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
Claims 14-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II-IV, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/27/26. Applicant argues there would be no serious burden to the examiner but the examiner reiterates that the groups are placed in different subclasses which presents more time to conduct a proper search on different inventions.
Claim Objections
Claims 4-13 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim as they recite “the method of any one of the preceding claims”. See MPEP § 608.01(n). Accordingly, the claims 4-13 not been further treated on the merits. For compact prosecution a rejection has been made.
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 and 3-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pamula et al. (US 2011/0104725; and PCT/US 06/47486 which is fully incorporated by reference).
Regarding claim 1, Pamula discloses a method for measuring blood coagulation, the method comprising:
a. on a microfluidics device (fig. 1a-1b,2a-2c, droplet actuator having a plurality of electrodes), merging (para 28) a blood sample droplet (para 5, 9) with an activation reagent (para 10-11 flowing blood sample droplet to a procoagulant area on the substrate; protamine sulphate droplet) comprising a coagulation-activator and with a coagulation initiation reagent to create a reaction droplet (protamine sulphate droplet, para 61, 118; para 58 further states coagulatable sample may include ore or more coagulants and coagulating a coagulatable sample on a droplet actuator may include incubating the sample droplet for a period of time sufficient to permit coagulation; CaCl2 is disclosed in para 115);
b. performing one or more shuttling impedance protocol cycles on the reaction droplet, wherein a single cycle of the one or more shuttling impedance protocol cycles comprises: transporting the reaction droplet from a first electrode across one or more electrodes to a destination electrode (fig. 1-2c show a plurality of electrodes where a reaction droplet is shuttled across to a final destination electrode; destination electrode is shown in fig. 3 as an electrode array 315; para 12), wherein a measurement of impedance is taken at one or both of the first electrode and/or the destination electrode (para 118, the electrode array 315 is being interpreted as the destination electrode where the impedance is taken. Fig. 1-2c show multiple electrodes used to shuttle the reaction droplet); and
c. determining an ability of the blood sample droplet to form a clot when a change in the measured impedance meets or surpasses a predetermined threshold indicative of clot formation (para 118).
Regarding claim 3, Pamula discloses a method for measuring blood coagulation, comprising: a. using electrowetting-mediated droplet operations on a microfluidics device:
dispensing a droplet of a blood sample in a droplet operations gap of the microfluidics device (fig. 1a-1b,2a-2c, droplet actuator having a plurality of electrodes, para 28, para 5, 9);
initiating an activated partial thromboplastin time (aPTT) test by merging the sample droplet with an activation reagent droplet and an initiation reagent droplet to create a reaction droplet (para 10-11 flowing blood sample droplet to a procoagulant area on the substrate; protamine sulphate droplet; protamine sulphate droplet, para 61, 118; para 58 further states coagulatable sample may include ore or more coagulants and coagulating a coagulatable sample on a droplet actuator may include incubating the sample droplet for a period of time sufficient to permit coagulation; CaCl2 is disclosed in para 115); and
performing one or more shuttling impedance protocol cycles on the reaction droplet, wherein a single cycle of the one or more shuttling impedance protocol cycles comprises transporting the reaction droplet from a first electrode to a destination electrode (fig. 1-2c show a plurality of electrodes where a reaction droplet is shuttled across to a final destination electrode; destination electrode is shown in fig. 3 as an electrode array 315; para 12), wherein a measurement of impedance is taken at one or both of the first electrode and/or the destination electrode (para 118, the electrode array 315 is being interpreted as the destination electrode where the impedance is taken. Fig. 1-2c show multiple electrodes used to shuttle the reaction droplet); and
using a computer, determining an ability of the blood sample droplet to form a clot when a change in the measured impedance meets or surpasses a predetermined threshold indicative of clot formation (para 118, 119-123).
Regarding claim 4, the method of any one of the preceding claims, the method further comprising measuring the change in impedance over time and determining a time to clot formation when a change in the measured impedance meets or surpasses a predetermined threshold indicative of clot formation (para 118, 119-123).
Regarding claim 5, the method of any one of the preceding claims, wherein the activation reagent comprises ellagic acid in a phospholipid solution or silica in a phospholipid solution (para 58).
Regarding claim 6, the method of any one of the preceding claims, wherein the initiation reagent overcomes the effect of an anticoagulant agent used during initial collection of the blood sample (coagulation occurs therefore it overcomes any effect of an anticoagulant agent used).
Regarding claim 7, the method of any one of the preceding claims, wherein the initiation reagent comprises CaCl2 (para 130).
Regarding claim 8, the method of any one of the preceding claims, wherein the reaction droplet is held for a defined period of time after each measurement of impedance (para 58, 118).
Regarding claim 9, the method of claim 8, wherein the defined period of time comprises about 2 seconds or more (para 58, 118, 138).
Regarding claim 10, the method of any one of the preceding claims, wherein the single cycle comprises transporting the reaction droplet from the first electrode across the one or more electrodes to the destination electrode and transporting the reaction droplet back to the first electrode which becomes the destination electrode (fig. 1-2c show a plurality of electrodes where a reaction droplet is shuttled across to a final destination electrode; destination electrode is shown in fig. 3 as an electrode array 315; para 12).
Regarding claim 11, the method of claim 11, wherein forty or fewer shuttling impedance protocol cycles are performed (1 shuttling protocol is performed which meets the broadest reasonable interpretation of the instant claim).
Regarding claim 12, the method of any one of the preceding claims, wherein if the change in measured impedance is sudden it is indicative of more severe clot clotting, and wherein if the change in measured impedance is gradual it is indicative of less severe clotting (para 118).
Regarding claim 13, the method of any one of the preceding claims, wherein the measurement of impedance is a measurement of current at the electrode for an applied voltage (para 118).
Allowable Subject Matter
Claim 2 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 prior art of Pamula does not teach a single shuttling impedance protocol cycle comprises:
a. holding the reaction droplet across the first electrode designated 1 and two electrodes designated 2 and 3 for about two seconds or more, wherein the reaction droplet is three reaction droplet units in size (3DU);
b. transporting the 3DU reaction droplet to electrodes 2-4 and holding for about 100 ms or less of settling time, wherein electrode 4 is the destination electrode;
c. taking a measurement of impedance at the first electrode and the destination electrode;
d. holding the 3DU reaction droplet across electrodes 2-4 for about two seconds or more;
e. transporting the 3DU reaction droplet to electrodes 1-3 and holding for about 100 ms or less of settling time; and
f. taking a measurement of impedance at the first electrode and the destination electrode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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