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 .
Claim Rejections - 35 USC § 102
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, 4-6, 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denomme et al (WO2020/049524A1).
As to claim 1, Denomme et al disclose (fig. 2) a method for determining a dissociation rate constant (dissociation rate constant) in ligand-target analyte affinity analysis (analyte affinity measured by standard analysis software, Tracedrawer for kinetic analysis), (paragraph [0188]), the method comprising: (a) providing a digital microfluidic (DMF) cartridge (110) comprising: (i) at least one electrode (124, 126, 128) to perform fluid operations (liquids of interest via droplet operations) on a fluid (liquids, droplets) in the DMF cartridge (110): (ii) a fluid channel (122), (paragraphs [0094]-[0096]); and (iii) a sensor (112, 136) located in the fluid channel (122), wherein the sensor (112, 136), (paragraph [0097]) includes an immobilized ligand (immobilized ligand), (paragraphs [0008], [0079], [0101-0102]); (b) providing a first fluid (liquids, droplets, solution) including the target analyte (target analytes 216), (paragraphs [0097], [0106]); and (c) flowing the first fluid (liquids, droplets) through the fluid channel (122) and into contact with the sensor (112, 136); (d) detecting (detecting) a ligand-analyte interaction (ligand analyte, chemical in sample), (paragraph [0097]); and (e) determining (determine) a dissociation rate constant (koff) (dissociation rate constant koff) during a dissociation phase (dissociation phase) of the analyte (analyte) at the sensor (112, 136), wherein the dissociation rate constant (dissociation rate constant) is determined in the presence of a second fluid (liquids of interest, droplets, solution) containing free ligand molecules (ligand molecules), (paragraphs [0106], [0188]).
As to claim 4, Denomme et al disclose (fig. 2) the method wherein the immobilized ligand (immobilized ligand) and the free ligand (ligand) are the same ligand molecule (ligand molecule), (paragraphs [0079]-[0081], [0101]-[0102]).
As to claim 5, Denomme et al disclose (fig. 2, fig. 3) the method wherein the immobilized ligand (immobilize ligand) and the tree ligand (214, ligands, molecules) are different ligands (214, ligands, molecules) that bind (bind) in the same binding site of the target analyte (216), (paragraphs [0102]-[0103]).
As to claim 6, Denomme et al disclose (fig. 2) the method wherein the cartridge (110) further comprises a running buffer reservoir (buffer solution) in fluid (liquids, droplets) communication with the fluid channel (122), (paragraphs [0094]-[0097]).
As to claim 13, Denomme et al disclose (fig. 2) the method wherein the first fluid (liquids of interest, droplets) is split into a first portion (solution, sample droplets, liquid reagents) and a second portion (solution, sample droplets, liquid reagents), wherein the first portion (solution, sample droplets, liquid reagents) is used to immobilize (immobilize) the ligand (214, ligand) to the sensor (112) in an immobilization phase (immobilization phase) and wherein the second portion (solution, sample droplets, liquid reagents) is used as the free ligand (214, ligand, chemical, molecules) of the second fluid (liquids of interest, droplets), (paragraphs [0094], [0101]-[0102], [0106]).
As to claim 14, Denomme et al disclose (fig. 2) the method wherein the first fluid (liquids of interest, droplets, solution) and/or the second fluid (liquids of interest, droplets, solution) flow through the fluid channel (122) in a continuous manner, (paragraphs [0094]-[0097], [0106]).
As to claim 15, Denomme et al disclose (fig. 2) the method wherein the first fluid (liquids of interests, droplets, solution) and the second fluid (liquids of interest, droplets, solution) flow through the fluid channel (122) in separate distinct steps, (paragraphs [0094]-[0097], [0106]).
As to claim 16, Denomme et al disclose (fig. 2) the method wherein functionalized ligand binding sites (active bonding sites) on the sensor surface (112, 136), (paragraphs [0101]-[0102]) are blocked (via blocking solution) with a blocking agent (ethanolamine), (paragraph [0153] after immobilization of ligand to the sensor (112, 136) and prior to determining the dissociation rate constant (koff) (dissociation rate constant koff), (paragraphs [0185]-[0188]).
Allowable Subject Matter
20. Claims 2-3, 7-8, 9-12 are 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.
21. The prior art of record fail to teach either singly or in combination further comprises a first ligand reservoir storing the immobilization ligand, and wherein the first ligand reservoir is in fluid communication with the fluid channel, further comprises a ligand collection reservoir, and wherein the ligand collection reservoir is in fluid communication with the fluid channel and operable to recover a ligand containing fluid after an immobilization phase and/or after the dissociation phase, further comprises a running buffer reservoir in fluid communication with the fluid channel, the first ligand reservoir and/or the second ligand reservoir, wherein the first ligand in the first ligand reservoir and/or the second ligand in the second ligand reservoir is at a concentration of between about 1μg/mL to about 100 μg/mL.
Conclusion
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DON J WILLIAMS whose telephone number is (571)272-8538. The examiner can normally be reached M-F 8 a.m.-5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Georgia Epps can be reached at 571-272-2328. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DON J WILLIAMS/Examiner, Art Unit 2878
/GEORGIA Y EPPS/Supervisory Patent Examiner, Art Unit 2878
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