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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/27/22, 10/26/23, 10/18/24 is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 1-5 in the reply filed on 2/12/26 is acknowledged.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (detection device), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/12/26.
Claim Status
Claims 1-5 are pending and are examined. Claims 6-10 are withdrawn and are not examined.
Claim Objections
Claim 4 is objected to because of the following informalities: Please correct “unbound particle is smaller than or equal to 1. 0.”. Appropriate correction is required. For purposes of examination, the claim is interpreted to read as “smaller than or equal to 1.”
Claim Rejections - 35 USC § 103
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hsieh (US Pub 2009/0283406), in view of Seul (US Pub 2002/0166766).
Regarding Claim 1, Hsieh teaches a detection method (The method includes the steps of immobilizing a single DEP bead in one electric field; immobilizing a first bio-recognizing molecule on the single DEP bead; intromitting at least one target bioparticle into the electric field for binding the first bio-recognizing molecule, whereby the target bioparticle and the first bio-recognizing molecule are bound with each other to form a complex molecule; and detecting the complex molecule by a detection device. See Abstract) comprising:
forming a complex by binding a target substance and a dielectric particle modified by a single-domain antibody that is bindable to the target substance; separating the complex and an unbound particle in a fluid with dielectrophoresis ([0031] The single DEP bead 11 can be placed on the chip 21 for movement along with the polarity of the electric field. The single DEP bead 11 includes a first label signal and at least one first bio-recognizing molecule 12, wherein the first bio-recognizing molecule 12 can be bound with the target bioparticle 13.),
detecting the target substance contained in the separated complex with an imaging element (The detection device 41 is adapted for detection of a signal generated when the bioparticle 13 is bound with the first bio-recognizing molecule 12.).
Hsieh is silent to the unbound particle being the dielectric particle not forming the complex.
Seul teaches in the related method of dielectrophoresis. [0130] A molecular binding event on a known particle surface causing a change in the surface chemical property (i.e. a change in the dielectric property of the particle plus bound molecule over that of the particle) can be easily be detected utilizing the fact that the effect of the binding is reflected in change in the relaxation frequency of the particle. The binding of the oligonucleotide fragment increased the characteristic frequency, ωmod, of oligo bound particles relative to the characteristic frequency, ωbare, of unbound particles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the step of the unbound particle being the dielectric particle not forming the complex, as taught by Seul, to the method, as taught by Hsieh, to allow for detection on the basis of characteristic frequency dependence of particle polarization and also to analysis of electrochemical properties of particles, as taught by Seul in [0130].
Regarding Claim 2, modified Hsieh teaches the detection method according to claim 1, wherein, in separating the complex and the unbound particle, an alternate current voltage of a predetermined frequency is applied such that one of positive dielectrophoresis and negative dielectrophoresis acts on the complex and the other of the positive dielectrophoresis and the negative dielectrophoresis acts on the unbound particle (Seul teaches the particles comprise at least two types, each type having a distinguishable relaxation frequency. An electric field, having a frequency that is less than or equal to the relaxation frequency of at least one of said particle types but greater than the relaxation frequencies of other particle types, is generated at the interface by application of an AC voltage.).
Regarding Claim 3, modified Hsieh teaches the detection method according to claim 2, wherein the predetermined frequency is a value higher than a first frequency and lower than a second frequency, both the positive dielectrophoresis and the negative dielectrophoresis act on the complex due to an electric field gradient generated when the alternate current voltage of the first frequency instead is used instead of the alternate current voltage of the predetermined frequency, and both the positive dielectrophoresis and the negative dielectrophoresis act on the unbound particle due to an electric field gradient generated when the alternate current voltage of the second frequency is used instead of the alternate current voltage of the predetermined frequency ([0005] As regards the researches of the DEP force, most of them were related to capturing particles, cells, antigens, antibodies, etc. and to which phenomena, like positive and negative DEP for separation, control, sampling, collection, calculation, rotation, property calibration, or other application would happen under adjustment of parameters, like different geometric shapes and arrangements of electrodes, environmental solution, intensity of electric field, and frequency.).
Regarding Claim 4, modified Hsieh teaches the detection method according to claim 1, and zeta potential ([0021] The present invention also provides for the determination of the frequency-dependent and voltage-dependent maximal velocity, vmax attained by particles crossing impedance gradients in the course of array assembly. As described herein, vmax may be determined by image analysis and particle tracking. In certain embodiments, the combination of ωR and vmax provides for the simultaneous determination of the particles' surface ("zeta") potential, (o-slashed)s, and surface conductivity, σ, e.g., based on numerical analysis of phenomenological equations of particle motion described herein. [0022] Once these values are found, they may be used to characterize the particles, e.g., determine the zeta potential of the particles and/or the mobility of ions or molecules within the electrolyte solution in proximity to the particle surface).
Modified Hsieh is silent to wherein a ratio of a zeta potential of the complex to a zeta potential of the unbound particle is smaller than or equal to 1.
A particular parameter can be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, and the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation (see MPEP 2144.05.II.B.). There is no evidence indicating that the zeta potential is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured a ratio of a zeta potential of the complex to a zeta potential of the unbound particle is smaller than or equal to 1 to minimize particle aggregation.
Regarding Claim 5, modified Hsieh teaches the detection method according to claim 1, wherein the dielectric particle contains a fluorescent substance, and detecting the target substance comprises illuminating the separated complex with excitation light, taking an image of fluorescence generated from the fluorescent substance contained in the complex with the imaging element, and detecting the target substance contained in the complex ([0025] fluorescence labeling. Figs. 3A and 3B [0032] the single DEP bead 11 contains a first fluorescence label signal.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798