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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US 2016/0356715 A1), hereinafter “Zhong”, in view of Baek (US 2005/0183496 A1), hereinafter “Baek”, and Elkind et al. (US PAT 6,326,612 B1), hereinafter “Elkind”.
Regarding Claim 1, Zhong teaches a method comprising providing a wafer level flow cell structure 400 (Fig. 7), the wafer level flow cell structure 400 comprising a plurality of integral flow cell devices 404 (Fig. 8) positioned on a common base wafer 431 (Fig. 8 and [0100]: “base 431, which is a silicon layer or wafer”), the flow cell devices comprising:
a portion of the base wafer 431 (Fig. 8);
a plurality of dielectric layers 432-437 extending over the portion of the base wafer 431 (Fig. 8 and [0103]: “a plurality of metal-dielectric layers 432-437”);
a reaction structure 408 extending over the dielectric layers 432-437 that comprises a detector surface 412 (Fig. 8 and [0096]: “The detector surface 412 has an array of reaction recesses or open-sided reaction chambers 408.”);
a plurality of light sensors 440 positioned within the dielectric layers (Figs. 7 and 8, and [0090]: “The device base 425 may include a sensor array 424 of light sensors 440” – Note that the device base includes the dielectric layers.);
device circuitry 446 extending through the dielectric layers 432-437 (Fig. 8: “device circuitry 446” – “M1, M2, M3, M4, 4M, 7E” – [0104-0105]) electrically coupled to the light sensors to transmit data signals based on photons detected by the light sensors ([0098]: “associated circuitry 446 for transmitting signals based on the light emissions (e.g., photons) detected by the light sensor 440”);
a plurality of light guides 462 positioned within the dielectric layers 432-437 between the detector surface 412 and the light sensors 440 (Figs 7 and 8, and [0090]: “the components are arranged such that each light sensor 440 aligns with a single light guide 462 and a single reaction site 414”); and
a lid 410 extending over the detector surface 412 with a flow channel 418 therebetween (Fig. 7 and [0093]: “The flow cell 402 is sized and shaped so that a flow channel 418 exists between the flow cover 410 and the detection device 404.”), the lid 410 comprising at least one first port 420/422 in communication with the flow channel 418 (Fig. 7 and [0094]: “Also shown, the flow cover 410 may include inlet and outlet ports 420, 422”); as in Claim 1.
Further regarding Claim 1, Zhong does not specifically teach the method discussed above comprising separating each flow cell device from the wafer level flow cell structure, as in Claim 1.
However, Baek teaches a respective method comprising fabricating a plurality of flow cell devices on a single wafer layer, then separating each flow cell device by dicing the wafer so as to produce individual flow cell devices ([0051]: “Since many flow cells can be made on each wafer, the combined wafer forming the completed flow cells can be diced to separate the flow cells into individual flow cells or into pieces containing a desired number of individual flow cells.”). Therein, this method allows the production of individual sensors after fabrication on an overall wafer, thereby streamlining the production of large quantities of individual sensors ([0007, 0052]).
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 method of Zhong to further comprise separating each flow cell device from the wafer level flow cell structure, such as suggested by Baek, so as to allow the production of individual sensors after fabrication on an overall wafer, thereby streamlining the production of large quantities of individual sensors; and would have a reasonable expectation of success in Zhong given its commensurate structure of flow cell devices positioned on a common wafer.
Further regarding Claim 1, Zhong does not specifically teach the method discussed above further comprising positioning the separated flow cell device within a portion of an enclosure of a socket over a base portion of the socket, and electrically coupling the device circuitry with electrical contacts of the socket that are exposed within the enclosure and extend through a portion of the base portion; and coupling a cover portion of the socket with the base portion of the socket to secure the separated flow cell device within the enclosure of the socket beneath the cover portion and to couple at least one second port of the cover portion in communication with the at least one first port of the flow cell device, as in Claim 1.
However, Elkind teaches a respective fluidic sensing cartridge comprising a cartridge 10 inserted into a socket 28 an analytical unit 30 so as to electrically couple the cartridge circuitry via electrical connectors 34 to the analytical unit 30 (Fig. 1), wherein a base portion of the socket is coupled with a cover portion to secure the cartridge 10 within the socket 28 of the analytical unit 30 (col. 4, line 19), and couples with the fluidic ports 36. Therein, this arrangement allows the use of disposable cartridges with an analytical unit, thereby reducing the components of each disposable cartridge through a reusable analytical unit.
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 method of Zhong to further include positioning the separated flow cell device within a portion of an enclosure of a socket over a base portion of the socket, and electrically coupling the device circuitry with electrical contacts of the socket that are exposed within the enclosure and extend through a portion of the base portion; and coupling a cover portion of the socket with the base portion of the socket to secure the separated flow cell device within the enclosure of the socket beneath the cover portion and to couple at least one second port of the cover portion in communication with the at least one first port of the flow cell device, such as suggested by Elkind, so as to allow the use of disposable cartridges with an analytical unit, thereby reducing the components of each disposable cartridge through a reusable analytical unit, and would have a reasonable expectation of success therein given that similar cartridge arrangement in Zhong (Fig. 4).
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong to include separating the wafer to produce individual flow cells, as suggested by Baek. Further therein, Baek teaches said separation as occurring by way of dicing of the wafer level flow cell structure ([0010]: “The combined wafer has many flow cells, which are further diced to separate individual flow cells.”).
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 the method of Zhong with the wafer separation of Baek, to provide said separation through dicing of the wafer level flow cell structure, as suggested by Baek, so as to provide a suitable means of separation appropriate in application to a wafer.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong to include separating the wafer to produce individual flow cells, as suggested by Baek. Given that the wafer of Zhong is commensurate with that of Baek, and that Baek cuts the wafer by dicing, the wafer must thereby emerge from the dicing step with exposed lateral sides.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when dicing the wafer of Zhong as suggested by Baek, that said dicing will result in exposed lateral sides of at least the wafer.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong to include separating the wafer to produce individual flow cells, as suggested by Baek. Further, Given that Zhong teaches an integral layered device comprising the wafer, dielectric layers, and reaction structure, that the dicing step provided through Baek would result in cutting through every layer so as to achieve the sought separate individual flow cell devices of Baek. Thus, said dicing step would result in exposed lateral sides of all of the wafer, dielectric layers, and reaction structure.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that, when dicing the wafer of Zhong as suggested by Baek, that said dicing will result in exposed lateral sides of at least the wafer, dielectric layers, and reaction structure.
Regarding Claim 5, the prior art meets the limitations of Claim 3 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong to include inserting the cartridge device into a socket of an analytical device to control the cartridge device as suggested by Elkind. Therein, given that the lateral side surfaces 38 of the device of Elkind are spaced away from the side walls of the socket so as to protect the electrical connections 34 disposed on the lateral side surfaces 36.
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 the method of Zhong to include the cartridge/socket arrangement of Elkind, to position the separated flow cell device within the portion of the enclosure such that the exposed lateral side surfaces of the separated flow cell device are spaced from side wall portions of the socket, such as suggested by Elkind, so as to protect the electrical contacts/conducting elements from contacting the side surface.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhong does not specifically teach the method discussed above wherein the flow cell devices further comprise contact pads at a back side of the base wafer in electrical connection with the device circuitry, and wherein positioning the separated flow cell device within the portion of the enclosure of the socket comprises engaging an exposed surface of the contact pads of the separated flow cell device with the electrical contacts within the enclosure to electrically couple the device circuitry and the electrical contacts, as in Claim 6.
However, as discussed above regarding Claim 1, Elkind teaches a respective cartridge/reader arrangement wherein the cartridge comprises electrical contact pads 34 and the reader comprises electrical contacts within the enclosure 28 (Fig. 1). Therein, this arrangement provides the cartridge as being powered and operated by the reader, allowing for automation and use of disposable cartridges.
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 method of Zhong wherein the flow cell devices further comprise contact pads in electrical connection with the device circuitry, and wherein positioning the separated flow cell device within the portion of the enclosure of the socket comprises engaging an exposed surface of the contact pads of the separated flow cell device with the electrical contacts within the enclosure to electrically couple the device circuitry and the electrical contacts, such as suggested by Elkind, so as to provide the cartridge as being powered and operated by the reader, allowing for automation and use of disposable cartridges.
Further, regarding the contact pads “at a back side of the base wafer”, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of contact pads would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the contact pads.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhong teaches the method discussed above wherein the device circuitry does not extend through the base wafer to a back side of the base wafer (Fig. 1 shows that the electrical components “device circuitry 446” – “M1, M2, M3, M4, 4M, 7E” do not extend through the wafer layer 431.), as in Claim 7.
Regarding Claim 8, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhong teaches the method discussed above wherein the device circuitry 446 extends to a side of the flow cell devices and forms exposed contact surfaces at the side (Given the cartridge configuration of Fig. 4 and discussion of electrical contacts in para. [0041], the device circuitry 446 must necessarily extend to a surface so as to form the electrical contacts needed to power the circuitry.), as in Claim 8.
Further, regarding the contact surfaces at a “top side”, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of contact surfaces would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the contact surfaces.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, Zhong teaches the method discussed above wherein electrically coupling the device circuitry with the electrical contacts comprises electrically coupling the exposed contact surfaces at the top side of the separated flow cell device with the electrical contacts via respective electrically conductive structures extending therebetween ([0041]: “mating contacts of the bioassay system” – see also [0061].), as in Claim 9.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge arrangement of Elkind. Therein, the cartridge of Elkind comprises cartridge components such as the light source 68 and photodetector array 74 as disposed on a substrate 38 having electrical leads connected to the components and disposed on an edge of the substrate so as to connect with electrical connectors of a socket, thereby forming the overall cartridge having a protective housing.
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 the method of Zhong with the cartridge arrangement of Elkind, to couple the base wafer of the separated flow cell device over a substrate portion of a device carrier, and electrically coupling the device circuitry of the separated flow cell device with electrical leads of the substrate portion, such as suggested by Elkind, so as to provide connections to electrical connectors of a socket while providing an overall base layer surrounded by a protective housing for protecting the cartridge components.
Regarding Claim 12, the prior art meets the limitations of Claim 11 as discussed above. Further, Zhong teaches the method discussed above wherein the device circuitry of the flow cell device forms exposed contact surfaces at side of the separated flow cell device (Given the cartridge configuration of Fig. 4 and discussion of electrical contacts in para. [0041], the device circuitry 446 must necessarily extend to a surface so as to form the electrical contacts needed to power the circuitry.), as in Claim 12. See also Claim 1 above regarding the separation for forming individual flow cell devices suggested by Baek.
Further, regarding the contact surfaces at a “at a top side or a lateral side”, mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Herein, one of ordinary skill in the art would find it obvious that the device having the claimed relative arrangement of contact surfaces would not perform differently than the prior art device, absent evidence of criticality, non-obviousness, or unexpected results associated with the position of the contact surfaces.
Further regarding Claim 12, Zhong does not specifically teach the method discussed above wherein electrically coupling the device circuitry with the electrical leads comprises coupling electrically conductive wires between the electrical leads and the exposed contact surfaces, as in Claim 12.
However, Elkind teaches cartridge components attached to a substrate 38 wherein the electrical leads 34 comprise conductive coupling wires to exposed contact surfaces of the cartridge components – see above regarding Claim 11. Therein, the electrical wires provide conductive paths to the cartridge elements, providing them with power needed for their functionality.
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 the method of Zhong to include the cartridge platform and electrical leads of Elkind, wherein electrically coupling the device circuitry with the electrical leads comprises coupling electrically conductive wires between the electrical leads and the exposed contact surfaces, as suggested by Elkind, so as to provide conductive paths to the cartridge elements, providing them with power needed for their functionality.
Regarding Claim 13, the prior art meets the limitations of Claim 11 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge/socket arrangement of Elkind. Therein, the arrangement of Elkind is provided as a cartridge 10 having electrical leads 34 which interact with electrical leads disposed within a socket 28 of an analysis unit 30, thereby engaging surfaces to form a circuit for supplying power to the cartridge (Fig. 4 and col. 4, line 31).
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 the method of Zhong with the cartridge elements of Elkind, to provide the device such that positioning the separated flow cell device within the portion of the enclosure of the socket and electrically coupling the device circuitry with the electrical contacts comprises positioning the coupled separated flow cell device and device carrier within the portion of the enclosure of the socket and engaging exposed surfaces of the electrical leads of the substrate portion with the electrical contacts of the socket, such as suggested by Elkind, so as to form a completed circuit between the cartridge and analysis unit, thereby supplying power to the cartridge necessary for its operation.
Regarding Claim 14, the prior art meets the limitations of Claim 11 as discussed above. Further, as discussed above regarding Claim 11, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge/socket arrangement and base substrate of Elkind. Therein, the substrate of Elkind is provided as a printed circuit board (col. 4, line 33), so as to form the conductive paths necessary for supplying power to analytical elements of the cartridge.
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 the method of Zhing with the substrate of Elkind, to provide the substrate portion and the electrical leads of the device carrier as a printed circuit board, such as suggested by Elkind, so as to form the conductive paths necessary for supplying power to analytical elements of the cartridge.
Regarding Claim 15, the prior art meets the limitations of Claim 11 as discussed above. Further, as discussed above regarding Claim 11, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge/socket arrangement and base substrate of Elkind. Therein, the device of Elkind comprises side wall portions 14/16/22/24 extending from the base substrate 38 forming a cavity holding the flow cell device (Fig. 2), thereby protecting the flow cell device from damage.
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 the method of Zhong with the cartridge/socket arrangement and base substrate of Elkind, to provide the device carrier further comprising side wall portions extending from the substrate portion, the substrate portion and the side wall portions forming a cavity, and wherein coupling the base wafer of the separated flow cell device over the substrate portion of the device carrier couples the separated flow cell device within the cavity of the device carrier, such as suggested by Elkind, so as to protect the flow cell device from damage.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge/socket arrangement of Elkind. Therein, the device of Elkind comprises a plurality of electrical contacts extending through a plurality of apertures (See Figs. 1 and 4, and cols. 3-4) so as to form a mating arrangement configured to couple with the electrical leads of the cartridge.
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 method of Zhong wherein the plurality of electrical contacts respectively extend through a plurality of apertures in the base portion between the enclosure and an exterior side of the base portion, such as suggested by Elkind, so as to form a mating arrangement configured to couple with the electrical leads of the cartridge.
Further, if the electrical leads of Elkind are taken as extending through a single aperture, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Therein, one skilled in the art would not expect the device to function differently merely for the number of apertures provided for leads to extend through, absent evidence of a criticality or unexpected results.
Regarding Claim 17, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge/socket arrangement of Elkind. Therein, the device of Elkind comprises electrical contacts embedded in a base portion so as to form an array of contact surfaces exposed in the socket, and wherein the circuitry of the electrical leads of the cartridge physically engage with the contact surfaces of the socket enclosure (Figs. 1 and 4, and cols. 3-4) so as to supply power to the cartridge necessary for its operation.
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 the method of Zhong with the cartridge/reader elements of Elkind, to provide the plurality of electrical contacts as embedded in the base portion such that they form an array of contact surfaces that are exposed within the enclosure, and wherein the device circuitry of the separated flow cell device physically engages the contact surfaces within the enclosure, such as suggested by Elkind, so as to supply power to the cartridge necessary for its operation.
Regarding Claim 18, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhong teaches the method discussed above wherein the flow cell device comprise complementary metal- oxide semiconductor (CMOS) light sensors ([0038, 0100, 0157]), as in Claim 18.
Regarding Claim 19, the prior art meets the limitations of Claim 1 as discussed above. Further, as discussed above regarding Claim 1, one skilled in the art would find it obvious to modify the method of Zhong with the cartridge/socket arrangement of Elkind. Therein, the device of Elkind comprises coupling the cartridge to a biosensor instrument (computer) having its own port and plurality of electrical contacts (usb port) in communication with the port of the socket (col. 3, line 18 – col. 4, line 28) wherein this arrangement allows for automation of the cartridge processes and data collection and analysis. See also Zhong Fig. 1 and [0056] suggesting hardwired connections to the analytical device.
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 method of Zhong further comprising operatively coupling the coupled socket and separated flow cell device with a biosensor instrument that comprises at least one third port and a plurality of instrument electrical contacts such that the at least one third port is in communication with the at least one second port of the socket and the plurality of instrument electrical contacts are in electrical connection with the electrical contacts of the socket, such as suggested by Elkind, so as to provide for automation of the cartridge processes and data collection and analysis.
Regarding Claim 20, the prior art meets the limitations of Claim 19 as discussed above. Further, Zhong teaches the method discussed above further comprising delivering a reaction solution into the flow channel of the separated flow cell device over a plurality of reaction sites on the detector surface of the separated flow cell device ([0030, 0038, 0050]), as in Claim 20.
Further regarding Claim 20, as discussed above regarding Claim 19, one skilled in the art would find it obvious to modify the method of Zhong with control through a biosensor system/computer as suggested by Elkind to provide automation over the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the reagent flow of Zhong via the biosensor instrument of Elkind so as to automate the process.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong in view of Baek and Elkind, as applied to Claims 1-9 and 11-20 above, and in further view of Hoffmann et al. (US 2017/0113221 A1), hereinafter “Hoffmann”.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Zhong does not specifically teach the method discussed above wherein coupling the cover portion with the base portion of the socket comprises removably coupling the cover portion and the base portion together, and wherein the separated flow cell device is removably secured within the enclosure, as in Claim 10.
However, Hoffmann teaches an analogous cartridge/reader arrangement wherein top and bottom portions of a slot for receiving the cartridge engage to clamp the cartridge within the slot ([0109]: “a docking bay (here 1001) for receiving and reversibly clamping a microfluidic cartridge” – see also paras. [0130-0131].) so as to secure the cartridge within the slot, thereby reducing errors related to loose/dislodged cartridges in the slot.
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 method of Zhong wherein coupling the cover portion with the base portion of the socket comprises removably coupling the cover portion and the base portion together, and wherein the separated flow cell device is removably secured within the enclosure, such as suggested by Hoffmann, so as to to secure the cartridge within the slot, thereby reducing errors related to loose/dislodged cartridges in the slot.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798