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 .
Applicant’s amendment has been considered and entered for the record.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim(s) 1-8, 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Swami et al. (WO 2020/154566 A1 – hereafter ‘566) in view of Chodavaraplu et al. (US 2011/0115499 A1 – hereafter ‘499).
‘566 (Swami) discloses a system for the integration of on-chip impedance sensors (Abstract) which includes the following limitations for claim 1:
“A microfluidic bio-sensing system”: ‘566 discloses a microfluidic device ([0006]) that can be used for bio-sensing and is being interpreted as the microfluidic biosensing system of the instant application.
“a substrate comprising a microfluidic channel”: ‘566 discloses a microfluidic chip ([0012]; Fig. 8A; Fig. 8B) that includes a microfluidic channel.
“a plurality of electrodes in the microfluidic channel”: ‘566 discloses that a plurality of electrodes are within the channel ([0012]).
“at least one semiconductor chip operably coupled to the plurality of electrodes.”: ‘566 discloses a printed circuit board (PCB) that is connected to the chip and operates the electrodes ([0114]; Fig. 8A; Fig. 8B).
“the at least one semiconductor chip is configured to control the plurality of electrodes”: ‘566 discloses that the chips on the PCB operates the electrodes ([0012]; [0114]).
“manipulate a flow through the microfluidic channel”: The PCB of ‘566 is fully capable of controlling the flow through the channel ([0041]).
“sensor cells and/or biomolecules”: ‘566 discloses that the electrodes detect the presence of biological particles or cells ([0041]).
With regards to the semiconductor, ‘566 does not specify that the PCB includes a semiconductor such as a CMOS chip, but such elements are common components of PCB and would therefore be obvious to one of ordinary skill in the art at the time of filing to include this common component on the PCB of ‘566 in order to operate the electrodes in the microfluidic channel.
‘499 discloses a high throughput microfluidic device that measures impedance (Abstract) that for claim 1 includes using a printed circuit board (Fig. 8B) that is connected to an electrode array that uses standard CMOS integrated circuits ([0071]) in order to operate the electrodes.
Therefore, it would have been obvious to one of ordinary skill in the art at the earliest effective filing date of the instant application to use the CMOS chip of ‘499 within ‘566 in order to control the electrodes. The suggestion for doing so at the time would have been in order to provide low cast and common components to operate the electrodes.
For claim 2, ‘566 discloses controlling the voltage of the electrodes ([0009]).
For claim 3, ‘566 discloses that the voltage is an AC voltage ([0085]).
For claim 4, the electrodes of ‘566 are being interpreted as an asymmetric electrode.
For claim 5, ‘566 does not specify the material for the electrode.
For claim 5, ‘499 discloses using a gold electrode ([0058]).
Therefore, it would have been obvious to one of ordinary skill in the art to employ the conventional and well-known electrode material of ‘499 within ‘566 in order to provide a conductive electrode. The suggestion for doing so at the time would have been in order to have an electrode with a high affinity for proteins ([0058]). See also MPEP §2144.07.
For claim 6, ‘566 discloses controlling the voltage to generate electric fields ([0012]).
For claim 7, ‘566 discloses that the voltage is an AC voltage ([0085]).
For claim 8, the chip of ‘566 is fully capable of generating an asymmetric excitation of the electrodes.
For claim 19, ‘566 discloses that the electrodes are within a microfluidic device ([0012]) that can be made from PDMS ([0188]). However, ‘566 differs regarding a CMOS chip.
499 discloses a high throughput microfluidic device that measures impedance (Abstract) that for claim 19 includes using a printed circuit board (Fig. 8B) that is connected to an electrode array that uses standard CMOS integrated circuits ([0071]) in order to operate the electrodes.
Therefore, it would have been obvious to one of ordinary skill in the art at the earliest effective filing date of the instant application to use the CMOS chip of ‘499 within ‘566 in order to control the electrodes. The suggestion for doing so at the time would have been in order to provide low cast and common components to operate the electrodes.
‘566 (Swami) discloses a system for the integration of on-chip impedance sensors (Abstract) which includes the following limitations for claim 22:
“A microfluidic bio-sensing system”: ‘566 discloses a microfluidic device ([0006]) that can be used for bio-sensing and is being interpreted as the microfluidic biosensing system of the instant application.
“a substrate comprising a microfluidic channel”: ‘566 discloses a microfluidic chip ([0012]; Fig. 8A; Fig. 8B) that includes a microfluidic channel.
“a plurality of electrodes in the microfluidic channel”: ‘566 discloses that a plurality of electrodes are within the channel ([0012]).
“at least one semiconductor chip operably coupled to the plurality of electrodes.”: ‘566 discloses a printed circuit board (PCB) that is connected to the chip and operates the electrodes ([0114]; Fig. 8A; Fig. 8B).
“the at least one semiconductor chip is configured to control the plurality of electrodes”: ‘566 discloses that the chips on the PCB operates the electrodes ([0012]; [0114]).
“manipulate a flow through the microfluidic channel”: The PCB of ‘566 is fully capable of controlling the flow through the channel ([0041]).
“sensor cells and/or biomolecules”: ‘566 discloses that the electrodes detect the presence of biological particles or cells ([0041]).
With regards to the semiconductor, ‘566 does not specify that the PCB includes a semiconductor such as a CMOS chip, but such elements are common components of PCB and would therefore be obvious to one of ordinary skill in the art at the time of filing to include this common component on the PCB of ‘566 in order to operate the electrodes in the microfluidic channel.
‘499 discloses a high throughput microfluidic device that measures impedance (Abstract) that for claim 22 includes using a printed circuit board (Fig. 8B) that is connected to an electrode array that uses standard CMOS integrated circuits ([0071]) in order to operate the electrodes.
Therefore, it would have been obvious to one of ordinary skill in the art at the earliest effective filing date of the instant application to use the CMOS chip of ‘499 within ‘566 in order to control the electrodes. The suggestion for doing so at the time would have been in order to provide low cast and common components to operate the electrodes.
Modified ‘566 does not explicitly disclose a plurality of these controllers. However, it would have been obvious to one of ordinary skill in the art at the time of filing to include a plurality of the chips in order to increase the throughput of the sensing system. The suggestion for doing so at the time would have been in order to run multiple tests in parallel. See MPEP § 2144.04 VI B.
Claims 9, 10, 12-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Swami et al. (WO 2020/154566 A1 – hereafter ‘566) in view of Chodavaraplu et al. (US 2011/0115499 A1 – hereafter ‘499) and in further view of Baba et al. (US 2018/0100792 A1 – hereafter ‘792).
For claim 9, modified ‘566differs from the instant claim by not explicitly stating if some of the electrodes are top electrodes.
‘792 discloses for claim 9 that the electrodes can be placed on different surfaces (Fig. 7(1)) such that there is a top electrode and a bottom electrode ([0086]). This allows the electrodes to sandwich the migration channel where the electrical measurement is allowed to cut across the channel.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the electrode positioning of ‘792 within modified ‘566 in order to allow the measurement to cut across the channel. The suggestion for doing so at the time would have been to allow the potential difference between the resistance element to be balanced ([0134]).
For claim 10, ‘566 discloses measuring the impedance of the cells ([0010]; [0011]) where this is done by electronic circuits ([0081]) and is being interpreted as the impedance spectrum receiver.
For claim 12, the impedance connect of ‘566 is configured to receive a variable frequency ([0094]).
For claim 13, ‘566 discloses that the frequencies vary from greater than 0.1 MHz ([0094]).
For claim 14, modified ‘566differs from the instant claim by not explicitly stating if some of the electrodes are top electrodes.
‘792 discloses for claim 14 that the electrodes can be placed on different surfaces (Fig. 7(1)) such that there is a top electrode and a bottom electrode ([0086]). This allows the electrodes to sandwich the migration channel where the electrical measurement is allowed to cut across the channel. The top electrodes are fully capable of being excitation electrodes and the bottom of being sensing electrodes.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the electrode positioning of ‘792 within modified ‘566 in order to allow the measurement to cut across the channel. The suggestion for doing so at the time would have been to allow the potential difference between the resistance element to be balanced ([0134]).
For claim 15, the electrode array of ‘566 is being interpreted as a four corner arrangement as there is a center electrode and four end electrodes that would be the corners (Fig. 8B).
For claim 18, ‘566 discloses that the electrodes can be on a printed circuit board ([0178]).
Allowable Subject Matter
Claim 11 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 11, the prior art fails to teach or fairly suggest where the impedance spectroscopy receiver includes a voltage excitation driver, a transimpedance amplifier and an in-phase and quadrature mixer.
Claim 58 is allowed.
The following is an examiner’s statement of reasons for allowance: For claim 58, the prior art fails to teach or fairly suggest a microfluidic bio-sensing system where at least one semiconductor chip configured to control at least one of electrokinetic fluid flow, cell manipulation and sensing, and bio-molecular sensing by utilizing at least one plurality of electrodes in a microfluidic channel; and an impedance spectroscopy receiver configured to provide impedance measurements in real- time; wherein a top portion of the plurality of electrodes is designated for voltage excitation and a bottom portion of the plurality of electrodes is connected to a receiver for cell sensing; wherein the impedance spectroscopy receiver includes a voltage excitation driver, a transimpedance amplifier and an in-phase and quadrature mixer.
The closest prior art is Swami et al. (WO 2020/154566 A1) which discloses a microfluidic device with electrodes and a PCB with electronics for operating the electrodes, but Swami does not teach or suggest the voltage excitation driver, a transimpedance amplifier and an in-phase and quadrature mixer.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10, 12-15, 18, 19 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kashanin et al. (US 2019/0232290 A1) discloses a microfluidic chip for imaging a particle within a microchannel.
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 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.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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