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 .
Election/Restrictions
Applicant’s election without traverse of Claim in the reply filed on 11/09/2025 is acknowledged.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medical product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/09/2025.
Claims 6-10, 38, 39, 41-46, and 48-49 are pending examination in this response.
Claim status
Claims 1-5 are withdrawn.
Claims 6-10, 38, 39, 41-46, 48, and 49 are pending.
Claims 11-37, 40, 47, 50-132 are canceled.
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.
Claims 6-10, 38, 45, 46, 48, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al. (WO 2020098761 A1) and in view of Ackley et. al. (US6254827B1).
Regarding claim 6, Wang teaches “A flow cell, comprising:” (Para [0005], methods and apparatus for integrating a microfluidic housing with a biological chip and substrate, such as a printed circuit board (PCB) , to form an integrated microfluidic apparatus with hermetic seal of flow cell and reliable performance.); “a substrate” (Para [0041], substrate 110, such as a PCB (printed circuit board); “comprising electrical contacts on a top surface” (Fig. 1, contact pads 122), “wherein the electrical contacts on the top surface of the substrate are connected to electrical contact points on a top surface of a die” (Para [0044], the biological chip 120 (die) is electrically coupled to the PCB 110 (substrate) using wire bonds. In FIG. 1, a contact pad 122 on the biological chip (electrical contact points of the (die) is connected to a contact pad 112 on the PCB (electrical contacts of substrate) with a bond wire 114.); “a first cured adhesive, wherein the first cured adhesive is joined to a package, the package comprising: the die,” (Paras [0044], [0053], [0067], and Abstract, In FIG. 3B, an adhesive layer 113, or die attach glue, (first cured adhesive) can be an epoxy base adhesive for attaching a chip (die) to the PCB (substrate). Next, as shown in FIG. 3C, a biological chip 120 is attached to PCB 110 using the adhesive layer 113. Also has a first adhesive layer (141) attaching the microfluidic housing (130) to the biological chip. The contact pad 122, contact pad 112, and bond wire 114 can be encapsulated in a wire bond protection structure 115. In this regard, the microfluidic housing 130 can also include second cavities 138 for accommodating wire 10 bonds. A gap 148 between the microfluidic housing 130 and the PCB 110 can be filled with an underfill material 149, which can be an epoxy material to provide a compliant layer between the package and PCB. In some embodiments, the first glue can be a solid glue before 5 curing and substantially maintains its thickness after curing to ensure uniformity of the microfluidic apparatus.); “wherein the top surface of the die further comprises an active surface” (Para [0103] In some embodiments, the active spot or well on the surface of the biosensor); “and fanout regions comprising surfaces adjacent at least two opposing sides of the active surface, the fanout regions at least partially defining a fluidic path of the flow cell” (Fig 1, Each region of 130 on two opposite sides of the chip which has the active surface on it in which the inlet 131 and outlet 132 formed between the flow cell). Therefore, the regions of 130 on opposite sides of the chip (die) which partially define the inlet and outlet teach to the fanout regions at least partially defining a fluidic path of the flow cell.
Wang teaches a second cured adhesive layer within (Abstract, The second adhesive layer (142). However does not teach “a second cured adhesive, wherein the second cured adhesive joins a portion of a top surface of the package to a lid defining a fluidic flow-cell cavity below the lid and above a surface comprising the active surface and the fanout regions; and the lid.”
Ackley teaches a device including a chip disposed adjacent to a substrate, the substrate including a via therethrough. The device is adapted to receive a fluid to be placed on the substrate, wherein the fluid then flows through the via down to the chip. In addition to, “a second cured adhesive, wherein the second cured adhesive joins a portion of a top surface of the package to a lid defining a fluidic flow-cell cavity below the lid and above a surface comprising the active surface and the fanout regions; and the lid.” (Column 19 lines 9-15 and Fig. 6B, An adhesive layer 160 (second cured adhesive) is disposed adjacent the trace support layer 150, and provides adhesive contact to an upper layer 170 (lid). The upper layer 170 may optionally include pathways, (fluidic flow-cell cavity) indentations, or other cutouts, such as shown for an inlet 176 and an outlet 176'.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to incorporate the teachings of Ackley having a second cured adhesive, wherein the second cured adhesive joins a portion of a top surface of the package to a lid defining a fluidic flow-cell cavity below the lid and above a surface comprising the active surface and the fanout regions; and the lid. Doing so would allow for the device to have a lid securely attached to the device and have the flow cell capability in an optimal location which is above the active surface. Allowing for the active surface to be above the flow cell area allows for a faster run time and decreases the logistics of getting the flow cell to the active surface.
Regarding claim 7, modified wang teaches all of claim 6 in addition to, “wherein the package further comprises: one or more support pieces adjacent to the at least two opposing sides of the active surface of the die, wherein the one or more support pieces comprise the fanout regions.” (Fig 1, Each region of 130 on two opposite sides of the chip which has the active surface on it in which the inlet 131 and outlet 132 formed between the flow cell). Therefore, the regions of 130 on opposite sides of the chip (die) which are the fanout regions teach to the support pieces. In order for the support pieces to be on at least two opposing sides of the active surface structurally there must be more than one support piece.
Regarding claim 8, modified wang teaches all of claim 7 in addition to, “wherein
the one or more support pieces comprise two support pieces oriented on the at least two opposing sides of the active surface of the die.” (Fig 1, Each region of 130 on two opposite sides of the chip which has the active surface on it in which the inlet 131 and outlet 132 formed between the flow cell). Therefore, having two regions of 130 on opposite sides of the chip (die) which are the fanout regions teach to the claim if the initial support piece was one which comprised two support pieces on at least two opposing sides. If the claim required the “or more support pieces” initially in the claim t would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the apparatus support pieces. It has been held that a mere duplication of working parts of a device involves only routine skill in the art, MPEP 2144.04 (VI)(B). One would have been motivated to duplicate the apparatus parts for the purposes of supporting components within the device.
Regarding claim 9, modified Wang teaches all of claim 7 as above in addition to, “wherein the one or more support pieces comprise one support piece, wherein the one support piece comprises a cutout,” (Fig 1, Each region of 130 on two opposite sides of the chip which has the active surface on it in which the inlet 131 and outlet 132 formed between the flow cell). Therefore, having two regions of 130 on opposite sides of the chip (die) which are the fanout regions teach to the claim if the initial support pieces being the “or more support pieces comprising one support pieces”. Further taught “wherein the die and the electrical contacts on the top surface of the substrate are oriented within the cutout.” (Fig 1, second cavities 138 on either side.).
Regarding claim 10, modified Wang teaches all of claim 6 as above in addition to, “wherein the package further comprises: a cured electronic molded compound (EMC) material molded around portions of the die; a portion of the EMC material forming EMC material surfaces adjacent to the active surface on the biosensor on the at least two opposing sides of the active surface; and a portion of the EMC material surfaces comprise the fanout regions.”(Claim 8, Paras [0007], [0044], [0053], and [0069]-[0072], Wherein the first adhesive material and the second adhesive material are cured through different curing processes, such as heat, moisture or ultraviolet illumination curing.The first adhesive material includes a die attach film (DAF) , and the second adhesive material includes liquid epoxy.The gap 148 between the microfluidic housing 130 and the PCB 110 can be filled with an underfill material 149, which can be an epoxy material to provide a compliant layer between the package and PCB. In FIG. 3B, an adhesive layer 113, or die attach glue, can be an epoxy base adhesive for attaching a chip to the PCB. Next, as shown in FIG. 3C, a biological chip 120 is attached to PCB 110 using the adhesive layer 113. The first adhesive layer 141 can be used to maintain a defined thickness before curing to maximize the flow cell’s fluid field uniformity, since the first adhesive layer 141 is used to form the flow cell chamber between the microfluidic housing 130 and the biological chip 120. In these amendments, a dry film adhesive, such as die attach film (DAF) , can be used. Die attach films include epoxy adhesives which are film-based instead of paste based and are often attached to the back of the wafer prior to dicing. Other examples of the die attach film can include materials such as an epoxy resin, a phenol resin, acrylic rubber, silica filler, or a combination thereof, and may be applied using a lamination technique. Examples of die attach films are described in U.S Patent Application Publication No. 20060154078 to Watanabe, published Jul. 13, 2006, entitled “Curing Resin Composition, Adhesive Epoxy Resin Paste, Adhesive Epoxy Resin Sheet, Conductive Connection Paste. The second glue can be a liquid epoxy, which is in liquid form after being dispensed on the PCB 110 and before curing. ). Therefore the cured adhesive material which is an epoxy which connects the die to the substrate below the fanout regions teaches to the electronic molded compound material molded around portions of the die, which are adjacent to the active surfaces (which are on the fanout regions).
Regarding claim 38, modified Wang teaches all of claim 6 as above in addition to, “wherein the package comprises: a cured electronic molded compound (EMC) material molded around portions of the die; a layer deposited on the EMC material surfaces adjacent to the active surface on the at least two opposing sides of the active surface, wherein the fanout regions comprise portions of the layer.” (Fig 1, the adhesive layers 136 and 135 as taught within claim 10).
Regarding claim 45, modified Wang teaches all of claim 6 as above. Wang does not explicitly teach “wherein the lid comprises two apertures and each aperture defines one of an inlet or an outlet fluidic port.”.
Ackely teaches “wherein the lid comprises two apertures and each aperture defines one of an inlet or an outlet fluidic port.” (Column 19 lines 9-15 and Fig. 6B, The upper layer 170 (lid) may optionally include pathways, (fluidic flow-cell cavity) indentations, or other cutouts, such as shown for an inlet 176 and an outlet 176'.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to incorporate the teachings of Ackely wherein the lid comprises two apertures and each aperture defines one of an inlet or an outlet fluidic port. Doing so provides for a device which delivers fluid in a uniform manner as there is a pressure driven flow due to the inlet and outlet within the lid.
Regarding claim 46, modified Wang teaches all of claim 6 as above in addition to, “wherein the top surface of the die comprises nanowells.” (Paras [0103] and [0108], In some embodiments, the active spot or well on the surface of the biosensor. Such that the nucleic acid macromolecule binds and is retained by the active spots or wells,).
Therefore the active surface is on the top surface of the substrate (die) and the active sports or wells are used for macromolecule binding. Provided the claims required the nanowells, modified Wang does not teach such arrangement. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Wang by having arranged the active sports/ wells as nanowells, since that would have been a matter of an obvious engineering choice, as nanowells are known in the art and widely used for processing and detecting macromolecules which such macromolecules are taught within Wang.
Regarding claim 48, modified Wang teaches all of claim 6 as above in addition to, “wherein the substrate comprises a material selected from the group consisting of: a glass- reinforced epoxy laminate material, FR4, and co-fired ceramic sheets.” (Para [0041] and {0053], The substrate described herein is not limited to the PCB, and other substrate can also be used, for example, semiconductor (e.g., silicon) substrate, glass substrate, ceramic substrate. In FIG. 3B, an adhesive layer 113, or die attach glue, can be an epoxy base adhesive for attaching a chip to the PCB. Next, as shown in FIG. 3C, a biological chip 120 is attached to PCB 110 using the adhesive layer 113.) Therefore the glass substrate with the epoxy base adhesive teaches to the glass-reinforced epoxy laminate material.
Regarding claim 49, modified Wang teaches all of claim 6 as above in addition to, “wherein the die is a complementary metal-oxide-semiconductor.” (Para [0054], a biological sensor can include flow cells overlying a complementary metal-oxide-semiconductor (CMOS) layer. The CMOS layer can include a photo sensing layer having a plurality of photodiodes, and an electronic circuit layer coupled to the photo sensing layer for processing sensed signals.)
Claims 39 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al. (WO 2020098761 A1) in view of Ackley et. al. (US6254827B1) as applied to claims 6 and 10 as above and further view of Drbal et. al. (WO 2014164809 A1).
Regarding claim 39, modified Wang teaches all of claim 10 as above but does not teach “wherein the package further comprises vias embedded in the EMC material.”.
Drbal teaches a device which has a sealed elastomere chamber may be adapted for use as a flow cell. In addition to, “wherein the package further comprises vias embedded in the EMC material.” (Para [0323], The die is wire bonded from the contacts on the sensor to Au pads on the PCB. The pads are electrically conductive to corresponding pads 4315 on the back of the PCB through plated vias. The wire bonds are encapsulated with an epoxy or thermoset or other encapsulating material.),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Wang to incorporate the teachings of Drbal wherein the wherein the package further comprises vias embedded in the EMC material. Doing so allows for the device to be more compact as the vias are embedded with the EMC material. Having a more compact device increases the flexibility of uses.
Regarding claim 41, modified Wang teaches all of claim 6 as above but does not explicitly teach a electrical contact on the bottom surface of the substrate. However, Wang teaches an electrical contact on the top surface of the substrate and an electrical contact which is close to the bottom of the substrate within Claim 6. In addition, Drbal teaches vias through the substrate within (Para [0323], The die is wire bonded from the contacts on the sensor to Au pads on the PCB. The pads are electrically conductive to corresponding pads 4315 on the back of the PCB through plated vias. The wire bonds are encapsulated with an epoxy or thermoset or other encapsulating material.).
Therefore the recitation “wherein the substrate further comprises electrical contacts on a bottom surface of the substrate, wherein the electrical contacts on a bottom surface of the substrate are electrically coupled to the electrical contacts on the top surface of the substrate by vias formed through the substrate.” would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine. Having an electrical contacts on the bottom of the substrate and vias connecting the two allow for a more compact substrate and increased heat distribution in and around the substrate.
Claims 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et. al. (WO 2020098761 A1) in view of Ackley et. al. (US6254827B1) as applied to claim 6 above and further view of Nowakowski et. al. (CN 107810060 A).
Regarding claim 42, modified Wang teaches all of claim 6 as above but does not teach “the substrate further comprising a heating element.”.
Nowakowski teaches a diagnostic system having a device, such as a flow cell, that measures fluorescence. In addition to “the substrate further comprising a heating element.” (Page 34, In some embodiments, the back of the detection box or a portion thereof comprising a flexible circuit, such as on a substrate made of polyimide. flexible circuit may be used to provide low cost resistive heating element with low heat capacity. the flexible circuit substrate may preferably be arranged to directly contact to achieve efficient and rapid heating and cooling the solution present in the detection box of the fluid network. The connector 810 shown in FIG. 8 preferably provides the current to the selectable resistor with power and signal line to the resistive heater.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Wang to incorporate the teachings of Nowakowski wherein the substrate has a heating element. Doing so increases reaction times and allows for temperature control.
Regarding claim 43, modified Wang teaches all of claim 42 as above but does not teach “the heating element comprising: one or more resistors on one or more of the top surface of the substrate and the bottom surface of the substrate; a metal plane in the substrate; and vias through the substrate coupling the one or more resistors to the metal plane in the substrate.”
Nowakowski teaches “the heating element comprising: one or more resistors on one or more of the top surface of the substrate and the bottom surface of the substrate; a metal plane in the substrate; and vias through the substrate coupling the one or more resistors to the metal plane in the substrate.” (Page 34, 40, 12, 26, 4, 19, 20, the back of the detection box or a portion thereof comprising a flexible circuit, such as on a substrate made of polyimide. flexible circuit may be used to provide low cost resistive heating element with low heat capacity. The flexible circuit substrate may preferably be arranged to directly contact to achieve efficient and rapid heating and cooling the solution present in the detection box of the fluid network. The connector 810 shown in FIG. 8 preferably provides the current to the selectable resistor with power and signal line to the resistive heater. Further comprising a flexible circuit, the flexible circuit comprises a patterned metal electrical component is provided on the thermally stable material. The circuit board can include a flexible circuit board, the flexible circuit board comprises a thermally stable substrate such as polyimide. In some embodiments, the flexible circuit may comprise a deposited on or bonded to the thermally stable substrate of copper or other conductive coating or layer. The window with temperature control heat-unstable film is aligned to allow fluid within the chamber with fusion box after the detection of direct contact between the flexible circuit substrate of the part. The box preferably includes a flexible circuit, the flexible circuit comprises a patterned metal electrical component is provided on the thermally stable material. An embodiment having flexible circuit comprises metal trace forming a heating element in the heater may cause a polyimide flexible circuit local deformation is formed, usually extends into the opening in the gasket bump (usually comprising a heater material), because the sealing member melted material may make the vent opening is closed. recesses 7004 can help prevent the occurrence of such a condition. These coatings can be etched or otherwise patterned to include for a biochemical reaction temperature control of the resistance heating element and/or a conductive trace to accommodate such heater and/or surface mount components, such as resistor.) Therefore, the one or more resistors is taught within the selectable resistor with power and signal line to the resistive heater. The metal plane is in the substrate is taught within the flexible circuit which has a thermally stable substrate of copper. The vias through the substrate coupling to the resistors are taught within etching within the substrate to accommodate the heater.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Wang to incorporate the teachings of Nowakowski wherein the substrate has one or more resistor, the substrate has a metal plane, and the substrate has vias. Doing so would provides for a device which has increased thermal control and heating management.
Modified Wang does not explicitly teach the resistors on the top and bottom of the substrate nor the vias coupling the resistor to the metal plane. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Wang by having such arrangement, since Nowakowski teaches to the substrate having metal plate (copper) and the etched area connects the substrate to the resistor which teaches would lead to an obvious engineering choice to have the etched area as the vias which connects the metal to the resistor. In addition, it would have been an obvious engineering choice, place resistors to the top and bottom of the substrate. Nowakowski teaches to the resistors being placed on the substrate and the top and bottom would be locations on the substrate. These modifications would provide optimal heat dispersion and allows for a lot of components in a small space. Having the metal on top and bottom of the substate provides for a device which has increased control over which part of the substrate is heated.
Regarding claim 44, modified Wang teaches all of claim 42 as above. Modified Wang does not explicitly teach “the heating element comprising: a long wound metal trace in the substrate to function as a resistive heater.”. However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have further modified the invention of Wang by having a long wounded metal trace in the substrate to function as a resistive heater as since it would have been an obvious engineering choice, Nowakowski teaches a resistive heater directly contacting the substrate, to better adjust the device to heat any solution as taught within Nowakowski within page 34.
Conclusion
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798