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, claims 1-8, in the reply filed on 11/18/2025 is acknowledged.
Claims 9-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/18/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, claim 3 recites the limitation "the respective portions" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the respective portions” are interpreted as any portions of the conductive materials.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nisch (US 6032062 A).
Regarding claim 1, Nisch teaches a device (abstract; Figs. 1-4) comprising:
a culture vessel (Fig. 2, culture vessel Ge) in which a living cell is cultured (Fig. 2 teaches biological cells Ze inside culture vessel Ge; “cultured” is interpreted as an intended use, MPEP 2114; cells Ze are in physiological electrolyte E, therefore is capable of being cultured); and
a multi-electrode array (Figs. 1-2, microelectrodes M, which are in an array) comprising first electrodes arranged with a pattern (Figs. 1-2 teach microelectrodes M in arranged in a pattern) and configured to conductively receive an electrical signal generated by the living cell (column 5, lines 39-47) and conductively transmit an electrical signal to the living cell through the first electrodes (column 5, lines 39-47),
wherein the culture vessel (Fig. 2, culture vessel Ge) is mateable with the MEA (Fig. 2 shows culture vessel Ge is structurally mateable with the microelectrodes M, since the substrate S having the microelectrodes M are mated or combined with the culture vessel Ge), and configured to, when mated with the MEA, conductively transmit an electrical signal generated by the living cell to the first electrodes (column 5, lines 39-47 and Fig. 2 teaches the culture vessel Ge combined with the microelectrodes M, allows for electrical potential of a biological cell to be measured by the microelectrodes) or conductively transmit an electrical signal to the living cell via the first electrodes through a surface mated with the MEA (column 5, lines 39-47 and Fig. 2 teaches the culture vessel Ge combined with the microelectrodes M, allows for electrical stimulation of the cell by the microelectrodes).
Regarding claim 8, Nisch teaches wherein the MEA comprises: an integrated circuit (Figs. 1-2, pad electrodes A, which are integrated in the microelectrode arrangement 10); and a passivation layer (Fig. 1, light-sensitive layer P) formed on one side of the integrated circuit (Fig. 1), and wherein the first electrodes (microelectrodes M) are connected to the integrated circuit through the passivation layer (Figs. 1-2 teaches the microelectrodes M are electrically connected to the pad electrodes A through light-sensitive layer P).
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.
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 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20050196776 A1) in view of Curley et al. (US 20210198613 A1).
Regarding claim 1, Yang teaches a device (abstract; Fig. 4) comprising:
a culture vessel (well plate 12); and
a multi-electrode array (Fig. 4, multiplexer 420 comprising connections 410; paragraphs [0063]-[0064] teaches connections 410 are for couple to contact pads 402 of sample array 10, therefore connections 410 are interpreted as multiple electrodes in an array) comprising first electrodes arranged with a pattern (Fig. 4, connections 410 are arranged with a pattern) and configured to conductively receive an electrical signal generated by the living cell (paragraphs [0063]-[0064] teaches connections 410 are used to couple signals from electrodes 210 to analyzer 430, therefore connections 410 are configured to conductively receive an electrically signal generated by a living cell via electrodes 210 at a later time) and conductively transmit an electrical signal to the living cell through the first electrodes (paragraphs [0063]-[0064] teaches connections 410 are used to apply a potential to electrodes 210 of sample array 10, therefore connections 410 are configured to conductively transmit an electrical signal to the living cell at a later time),
wherein the culture vessel (Fig. 4, well plate 12) is mateable with the MEA (Fig. 4 and paragraph [0059] teaches the culture vessel 12 comprising substrate 20 is mateable or capable of being coupled with the connections 410), and configured to, when mated with the MEA, conductively transmit an electrical signal generated by the living cell to the first electrodes (paragraphs [0063]-[0064] teaches connections 410 are used to couple signals from electrodes 210 to analyzer 430, therefore culture vessel 12 comprising electrodes 210 is configured to conductively transmit an electric signal generated by a living cell to the connections 410 at a later time) or conductively transmit an electrical signal to the living cell via the first electrodes through a surface mated with the MEA (paragraphs [0063]-[0064] teaches connections 410 are used to apply a potential to electrodes 210 of sample array 10, therefore culture vessel 12 comprising electrodes 210 is configured to conductively transmit an electrical signal to a living cell via connections 410 through substrate 20 mated with the connections 410 at a later time).
While Yang teaches electrochemical detection and multiplexed electrochemical detection of samples (paragraph [0003]), applying potential to electrodes and receiving potentials from electrodes (paragraph [0051]), adding samples to wells (paragraph [0019], [0090]), Yang fails to teach: the culture vessel (well plate 12) in which a living cell is cultured.
Curley teaches a microelectrode array for use in microengineered physiological systems (abstract). Curley teaches a desire for higher throughput systems capable of providing relevant in vivo metrics of cells (paragraph [0006]). Curley teaches the microelectrode array allows for reliable detection of one or more bioelectrical signals in a microengineered physiological system (paragraph [0007]). Curley teaches electrical stimulation via electrodes to a cell culture vessel, wherein electrodes are in operable connection with electrochemical systems (paragraph [0060]). Curley teaches the microelectrode arrays disclosed herein can be employed in microengineered physiological systems to assist with electrophysiological stimulation and recording of electrically active cellular populations (paragraph [0077]). Curley teaches the microelectrode arrays for cell cultures can impart the necessary complexity required to reduce animal testing and improve the efficacy of cell-based biosensors for a variety of applications (paragraph [0121]).
Since Curley teaches a microelectrode array similar to Yang, and Curley teaches a need for higher throughput systems capable of providing relevant in vivo metrics of cells (paragraph [0006]), 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 the culture vessel of Yang to incorporate the teachings of a microelectrode array for electrophysiological stimulation and recording of electrically active cellular populations of Curley (paragraphs [0006],[0060],[0077],[0121]) to provide: the culture vessel in which a living cell is cultured. Doing so would have a reasonable expectation of successfully utilizing the MEA of Yang for improved electrical analysis of a sample, such as cells, therefore improving efficacy, versatility, and characterization of cell samples for a variety of applications (Curley, paragraph [0121]).
Regarding claim 2, Yang further teaches wherein the culture vessel (Fig. 4, well plate 12) comprises a conductive material formed on the bottom (contact pads 402), the conductive material comprising portions arranged in the pattern of the first electrodes (Fig. 4 teaches contact pads 402 arranged in the pattern of connections 410).
Regarding claim 3, modified Yang fails to teach: wherein the bottom of the culture vessel comprises through-holes containing the respective portions of the conductive material.
Yang teaches contact pads can be conductive pads, springs, sockets, plugs, and the like, or some other means for connection (paragraph [0062]), wherein the contact pads couple to corresponding connections (paragraph [0063]), wherein connections can be conductive pads, springs, sockets, plugs, and the like, or some other complementary means for connection (paragraph [0063]).
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 the bottom of the culture vessel of modified Yang to incorporate the teachings of known means for electrical connections, such as sockets and plugs, of Yang (paragraphs [0062]-[0063]) to provide: wherein the bottom of the culture vessel comprises through-holes, e.g. sockets, containing the respective portions of the conductive material. Doing so would have utilized known electrical connection structures with a reasonable expectation of successfully providing electrical communication between the culture vessel and MEA.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a culture vessel with through-holes containing the respective portions of the conductive material, such as sockets) by known methods with no change in their respective functions (i.e. electrical connection between the culture vessel and MEA), and the combinations yielded nothing more than predictable results (i.e. providing the bottom of the culture vessel with through-holes containing the respective portions of the conductive material, such as sockets through the substrate, would yield nothing more than the obvious and predictable result of enabling electrical communication between the culture vessel and MEA). See MPEP 2143(A).
Regarding claim 4, modified Yang fails to teach: wherein the first electrodes are configured such that when the MEA is mated with the culture vessel the first electrodes are inserted into the respective portions of the conductive material.
Yang teaches contact pads can be conductive pads, springs, sockets, plugs, and the like, or some other means for connection (paragraph [0062]), wherein the contact pads couple to corresponding connections (paragraph [0063]), wherein connections can be conductive pads, springs, sockets, plugs, and the like, or some other complementary means for connection (paragraph [0063]).
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 the bottom of the culture vessel of modified Yang to incorporate the teachings of known means for electrical connections, such as sockets and plugs, of Yang (paragraphs [0062]-[0063]) to provide: wherein the first electrodes are configured such that when the MEA is mated with the culture vessel the first electrodes are inserted into the respective portions of the conductive material. Doing so would have utilized known electrical connection structures with a reasonable expectation of successfully providing electrical communication between the culture vessel and MEA.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a culture vessel with through-holes containing the respective portions of the conductive material, such as sockets) by known methods with no change in their respective functions (i.e. electrical connection between the culture vessel and MEA), and the combinations yielded nothing more than predictable results (i.e. providing the bottom of the culture vessel with through-holes containing the respective portions of the conductive material, such as sockets through the substrate, would yield nothing more than the obvious and predictable result of enabling electrical communication between the culture vessel and MEA via insertion of the MEA into the sockets of the culture vessel). See MPEP 2143(A).
Regarding claim 5, modified Yang fails to teach: wherein the first electrodes being inserted into the portions of the conductive material comprises ends of the first electrodes deforming or penetrating the portions of the conductive material.
Yang teaches contact pads can be conductive pads, springs, sockets, plugs, and the like, or some other means for connection (paragraph [0062]), wherein the contact pads couple to corresponding connections (paragraph [0063]), wherein connections can be conductive pads, springs, sockets, plugs, and the like, or some other complementary means for connection (paragraph [0063]).
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 the bottom of the culture vessel of modified Yang to incorporate the teachings of known means for electrical connections, such as springs, sockets and plugs, of Yang (paragraphs [0062]-[0063]) to provide: wherein the first electrodes being inserted into the portions of the conductive material comprises ends of the first electrodes deforming or penetrating the portions of the conductive material. Doing so would have utilized known electrical connection structures with a reasonable expectation of successfully providing electrical communication between the culture vessel and MEA.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the first electrodes deforming or penetrating the conductive material, such as the electrodes penetrating into sockets of the culture vessel) by known methods with no change in their respective functions (i.e. electrical connection between the culture vessel and MEA), and the combinations yielded nothing more than predictable results (i.e. providing the first electrodes deforming or penetrating the conductive material would yield nothing more than the obvious and predictable result of enabling electrical communication between the culture vessel and MEA via insertion or penetration of the MEA into the sockets of the culture vessel). See MPEP 2143(A).
Regarding claim 7, Yang further teaches wherein the culture vessel comprises second electrodes arranged with the pattern (Fig. 4 teaches contact pads 402 arranged with the pattern of the connections 410).
Modified Yang fails to teach: the second electrodes vertically penetrating the bottom.
Yang teaches contact pads can be conductive pads, springs, sockets, plugs, and the like, or some other means for connection (paragraph [0062]), wherein the contact pads couple to corresponding connections (paragraph [0063]), wherein connections can be conductive pads, springs, sockets, plugs, and the like, or some other complementary means for connection (paragraph [0063]).
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 the bottom of the culture vessel of modified Yang to incorporate the teachings of known means for electrical connections, such as sockets and plugs, of Yang (paragraphs [0062]-[0063]) to provide: the second electrodes vertically penetrating the bottom. Doing so would have utilized known electrical connection structures, e.g. sockets, with a reasonable expectation of successfully providing electrical communication between the culture vessel and MEA.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. a culture vessel with electrodes vertically penetration the bottom, such as sockets) by known methods with no change in their respective functions (i.e. electrical connection between the culture vessel and MEA), and the combinations yielded nothing more than predictable results (i.e. providing the bottom of the culture vessel vertically penetrating electrodes, such as sockets through the substrate, would yield nothing more than the obvious and predictable result of enabling electrical communication between the culture vessel and MEA). See MPEP 2143(A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Curley as applied to claim 1 above, and further in view of Lauf (US 20030113832 A1).
Regarding claim 6, modified Yang fails to teach: wherein the culture vessel comprises a porous membrane on the bottom.
Lauf teaches a culture vessel for biological samples containing a plurality of individually addressable electrodes (abstract). Lauf teaches the use of a porous layer disposed upon an electrode array in order to immobilize the cells and suppress fluid convection (Fig. 7; paragraph [0017]), wherein the porous layer (71) is at the bottom of the culture vessel (Fig. 7). Lauf teaches it may be desirable to immobilize the cells, suppress fluid convection, or otherwise ensure that any particular cell remains in the selected electric field region, therefore a porous coating can be placed on the array (paragraph [0045]).
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 the culture vessel of modified Yang to incorporate the teachings of a porous layer at the bottom of a culture vessel of Lauf (Fig. 7; paragraphs [0017],[0045]) to provide: wherein the culture vessel comprises a porous membrane on the bottom. Doing so would have a reasonable expectation of successfully improving immobilization of cells, suppression of fluid convection, and ensuring that any particular cell remains in the selected electric field region of the MEA (Lauf, paragraph [0045]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Curley as applied to claim 1 above, and further in view of Gandolfo et al. (US 20210310979 A1).
Regarding claim 8, modified Yang fails to teach: wherein the MEA comprises: an integrated circuit; and a passivation layer formed on one side of the integrated circuit, and wherein the first electrodes are connected to the integrated circuit through the passivation layer.
Yang teaches interchangeability of hardware and software, such as circuits (paragraphs [0093],[0094]). Yang teaches an application specific integrated circuit (paragraph [0094]).
Gandolfo teaches a probe array comprising a substrate having an array of pillar probes, which may be electrodes (abstract). Gandolfo teaches a fabrication process of an electrode array (Fig. 9, paragraph [0054]), comprising an integrated circuit (Fig. 9; paragraph [0054], ASIC 121); and a passivation layer (123) formed on one side of the integrated circuit (Fig. 9), and wherein first electrodes of an electrode array (122) are connected to the integrated circuit (121) through the passivation layer (Fig. 9).
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 the MEA of modified Yang to incorporate the teachings of fabrication of electrode arrays of Gandolfo (Fig. 9; paragraph [0054]) to provide: wherein the MEA comprises: an integrated circuit; and a passivation layer formed on one side of the integrated circuit, and wherein the first electrodes are connected to the integrated circuit through the passivation layer. Doing so would have a reasonable expectation of successfully allowing for fabrication of the MEA as taught by Gandolfo.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Joucla et al. (US 8352045 B2) teaches a device for stimulating living tissue comprising an array of stimulating microelectrodes (abstract; Fig. 10). Joucla teaches a stimulation device (Fig. 10, element 8) comprises microelectrodes (11) of array (1) comprising ports (13,33). Joucla teaches: the array of stimulation microelectrodes 11 provided with surface 3 and their ports 13 and 33 can be arranged in a removable independent module 1 which, in its input-output electric circuit 16 for interface with the outside, has the electric ports 13 for access to the microelectrodes 11 and the terminal 33 for access to the surface 3 (column 7, lines 29-35); wherein this independent module 1 can be mounted on a base 4 respectively having terminals 41 for electric connection to the ports 13 of the stimulation microelectrodes 11, and the terminal 35 for electric connection to port 33 (column 7, lines 35-40).
Faldu et al. (US 20210313987 A1) teaches a system comprising a MEA comprising an integrated circuit and a microprocessor, wherein the MEA and microprocessor are removably or detachably engageable with each other (abstract; Fig. 2).
Parce et al. (US 5496697 A) teaches a controlling electrode 13, preferably a platinum wire, penetrates the plastic housing of the flow chamber to make electrical contact with the ITO controlling electrode (column 6, lines 8-10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758