Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-13 and 18-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 11-14 of U.S. Patent No. 11, 906, 508 (thereafter referred to as Patent ‘508). Although the claims at issue are not identical, they are not patentably distinct from each other.
As for claim 1, Patent ‘508 discloses a system for monitoring cells, the system comprising:
a) a device for monitoring cell-substrate impedance, the device comprising a plurality of wells on a nonconductive substrate, wherein each of the plurality of wells comprises an electrode array fabricated on the substrate for measurement of cell-substrate impedance (see claim 1, part a of Patent ‘508);
b) an impedance analyzer that measures cell-substrate impedance from the plurality of wells(see claim 1, part b of Patent ‘508).
c) electronic circuitry comprising multiple analogue-to-digital conversion channels, wherein the electronic circuitry electrically connects the electrode arrays to the impedance analyzer such that the electrode arrays are electrically monitored at millisecond time resolution (see the at least two analog-to-digital conversion channels in claim 1, part b of Patent ‘508); and
d) a software program that analyzes the measured cell-substrate impedance (see claim 1, part c of Patent ‘508).
As for claim 2, Patent ‘508 discloses the system of claim 1, wherein the multiple analogue-to-digital conversion channels are configured to convert analog electronic signals from multiple wells to digital signals simultaneously (see claim 2 of Patent ‘508).
As for claim 3, Patent ‘508 discloses the system of claim 1, wherein the electronic circuitry allows parallel analogue-to- digital (AD) conversion of impedance signals from multiple wells (see claim 3 of Patent ‘508).
As for claim 4, Patent ‘508 discloses the system of claim 1, wherein the electronic circuitry performs signal conversion in parallel across multiple wells (see claim 3 of Patent ‘508).
As for claim 5, Patent ‘508 discloses the system of claim 4, wherein said parallel signal conversion allows for parallel signal processing and impedance calculation for measurements obtained from multiple wells (see claim 3 of Patent ‘508).
As for claim 6, Patent ‘508 discloses the system of claim 1, wherein the electronic circuitry is configured for monitoring cell-substrate impedance in a plurality of wells at approximately the same time (see claim 4 of Patent ‘508).
As for claim 7, Patent ‘508 discloses the system of claim 1, wherein the electronic circuitry performs parallel analogue-to- digital (AD) conversion of impedance signals from multiple wells (see claim 3 of Patent ‘508)
As for claim 8, Patent ‘508 discloses the system of claim 1, wherein the electronic circuitry performs signal conversion, signal processing, and impedance calculation in parallel across multiple wells (see claim 3 of Patent ‘508).
As for claim 9, Patent ‘508 discloses the system of claim 1, wherein the system comprises an electromechanical apparatus capable of interfacing a multiwell device with one or more platforms (see claim 5 of Patent ‘508).
As for claim 10, Patent ‘508 discloses the system of claim 9, wherein the one or more platforms of the electromechanical apparatus comprise an impedance platform and an optical platform (see claim 6 of Patent ‘508).
As for claim 11, Patent ‘508 discloses the system of claim 1, wherein the device for monitoring cell-substrate impedance comprising a two-piece structure wherein the nonconductive substrate is attached to a bottomless plate to form a bottom surface of the wells(see claim 7 of Patent ‘508).
As for claim 12, Patent ‘508 discloses the system of claim 1, wherein the substrate is suitable for cell attachment via a precoat comprising one or more compounds that improve attachment (see claim 8 of Patent ‘508).
As for claim 13, Patent ‘508 discloses the system of claim 1, wherein the electronic circuitry is configured to measure with a time difference between two adjacent impedance measurements is less than 500 ms (see claims 11-14 of Patent ‘508).
As for claim 18, Patent ‘508 discloses a system for monitoring cells, the system comprising:
a) a device for monitoring cell-substrate impedance, the device comprising a plurality of wells on a nonconductive substrate, wherein each of the plurality of wells comprises an electrode array fabricated on the substrate for measurement of cell-substrate impedance (see claim 1, part a of Patent ‘508);
b) an impedance analyzer that measures cell-substrate impedance from the plurality of wells (see claim 1, part b of Patent ‘508).
c) electronic circuitry that electrically connects the electrode arrays to the impedance analyzer, wherein the electronic circuitry performs signal conversion in parallel across multiple wells such that the electrode arrays are electrically monitored at millisecond time resolution (see claim 1, part b and claim 3 of Patent ‘508); and
d) a software program that analyzes the measured cell-substrate impedance (see claim 1, part d of Patent ‘508).
As for claim 19, Patent ‘508 discloses the system of claim 18, wherein the electronic circuitry comprises multiple analogue- to-digital conversion channels (see claim 1, part b of Patent ‘508).
As for claim 20, Patent ‘508 discloses the system of claim 19, wherein the multiple analogue-to-digital conversion channels are configured to convert analog electronic signals from multiple wells to be converted to digital signals simultaneously (see claim 2 of Patent ‘508).
As for claim 21, Patent ‘508 discloses the system of claim 18, wherein the electronic circuitry allows parallel analogue-to- digital (AD) conversion of impedance signals from multiple wells (see claim 3 of Patent ‘508).
As for claim 22, Patent ‘508 discloses the system of claim 18, wherein said parallel signal conversion allows for parallel signal processing and impedance calculation for measurements obtained from multiple wells (see claim 3 of Patent ‘508).
As for claim 23, Patent ‘508 discloses the system of claim 22, wherein the electronic circuitry performs signal conversion, signal processing, and impedance calculation in parallel across multiple wells (see claim 3 of Patent ‘508).
As for claim 24, Patent ‘508 discloses the system for monitoring cells, the system comprising:
a) a device for monitoring cell-substrate impedance, the device comprising a plurality of wells on a nonconductive substrate, wherein each of the plurality of wells comprises an electrode array fabricated on the substrate for measurement of cell-substrate impedance (see claim 1, part a of Patent ‘508);
b) an impedance analyzer that measures cell-substrate impedance from the plurality of wells (see claim 1, part b of Patent ‘508);
c) electronic circuitry that electrically connects the electrode arrays to the impedance analyzer to electrically monitor the electrode arrays such that a time difference between two adjacent measurements is less than 500 ms (see claim 1, part b and claim 9 of Patent ‘508); and
d) a software program that analyzes the measured cell-substrate impedance (see claim 1, part d of Patent ‘508).
As for claim 25, Patent ‘508 discloses the system of claim 24, wherein the electronic circuitry comprises multiple analogue- to-digital conversion channels (see claim 1, part b of Patent ‘508).
As for claim 26, Patent ‘508 discloses the system of claim 25, wherein the multiple analogue-to-digital conversion channels are configured to convert analog electronic signals from multiple wells to digital signals simultaneously (see claim 2 of Patent ‘508).
As for claim 27, Patent ‘508 discloses the system of claim 24, wherein the electronic circuitry allows parallel analogue-to- digital (AD) conversion of impedance signals from multiple wells (see claim 3 of Patent ‘508).
As for claim 28, Patent ‘508 discloses the system of claim 24, wherein the electronic circuitry performs signal conversion in parallel across multiple wells (see claim 3 of Patent ‘508).
As for claim 29, Patent ‘508 discloses the system of claim 28, wherein said parallel signal conversion allows for parallel signal processing and impedance calculation for measurements obtained from multiple wells (see claim 3 of Patent ‘508).
As for claim 30, Patent ‘508 discloses the system of claim 24, wherein the electronic circuitry performs signal conversion, signal processing, and impedance calculation in parallel across multiple wells (see claim 3 of Patent ‘508).
3. Claims 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11, 906, 508, in view of Yukimasa (U. S. Pub. 2002/0113607).
As for claims 14-15, Patent ‘508 discloses the system of claim 1, as discussed above.
Patent ‘508 does not specifically disclose a further optical device, wherein the measurement at millisecond time resolution is initiated by a change in optical property determined by the device for optically monitoring the one or more wells.
Yukimasa discloses a cellular potential measurement system and an optical monitoring apparatus for optically monitoring a biological specimen (see [0023--0024]).
A person of ordinary skill in the art would recognize that, adding a conventional optical device, as taught by Yukimasa, to measure a change in optical property for the purpose of automatically starting the measurement at millisecond time resolution when it is optically determined that the cells/test compound have been added into the wells, does not make the current application patentably distinct from Patent ‘508.
Claims 16 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11, 906, 508 in view of Xu et al. (U. S. Patent. 7,192,752).
As for claim 16, Patent ‘508 discloses the system of claim 1, as discussed above.
Patent ‘508 does not specifically disclose wherein the electrode array comprises electrical traces and connection pads configured to connect the electrode array to the impedance analyzer, wherein the electrical traces are covered with an insulating layer.
Xu et al. discloses a system for measuring cell-substrate impedance wherein an electrode array (102 in Fig. 1A) comprises electrical traces (103) and connection pads (104) configured to connect the electrode array (102) to an impedance analyzer, wherein the electrical traces are covered with an insulating layer (see col. 19, lines 27-29).
A person of ordinary skill in the art would recognize that using such electrical traces and connection pads to connect the electrode array to an impedance analyzer, as taught by Xu et al., is routine practice in the art, and it does not make the current application patentably distinct from Patent ‘508.
As for claim 17, Patent ‘508 discloses the system of claim 1, as discussed above.
Patent ‘508 does not specifically disclose wherein the electrode array comprises a plurality of electrode elements that are evenly spaced.
Xu et al. discloses a system for measuring cell-substrate impedance wherein the electrode array comprises a plurality of electrode elements that are evenly spaced (see electrode elements evenly spaced as shown in Fig. 1A).
A person of ordinary skill in the art would recognize that making the plurality of electrode elements evenly spaced, as taught by Xu et al., is routine practice in the art, and the difference does not make the current application patentably distinct from Patent ‘508.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9, 11-13 and 16-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Xu et al. (U. S. Patent. 7,192,752) in view of Jones et al. (Pub. No. US 2007/0057680) and Gascoyne (WO 03/048728).
As for claim 1, Xu et al. discloses a system for monitoring cells (see the Cell-substrate impedance measurement systems described in col. 22, lines 47—61; Figs 1-4), the system comprising:
a) a device for monitoring cell-substrate impedance, the device comprising a plurality of wells on a nonconductive substrate (glass substrate 101), wherein each of the plurality of wells comprises an electrode array (102) fabricated on the substrate for measurement of cell-substrate impedance (see a) the multiple-well substrate impedance measuring device in col. 22, lines 50-52; also see col. 3, lines 60-65);
b) an impedance analyzer that measures cell-substrate impedance from the plurality of wells (see b) the impedance analyzer in col. 22, lines 52-54).
c) electronic circuitry electrically connects the electrode arrays to the impedance analyzer (see c) the device station comprising electronic circuitry in col. 22, lines 54-58); and
d) a software program that analyzes the measured cell-substrate impedance (see d) the software program in col. 22, lines 58-61).
Still referring to claim 1, Xu et al. does not specifically disclose that the electronic circuitry comprising multiple analogue-to-digital conversion channels, and that the electrode arrays are electrically monitored at millisecond time resolution;
Jones et al. discloses an impedance measurement system that uses multiple analogue-to-digital conversion channels for parallel impedance measurement of multiwell microtiter plates to improve throughput. (abstract; [0003], [0012], [0018] and [0035]).
Gascoyne discloses a conventional flow-through impedance sensor for monitoring cells with particle event that typically last from 1 to 5 milliseconds (see page 21, lines 6—28).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Xu et al. to incorporate the use of multiple analogue-to-digital conversion channels, as taught by Jones et al. for converting the analogue signals into digital form for further processing in the digital processor of Xu et al., and for providing parallel conversion and impedance measuring of the multiwell in Xu et al. with improved measurement speed and accuracy (see [0003], [0030], [0035], [0038] in Jones).
Furthermore, the person of ordinary skill in the art would also find it obvious to further modify Xu et al. to disclose that the electrode arrays are electrically monitored at millisecond time resolution, as taught by Gascoyne, for the purpose of accurately measuring impedance change in applications wherein the particle event last only a very short time (e.g., 1 to 5 milliseconds in Gascoyne).
As for claim 18, Xu et al. discloses a system for monitoring cells, the system comprising:
a) a device for monitoring cell-substrate impedance, the device comprising a plurality of wells on a nonconductive substrate (glass substrate 201), wherein each of the plurality of wells comprises an electrode array fabricated on the substrate for measurement of cell-substrate impedance (see a) the multiple-well substrate impedance measuring device in col. 22, lines 50-52; also see col. 3, lines 60-65);
b) an impedance analyzer that measures cell-substrate impedance from the plurality of wells (see b) the impedance analyzer in col. 22, lines 52-54).
c) electronic circuitry that electrically connects the electrode arrays to the impedance analyzer, (see c) the device station comprising electronic circuitry in col. 22, lines 54-58); and
d) a software program that analyzes the measured cell-substrate impedance (see d) the software program in col. 22, lines 58-61).
Still referring to claim 18, Xu et al. does not specifically disclose that the electronic circuitry performs signal conversion in parallel across multiple wells such that the electrode arrays are electrically monitored at millisecond time resolution.
Jones et al. discloses an impedance measurement system that uses multiple analogue-to-digital conversion channels for parallel signal conversion and impedance measuring of multiwell microtiter plate. (abstract; [0003], [0012], [0018] and [0035]).
Gascoyne discloses a conventional flow-through impedance sensor for monitoring cells with particle event that typically last from 1 to 5 milliseconds (see page 21, lines 6—28).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Xu et al. to incorporate the use of multiple analogue-to-digital conversion channels, as taught by Jones et al. for converting the analogue signals into digital form for further processing in the digital processor of Xu et al., and for providing parallel conversion and impedance measuring of the multiwell in Xu et al. with improved measurement speed and accuracy (see [0003], [0030], [0035], [0038] in Jones).
Furthermore, the person of ordinary skill in the art would also find it obvious to further modify Xu et al. to disclose that the electrode arrays are electrically monitored at millisecond time resolution, as taught by Gascoyne, for the purpose of accurately measuring impedance change in applications wherein the particle event last only a very short time (e.g., 1 to 5 milliseconds in Gascoyne).
As for claims 2-8 and 19-23, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1 and 18, wherein the electronic circuitry comprises multiple analogue-to-digital conversion channels configured to convert analog electronic signals from multiple wells to digital signals simultaneously; or wherein the electronic circuitry allows parallel analogue-to- digital (AD) conversion of impedance signals from multiple wells; or wherein said parallel signal conversion allows for parallel signal processing and impedance calculation for measurements obtained from multiple wells; or wherein the electronic circuitry is configured for monitoring cell-substrate impedance in a plurality of wells at approximately the same time (i.e., by using the impedance measurement system of Xu et al. and the multiple analogue-to-digital conversion channels of Jones et al. for providing the parallel analog to digital conversion and impedance calculation from multiple wells simultaneously.
As for claim 9, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1, wherein the system comprises an electromechanical apparatus capable of interfacing a multiwell device with one or more platforms (see col. 23, lines 31-35).
As for claim 11, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1, wherein the device for monitoring cell-substrate impedance comprising a two-piece structure (see Fig. 1B and col. 19, lines 39-60 in Xu et al.) wherein the nonconductive substrate is attached to a bottomless plate (207 in Fig. 2 of Xu et al.) to form a bottom surface of the wells.
As for claim 12, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1, wherein the substrate is suitable for cell attachment via a precoat comprising one or more compounds that improve attachment (see precoat fibronectin in col. 7, lines 63-67 of Xu et al.).
As for claim 13, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1, wherein the electronic circuitry is configured to measure with a time difference between two adjacent impedance measurements is less than 500 ms (e.g., 1 to 5 milliseconds in Gascoyne page 21, lines 6—28).
As for claim 16, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1, wherein the electrode array (102 in Fig. 1A) comprises electrical traces (103) and connection pads (104) configured to connect the electrode array to the impedance analyzer, wherein the electrical traces are covered with an insulating layer (see col. 19, lines 27-29).
As for claim 17, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claim 1, wherein the electrode array comprises a plurality of electrode elements that are evenly spaced (see electrode elements evenly spaced as shown in Fig. 1A).
As for claims 24-30, Xu et al. discloses a system for monitoring cells (see the Cell-substrate impedance measurement systems described in col. 22, lines 47—61), the system comprising:
a) a device for monitoring cell-substrate impedance, the device comprising a plurality of wells on a nonconductive substrate (glass substrate 201), wherein each of the plurality of wells comprises an electrode array fabricated on the substrate for measurement of cell-substrate impedance (see a) the multiple-well substrate impedance measuring device in col. 22, lines 50-52; also see col. 3, lines 60-65);
b) an impedance analyzer that measures cell-substrate impedance from the plurality of wells (see b) the impedance analyzer in col. 22, lines 52-54).
c) electronic circuitry electrically connects the electrode arrays to the impedance analyzer (see c) the device station comprising electronic circuitry in col. 22, lines 54-58); and
d) a software program that analyzes the measured cell-substrate impedance (see d) the software program in col. 22, lines 58-61).
Still referring to claims 24-30, Xu et al. does not specifically disclose that the electronic circuitry comprising multiple analogue-to-digital conversion channels configured to convert analog electronic signals from multiple wells to digital signals simultaneously and allow parallel analogue-to-digital conversion and parallel signal processing and impedance calculation for multiple wells; or that the time difference between two adjacent measurement is less than 500ms.
Jones et al. discloses an impedance measurement system that uses multiple analogue-to-digital conversion channels for parallel impedance measuring of multiwell microtiter plate. (abstract; [0003], [0012], [0018] and [0035]).
Gascoyne discloses a conventional flow-through impedance sensor for monitoring cells with particle event that typically last from 1 to 5 milliseconds (see page 21, lines 6—28).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify Xu et al. to incorporate the use of multiple analogue-to-digital conversion channels, as taught by Jones et al. for converting the analogue signals into digital form for further processing in the digital processor of Xu et al., and for providing parallel conversion channels and impedance measuring of the multiwell in Xu et al. with improved speed and accuracy (see [0003], [0030], [0035], [0038] in Jones).
Furthermore, the person of ordinary skill in the art would also find it obvious to further modify Xu et al. to disclose that the electrode arrays are electrically monitored at millisecond time resolution, as taught by Gascoyne, and that the time different between two adjacent measurement is less than 500ms, for the purpose of accurately measuring impedance change due to particle event that last only a few milliseconds (e.g., 1 to 5 milliseconds in Gascoyne).
Claims 10 and 14-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Xu et al. (U. S. Patent. 7,192,752) in view of Jones et al. (Pub. No. US 2007/0057680) and Gascoyne (WO 03/048728), and further in view of Yukimasa (U. S. Pub. 2002/0113607).
As for claims 10 and 14-15, Xu et al. in view of Jones et al. and Gascoyne discloses the system of claims 1 and 9, wherein the one or more platforms of the electromechanical apparatus comprise an impedance platform (i.e., the impedance monitoring device with the impedance analyzer and electronic switches, see col. 23, lines 31-46).
Xu et al. in view of Jones et al. and Gascoyne does not specifically disclose a further optical platform, wherein the measurement at millisecond time resolution is initiated by a change in optical property determined by a device for optically monitoring the one or more wells.
Yukimasa discloses a cellular potential measurement system and an optical monitoring apparatus for optically monitoring a biological specimen (see [0023--0024]).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to further modify Xu et al. to disclose using an optical platform with an optical device, as taught by Yukimasa, for optically monitoring the one or more wells, for the purpose of automatically starting the impedance measurement at millisecond time resolution when it is optically determined that the cells have been added into the wells and/or the test compound has been added into the cells.
Conclusion
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/AMY HE/ Primary Examiner, Art Unit 2858