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 § 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 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 8 depends on the canceled claim 6 and is therefore indefinite. For prosecution, the limitation will be interpreted to mean that claim 8 is dependent on claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ragsdale (US20090209017A1 published 08/20/2009) in view of Talebpour et al (US20150276727A1 published 10/01/2015; hereinafter Talebpour).
Regarding claim 1, Ragsdale teaches a system comprising:
a cuvette (a cuvette 11 – Fig. 1) consisting of one opening to an interior (one opening at the top of a back wall 14 and leading to an interior – Fig. 1) and configured to hold a tissue or cellular sample inside (the cuvette is filled with a buffered aqueous solution of the DNA, protein, or exogenous species – Fig. 1 and paragraphs 14-15);
one or more electrodes in contact with at least a first side of the cuvette (an electrodes 17 on the left of the cuvette 11 – Fig. 1 and paragraphs 13-16);
another one or more electrodes in contact with at least a second side of the cuvette opposite the at least the first side (an electrodes 18 on the right of the cuvette 11 – Fig. 1 and paragraphs 13-16).
However, Ragsdale does not a power source configured to provide an adjustable power having a voltage between 2 V and 20 V to the one or more electrodes or the other one or more electrodes when powered that establishes and applies a uniform electric field through the cuvette and the tissue or the cellular sample for 15 minutes or less, wherein the uniform electric field strength is between 10 V/cm and 100 V/cm, wherein application of the uniform electric field for 15 minutes or less is configured to induce electrical dissociation of the tissue or cellular sample into viable single cells and/or smaller groups of viable cells inside the cuvette without prior alteration to the tissue or cellular sample.
Talebpour teaches an electroporation device comprising a power source (an external voltage source 25 connected via external contact pads – Fig. 2 and paragraph 98, 113) configured to provide an adjustable power having a voltage between 2 V and 20 V (“provide an adjustable power having a voltage between 2 V and 20 V” is an intended use of the “power source” and is deemed to read on a power source or equivalent structure capable of providing a voltage between 2-20V ) to the one or more electrodes or the other one or more electrodes when powered (the external voltage source 25 applies a potential difference between the two electrodes 15 and 16 and is deemed capable of providing an adjustable power having a voltage between 2 V and 20 V – Fig. 2 and paragraphs 113, 276) that establishes and applies a uniform electric field (“establishes and applies a uniform electric field” is an intended use of the “power source” and is deemed to read on a power source or equivalent structure capable of providing a uniform electric field) through the cuvette device and the tissue or the cellular sample for 15 minutes or less (the external voltage source 25 is capable of applying a potential difference between the two electrodes 15 and 16 to provide a uniform electric field for 15 minutes or less – Fig. 2 and paragraphs 113, 276), wherein the uniform electric field strength is between 10 V/cm and 100 V/cm (the external voltage source 25 is capable of applying a uniform electric field strength between 10 V/cm and 100 V/cm s – Fig. 2 and paragraphs 113, 276), wherein application of the uniform electric field for 15 minutes or less is configured to induce electrical dissociation of the tissue or cellular sample into viable single cells and/or smaller groups of viable cells inside the cuvette device without prior alteration to the tissue or cellular sample (the examiner points out that “configured to induce electrical dissociation” is an intended use of the power source and reads on the external voltage source 25 because the external voltage source 25 is capable of providing a uniform electric field between 10 V/cm and 100 V/cm for 15 minutes or less – paragraphs 113, 276; see MPEP2114 II). Talebpour teaches to use an external voltage source 25 applied electric waveform may be selected according to the feedback based on the current monitored by the meter 26 to optimize the performance of the device (paragraph 113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the electrode, as taught by Ragsdale, by connecting the electrode to external voltage source via external contact pads, taught by Talebpour, to optimize the performance of the device by changing the electric waveform according to feedback from the meter. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Ragsdale and Talebpour teach devices for generating electric fields for electroporation.
Regarding claim 2, Ragsdale, modified by Talebpour, teaches the system of claim 1, wherein the cuvette is configured to hold the tissue or cellular sample in at least one fluid (the cuvette is filled with a buffered aqueous solution of the DNA, protein, or exogenous species – Ragsdale Fig. 1 and paragraph 15).
Regarding claim 3, Ragsdale, modified by Talebpour, teaches the system of claim 2, wherein the at least one fluid comprises a nonionic liquid (the cuvette is capable of holding and processing a sample comprising a nonionic liquid – Ragsdale Fig. 1 and paragraph 15) (the examiner points out the fluid is not positively recited in the claims and therefore the specifics of the fluid do not further define the system structure) (“a nonionic liquid” is therefore a material worked upon by the claimed device; see MPEP2115).
Regarding claim 4, Ragsdale, modified by Talebpour, teaches the system of claim 3, wherein the nonionic liquid comprises an additive (the cuvette is capable of holding and processing a sample comprising a nonionic liquid comprising an additive – Ragsdale Fig. 1 and paragraph 15) (the examiner points out the fluid is not positively recited in the claims and therefore the specifics of the fluid do not further define the system structure) (“an additive” is therefore a material worked upon by the claimed device; see per MPEP2115).
Regarding claim 5, Ragsdale, modified by Talebpour, teaches the system of claim 1, wherein the cuvette is configured to hold and process a plurality of tissue and/or cellular samples (the cuvette is filled with a buffered aqueous solution of the DNA, protein, or exogenous species – Ragsdale Fig. 1 and paragraph 15).
Regarding claim 7, Ragsdale, modified by Talebpour, teaches the system of claim 1 wherein the one or more electrodes and/or the other one or more electrodes are located within the cuvette (the electrode 17 and the electrodes 18 are located within the cuvette 11 – Ragsdale Fig. 1).
Regarding claim 8, Ragsdale, modified by Talebpour, teaches the system of claim 6 (see 112b rejection), wherein the one or more electrodes and/or the other one or more electrodes are located on an outside of the cuvette (the two electrodes 17 and 18 are connected to the external voltage source via external contact pads – Ragsdale Fig. 1 and Talebpour paragraph 98).
Regarding claim 10, Ragsdale, modified by Talebpour, teaches the system of claim 1, wherein a voltage between the one or more electrodes within the cuvette is below an electroporation threshold of the tissue or cellular sample (external voltage source 25 is capable of generating a voltage between the electrodes 17 and 18 below an electroporation threshold of the cells – Ragsdale Fig. 1 and Talebpour paragraph 113).
Regarding claim 11, Ragsdale, modified by Talebpour, teaches the system of claim 1, wherein the voltage is an oscillating voltage (the waveform may be varied in order to optimize the performance of the device – Talebpour paragraph 113).
Regarding claim 12, Ragsdale, modified by Talebpour, teaches the system of claim 1, wherein the electric field is an AC field or a DC field (the external voltage source is capable being used to apply an AC field or a DC field within the cuvette 11 – Ragsdale Fig. 1 and Talebpour paragraphs 98, 113).
Response to Arguments
Applicant’s arguments with respect to the 102 rejections of the claims have been considered, and the arguments are moot as they are towards the amended claims and not the current rejection. A new rejection has been made 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, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.C.S./Examiner, Art Unit 1796
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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