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
Claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/04/2026.
Claim Objections
Claims 1-8 are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
Claim 2 is objected to because of the following informalities:
Claim 2 line 2 recites “ot at least 60%” and should be amended to “or at least 60%”
Claim 4 is objected to because of the following informalities:
Claim 4, lines 1-2, the reference numeral ‘20’ in expression “substrate 20” should be in parenthesis to read as “substrate (20)”.
Appropriate correction is required.
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.
Claims 1-8 are 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 1 lines 19-20 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “at least 90%”, and the claim also recites “at least 90%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-8, dependent on claim 1, are also rejected based on said dependency.
Claim 2 line 2-3 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “least 50%” and the claim also recites “ot at least 60%, or at least 70%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 line 3 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “least 80%” and the claim also recites “at least 90%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al (US20110312518A1 published 02/22/2011; hereinafter Davis).
Regarding claim 1, Davis teaches a microfluidic chip (a biochip – paragraph 188) for identifying and/or isolating small particles comprising
at least a first microfluidic channel (a microchannel – paragraph 190 and Fig. 7),
at least a first dielectrophoresis-producing electric field generating unit (DEP unit) (gold electrodes labeled A and C on either side of the channel is capable of generation an electric field to create dielectrophoresis – paragraph 190 and Fig. 7) (first dielectrophoresis-producing electric field generating unit is deemed to read on an electric field generating unit capable of creating dielectrophoresis),
at least one immunoaffinity capturing zone (a protein functionalized microchannel biosensor – paragraph 190 and Fig. 7d) and
a voltage source electrically coupled to said DEP unit (a voltage is applied across the channel in the region between electrodes A and C – paragraph 203), wherein
said first channel comprises a channel first end (a first end by electrode A – Fig. 7) and a channel second end (a channel end by electrode C – Fig. 7) of a channel flow path for the fluid through the channel (a path though the microchannel between the first and second ends – Fig. 7),
in said microfluidic channel are defined two portions: an upper portion (a top portion – Fig. 7g) and a lower portion (a bottom portion with immobilized protein receptors – Fig. 7g), wherein the internal surface of said channel is defined ceiling in the upper portion (a ceiling on the top portion – Fig. 7g) and floor in the lower portion (a floor on the bottom portion with immobilized protein receptors – Fig. 7g) (the examiner points out that upper and lower is a positional configuration and the channel only needs to be rotated 180 degrees to read on the claimed configuration), wherein
said immunoaffinity capturing zone extends along said floor inside the channel (a floor on the bottom portion with immobilized protein receptors – Fig. 7g), characterized in that said at least first DEP unit extends continuously along said ceiling inside said channel covering at least 80% of the length of the channel itself (the gold electrodes labeled A and C extends continuously along the ceiling in the top portion covering at least 80% of the length – Fig. 7g), or at least 90% (the narrower 90% limitation is interpreted as merely exemplary; see 112b rejection).
Regarding claim 2, Davis teaches the microfluidic chip according to claim 1, wherein said at least one DEP unit is centered on said ceiling, covering at least 50% of its width (the gold electrodes A and C are centered on the ceiling, covering at least 50% the length of the ceiling – Fig. 7g), ot at least 60%, or at least 70% (see 112b rejection).
Regarding claim 3, Davis teaches the microfluidic chip according to claim 1, wherein said at least one DEP unit generates a non-uniform electric field for a continuous portion covering at least 80% (the gold electrodes A and C are capable of being used to generate a non-uniform electric field for a continuous portion covering at least 80% of the length of the channel – Fig. 7g), or at least 90% of the length of the channel.
Regarding claim 4, Davis teaches the microfluidic chip according to claim 1, comprising a substrate (glass substrate – Fig. 9), consisting in one or more substrates associated with one another to define fluid channels there between (one or more substrates associated one another to define fluid channels – Fig. 9).
Regarding claim 6, Davis teaches the microfluidic chip according to claim 1, wherein said at least one DEP unit is curved (the voltage to electrodes A and C and creating a curved electric field between the electrodes A and C – paragraph 203).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Reboud et al (US20110117577A1 published 05/19/2011; hereinafter Reboud).
Regarding claim 5, Davis teaches the microfluidic chip according to claim 1.
However, Davis does not teach wherein said channel is curved along its length.
Reboud teaches microfluidic system for trapping a biological entity (paragraph 73) wherein said channel is curved along its length (a microchannel having a serpentile shape, a meander shape, a spiral shape or any combination thereof – paragraph 66). Reboud also teaches that the curved microchannel lowers the flow rate of the sample volume when entering the chamber, thereby lowering the shear force, while also increasing the residence time.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Davis, with the curved microchannel, taught by Reboud, to lower the shear force and increase the residence time. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Davis and Reboud teach microfluidic chips for detecting biological entities.
Claim 7 are rejected under 35 U.S.C. 103 as being unpatentable over Davis.
Regarding claim 7, Davis teaches the microfluidic chip according to claim 1, each channel comprising one or more independent DEP unit and at least one immunoaffinity capturing zone on an opposing wall (the immobilized protein receptors on the floor on the bottom portion – Fig. 7g) with respect to the one wherein said DEP units are positioned (the gold electrodes labeled A and C on the ceiling in the top portion of the microchannel – Fig. 7g), each channel including a channel second end (a channel end by electrode C – Fig. 7).
However, Davis (Fig. 7) does not teach wherein said microfluidic channel having a first end splits into multiple channels.
Davis (Fig. 5) teaches an optimization (paragraph 186) of the device for high throughput wherein the electrical detection region are splits into multiple channels for multiplexed detection (paragraph 186).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the chip, as taught by Davis, with the high throughput electrical detection region, taught by Davis (Fig. 5), for multiplexed detection and to gain high throughput. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Davis teaches an optimization of the same invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Heller et al (US20110108422A1 published 05/12/2011; hereinafter Heller)
Regarding claim 8, Davis teaches the microfluidic chip according to claim 1, wherein said microfluidic apparatus is a multiplexing (provide the opportunity for multiplexed analysis of biomolecules – paragraph 7) and comprising a first end (a first end by electrode A – Fig. 7) and a second end (a channel end by electrode C – Fig. 7).
However, Davis does not teach the microfluidic device for with sequential DEP units and immunoaffinity capturing zones arranged linearly along a single channel and valves at the exit of each one of said capturing zone
Heller teaches a microfluidic device for with sequential DEP units and immunoaffinity capturing zones arranged linearly along a single channel (separately controlled separations zones combining controlled fluid flow and pulsed DC electrophoresis with using multiple AC frequencies, i.e. low frequency and higher AC frequencies – paragraph 88 and Fig. 4) and valves at the exit of each one of said capturing zone (controlled fluid flow with multiple DC/AC electrokinetic driven electrodes 310 – paragraph 69 and Fig. 4) (continuous and/or pulsed electrokinetic/dielectrophoretic (DEP) forces is used to control flow; therefore, the electrodes 310 act as valves – paragraph 69). Heller further teaches to use the DEP devices will allow rare cells, nanoparticles, and a variety important disease biomarkers to be directly isolated, concentrated, and detected in biological samples and buffers (paragraph 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the microchannel, as taught by Davis, with a series of DEP devices, taught by Heller, to directly isolate rare cells, nanoparticles, and a variety important disease biomarkers. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because the modification is a simple duplication of parts.
Conclusion
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.
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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
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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