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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 JUNE 2026 has been entered.
Status of Claims
The claim set submitted with the RCE on 23 JUNE 2026 is acknowledged and considered. In the claim set, Claims 1-6, 8, 13, 14, 17, 18, 20, 24-26, 28, 30, 32 and 42-43 are ‘Original’ or ‘Previously Presented’; Claims 7, 9-12, 15, 16, 19, 21-23, 27, 29, 31, 33, 35, 37-41 are ‘Cancelled’; Claim 36 is ‘Withdrawn’; and Claims 44-48 are ‘New’.
Current pending claims are Claims 1-6, 8, 13, 14, 17, 18, 20, 24-26, 28, 30, 32 and 42-48 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 JANUARY 2026 was filed after the mailing date of the Non-Final Office Action on 16 OCTOBER 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 20 JANUARY 2026 was filed after the mailing date of the Non-Final Office Action on 16 OCTOBER 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 23 JUNE 2026 was filed after the mailing date of the Final Office Action on 27 MARCH 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 22 JULY 2026 was filed after the mailing date of the Final Office Action on 27 MARCH 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
In response to Applicant’s assertion that the CHEN reference does not teach the first, second and third zones; Examiner respectfully disagrees. Using the broadest reasonable interpretation of a ‘zone’ is any continuous area that differs in some respect, or is distinguished for some purpose, from adjoining areas, or within which certain distinctive circumstances exist or are established. The instant application does not define structural limitations of what these zones are so under BRI, zones are just areas.
In response to the assertion on page 10 which Applicant asserts that the CHEN reference does not teach transfer means; based on the 112f analysis, the transfer means is a piston pump or displacement member. Similarly, for the ‘flow control means’, the Examiner has mapped portions of CHEN to teach the structural limitation in view of the 112(f) analysis as presented in the first Office Action on the merits.
If applicant does not want to have the claim limitation interpreted under 35 U.S.C. 112(f), applicant may: (1) present a sufficient showing to establish that the claim limitation recites sufficient structure to perform the claimed function so as to avoid interpretation under 35 U.S.C. 112(f); or (2) amend the claim limitation in a way that avoids interpretation under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8, 13, 14, 17, 18, 20, 24-26, 28, 30, 32, 34 and 42-48 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by CHEN, US Publication No. 2010/0304986 A1.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference CHEN discloses a device for use in the analysis of a biomolecule in a liquid sample, Figure 24A, [0049, 0128], the device comprising:
at least three zones for accommodating at least part of the liquid sample, Figure 24 A, [0049, 0074, 0128, 0140], using BRI: a zone is any continuous area that differs in some respect, or is distinguished for some purpose, from adjoining areas, or within which certain distinctive circumstances exist or are established, or Figure 7a-d;
a transfer means for transferring at least part of the liquid sample from a first zone to a second zone and for subsequently transferring at least part of the liquid sample from the second zone to a third zone along respective flow paths, [0128], a fluid reservoir, the piston depresses the membrane capping the reservoir, which in turn forces fluid out of the reservoir;
a mechanically powered driver for operating the transfer means, [0128], piston;
a flow control means for selectively opening the flow paths between the at least three zones, [0074, 0075, 0077, 0127], valves; and
a manually-operated common actuating member movable between a first and a second position to sequentially control both the mechanically powered driver and the flow control means to achieve transfer of at least part of the liquid sample between said zones, [0102, 0127], single actuator, the movement of the actuator moves fluids, open valves, introduces reagents into a sample mixes the sample and reagents, an transports the reaction products to a detector or analysis device, without the need for user intervention beyond activating the actuator.
Examiner Note: In the instant claim, in the newly added portion of “wherein movement of the manually-operated common actuating member from the first position to the second position acts on the mechanically powered driver to achieve transfer of at least part of the liquid sample from the first zone to the second zone, and wherein the mechanically powered driver effects the subsequent transfer of at least part of the liquid sample from the second zone to the third zone independently of the movement of the manually-operated common actuating member.” is directed to a manner of operating the device. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) . It should be noted that a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Additional Disclosures Included are: Claim 2: wherein the device according to claim 1, which is arranged and configured to effect the transfer of at least part of the liquid sample from the second zone to the third zone a predetermined time after the transfer of at least part of the liquid sample from the first zone to the second zone, [0124], movement governed by controller; sequence of reactions are to proceed for a specific period of time.; Claim 3: wherein the device according to claim 1, which further comprises a timed release mechanism which is actuated by the movement of the manually-operated common actuating member from the first position to the second position to effect the transfer of at least part of the liquid sample from the second zone to the third zone a predetermined time after the manually-operated common actuating member has moved to the second position from the first position, [0124], movement governed by controller; sequence of reactions are to proceed for a specific period of time, such control accomplished by controllers, gears, or even by spring-loaded mechanism.; Claim 4: wherein the device according to claim 1, in which the mechanically powered driver comprises a rotary member, [0119], Figure 19 and 20, camshaft of the embodiment is rotated.; Claim 5: wherein the device according to claim 4, in which the transfer means comprises a displacement member which is linearly movable, the rotary member being coupled to the transfer means by a linkage which converts rotational movement of the rotary member into linear movement of the displacement member, to cause one or more transfers between zones under the power of the drive means, [0119], Figure 19 and 20, several hinged members are positioned above several plunger, camshaft of the embodiment is rotated, actuated members in turn depress the plungers located below.; Claim 6: wherein the device according to claim 5, wherein the displacement member comprises at least one piston, Figure 24a, see right side of device.; Claim 8: wherein the device according to claim 1, wherein the mechanically powered driver comprises a mechanical energy store for storing mechanical energy for powering the driver, the mechanical energy store comprising at least one of a mechanical spring and a torsional spring, and wherein the mechanical energy store is preloaded with sufficient energy to cause movement of the displacement member along two, opposite linear strokes, [0124], spring-loaded mechanisms.; Claim 13: wherein the device according to claim 1, in which the at least three zones comprise a sample receiving means through which the sample is introduced into the device, a reaction chamber in which the sample undergoes one or more reactions specific to the analysis, and a test region for subsequently analysing the reacted sample, [0127]. ; Claim 14: wherein the device according to claim 13, wherein the sample receiving means comprises a sample receiving chamber, the device further comprising a cap or cover for closing the sample receiving chamber during the operation of the device, wherein the common actuating member comprises the cap or cover for closing the sample receiving chamber, [0127].; Claim 17: wherein the device according to claim 1, wherein the device includes a heater for heating at least part of the liquid sample in at least the second zone, [0125], heater.; Claim 18: wherein the device according to claim 17, wherein the heater is an electrically powered heater forming part of a printed circuit board (PCB), the PCB comprising control electronics for the device, [0124], computer control/controllers inherently have PCB.; Claim 20: wherein the device according to claim 17, wherein the heater is thermally coupled to a reaction chamber and the analysis includes the step of heating at least part of the liquid sample in the reaction chamber, wherein the reaction chamber comprises a metallic foil, wherein the device comprises a biasing means for urging the heater against the thermally conductive material, and wherein each of the heater and the thermally conductive material extend beyond the reaction chamber, [0125, 0136].; Claim 24: wherein the device according to claim 13, wherein the device includes a temperature sensor thermally coupled to the reaction chamber, [0125, 0126, 0132]; temperature is moderated by heater/cooler and controlled which would imply there is a sensor.; Claim 25: wherein the device according to claim 1, wherein the device includes retaining means for temporarily interrupting the operation of the mechanically powered driver so as to delay the completion of the operation of the transfer means for a period., [0107], eccentricities disposed along the camshaft, upon rotation of the camshaft, Figure 21.; Claim 26: wherein the device according to claim 25: wherein the retaining means comprises : a fusible retaining member for engaging, and acting as a stop to, the mechanically powered driver; and a heater for heating the fusible retaining member, causing the fusible retaining member to soften, melt, weaken or break, so as to release the driver therefrom after said period, [0107]; Claim 28: wherein the device according to claim 1, herein the manually-operated common actuating member is movable along a single actuating member stroke, the device being arranged for this single movement to cause the device to perform a predetermined sequence of operations to achieve said analysis of the sample, [0127], single actuator.; Claim 30: wherein the device according to claim 1, wherein the flow control means comprises a valve, wherein the valve comprises a rod linearly movable in a valve chamber to bring selective pairs of ports into fluid communication, so as to create said one or more flow paths, [0110].; Claim 32: wherein the device according to claim 13 wherein the device includes a detent that resists movement of the manually-operated common actuating member beyond a position part way along said stroke, at which position a flow path has been established by the flow control means between the sample receiving means and the reaction chamber and the operation of the transfer means to transfer the sample into the reaction chamber has been triggered, but before completion of the stroke at which position a flow path between the reaction chamber and the test region has been established by the flow control means, [0010, 0056, 0102, 0104]. ; Claim 34: wherein the device according to claim 1, wherein the device includes monitoring means for monitoring the operation of the device and providing a warning if incorrect operation is detected, [0124, 0127, 0130], wherein the monitoring means comprises a timer, and wherein the warning is provided by a LED, [0124], use of a computer for control includes timers and LED; and Claim 42: wherein the device according to claim 1, in which the transfer means comprises a transfer pump, [0087].; and Claim 43: wherein the device according to claim 4, further comprising a proximity sensor for detection the position of the rotary member, [0119].; Claim 44: wherein the device according to claim 5, wherein the displacement member comprises multiple pistons each movable in a respective cylindrical piston chamber, [0150].; Claim 45: wherein the device of claim 30, wherein the valve comprises a one-way valve, [0124] .; Claim 46: wherein the device of claim 32, in which the test region comprises a lateral flow strip, [0143], Figure 7a-7c.; Claim 47: wherein the device of claim 32, wherein the detent is configured to maintain the manually- operated common actuating member at a position part way along its stroke for a time sufficient to enable the transfer means to transfer the liquid sample from the sample receiving means to the reaction chamber before the transfer means is reconfigured to provide a flow path from the reaction chamber to the test region, [0010, 0056, 0102, 0104]. ; and Claim 48: wherein the device of claim 47, wherein movement of the manually-operated common actuating member beyond the position part way along its stroke establishes a second flow path between the reaction chamber and the test region, [0124], movement governed by controller; sequence of reactions are to proceed for a specific period of time, such control accomplished by controllers, gears, or even by spring-loaded mechanism
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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