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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9-12 are 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.
Claim 9 recites, in part, “wherein the second tape corresponds to the circular shape of the first tape.” However, claim 9 depends from claim 2, and claim 2 does not previously recite “a circular shape” of the first tape. The circular shape of the first tape is first recited in claim 3, but claim 9 does not depend from claim 3. Therefore, the phrase “the circular shape of the first tape” lacks proper antecedent basis, rendering the scope of claim 9 unclear.
Claim 9 is further indefinite because it is unclear what portion of the first tape is covered by the second tape. Claim 9 recites that the second tape is “disposed on a lower side of the well array and covering the connection hole and the input hole formed in the first tape,” while also reciting that “the second tape corresponds to the circular shape of the first tape.” However, claim 2 separately recites an “inlet hole,” an “input hole,” and a “connection hole,” and the specification indicates that the input hole is formed in the rectangular shape corresponding to the well array, while the inlet hole is formed in the circular shape corresponding to the inlet unit. Thus, it is unclear whether the second tape is intended to cover the input hole corresponding to the well array, the inlet hole corresponding to the circular shape, the connection hole, or some combination thereof.
Accordingly, the metes and bounds of the second tape arrangement in claim 9 are unclear.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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-well (Fig. 5B, par [0077]).
Oleksandrov does not explicitly disclose that the sample introduced through the inlet unit through the pass to reach the micro-well by capillary action. However, microflow paths utilizing capillary flow rely on surface tension rather than active pumps to drive fluids through microchannels. This passive approach leverages the adhesion of fluid to channel walls combined with cohesion between fluid molecules, making it ideal for point-of-care diagnostics, lab-on-a-chip devices, and portable analytical systems. For example, in the analogous art of microfluidic device, Oberhardt discloses the sample introduced through the inlet unit through the capillary member (26) to reach the reaction chamber (24) by capillary action (Fig. 2, col. 6, lines 9-14).
Thus, it would have been obvious to one of ordinary skill in the art to let the sample introduced through the inlet unit through the capillary pass to reach the micro-well by capillary action, in order to simplify the device.
Regarding claim 2, Oberhardt discloses that wherein the capillary member comprises a first tape (20) disposed between the microfluidic chamber and the well array (Fig. 4, col. 9, line 39-40), and comprising an inlet hole (22) formed corresponding to the inlet unit, an input hole (24) formed corresponding to the well array (Fig. 2), and
a connection hole (26) having a width narrower than a diameter of the inlet hole and configured to connect the inlet hole (22) and the input hole (24) (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, Oleksandrov teaches a lower sticker/tape-like member (180) corresponding to the claimed second tape (Fig. 6, par [0089]). Oleksandrov teaches that liquid sample flows to the well array through microchannel/micro flow path 134e, and further 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 explains that, because sticker 180 is attached to the microfluidic chamber, “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 lower cover/sticker member that covers the bottom of the connection-channel region so that liquid is guided to the well array without leakage.
Oleksandrov further teaches the inlet-side/circular region corresponding to the claimed circular shape (par [0074]). Oleksandrov teaches a base member 132 with “a flat hole 132c of a circle shape formed in a corner region,” (par [0074]) and a top member 134 including inlet portion 134c and inlet 134d (Fig. 5, par [0075][0076]).
Oleksandrov does not explicitly teach that the connection/input openings are formed in a first tape as recited in claim 2. However, Oberhardt teaches forming a microfluidic spacer layer from double-sided tape with cutouts. Oberhardt teaches that a “two-layer spacer” may consist 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 1-12). Oberhardt also teaches that spacer 60 is made of overlay 20 sandwiched between adhesive layers 62, and the openings form a sample well, reaction volume, conduit, and vent (Fig. 7, 4, col. 35, lines 1-12).
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/inlet/input structure by forming the inlet region, connection channel, and well-array input region as cutouts in a first tape/spacer layer, as taught by Oberhardt. The motivation would have been to provide a known laminated microfluidic alternative in which the tape/spacer layer defines the sample well, conduit, and reaction region. In the resulting structure, Oleksandrov’s sticker 180 would correspond to the claimed second tape because it forms a lower cover/bottom for the microchannel region, prevents leakage, and cooperates with the channel structure to supply liquid to the well array. Therefore, Oleksandrov in view of Oberhardt teaches or suggests the capillary member further comprising a second tape covering the connection/input region formed in the first tape.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797
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