array 140 and the microfluidic chamber 130 and the microwells 142 of the well array 140.” (par [0102]).
Oleksandrov teaches structure corresponding to the claimed inlet/input relationship because Oleksandrov teaches “an inlet 134d” and a “micro flow path 134e” connected to the well-array region, as discussed above. Oleksandrov further teaches a single well-array exposure/input region because Oleksandrov teaches that “the base member 132 includes a first flat portion 132a of a square shape, a support hole 132b of a rectangular shape formed in a central region of the first flat portion 132a,” (par [0074]), and that “[t]he CMOS photo sensor array 150 and the well array 140 may be accommodated in the recessed space.” (par [0075]). Oleksandrov also teaches that “the liquid sample may be fully charged into each of the microwells of the well array 140 exposed through the micro channel 134e.” (par [0079]).
Oleksandrov does not explicitly teach that the capillary member comprises an inlet hole, a connection hole, and an input hole formed as a cutout-type capillary member. However, Oberhardt teaches a capillary channel structure comprising an inlet/sample well, a conduit/connection channel, and a reaction/input region. Oberhardt teaches that “[t]his element comprises a channel structure defining a sample well and a reaction volume in communication with each other,” and that “[t]he channel structure possesses a geometry which causes a liquid sample placed into the sample well to be drawn into and fill the reaction volume via capillary action.” (col. 6, lines 7-14). Oberhardt further teaches that the fluidic structure includes “a sample well 64, a reaction volume 66, a conduit communicating the reaction volume 66 and the sample well 64,” (col. 10, line 9-12), and that the spacing is “sufficiently small to cause a sample placed in Sample well 64 to be drawn into the reaction volume 66 by capillary action.” (col. 10, line 15-19).
Oberhardt also teaches forming the capillary path using a spacer/tape structure having cutouts. Oberhardt teaches, in Example 1, “a two-layer spacer consisting of two pieces of a double-sided tape,” where “[t]he two-layer overlay had previously been cut out in the center to create a sample well, conduit, reaction space, and vented area.” Oberhardt further teaches that “[t]he cover was placed on top of the overlay and pressure applied by means of a small roller to join the overlay to the cover and base.” (col. 35, line 4-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Oleksandrov’s micro flow path/well-array loading structure by using Oberhardt’s cutout spacer/tape capillary-channel structure, wherein the sample well of Oberhardt corresponds to the claimed inlet hole, the conduit of Oberhardt corresponds to the claimed connection hole, and the reaction/input region corresponding to Oleksandrov’s well-array exposure region corresponds to the claimed input hole. The motivation would have been to provide a known laminated capillary microfluidic structure for delivering a small-volume biological sample from an inlet region to a reaction/well-array region, because Oberhardt teaches that the channel geometry causes liquid sample to be drawn into and fill the reaction volume by capillary action.
One of ordinary skill in the art would have had a reasonable expectation of success in making the modification because Oberhardt teaches an actual working double-sided-tape spacer structure and teaches that, in use, “[o]ne drop of the plasma sample was placed in the sample well of the reaction slide” and “[t]he plasma sample immediately flowed into the reaction volume.” (col. 35, lines 37-43). The resulting modified Oleksandrov device would have included a capillary member comprising an inlet hole, a connection hole, and an input hole, wherein the connection hole fluidly connects the inlet hole and the input hole, and wherein the input hole is a single expanse corresponding to the plurality of micro-wells of Oleksandrov’s well array.
Therefore, Oleksandrov in view of Oberhardt teaches or suggests all limitations of claim 1.
Regarding claim 2, Oberhardt discloses that wherein the capillary member further comprises a first tape (20) disposed between the microfluidic chamber and the well array (Fig. 4, col. 9, line 39-40), wherein the first tape comprises the inlet hole (22) formed corresponding to the inlet unit, the input hole (24) formed corresponding to the well array (Fig. 2), and the connection hole (26), wherein the connection hole has a width narrower than a diameter of the inlet hole (Fig. 2).
Regarding claim 3, Oberhardt discloses that wherein the first tape (20) has a shape of a rectangular shape and a circular shape superimposed on a corner area of the rectangular shape (Fig. 4), and
wherein the rectangular shape corresponds to the well array, and the circular shape corresponds to the inlet unit of the microfluidic chamber (Fig. 4).
Regarding claim 4, Oberhardt discloses that wherein the input hole is formed in the rectangular shape, the inlet hole is formed in the circular shape, and the connection hole is formed in an area where the rectangular shape and the circular shape are superimposed (Fig. 4).
Regarding claim 5, Oberhardt discloses that wherein the first tape comprises a double-sided tape with adhesive layers formed on a surface in contact with the microfluidic chamber and a surface in contact with the well array, respectively (col. 35, lines 5-8).
Regarding claim 6, Oleksandrov teaches a rectangular opening corresponding to the well-array region because Oleksandrov teaches that “the base member 132 includes a first flat portion 132a of a square shape, a support hole 132b of a rectangular shape formed in a central region of the first flat portion 132a,” (par [0074]) and that the lower region of membrane switch 134b corresponds to support hole 132b such that “the CMOS photo sensor array 150 and the well array 140 may be accommodated in the recessed space.” (par [0075]). Oleksandrov further teaches that the well array includes microwells and is exposed for filling because “the well array 140 includes a plurality of microwells 142,” (par [0083]) and when liquid sample is introduced through inlet 134d and micro flow path 134e, the sample “may be fully charged into each of the microwells of the well array 140 exposed through the micro channel 134e.” (par [0079]). Thus, Oleksandrov teaches an opening/input region corresponding to the well array and exposing the microwells of the well array.
Oleksandrov does not explicitly teach that the input hole is formed in a first tape as recited in claim 2. However, Oberhardt teaches forming the fluidic openings in a spacer/tape layer. Oberhardt teaches that “the spacer 60 [is] made up of the overlay 20 sandwiched between two adhesive layers 62,” (col. 10, line 1-5) and that each adhesive layer is formed with openings corresponding to “the sample receiving opening 22, the reaction space 24 and the conduit 26 of the overlay 20.” (col. 10, lines 5-9). Oberhardt also teaches in Example 1 that the spacer may be a double-sided tape with center cutouts: “a two-layer spacer consisting of two pieces of a double-sided tape,” where the overlay “had previously been cut out in the center to create a sample well, conduit, reaction space, and vented area.” (col. 35, lines 1-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Oleksandrov’s rectangular support-hole/input region corresponding to the well array by forming that region as a rectangular cutout in a first tape/spacer layer, as taught by Oberhardt. The motivation would have been to provide an alternative known laminated microfluidic construction in which the spacer/tape layer defines the sample input region and connecting channel. The resulting input hole would be rectangular and larger than the rectangular well array because Oleksandrov’s support-hole/input region accommodates and exposes the well-array/microwell region for sample filling, and the opening would need to be sized to expose the microwells rather than block them. Therefore, Oleksandrov in view of Oberhardt teaches or suggests the input hole having a rectangular shape larger than the rectangular shape of the well array to expose the micro-wells of the well array.
Regarding claim 7, Oleksandrov teaches a PCR module including a microfluidic chamber 130 and a well array 140 (Fig. 2). Oleksandrov teaches that “the well array 140 is attached to the lower surface of the microfluidic chamber 130,” (par [0064]) and that the well array includes a plurality of microwells 142 (Fig. 6). Oleksandrov also shows the well array 140 as a rectangular plate/array in Fig. 3, and the well array is received in the recessed space of the microfluidic chamber (Fig. 6).
Oleksandrov does not explicitly teach that the well array is attached to a first tape. However, Oberhardt teaches using a spacer/tape/adhesive-layer structure in a microfluidic diagnostic device. Oberhardt teaches that the spacer 60 is made up of overlay 20 sandwiched between adhesive layers 62, which join the overlay to the cover and base (Fig. 7). Oberhardt further teaches that the adhesive layers have openings corresponding to the sample receiving opening, reaction space, and conduit, thereby forming fluidic structures in the laminated device (Fig. 4). Oberhardt also teaches, in Example 1, a “two-layer spacer consisting of two pieces of a double-sided tape” with cutouts creating the sample well, conduit, reaction space, and vented area (col. 35, lines 1-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Oleksandrov’s structure by forming the intermediate microfluidic path/input region using a double-sided tape/spacer layer as taught by Oberhardt. The motivation would have been to provide a known laminated microfluidic construction in which the spacer/tape layer both defines the fluidic openings and attaches adjacent layers. In the resulting structure, the rectangular well array of Oleksandrov would have its four peripheral edge areas attached to the first tape/spacer layer surrounding the input opening, while the microwells remain exposed for sample filling. Therefore, Oleksandrov in view of Oberhardt teaches or suggests the well array having four edge areas attached to the first tape.
Regarding claim 8, Oleksandrov teaches the underlying PCR/well-array microfluidic structure and teaches that sample is delivered through a micro flow path to the well array (abstract). Oleksandrov teaches that “a micro flow path 134e is formed” connecting inlet 134d to the membrane-switch/well-array region, and that liquid sample reaches that region through micro flow path 134e (par [0077]). Oleksandrov further teaches hydrophilic treatment in the PCR module because “a hydrophilic coating layer may be formed on the well array 140.” (par [0066]).
Oleksandrov does not explicitly teach that the side surface forming the connection hole of the first tape is hydrophilic treated. However, Oberhardt teaches that internal fluid-contacting surfaces of a capillary microfluidic device may be treated to increase hydrophilic character (col. 14, line 21-28). Oberhardt teaches that it may be desired to modify the internal surfaces contacting the sample or reagent to modify the liquid/solid/air contact angle and increase hydrophilic character, thereby increasing the ease of sample flow from the sample well to the reaction volume (col. 14, line 29-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date to hydrophilic treat the side surface of the connection hole in the first tape of the modified Oleksandrov/Oberhardt device. The motivation would have been to improve flow of the liquid sample through the narrow connection hole/capillary channel, because Oberhardt teaches that increasing hydrophilic character of internal fluid-contacting surfaces increases the ease of sample flow. Since the connection hole side surface is an internal surface contacting the sample as it moves from the inlet hole to the input hole, applying the known hydrophilic treatment to that surface would have been a predictable use of a known microfluidic surface treatment. Therefore, Oleksandrov in view of Oberhardt teaches or suggests the side surface forming the connection hole of the first tape being hydrophilic treated.
Regarding claim 9, As discussed above for claim 2, Oleksandrov in view of Oberhardt teaches or suggests a capillary member comprising a first tape/spacer layer having an inlet hole, a connection hole, and an input hole. Oberhardt teaches a tape/spacer structure because Oberhardt teaches “a two-layer spacer consisting of two pieces of a double-sided tape,” where “[t]he two-layer overlay had previously been cut out in the center to create a sample well, conduit, reaction space, and vented area.” In the modified Oleksandrov/Oberhardt structure, Oberhardt’s sample well corresponds to the claimed inlet hole, Oberhardt’s conduit corresponds to the claimed connection hole, and the well-array exposure/input region of Oleksandrov corresponds to the claimed input hole.
Oleksandrov teaches the claimed second tape because Oleksandrov teaches that “the PCR module may further include a sticker 180 that forms a bottom of the microchannel 134e formed in the microfluidic chamber 130.” (Fig. 6, par [0089]). Oleksandrov further teaches that “[a]s the sticker 180 is attached to the microfluidic chamber 130, the liquid samples introduced into the micro flow path 134e may be supplied to the well array 140 without being leaked to other areas.” (par [0089]). Thus, Oleksandrov teaches a sticker/tape-like member that covers a lower side of the microchannel/connection-hole region so that liquid sample is supplied to the well array without leakage.
Oleksandrov further teaches the inlet-side circular region corresponding to the claimed circular shaped section of the first tape because Oleksandrov teaches that “the base member 132 includes a first flat portion 132a of a square shape, a support hole 132b of a rectangular shape formed in a central region of the first flat portion 132a, and a flat hole 132c of a circle shape formed in a corner region of the first flat portion 132a.” (par [0074]). Oleksandrov also teaches that “[t]he inlet portion 134c has a fence shape” and that “[a]n inlet 134d is formed in a central region of the inlet portion 134c.” (par [0076])
It would have been obvious to one of ordinary skill in the art before the effective filing date to use Oleksandrov’s sticker 180 as the claimed second tape in the modified Oleksandrov/Oberhardt laminated capillary-member structure. The motivation would have been to close or form the bottom of the inlet/connection-hole region so that liquid sample introduced into the micro flow path is supplied to the well array without leaking to other areas, as expressly taught by Oleksandrov. In the modified structure, the second tape/sticker would cover the connection hole and inlet hole formed in the first tape/spacer layer, and would have a circular shape corresponding to the circular inlet-side section of the first tape, because the sticker is associated with the inlet-side microchannel region and Oleksandrov teaches a circular inlet-side hole/region.
Regarding claim 10, As discussed for claim 9, Oleksandrov teaches a sticker/second-tape-like member because Oleksandrov recites “a sticker attached to the microfluidic chamber to form a bottom of micro flow path formed in the microfluidic chamber.” (par [0089]). Oleksandrov also teaches the relevant micro flow path/connection-channel structure because “a micro flow path 134e is formed in a region connecting the inlet 134d … and a bottom edge region of the membrane switch 134b,” and the liquid sample reaches the well-array region through micro flow path 134e (par [0077]).
Oleksandrov further teaches hydrophilic treatment in the PCR module because Oleksandrov recites that “the well array is coated in a hydrophilic.” (par [0020]). Oleksandrov does not explicitly teach that the surface of the sticker/second tape corresponding to the connection hole is hydrophilic treated.
However, Oberhardt teaches hydrophilic treatment of internal fluid-contacting surfaces in a capillary microfluidic device. Oberhardt teaches that “it may be desired to modify the internal surfaces of the reaction slide which will contact the sample or reagent or both,” that the surfaces may be treated “to increase their hydrophilic character,” and that such treatment “will increase the ease with which the sample flows from the sample well to the reaction volume.” (col. 14, lines 21-28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to hydrophilic treat the surface of Oleksandrov’s sticker/second tape corresponding to the micro flow path/connection hole in the modified Oleksandrov-Oberhardt device. The motivation would have been to improve movement of the liquid sample through the capillary channel because Oberhardt teaches that hydrophilic treatment of sample-contacting internal surfaces increases the ease of sample flow. Therefore, Oleksandrov in view of Oberhardt teaches or suggests a surface of the second tape corresponding to the connection hole being hydrophilic treated.
Regarding claim 11, as discussed for claim 9, Oleksandrov teaches a sticker/second-tape-like member because Oleksandrov teaches that “the PCR module may further include a sticker 180 that forms a bottom of the microchannel 134e formed in the microfluidic chamber 130.” (par [0089]). Oleksandrov further teaches that the sticker prevents leakage because “the liquid samples introduced into the micro flow path 134e may be supplied to the well array 140 without being leaked to other areas.” (par [0089]). Oleksandrov then expressly teaches the claimed same-thickness relationship because “the thickness of the sticker 180 and the thickness of the well array 140 may be substantially equal to each other.” (par [0089]).
Oleksandrov does not explicitly call sticker 180 a “second tape” formed with a first tape. However, Oberhardt teaches using double-sided tape/spacer layers to form a microfluidic device. Oberhardt teaches a “two-layer spacer consisting of two pieces of a double-sided tape,” where the overlay is cut out to create a sample well, conduit, reaction space, and vented area. (col. 35, lines 1-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use Oleksandrov’s sticker 180 as the claimed second tape in the modified Oleksandrov/Oberhardt laminated tape structure. Oleksandrov expressly teaches making the sticker thickness substantially equal to the thickness of the well array, and one of ordinary skill would have understood this as providing a flush or compatible layer arrangement next to the well array while forming the bottom of the microchannel and preventing leakage. Therefore, Oleksandrov in view of Oberhardt teaches or suggests the second tape having a thickness the same as a thickness of the well array.
Regarding claim 12, As discussed for claim 9, Oleksandrov teaches the claimed second-tape-like structure because Oleksandrov recites “a sticker attached to the microfluidic chamber to form a bottom of micro flow path formed in the microfluidic chamber.” (par [0016]). Oleksandrov also shows sticker 180 positioned at the lower/bottom side of the micro flow path region in the figures (Fig. 6). Thus, Oleksandrov teaches a sticker/tape-like member attached to another microfluidic layer to form the bottom of the micro flow path.
Oleksandrov does not explicitly recite that the sticker is a “single-sided tape” contacting a “first tape.” However, Oberhardt teaches forming the fluidic structure using tape/spacer layers. Oberhardt teaches “a two-layer spacer consisting of two pieces of a double-sided tape,” (col. 35, lines 3-7) where the overlay is cut out to create a “sample well, conduit, reaction space, and vented area,” and the cover is placed on top of the overlay and pressure is applied “to join the overlay to the cover and base.” (col. 35, line 16-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date to implement Oleksandrov’s sticker 180 as a single-sided adhesive tape in the modified Oleksandrov/Oberhardt laminated structure. The motivation would have been to provide a simple adhesive cover/sealing member for forming the bottom of the micro flow path and preventing leakage. In the modified structure, because the fluidic inlet/channel/input region is formed in the first tape/spacer layer as taught by Oberhardt, the adhesive surface of Oleksandrov’s sticker/second tape would contact the first tape to close the channel. Therefore, Oleksandrov in view of Oberhardt teaches or suggests the second tape being a single-sided tape with an adhesive layer formed on a surface in contact with the first tape.
Regarding claim 13, Oleksandrov teaches that the “microfluidic chamber 130 may be formed of a material such as PDMS,” (par [0063]) and further teaches that the microfluidic chamber has flexibility, transparency, PCR compatibility, and low autofluorescence. Oleksandrov also expressly claims that “the microfluidic chamber comprises at least one of a PDMS material, a transparent plastic having flexibility or transparent rubber having flexibility.” (claim 3).
Therefore, Oleksandrov teaches the microfluidic chamber comprising polydimethylsiloxane (PDMS) material.
Regarding claim 13, Oleksandrov teaches that the microfluidic chamber 130 includes “a base member 132 of a rectangular shape and a top member 134 of a rectangular shape disposed on the base member 132.” (par [0073]). Oleksandrov further teaches that the base member 132 includes “a first flat portion 132a of a square shape,” “a support hole 132b of a rectangular shape formed in a central region of the first flat portion 132a,” and “a flat hole 132c of a circle shape formed in a corner region of the first flat portion 132a.” (par [0074]).
Oleksandrov also teaches the claimed tower member because the top member 134 includes “a second flat portion 134a of a rectangular shape,” “a membrane switch 134b of a dish shape,” and “an inlet portion 134c of a closed loop shape.” Oleksandrov further teaches that the second flat portion 134a is in close contact with the upper surface of the base member’s first flat portion 132a, thereby teaching the tower/top member disposed on the base member (par [0075]).
Therefore, Oleksandrov teaches the microfluidic chamber structure recited in claim 14.
Regarding Claim 15, Oleksandrov teaches that the PCR module includes a well array 140 and a CMOS photo sensor array 150. Oleksandrov teaches that “the CMOS photo sensor array 150 is disposed below the well array 140 to capture an image of the PCR reaction product performed in the microwells 142 of the well array 140 in real time.” Oleksandrov further teaches that the CMOS photo sensor array receives emitted light and captures an image of the PCR reaction product performed in the PCR device (par [0084]).
Therefore, Oleksandrov teaches a CMOS photosensor array disposed below the well array and photographing reaction images of the sample filled in the micro-wells of the well array in real time.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive.
With respect to the rejection of claims 9-12 under 35 U.S.C. 112(b), Applicant amended claim 9 to recite “the inlet hole” and to recite that “the second tape has a circular shape that corresponds to a circular shaped section of the first tape.” Accordingly, the prior rejection of claims 9-12 under 35 U.S.C. 112(b) is withdrawn.
With respect to the rejection of claims 1-15 under 35 U.S.C. 103 over Oleksandrov in view of Oberhardt, Applicant argues that Oleksandrov’s element 134e is described as a “micro flow path” and is not correlated with a capillary member. Applicant further argues that Oleksandrov teaches that “The liquid samples pipetted into the inlet 134d do not flow into the micro flow path 134e due to a resistance of air present in the micro flow path 134e,” and that Oleksandrov uses vacuum suction rather than capillary action. Applicant further argues that Oberhardt does not remedy the deficiencies of Oleksandrov and that the cited references fail to provide a reasonable expectation of success.
Examiner respectfully disagrees.
First, the claims do not require the capillary member to be named a “capillary member” in the prior art. Rather, claim 1 requires “a capillary member configured to provide a path so that the sample introduced through the inlet unit reaches the micro-wells by capillary action,” wherein the capillary member includes an inlet hole, a connection hole, and an input hole. Oleksandrov teaches the PCR-module environment and the fluid path from the inlet to the well-array region. In particular, Oleksandrov teaches, at paragraph [0077], “A micro flow path 134e is formed in a region connecting the inlet 134d of the inlet portion 134c and a bottom edge region of the membrane switch 134b.” Oleksandrov further teaches, at paragraph [0077], “The liquid samples injected into the inlet 134d of the inlet portion 134c reaches the bottom edge region of the membrane switch 134b through the micro flow path 134e.” Thus, Oleksandrov teaches a path connecting the inlet region to the well-array/membrane-switch region.
Oleksandrov further teaches that the liquid sample reaches and fills the microwells using capillary force. Oleksandrov teaches, at paragraph [0099], “a liquid sample pipetted into the inlet 134e is provided to the well array 140 along the micro flow path 134e.” Oleksandrov further teaches, at paragraph [0101], “As the vacuum device is turned off, the liquid samples reaching the lower space of the well array 140 is gradually drawn up to the upper space of the well array 140 by the capillary force.” Oleksandrov then teaches, at paragraph [0102], “Thus, the liquid sample is filled in the space between the well array 140 and the microfluidic chamber 130 and the microwells 142 of the well array 140.” Therefore, Oleksandrov expressly teaches that capillary force participates in filling the microwells of the well array.
Applicant’s reliance on paragraph [0096] of Oleksandrov is not persuasive. Paragraph [0096] describes an initial condition before vacuum-assisted air removal, in which liquid sample pipetted into the inlet does not flow into the micro flow path due to air resistance. This does not negate Oleksandrov’s later teaching that, after air is pumped out and the vacuum device is turned off, the liquid sample is drawn upward through the well-array region “by the capillary force” and fills the microwells. Claim 1 does not exclude a device that also uses vacuum-assisted air removal, nor does claim 1 require the sample to reach the micro-wells exclusively by capillary action without any preceding or assisting pressure operation.
Second, the rejection is based on the combined teachings of Oleksandrov and Oberhardt. Oleksandrov is relied upon for teaching the PCR module, including the microfluidic chamber, inlet, well array, micro-wells, and sample path to the well-array region. Oberhardt is relied upon for teaching the known use of a laminated tape/spacer layer with cutouts to define a capillary sample path. Oberhardt teaches, at column 6, “This element comprises a channel structure defining a sample well and a reaction volume in communication with each other.” Oberhardt further teaches, at column 6, that “[t]he channel structure possesses a geometry which causes a liquid sample placed into the sample well to be drawn into and fill the reaction volume via capillary action.”
Oberhardt also teaches the tape/spacer construction used to form the fluidic openings and conduit. Oberhardt teaches in Example 1 “a two-layer spacer consisting of two pieces of a double-sided tape,” where “each sheet previously having been coated on both sides with medium-firm pressure sensitive acrylic adhesive.” Oberhardt further teaches that “[t]he two-layer overlay had previously been cut out in the center to create a sample well, conduit, reaction space, and vented area.” Thus, Oberhardt teaches that a tape/spacer layer can be cut to form a sample well, conduit, and reaction space, and that the resulting channel geometry draws sample by capillary action.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Oleksandrov’s micro flow path/well-array loading structure by using the tape/spacer capillary-channel construction taught by Oberhardt. The motivation would have been to provide a known laminated microfluidic alternative in which cutouts in a tape/spacer layer define the inlet hole, connection hole, and input hole for passively guiding a small-volume biological sample. One of ordinary skill would have had a reasonable expectation of success because Oberhardt expressly teaches that the channel geometry causes the sample to be drawn into the reaction volume by capillary action, and Oberhardt’s Example 1 demonstrates successful operation of the double-sided-tape spacer construction by teaching that “[t]he plasma sample immediately flowed into the reaction volume.”
Applicant’s argument that Oleksandrov does not teach “abandoning the vacuum pump” is not commensurate with the scope of claim 1. The rejection does not require bodily incorporation of Oberhardt into Oleksandrov or complete removal of every feature of Oleksandrov. Rather, the rejection relies on Oberhardt’s known tape/spacer capillary-channel structure as an obvious implementation of the sample path in Oleksandrov. In the modified device, the inlet hole corresponds to the inlet/sample-introduction region, the connection hole corresponds to the conduit/microchannel connecting the inlet region to the reaction/well-array region, and the input hole corresponds to the single open expanse corresponding to the plurality of microwells. The modified structure would still perform the same basic function of delivering sample from the inlet to the well-array region, while using the known capillary tape/spacer channel taught by Oberhardt.
Accordingly, Oleksandrov in view of Oberhardt teaches or suggests the capillary member of amended claim 1, including the inlet hole, connection hole, and input hole, wherein the connection hole fluidly connects the inlet hole and input hole, and wherein the input hole is a single expanse corresponding to the plurality of micro-wells. The combination also provides a reasonable expectation of success because both references are directed to small-volume diagnostic fluid handling, and Oberhardt expressly demonstrates a working capillary tape/spacer structure. Therefore, Applicant’s arguments do not overcome the rejection of claims 1-15 under 35 U.S.C. 103 over Oleksandrov in view of Oberhardt.
Conclusion
THIS ACTION IS MADE FINAL. 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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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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