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, claims 1-5 in the reply filed on 02/18/2026 is acknowledged.
Claims 6-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/18/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/25/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 09/25/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the Abstract is less than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
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 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.
Claims 1 and 2 are rejected under 35 U.S.C. 102a1 as being anticipated by Rubinsky et al. (US 2005/0282284 A1 – hereafter ‘284).
‘284 discloses an electroporation system (Abstract) that includes the following limitations for claim 1:
“A control system”: ‘284 discloses a computer that operates a device for electroporation ([0072]; Fig. 1) where this is being interpreted as the control system of the instant application.
“an apparatus configured to electrically induce gene expression”: ‘284 discloses a chamber (chamber 2; Fig. 1; [0051]) that is being interpreted as the apparatus of the instant application. Furthermore, this apparatus is able to apply a voltage across the sample by electrical pulses supplied by a power amplifier (amplifier 18; Fig. 1; [0051]).
“a detection system configured to detect level of the gene expression in the apparatus”: ‘284 discloses probe electrodes (electrodes 5-9; Fig. 1; [0051]) that are connected to a data acquisition card (card 15) and sends this data to a computer (computer 16).
“the detection system configured to provide electrical signals indicative of the level of gene expression”: The power amplifier (amplifier 18) of ‘284 provides an electrical signal to the electrode chamber and is being interpreted as part of the detection system.
“a computing device configured to implement closed loop control of the level of gene expression in the apparatus based on the electrical signals”: ‘284 discloses that the computer controls the device in a continuous manner ([0014]) and adjusts the applied voltage according to the detected signals ([0017]). This is being interpreted as a closed-loop control of the system.
“wherein the computing device controls the voltages applied by the apparatus to electrically induce the gene expression.”: ‘284 discloses that the voltage applied to the sample is adjusted by the computer ([0017]).
For claim 2, ‘284 discloses that the transgene expression gene delivery efficiency may be determined by a fluorescent signal and detected by a fluorescent microscope ([0063]).
Therefore, ‘284 meets the limitations of claims 1 and 2.
Claims 1, 2, 4 and 5 are rejected under 35 U.S.C. 102a1 as being anticipated by Peterson et al. (US 2016/0122792 A1 – hereafter ‘792).
‘792 discloses a system for the production of nucleic acid molecules (Abstract) that includes the following limitations for claim 1:
“A control system”: ‘792 discloses a computer controlled system ([0198]) where this is being interpreted as the control system of the instant application.
“an apparatus configured to electrically induce gene expression”: ‘’792 discloses a system for electrically inducing a gene expression (multiwell plate 200; Fig. 2A; 0195]; [0154])
“a detection system configured to detect level of the gene expression in the apparatus”: ‘792 discloses a detection system such as optical elements ([0331]) that can detect the level of gene expression in the wells.
“the detection system configured to provide electrical signals indicative of the level of gene expression”: ‘792 discloses supplying a voltage to the device ([0193]) through a power source (controller 203; Fig. 2A; [0194]) where this would indicative of the level of gene expression.
“a computing device configured to implement closed loop control of the level of gene expression in the apparatus based on the electrical signals”: ‘792 discloses that the apparatus is controlled by a computer ([0198]; [0199]; Fig. 15) that is being interpreted as a closed-loop control based on electrical signals. This type of system is configured to reduce error from chemically synthesized nucleic acid molecules by selection of nucleic acid molecules having correct nucleotide sequences ([0297]).
“wherein the computing device controls the voltages applied by the apparatus to electrically induce the gene expression.”: ‘792 discloses that this computer controls the voltage applied to the wells ([0199]).
For claim 2, ‘792 discloses optical systems for detecting fluorescent signals and using that in the determination of the gene expression ([0194]).
For claim 4, ’792 discloses using a potentiostat to supply the voltage to the system ([0160]).
For claim 5, ‘792 discloses that the system includes a plurality of wells (Fig. 2A; [0154]; [0195]) that includes three electrodes (electrodes 202, 204; & 205). These electrodes to a three electrode potential system of a counter electrode, working electrode and a reference electrode ([0157]).
Therefore, ‘792 meets the limitations of claims 1, 2, 4 and 5.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: For claim 3, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a control system where a closed loop control performs the following steps: computing a slope as a difference between two consecutive fluorescence measurements; accessing a stored maximum slope value; computing a ratio of the slope of the maximum slope value; and controlling, based on at least the ratio, the voltages applied by the apparatus.
The closes prior art is Rubinsky et al. (US 2005/0282284 A1) which discloses a system for electroporation that calculates the slope between the applied current-to-voltage, but does not teach or suggest calculating the slope as a difference between two fluorescent measurements.
The next closest prior art is Peterson et al. (US 2016/0122792 A1) that uses a potentiostat to apply voltage to a sample within a well, but does not teach or suggest calculating the slope as a difference between two fluorescent measurements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rubinsky et al. (US 6,387,671 b1) discloses a system for processing images created by impedance tomography.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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, Michael Marcheschi can be reached at 571-272-1374. 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.
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799