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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/1/2022 is acknowledged.
Claim Rejections - 35 USC § 103
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) 1-3,8,10-14,16-24,26-33,35,37,39-40,43,46-56,59-60,62 and 66-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hung et al. (US 2007/0275455) and further in view of Wikswo et al. (US 2014/0356849).
Regarding claim 1 Hung discloses microfluidic-enabled multiwell device for microfluidic control of fluids for cell cultures comprising: (See Abstract Figs. 1-3 wherein a microfluidic multiwell device is provided for cell culture.)
a microfluidics module comprising a well layer, a fluid channels layer, and a pneumatic layer, (See Hung. Figs. 2-6B and [0058]-[0065] wherein there is a microfluidic module having a well layer with wells 58, a fluid channel layer having channels which supply said wells with fluids, and a pneumatics layer for controlling valves as described.)
It is noted that the top of fluids channels layer is disposed in a first plain and the well layer is disposed in a second plain. It is noted that there are a numerous number of plains in which the fluids channel layer and well layer are disposed due to the fact that they are three dimensional objects and the claims do not require that the fluid channel layer and well layer cannot be disposed in intersecting plains.
and one or more processors; and memory storing instructions configured to be executed by the one or more processors to cause the multiwell device to execute a cell culture process (See Hung Fig.s 1 and [0055] wherein there is a computer, i.e. a device with a processor and memory storing instructions, to cause the device to execute a cell culture process.)
Hung does not specifically disclose a sensor module and computer control over said sensors.
Wikswo discloses a microfluidic multiwell cell culture device having a plurality of wells and a sensor module comprising one or more sensors configured to detect data regarding an environment inside the microfluidic module; and one or more processors; and memory storing instructions configured to be executed by the one or more processors to cause the multiwell device to execute a cell culture process, comprising: receiving data collected from the one or more sensors regarding the environment inside the microfluidic module; and based at least in part on the data received, causing fluid to flow to an individually addressable well in the multiwell device. (See Wikswo Abstract Fig. 2 [0103], [0128], [0142] and [0280]-[0282] wherein a microfluidic mutliwell device has a sensor module plurality of sensors detecting data regarding an environment in the multiwell module and a processor with programming, i.e. memory with instructions, which receive data from said sensors and based on said data cause fluids to flow to an individual well and control cell culture parameters.)
It would have been obvious to one of ordinary skill in the art at the time of filling to provide a sensor module and control procedures executed by a processor having instructions stored in memory as described by Wikswo in the device of Hung because such sensors and control allow culture to occur in an optimal and controlled environment as would be desirable in the device of Hung.
Furthermore even assuming arguendo with respect to the location of the fluid channels layer and well layer being in different plains it is noted that such a modification would have required a mere rearrangement of parts, i.e. form the wells above or below the fluids channels layer, which would have been obvious to one of ordinary skill in the art to optimize fluid delivery and because it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Regarding claim 2 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the microfluidic-enabled multiwell device further comprises a substrate layer.(See Hung Abstract and [000] wherein there is a substrate layer on which other layers are formed.)
Regarding claim 3 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the pneumatic layer comprises a pneumatic well-selection layer and pneumatic control layer.(See Hung [0088] and Figs. 14A-17D wherein there are layers which are pneumatic well-selection layer, i.e. holder which allows pneumatic access, and pneumatic control layer which provides pneumatic action.)
Regarding claim 8 modified Hung discloses all the claim limitations as set forth above as well as the device further comprising a control module comprising at least one of the one or more processors. (See Hung Fig. 1 and [0055] wherein the device comprises a control module 42,44,46,comprising a computer processor.)
Regarding claim 10 modified Hung discloses all the claim limitations as set forth above as well as the device wherein: the microfluidics module comprises a plurality of pumps; and causing fluid to flow to an individual well in the multiwell device comprises causing one or more of the plurality of pumps to be actuated.
Wikswo discloses a microfluidic device wherein fluids are pumped thorough the device utilizing a plurality of pumps to cause fluids to flow to individual wells. (See Wikswo abstract and [0008])
It would have been obvious to one of ordinary skill in the art at the time of invention to utilize pumps as described by Wikswo in the device of Hung because the use of pumps is a wells known method of allowing the controllable flow of fluids as would be desirable in the device of Hung.
Regarding claim 1 modified Hung discloses all the claim limitations as set forth above as well as the device wherein there are a plurality of micropumps but does not specifically disclose a syringe driven pump, a micro-diaphragm pump, a pneumatic micropump with doormat valve geometry, or a pneumatic micropump with lifting gate valve geometry.
It is noted that one of ordinary skill in the art at the time of invention would recognize the equivalve to the pumps of modified Hung and syringe driven pumps and diaphragm pumps as they are merely art as it is merely the selection of functionally equivalent microfluidic pumps recognized in the art and one of ordinary skill in the art would have a reasonable expectation of success in doing so.
Regarding claim 12 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the multiwell device comprises one or more microfluidics module sensors integrated into the microfluidic module of the multiwell device, wherein the one or more microfluidics module sensors are configured to detect a characteristic of a parameter of the environment inside the microfluidic module. (See Wikswo [0103] and [0128] wherein a plurality of microfluid module sensors are integrated into the device to detect characteristics of the environment inside the microfluid module.)
Regarding claim 13 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the sensor layer comprises one or more sensors configured to detect an external characteristic of an environment surrounding the multiwell device. (See Wikswo [0103], [0128], [0142] and [0280]-[0282] wherein the sensors are fully capable of detecting an external characteristic of an environment surrounding the multiwell device, i.e. a characteristic of temperature, atmosphere, etc.)
Regarding claim 14 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the device to do one or more of the following: store, in the memory, the data collected from the one or more sensors regarding the environment inside the microfluidic module; (See Wikswo [0103], [0128], [0142] and [0280]-[0282] wherein a processor and memory store, at least for some amount of time, data collected from the sensors regarding an environment inside the microfluidic module
Regarding claim 16 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the device to: transmit instructions for displaying a graphical user interface; detect an input executed by a user of the device via the graphical user interface; and in response to detecting the input, cause fluid to flow to a user-indicated individual well of the multiwell device. (See Hung Fig. 1 and [0055] wherein there is a display having a GUI and input device which allows manipulation of the GUI, and manipulation of the GUI allows device control and operation including flow to individual wells and said display, input, and control are performed via a computer having instructions allowing such by a processor.)
Regarding claim 17 and 18 modified Hung discloses all the claim limitations as set forth above as well as the device wherein a footprint of the multiwell device conforms to one or more SBS/ANSI multiwell plate standards and the multiwell device is compatible with one of industry-standard laboratory plate-reading and industry-standard automation equipment. It is noted that such a modification would have required a mere change in shape of the device which would have been obvious to one of ordinary skill in the art at the time of filing because the change in configuration of shape of a device is obvious absent persuasive evidence that the particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 19 modified Hung discloses all the claim limitations as set forth above as well as the device It is noted that the device of Hung is fully capable of being utilize for multiple cell culture procedures if one so wished and such limitations are directed to intended uses of the device which do not define structural elements which differentiate the claimed invention from the cited prior art. See MPEP 2114.
Regarding claim 20 modified Hung discloses all the claim limitations as set forth above as well as the device wherein one or more of the microfluidic module and the sensor module are configured to be removable from the multiwell device. (See Hung Figs and Wikswo wherein the microfluidic and sensor modules are fully capable of and configured to be removed if one so wished, i.e. such as by manually separating the layers.)
Additionally it would have been obvious to one of ordinary skill in the art to make the sensor and microfluidic modules removal be because doing so would have required merely making element separable in order to allow sensor reuse and because it has been held that making elements separable is obvious to one of ordinary skill in the art, See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)
Regarding claim 21 modified Hung discloses all the claim limitations as set forth above as well as the device wherein one or more of the microfluidic module and the sensor module are configured to be removable from the multiwell device following a first cell culture procedure for replacement by another component prior to a second cell culture procedure. (See Hung Figs wherein the well layer is fully capable of and configured to be removed if one so wished, i.e. such as by manually separating the layers.)
Additionally it would have been obvious to one of ordinary skill in the art to make the sensor and microfluidic module removable from the multiwell device because doing so would have required merely making elements separable in order to allow reuse and because it has been held that making elements separable is obvious to one of ordinary skill in the art, See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)
Regarding claim 22 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the well layer is configured to be one or more of the following: removable from the microfluidics module;(See Hung Figs wherein the well layer is fully capable of and configured to be removed if one so wished, i.e. such as by manually separating the layers.)
Regarding claim 23 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the well layer is configured to be removable from the microfluidics module following a first cell culture procedure for replacement by another component prior to a second cell culture procedure. (See Hung Figs wherein the well layer is fully capable of and configured to be removed if one so wished, i.e. such as by manually separating the layers.)
Additionally it would have been obvious to one of ordinary skill in the art to make the sensor and microfluidic module removable from the multiwell device because doing so would have required merely making elements separable in order to allow reuse and because it has been held that making elements separable is obvious to one of ordinary skill in the art, See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)
Regarding claim 24 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the well layer comprises one or more of the following: glass, cyclo-olefin copolymer, plastics, PDMS, poly-lysine, fibronectin, and matrigel.(See Hung [0019] and Claims 21-24 wherein the layers are formed from PDMS and plastics.)
Regarding claim 26 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the well layer is micropatterned. (See Hung Fig. 11 wherein the well layer has micropatterns of capillaries and other features.)
Regarding claim 27 modified Hung discloses all the claim limitations as set forth above as well as the device wherein one or more of a material, micropatterning, coating, and geometrical configuration of the well layer are configured for 2D culture of adherent cells. (See Hung Fig. 11 and [0019] wherein the materials of geometrical configuration of the well layer are fully capable of allowing 2D adherent cells.) Such limitations are directed to intended uses and materials worked on by the device which do not define structural elements which differentiate the claimed invention from the cited prior art. See MPEP 2114 and 2115.
Regarding claim 28 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause multiwell device to control fluid for the cell culture process for at least 24 hours. (See Hung [0076] wherein the assay is 1-2 days and thus the fluid control is performed for at least 24 hours and instructions are so provided.)
Regarding claim 29 modified Hung discloses all the claim limitations as set forth above as well as the device wherein causing fluid to flow to an individually addressable well comprises causing a valve to be actuated in association with displacement of a portion of the pneumatic layer. (See Hung Figs. 11-12 and [0060] wherein the fluid is caused to flow to each well by causing a valve to be actuated in associated with displacement of the pneumatic layer.)
Regarding claim 30 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the microfluidic module comprises one or more channels having a diameter of less than 1000 microns.
It is noted that such a modification would have required a mere change in size of the channels which would have been obvious to one of ordinary skill in the art at the time of filing because a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding claim 31 modified Hung discloses all the claim limitations as set forth above as well as the device wherein one or more micro-pumps of the microfluidic module are configured to pump a volume of less than 500 nL per pump stroke.
It is noted that such a modification would have required a mere change in size of the pump which would have been obvious to one of ordinary skill in the art at the time of filing because a change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding claim 32 modified Hung discloses all the claim limitations as set forth above as well as the device comprising an array of 96 or more individually-addressable wells.
It is noted that such a modification would have required a mere duplication of parts ,i.e. wells, which would have been obvious to one of ordinary skill in the art at the time of filing because mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 33 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the microfluidic module to cause one or more of the following: automated exchange of cell culture media. (See Wikswo [0142] and [0280]-[0282] wherein a processor, i.e. computer, is programmed to perform automated exchange of culture media.)
Regarding claim 35 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the device to perform one or more of the following: execution of an automated cell-based assay and protocol in the multiwell device, and monitoring the assay for a period of at least 24 hours during execution of the assay. (See Wikswo [0142] and [0280]-[0282] wherein a processor, i.e. computer, is programmed to cause automated assay protocol.)
Regarding claim 37 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the executing the assay comprises one or more of the following: causing the automated addition of one or more compounds to cells; and performing microscopy measurements. (See Wikswo [0142] and [0280]-[0282] wherein a processor, i.e. computer, is programmed to cause addition of compounds to cells.)
Regarding claim 39 modified Hung discloses all the claim limitations as set forth above as well as the device wherein cells of the assay comprise one or more of immortalized cells, primary cells, pluripotent cells, pluripotent-derived cells, adherent cells, or suspension cells. It is noted that such limitations are directed to materials worked on by the device, i.e. cells, and intended uses, which do not define structural elements which differentiate the claimed invention from the cited prior art because the cited prior art is fully capable of using such materials and performing such uses. See MPEP 2114 and 2115.
Regarding claims 40 and 43 Modified Hung discloses all the claim limitations as set forth above and it is noted that conducting an assay in and protocol in a laboratory environment or conducting the assay and protocol in one of a field location, a point-of-care location, and a pharmacy is an intended use of the claimed device which does not define a structural element thereof and the device of the prior art is fully capable of being used in such environments if one so wished. See MPEP 2115
Regarding claim 46 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the well layer contains cryopreserved cells that are thawed during the cell culture.
It is noted that such limitations are directed to materials worked on by the device, i.e. cryopreserved cells, and intended uses, i.e. thawing cells, which do not define structural elements which differentiate the claimed invention from the cited prior art because the cited prior art is fully capable of using such materials and performing such uses. See MPEP 2114 and 2115.
Regarding claim 47 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the device to: in accordance with receiving the data collected from the one or more sensors regarding the environment inside the microfluidic module, control one or more parameters of an environment inside the microfluidics module, wherein the one or more parameters includes one or more of temperature, pressure, pH, humidity, CO2, 02, confluency, fluid flow, alkalinity, input fluid temperature, output fluid temperature, or ambient light intensity.(See Wikswo [0142] and [0280]-[0282] wherein a processor, i.e. computer, is programmed to receive data collected from sensors and control parameters of an environment inside the microfluidics module said parameters include fluid flow,temperature, CO2, O2.)
Regarding claim 48 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the device to: monitor, by the sensor module, one or more parameters of an environment surrounding the multiwell device; store data regarding the monitoring of the parameters of the environment surrounding the multiwell device on a computer storage of the device; and wirelessly transmit the stored data regarding the monitoring of the parameters of the environment surrounding the multiwell device to a user. (See Wikswo [0068], [0141]-[0142] and [0280]-[0282] wherein the instructions allow monitoring of parameters of the environment surrounding the mutliwell device and store said data at least temporarily and wirelessly transmit said data.)
Regarding claim 49 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the instructions are configured to be executed by the one or more processors to cause the device to: monitor, by the sensor module, one or more parameters of an environment surrounding the multiwell device; in accordance with monitoring one or more environmental parameters, adjust one or more parameters of the environment inside the microfluidics module. (See Wikswo [0068], [0141]-[0142] and [0280]-[0282] wherein the instructions allow monitoring of parameters of the environment surrounding the mutliwell device and adjust parameters of the environment inside the microfluidics module)
Regarding claim 50 modified Hung discloses all the claim limitations as set forth above as well as the device wherein: the well layer comprises a first plurality of wells arranged into a plurality of rows; the fluid channels layer comprises a first input channel and a first output channel both corresponding to a first row of the plurality of rows; the fluidic channels layer comprises a second input channel and a second output channel both corresponding to a second row of the plurality of rows; two wells in the first row are individually fluidly connectible to the first input channel by a first plurality of respective input valves; the two wells in the first row are individually fluidly connectible to the first output channel by a first plurality of respective output valves; two wells in the second row are individually fluidly connectible to the second input channel by a second plurality of respective input valves; the two wells in the second row are individually fluidly connectible to the second output channel by a second plurality of respective output valves. (See Hung Figs. 2-6B and [0058]-[0060] wherein there are a plurality of rows of wells each having at least two wells and each row has an input and output channels connected thereto. The wells are each individually connected to input and output channels via valves.)
Furthermore assuming arguendo with respect to such a specific arrangement of channels, wells, and valves, it is noted that such a modification would have required a mere rearaangement of channel and valve structures which would have been obvious to one of ordinary skill in the art
since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Regarding claim 51 modified Hung discloses all the claim limitations as set forth above as well as the device wherein: the first input channel is fluidly connectible to a common input channel via a first channel input valve; the first output channel is fluidly connectible to a common output channel via a first channel output valve; the second input channel is fluidly connectible to the common input channel via a second channel input valve; the second output channel is fluidly connectible to the common output channel via a second channel output valve. (See Hung Figs. 3-6B wherein there are common input and output channels connected via valves to the first and second channels via valves.)
Regarding claim 52 modified Hung discloses all the claim limitations as set forth above as well as the device wherein causing fluid to flow to an individually addressable well in the multiwell device comprises: opening the first channel input valve and the first channel output to allow flow into and out of the first output channel; opening one of the first plurality of input valves and a corresponding one of the first plurality of output valves to allow flow into and out of the individually addressable well. It is noted that such an operation of valves and fluid flow is an intended use of the claimed device which does not define structural elements which differentiate the claimed invention from the cited prior art because the cited prior art is fully capable of causing such flow. See MPEP 2114.
Regarding claims 53 and 54 modified Hung discloses all the claim limitations as set forth above as well as moving fluids downstream the common output channel but does not specifically disclose the use of micropump providing vacuum force thereat.
Wikswo discloses utilizing micropumps to provide vacuum to move fluids through channels in microfluidic modules. (See Wikswo [0343])
It would have been obvious to one of ordinary skill in the art at the time of filling to provide such a microump as descried by Wikswo in the device of Hung because such a micropump allows movement of fluids in a controllable manner within channels of a microfluidic device as would be desirable in the device of Hung.)
Regarding claim 55 and 56 modified Hung discloses all the claim limitations as set forth above and includes numerous surfaces which are fully capable of being fluidly, pneumatically, or electronically coupled to some form of docking component.( See Hung [0110]) It is noted that the docking component is not positively recited and as such any structure thereof does not further limit the claimed invention.
Regarding claim 59 modified Hung discloses all the claim limitations as set forth above as well as the device system for microfluidic control of fluids for cell cultures, wherein the system comprises: the microfluidic-enabled multiwell device of claim 1; and a docking component configured to receive the multiwell device and to be fluidly coupled to the multiwell device. (See Rejection of claim 1 above and Hung Fig. 1 and [0051] wherein the microfluidic multiwell device docks to a docking component 22 which receives said device)
Regarding claim 60 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the docking component is configured to be one or more of the following: pneumatically coupled to the device; and electronically communicatively coupled to the device. (See Rejection of claim 1 above and Hung Fig. 1 and [0051] wherein the docking component is at least fluidically and pneumatically coupled to the device)
Regarding claim 62 modified Hung discloses all the claim limitations as set forth above as well as the device wherein the docking component comprises one or more of the following: a display configured to display a graphical user interface; and a user input device configured to receive a user input comprising an instruction. (See Rejection of claim 1 above and Hung Fig. 1 and [0055] wherein there is a display 44 and keyboard to display a GUI and input user instructions)
Regarding claim 66 modified Hung discloses all the claim limitations as set forth above but does not specifically disclose and inkjet reservoir system to add materials to the device.
Wikswo et al. discloses a microfluidic cell culture module wherein an inkjet printer having some for of input reservoir is provided to print reagents to allow sensing within the device. See Wikswo Abstract and [0256])
It would have been obvious to one of ordinary skill in the art at the time of filing to provide and inkjet input reservoir to interface as described by Wikswo to interface with the device of Hung because doing so allows deposition of sensor materials so that sensing of material properties may be performed and cell culture may be accurately controlled as would be desirable in the device of Hung.
Regarding claim 67 modified Hung discloses all the claim limitations as set forth above as well as the device comprising an output reservoir configured to be fluidly coupled to the multiwell device and to receive flow of one or more of media, cell suspension, and reagents from the multiwell device. (See Hung [001 and Figs. 1-2 wherein outlet areas and reservoirs are provided to be fluidly coupled to the multiwell device and receive flow of media.)
Regarding claim 68 modified Hung discloses all the claim limitations as set forth above as well as the device comprising a manifold configured to attach to one or more of a reservoir or a vacuum line. (See Rejection of claim 1 above and Hung Fig. 1 and [0051] wherein there is a manifold to connect to at least a reservoir.)
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hung et al. (US 2007/0275455) in view of Wikswo et al. (US 2014/0356849) as applied to claims above, and further in view of Liu et al. US 2012/0245042).
Regarding claims 4-7 Hung discloses all the claim limitations as set forth above but does not specificall disclose the use of a degasser.
Liu et al. discloses a microfluidic module comprising a degasser layer with a plurality of well-specific degassers each configured to remove gas bubbles from a specific well in the well layer which comprises a gas- permeable degasser membrane between the well layer and the degasser layer. A degasser control layer comprising a plurality of pneumatic channels pneumatically coupled to one or more of the well-specific degassers and wherein the microfluidics module comprises a global degasser configured to remove gas bubbles from a fluid channel configured to deliver fluid to two or more of the wells of the well layer. (See Liu Abstract and Figs. 1-2 wherein a degasser layer comprises a porous membrane and a plurality of degassers to remove bubbles from specific wells. Pneumatic channels in a control layer are coupled to the degassers and remove gas from individual wells. Any of the degassers may be a global degasser as said elements are fluidly connected and can remove gas from wells and channels which deliver fluid to the wells.)
It would have been obvious to one of ordinary skill in the art at the time of filling to provide a degassing system as described by Liu et al. in the device of Hung because such a degasser system allows quick removal of bubbles which negatively impact flow in microfluid devices and such would be desirable in the device of Hung.
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hung et al. (US 2007/0275455) in view of Wikswo et al. (US 2014/0356849) as applied to claims above, and further in view of Zhou et al. (US 2007/0166199)
Regarding claim 15 modified Hung discloses all the claim limitations as set forth above but does not disclose a remote computing device.
Zhou et al. discloses a microfluidic device controlled by a controller 106 having a processor with instructions to allow connection to a remote computer 118 over a network which includes storage of data from sensors. (See Zhou Fig. 1A-1B and [0199]-[0117])
It would have been obvious to one of ordinary skill in the art to provide instructions for execution by a processor to allow data transmission to remote computing system including storage of sensor data as described by Zhou because doing so allows remote access and control over said device in order to allow more adaptable user control as would be desirable in the device of Modified Hung.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-8, 10-14, 16-24, 26-33,35,37,39-40,43,46-56,59-60,62, and 66-68 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 11,946,035. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Ludlam et al. include all limitations of the present claims and are generally more specific.
Furthermore in regards to limitations directed to the location of the fluid channels layer and well layer being in different plains it is noted that such a modification would have required a mere rearrangement of parts, i.e. form the wells above or below the fluids channels layer, which would have been obvious to one of ordinary skill in the art to optimize fluid delivery and because it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Additionally it would have been obvious to one of ordinary skill in the art to make the sensor, well layer, and microfluidic modules removal be because doing so would have required merely making element separable in order to allow sensor reuse and because it has been held that making elements separable is obvious to one of ordinary skill in the art, See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 11,946,035 in view of Zhou et al. (US 2007/0166199).
Regarding claim 15 modified Hung discloses all the claim limitations as set forth above but does not disclose a remote computing device.
Zhou et al. discloses a microfluidic device controlled by a controller 106 having a processor with instructions to allow connection to a remote computer 118 over a network which includes storage of data from sensors. (See Zhou Fig. 1A-1B and [0199]-[0117])
It would have been obvious to one of ordinary skill in the art to provide instructions for execution by a processor to allow data transmission to remote computing system including storage of sensor data as described by Zhou in the device of U.S. Patent No. 11,946,035 because doing so allows remote access and control over said device in order to allow more adaptable user control as would be desirable in the device of U.S. Patent No. 11,946,035.
Conclusion
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799