Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7-12, 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al (US20080156640A1 published 07/03/2008; hereinafter Collins) in view of Dzekunov et al (US20110065171A1 published 03/17/2011; hereinafter Dzekunov)
Regarding claim 1, Collins teaches a processing assembly configured for use in an electroporation system (high-throughput electroporation on the well contents – abstract), the processing assembly comprising:
a housing (an upper plate 31 – Fig. 3);
a lid rotationally connected to the housing (a lid 11 connected to an upper plate 31 and rotate about a hinge connection 35 – Fig. 3);
an opening in a top surface of the housing (an opening on the top of the upper plate 31 – Fig. 3);
an electroporation chamber below the opening in the housing (a central depression 38 below the open top of the upper plate 31 – Fig. 3),
two or more electrodes (two plate electrodes 41, 42 – Figs. 2 and 4A-B) comprising an electrically conductive, non-cytotoxic metal (electrode material (e. g., gold) – paragraphs 15, 31; see page 10 line 8 of the incorporated reference WO2004050866A1), wherein the two or more electrodes are positioned on opposing sides of the electroporation chamber (two plate electrodes 41, 42, one along each side of the well row – paragraph 25); and
wherein the processing assembly comprises two or more electrode buses (two pairs of tulip contacts 46 – Fig. 4A-B), each connected to a single electrode to form an electrode-bus subassembly (each pair of tulip contacts 46 connected to an electrode 41, 42 to form an electrode-bus subassembly – Fig. 4A-B).
However, Collins does not teach a gasket forming the shape of the electroporation chamber and defining the volume of one or more wells within the electroporation chamber; a spacer coupled to the gasket, wherein the spacer maintains a distance between the two or more electrodes.
Dzekunov teaches a device for electroporation comprising a gasket forming the shape of the electroporation chamber and defining the volume of one or more wells within the electroporation chamber(a gasket 13 forming an electroporation chamber 10 and defining the volume of a chamber 11 – paragraph 74 and Fig. 6); and a spacer coupled to the gasket (a spacer 15 coupled to the gasket 13 – Fig. 6), wherein the spacer maintains a distance between the two or more electrodes (the spacer 15 maintains a distance between the electrodes 12 – Fig. 6). Dzekunov further teaches to use the device to electroporate large volumes of cells in a sterile closed system (paragraph 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the central depression 38, as taught by Colins, with the gasket 13 and spacer 15 forming an electroporation chamber 10, taught by Dzekunov, to electroporate large volumes of cells in a sterile closed system. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Colins and Dzekunov teach devices for electroporation.
Regarding claim 2, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, wherein each bus is configured to form an electrical connection between the electroporation chamber and an electroporation system (electrical contact between the sample plate 21 and the printed circuit board 32 by simply pressing the plate down into the central depression 38 of the upper plate 31 – Collins paragraph 25).
Regarding claim 3, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, wherein spacer arranges the two or more electrodes parallel to each other (the spacer 15 arranges the electrodes 12 parallel to each other – Dzekunov Fig. 6).
Regarding claim 4, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, comprising two electrodes (two plate electrodes 41, 42 – Collins paragraph 25).
Regarding claim 5, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, wherein the electrically conductive, non-cytotoxic metal is gold (electrode material (e. g., gold) – Collins paragraphs 15, 31; see page 10 line 8 of the incorporated reference WO2004050866A1).
Regarding claim 7, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, wherein the gasket comprises a non- cytotoxic material (The gasket 13 may be constructed of silicone, other synthetic or natural rubbers or other polymers – Dzekunov paragraph 78).
Regarding claim 8, Collins teaches a multi-well processing assembly configured for use in an electroporation system, the multi-well processing assembly comprising:
a housing (an upper plate 31 – Fig. 3);
a lid rotationally connected to the housing (a lid 11 connected to an upper plate 31 and rotate about hinge connection 35 – Fig. 3);
an opening in a top surface of the housing (an opening on the top of the upper plate 31 – Fig. 3);
an internal chamber below the opening the housing (a chamber 10 – Fig. 1);
an electroporation chamber below the opening in the housing (central depression 38 below the open top of the upper plate 31 – Fig. 3), the electroporation chamber comprising:
two or more electrodes (two plate electrodes 41, 42 – Figs. 2 and 4A-B) comprising an electrically conductive, non-cytotoxic metal, wherein the two or more electrodes are positioned on opposing sides of the electroporation chamber (electrode material (e. g., gold) – paragraphs 15, 31; see page 10 line 8 of the incorporated reference WO2004050866A1); and
two or more electrode buses (two pairs of tulip contacts 46 – Fig. 4A-B), each connected to a single electrode to form an electrode-bus subassembly (each pair of tulip contacts 46 connected to an electrode 41, 42 to form an electrode-bus subassembly – Fig. 4A-B).
However, Collins does not teach a gasket forming the shape of the electroporation chamber and defining the volume of one or more wells within the electroporation chamber; and a spacer coupled to the gasket, wherein the spacer maintains a distance between the two or more electrodes.
Dzekunov teaches a device for electroporation comprising a gasket forming the shape of the electroporation chamber and defining the volume of one or more wells within the electroporation chamber (a gasket 13 forming an electroporation chamber 10 and defining the volume of a chamber 11 – paragraph 74 and Fig. 6); and a spacer coupled to the gasket (a spacer 15 coupled to the gasket 13 – Fig. 6), wherein the spacer maintains a distance between the two or more electrodes the spacer 15 maintains a distance between the electrodes 12 – Fig. 6). Dzekunov further teaches to use the device to electroporate large volumes of cells in a sterile closed system (paragraph 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the central depression 38, as taught by Colins, with the gasket 13 and spacer 15 forming an electroporation chamber 10, taught by Dzekunov, to electroporate large volumes of cells in a sterile closed system. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Colins and Dzekunov teach devices for electroporation.
Regarding claim 9, Collins, modified by Dzekunov, teaches the processing assembly of claim 8, wherein the bus is configured to form an electrical connection between the processing assembly and an electroporation system (electrical contact between the sample plate 21 and the printed circuit board 32 by simply pressing the plate down into the central depression 38 of the upper plate 31 – Collins paragraph 25).
Regarding claim 10, Collins, modified by Dzekunov, teaches the processing assembly of claim 8, wherein the spacer arranges the two or more electrodes parallel to each other (the spacer 15 arranges the electrodes 12 parallel to each other – Dzekunov Fig. 6).
Regarding claim 11, Collins, modified by Dzekunov, teaches the processing assembly of claim 8, comprising two electrodes (two plate electrodes 41, 42 – Collins Figs. 2 and 4A-B).
Regarding claim 12, Collins, modified by Dzekunov, teaches the processing assembly of claim 8, wherein the electrically conductive, non-cytotoxic metal is gold (electrode material (e. g., gold) – Collins paragraphs 15, 31; see page 10 line 8 of the incorporated reference WO2004050866A1).
Regarding claim 14, Collins, modified by Dzekunov, teaches the processing assembly of claim 8, wherein the gasket comprises a non-cytotoxic material (The gasket 13 may be constructed of silicone, other synthetic or natural rubbers or other polymers – Dzekunov paragraph 78).
Regarding claim 15, Collins teaches a docking station (the lower plate 34 – Fig. 3) configured for use in an electroporation system, the docking station comprising:
a housing (outside walls of the lower plate 34 – Fig. 3);
a port in the housing configured to receive one or more processing assemblies (a notch 53 in the lower plate 34 for receiving the upper plate 31 – Fig. 3);
a lid rotationally connected to the housing (a lid 11 on an upper plate 31, rotates about hinge connection 35, and connected to the lower plate 34 – Figs. 2-3);
one or more contacts configured to connect the docking station to an electroporation system (a slot in the lower plate 34 to hold a cable connecting to the cable connector 36 – Fig. 3).
However, Collins does not teach the one or more processing assemblies including a gasket configured to receive a sample and a spacer coupled to the gasket.
Dzekunov teaches a device for electroporation comprising one or more processing assemblies including a gasket configured to receive a sample (a gasket 13 forming an electroporation chamber 10 and defining the volume of a chamber 11 – paragraph 74 and Fig. 6) and a spacer coupled to the gasket(a spacer 15 coupled to the gasket 13 – Fig. 6), wherein the spacer maintains a distance between the two or more electrodes (the spacer 15 maintains a distance between the electrodes 12 – Fig. 6). Dzekunov further teaches to use the device to electroporate large volumes of cells in a sterile closed system (paragraph 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the central depression 38, as taught by Colins, with the gasket 13 and spacer 15 forming an electroporation chamber 10, taught by Dzekunov, to electroporate large volumes of cells in a sterile closed system. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Colins and Dzekunov teach devices for electroporation.
Regarding claim 16, Collins teaches an electroporation system (high-throughput electroporation on the well contents – abstract) comprising:
a processing assembly configured for use in an electroporation system (a chamber 10 – Fig. 1), the processing assembly comprising:
a housing (an upper plate 31 – Fig. 3);
a lid rotationally connected to the housing (a lid 11 connected to an upper plate 31 and rotate about hinge connection 35 – Fig. 3);
an opening in a top surface of the housing (an opening on the top of the upper plate 31 – Fig. 3);
an electroporation chamber below the opening in the housing (central depression 38 below the open top of the upper plate 31 – Fig. 3), wherein the electroporation chamber comprises;
(i) two or more electrodes (two plate electrodes 41, 42 – Figs. 2 and 4A-B) comprising an electrically conductive, non-cytotoxic metal (electrode material (e. g., gold) – paragraphs 15, 31; see incorporated reference WO2004050866A1), wherein the two or more electrodes are positioned on opposing sides of the electroporation chamber (two plate electrodes 41, 42, one along each side of the well row – paragraph 25); and
a docking station (the lower plate 34 – Fig. 3), the docking station comprising:
a housing (outside walls of the lower plate 34 – Fig. 3);
a port in the housing configured to receive the processing assembly (a notch 53 in the lower plate 34 for receiving the upper plate 31 – Fig. 3);
a lid connected to the housing (supporting foot or base 16 covering the lower plate 34 – Fig. 3);
one or more contacts configured to connect the docking station to an electroporation system housing (a slot in the lower plate 34 to hold a cable connecting to the cable connector 36 – Fig. 3).
However, Collins does not teach a gasket forming the shape of the electroporation chamber and defining the volume of one or more wells within the electroporation chamber; a spacer coupled to the gasket, wherein the spacer maintains a distance between the two or more electrodes.
Dzekunov teaches a device for electroporation comprising a gasket forming the shape of the electroporation chamber and defining the volume of one or more wells within the electroporation chamber (a gasket 13 forming an electroporation chamber 10 and defining the volume of a chamber 11 – paragraph 74 and Fig. 6); a spacer coupled to the gasket, wherein the spacer maintains a distance between the two or more electrodes (the spacer 15 maintains a distance between the electrodes 12 – Fig. 6). Dzekunov further teaches to use the device to electroporate large volumes of cells in a sterile closed system (paragraph 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the central depression 38, as taught by Colins, with the gasket 13 and spacer 15 forming an electroporation chamber 10, taught by Dzekunov, to electroporate large volumes of cells in a sterile closed system. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Colins and Dzekunov teach devices for electroporation.
Regarding claim 17, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, wherein the lid is rotationally connected to the housing by a hinge (a lid 11 connected to an upper plate 31 and rotate about a hinge connection 35 – Fig. 3).
Regarding claim 18, Collins, modified by Dzekunov, teaches the processing assembly of claim 1, wherein the gasket is configured to receive a sample (“configured to receive a sample” is an intended use of the gasket and deemed to read on a gasket capable of receiving a sample; see MPEP 2111.02) (the gasket 13 is capable of receiving a sample – Dzekunov paragraph 74 and Fig. 6).
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Collins, modified by Dzekunov, in view of Iwata et al (US20110091974A1 published 04/21/2011; hereinafter Iwata).
Regarding claim 6, Collins, modified by Dzekunov, teaches the processing assembly of claim 1.
However, Collins, modified by Dzekunov, does not teach wherein the each of the two or more electrodes comprises gold disposed on a plastic film.
Iwata teaches an electroporation system wherein the each of the two or more electrodes comprises gold disposed on a plastic film (the electrode substrate coated with a gold thin film is a glass substrate or a polymer substrate on which gold is deposited – paragraphs 52-53). Iwata teaches to use a polymer substrate so that the electrode surface can be further modified with carbon nanotubes (CNTs) to markedly improves transfection efficiency into cells adherent to the electrode (paragraphs 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the electrodes, as taught by Collins as modified by Dzekunov, with the polymer electrode substrate coated with a gold thin film, taught by Iwata, so that the electrode surface can be further modified with carbon nanotubes (CNTs) to markedly improves transfection efficiency into cells adherent to the electrode. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Collins, Dzekunov, and Iwata teach electrode for electroporation systems.
Regarding claim 13, Collins, modified by Dzekunov, teaches the processing assembly of claim 8.
However, Collins, modified by Dzekunov, does not teach wherein the each of the two or more electrodes comprises gold that disposed on a plastic film.
Iwata teaches an electroporation system wherein the each of the two or more electrodes comprises gold disposed on a plastic film (the electrode substrate coated with a gold thin film is a glass substrate or a polymer substrate on which gold is deposited – paragraphs 52-53). Iwata teaches to use a polymer substrate so that the electrode surface can be further modified with carbon nanotubes (CNTs) to markedly improves transfection efficiency into cells adherent to the electrode (paragraphs 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the electrodes, as taught by Collins as modified by Dzekunov, with the polymer electrode substrate coated with a gold thin film, taught by Iwata, so that the electrode surface can be further modified with carbon nanotubes (CNTs) to markedly improves transfection efficiency into cells adherent to the electrode. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Collins, Dzekunov, and Iwata teach electrode for electroporation systems.
Response to Arguments
Applicant’s addition arguments with respect to the 102/103 rejections of the claims have been considered, and a new rejection has been modified in order to address the amended claim language.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TINGCHEN SHI whose telephone number is (571)272-2538. The examiner can normally be reached M-F 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 5712727129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796