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 .
Note
The examiner notes that this Office action is a second final rejection in response to applicant’s remarks dated 6/8/26.
Claim Status
Claims 37, 38, 42-58, and new claim 59 are pending and are examined. Claims 1-36 and 39-41 are cancelled.
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 37, 38, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 54, 56, 57, and 58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (US Pub 2010/0304986; previously cited).
Regarding Claim 37, Chen teaches a device for use in the analysis of a biomolecule in a liquid sample by a procedure comprising at least two stages ([0022] FIG. 7a depicts a cassette for processing of immunoassays or free-floating nucleic acids),
the device comprising:
a plurality of zones for accommodating at least part of the liquid sample at different stages of the procedure ([0024] FIG. 7c depicts the fluid connectors, fluidic conduits, and capture zones embedded in a lateral flow strip for the cassette of FIG. 7a);
a flow control means for selectively opening one or more flow paths between the zones ([0074] valves; [0075] By actuating one or more valves that control entry and exit of fluid from the channel, the user may effect fluid flow in a specific direction by controllably actuating the valves and depressing the deformable layer atop the channel. [0076] Valves may include a deformable layer, a hatch, a septum, a butterfly valve, a diaphragm valve, a ball valve, or any combination thereof. It is contemplated that a valve may be actuated by the accumulation of fluid pressure on one side of the valve or by application of external force. [0077] Valves may be capable or reversible or irreversible operations, and may be one-way or two-way valves. In embodiments that may require prevention of fluid backflow from one fluidic element into another, an irreversible or one-way valve may be used.), and
a transfer means for transferring the liquid sample from one to another of the zones along a respective open flow path ([0128] In one embodiment, the actuator comprises a piston, plunger, or other device capable of applying pressure to a discrete area, mounted on a stage capable of movement in the x-y plane.)
the plurality of zones comprises a sample receiving means for receiving the liquid sample to be analyzed, a reaction chamber for containing the liquid sample while the liquid sample undergoes one or more reactions, and a zone comprising an examination means for subsequently analyzing the liquid sample, and wherein the examination means is operable to indicate the presence of one or more biomolecules in the liquid sample ([0140] The cassette also included a lateral flow strip, suitable for immobilizing labeled target molecules. [0074] Fluidic elements include a number of structures, including conduits, chambers).
wherein the device further comprises a lid forming common actuating member for operating both the flow control means and the transfer means ([0102] Such systems include a component comprising at least one fluidic element sealed by a deformable sealing layer; and a moveable actuator residing proximate to the component. At least a portion of the actuator is capable of motion relative to the component, and the actuator suitably includes one or more actuator portions capable of actuating at least one fluidic element and also being arranged such that movement of the actuator effects a prescribed sequence of actuations. The actuations may be of the deformable sealing layer, or of one or more fluidic elements, or both. Movement of the actuator is suitably capable of effecting fluid motion within at least a portion of the component.)
wherein the lid is lockable following the introduction of the liquid sample to the sample receiving chamber ([0071] As further depicted in FIG. 1b, a reservoir may be filled by injecting fluid into the reservoir by way of the reservoir aperture. After such injection, the reservoir may be sealed by a sealant layer, as depicted in FIG. 1c. The examiner notes that the liquid sample is not part of the claimed device. Therefore, the limitation “the lid is lockable following the introduction of the liquid sample to the sample receiving chamber” is directed to intended use of the device.)
Regarding Claim 38, Chen teaches the device according to claim 37, wherein the device includes a mixing chamber for containing one or more reagents, enzymes, oligonucleotides, and/or antibodies ([0074] Fluidic elements include a number of structures, including conduits, chambers, valves, reservoirs, mixing zones, channels, vents, valves, and the like. [0094] FIG. 13 depicts an embodiment of the claimed invention of FIG. 12 suitable for application to PCR-based assays. FIG. 13a illustrates a first component that includes several blister reservoirs that contain reagents used for PCR reactions, including buffer, lysing reagent, and a binding reagent. The first component also includes a receiving chamber, which may be used to receive or hold any fluids that may participate or arise out of a given reaction, including waste fluids or even reaction products.)
Regarding Claim 42, Chen teaches the device according to claim 37, wherein the flow control means is operable and/or arranged to selectively open a reaction chamber flow path to the reaction chamber and an examination means flow path to the examination means, the transfer means being operable to transfer the liquid sample, under the control of the flow control means, to a selected one of the reaction chamber and the examination means along a respective flow path ([0074] valves; [0075] By actuating one or more valves that control entry and exit of fluid from the channel, the user may effect fluid flow in a specific direction by controllably actuating the valves and depressing the deformable layer atop the channel. [0076] Valves may include a deformable layer, a hatch, a septum, a butterfly valve, a diaphragm valve, a ball valve, or any combination thereof. It is contemplated that a valve may be actuated by the accumulation of fluid pressure on one side of the valve or by application of external force. [0077] Valves may be capable or reversible or irreversible operations, and may be one-way or two-way valves. In embodiments that may require prevention of fluid backflow from one fluidic element into another, an irreversible or one-way valve may be used. [0140] The cassette also included a lateral flow strip, suitable for immobilizing labeled target molecules.).
Regarding Claim 43, Chen teaches the device according to claim 37, wherein the device includes a mixing chamber for containing one or more reagents, enzymes, oligonucleotides, and/or antibodies ([0074] mixing zones), and wherein the flow control means is operable to selectively open the mixing chamber flow path from the sample receiving means to the mixing chamber (valve as taught by Chen – see claim 1 above- would be capable of this), and the transfer means is operable to propel the liquid sample from the sample receiving means to the mixing chamber ([0128] In one embodiment, the actuator comprises a piston, plunger, or other device capable of applying pressure to a discrete area, mounted on a stage capable of movement in the x-y plane. An exemplary device is shown in FIG. 24a and FIG. 24b, where a piston actuator is mounted on an x-y stage, which stage is disposed under a cassette. The piston may be moved to the x-y coordinates of a particular fluidic element, where the piston is actuated, thus pressing on the fluidic element. In the case of a fluid reservoir, the piston depresses the membrane capping the reservoir, which in turn forces fluid out of the reservoir.).
Regarding Claim 44, Chen teaches the device according to claim 43, wherein the mixing chamber flow path comprises a closed condition, achieved by means of the flow control means, wherein the mixing chamber is sealed from the external environment (([0074] valves; [0075] By actuating one or more valves that control entry and exit of fluid from the channel, the user may effect fluid flow in a specific direction by controllably actuating the valves and depressing the deformable layer atop the channel. [0076] Valves may include a deformable layer, a hatch, a septum, a butterfly valve, a diaphragm valve, a ball valve, or any combination thereof. It is contemplated that a valve may be actuated by the accumulation of fluid pressure on one side of the valve or by application of external force. [0077] Valves may be capable or reversible or irreversible operations, and may be one-way or two-way valves. In embodiments that may require prevention of fluid backflow from one fluidic element into another, an irreversible or one-way valve may be used.).
Regarding Claim 45, Chen teaches the device according to claim 43, wherein the reaction chamber flow path extends directly from the mixing chamber to the reaction chamber, and the examination means flow path extends directly from the mixing chamber to the examination means, the transfer means being operable to return the liquid sample from the reaction chamber to the mixing chamber, along the reaction chamber flow path, before transferring the liquid sample from the mixing chamber to the examination means along the examination means flow path ([0128] In one embodiment, the actuator comprises a piston, plunger, or other device capable of applying pressure to a discrete area, mounted on a stage capable of movement in the x-y plane.).
Regarding Claim 46, Chen teaches the device according to claim 37, wherein the examination means comprises a lateral flow test strip ([0143] A cassette according to the present invention is prepared and mated to a substrate comprising several fluid conduits and a lateral flow strip. FIGS. 7a-7c illustrates such a cassette, in which figure separate fluid reservoirs and the lateral flow strip are shown.).
Regarding Claim 47, Chen teaches the device according to claim 37, wherein the examination means comprises an electronic detection device ([0110] detector).
Regarding Claim 48, Chen teaches the device according to claim 38, wherein the transfer means is operable to transfer a dose of the liquid sample to the mixing chamber, the dose being of a predetermined volume, wherein the transfer means is operable to transfer a dose of the liquid sample to the reaction chamber, the dose being of a predetermined volume, and wherein the volume is determined to an accuracy of at least plus or minus 15µl (the volume is directed to intended use of the device; [0128] In one embodiment, the actuator comprises a piston, plunger, or other device capable of applying pressure to a discrete area, mounted on a stage capable of movement in the x-y plane. An exemplary device is shown in FIG. 24a and FIG. 24b, where a piston actuator is mounted on an x-y stage, which stage is disposed under a cassette. The piston may be moved to the x-y coordinates of a particular fluidic element, where the piston is actuated, thus pressing on the fluidic element. In the case of a fluid reservoir, the piston depresses the membrane capping the reservoir, which in turn forces fluid out of the reservoir.).
Regarding Claim 49, Chen teaches the device according to claim 37, wherein the common actuating member comprises the lid, wherein the lid is manually operable and movable between a first position and a second position to sequentially control the flow control means and the transfer means ([0143] A cassette according to the present invention is prepared and mated to a substrate comprising several fluid conduits and a lateral flow strip. FIGS. 7a-7c illustrates such a cassette, in which figure separate fluid reservoirs and the lateral flow strip are shown. The cassette is then inserted into an actuator, as shown in FIG. 7d. FIG. 18g shows a cassette being inserted into an actuator comprising a camshaft and several hinged members capable of actuating individual or multiple hinged members such that the members contact different portions of the cassette so as to squeeze reservoirs and mix fluids within the cassette-substrate assembly.).
Regarding Claim 50, Chen teaches the device according to claim 37, wherein the device is arranged such that movement of the common actuating member in a single direction operates the flow control means and the transfer means to convey the liquid sample, in sequence, to the zones ([0124] The movement of the actuator may be governed by a controller. Governance of the actuator's movement may be of particular interest where the user seeks to effect a relatively complex sequence of chemical, biochemical, or biomolecular reactions, in which sequence certain reactions are to proceed for a specific period of time. Such control may be accomplished by computer controllers, gears, or even by spring-loaded mechanisms that release stored energy over time and actuate different parts of a system as that energy is released.).
Regarding Claim 51, Chen teaches the device according to claim 37, wherein the device includes a one-way mechanism for permitting movement of the common actuating member only in the direction ([0124] The movement of the actuator may be governed by a controller. Governance of the actuator's movement may be of particular interest where the user seeks to effect a relatively complex sequence of chemical, biochemical, or biomolecular reactions, in which sequence certain reactions are to proceed for a specific period of time. Such control may be accomplished by computer controllers, gears, or even by spring-loaded mechanisms that release stored energy over time and actuate different parts of a system as that energy is released. The limitation beginning with “for permitting” is directed to intended use).
Regarding Claim 54, Chen teaches the device according to claim 37, wherein the device is arranged such that the procedure carried out by the device involves nucleic acid amplification, and wherein the procedure includes detection of one or more biomolecules by nucleic acid lateral flow ([0093] FIG. 12 depicts schematically the two parts of a cassette for the processing of nucleic acids. The depicted cassette meters a sample; lyses cells or viruses, isolates, concentrates, and purifies nucleic acids on a solid support; elutes the nucleic acids into a PCR chamber; and performs amplification of the eluted nucleic acids. [0140] The cassette also included a lateral flow strip, suitable for immobilizing labeled target molecules.)
Regarding Claim 56, Chen teaches the device according to claim 37, wherein the device comprises a heater for heating the liquid sample, and wherein the heater is arranged such that, in use, it heats the liquid sample while the latter is disposed within the reaction chamber ([0111] The system may also include a heater, which heater may be turned on and off by the movement of one or more hinged member. The examiner notes that the limitation “such that…” is directed to a conditional limitation).
Regarding Claim 57, Chen teaches the device according to claim 37, wherein the lid comprises a cap for closing the sample receiving chamber during the operation of the device, where the lid is configured to be retained in a closed position to prevent reopening of the sample receiving chamber ([0071] As further depicted in FIG. 1b, a reservoir may be filled by injecting fluid into the reservoir by way of the reservoir aperture. After such injection, the reservoir may be sealed by a sealant layer, as depicted in FIG. 1c.).
Regarding Claim 58, Chen teaches the device according to claim 37, wherein the examination means indicates a quantity of the one or more biomolecules in the liquid sample ([0092] Following sample binding to the bead array, the labels on the sample are excited by illumination at their excitation wavelength. Beads that bind captured analytes then emit light that allows for detection of the presence and quantity of target analytes.).
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 52, 53, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US Pub 2010/0304986; previously cited), in view of Dees (US Pub 2010/0285490; previously cited).
Regarding Claim 52, Chen teaches the device according to claim 37 and wherein the flow control means comprises a valve comprising a valve member, linear movement of which selectively opens and closes the flow paths, the transfer means comprising a piston and cylinder (see teachings of claim 37 above).
Chen is silent to the common actuating member comprises a rotary knob, and wherein the valve member and the piston are coupled to the rotary knob via cam followers which engage in a camway on the knob, so that rotation of the rotary knob operates the valve member and the piston.
Dees teaches in the related art of detection of agents. [0344] knob 15; a pivot joint, knob, a handle, knob 17; [0345] In some embodiments, an assay chamber holding device is a clamp. In some embodiments, an assay chamber clamp provides a mechanical advantage using cam levers to translate rotational motion (or torque) in linear force actuation.
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 a rotary knob, and wherein the valve member and the piston are coupled to the rotary knob via cam followers which engage in a camway on the knob, so that rotation of the rotary knob operates the valve member and the piston, as taught by Dees, to the actuator in the device of Chen, to allow for rotational motion, as taught by Dees, in [0345].
Regarding Claim 53, Chen teaches the device according to claim 37.
Chen is silent to the device comprises a timer and visual and/or audio signaling means for prompting a user to operate the common actuating member at correct times during operation of the device.
Dees teaches in the related art of detection of agents. [0074] In some embodiments, a GUI is utilized wherein "windows" are shown to the user with explicit instructions for each step in the assay, and optionally with a countdown timer, e.g., to show assay progress. [0106] In some embodiments, a positive and or negative result/hit can result in an audible and/or visible alarm. In some embodiments, if a sample(s) contains an agent(s) with a concentration or level exceeding or below a predetermined value an audible and/or visible alarm is activated. In some embodiments, an audible alarm is sounded only if a positive signal is detected. In some embodiments, different sounds are produced based on a positive or negative result.
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 a timer and visual and/or audio signaling means for prompting a user to operate the common actuating member at correct times during operation of the device, as taught by Dees, to the device of Chen, to allow for monitoring of processing and results, as taught by Dees in [0106].
Regarding Claim 55, Chen teaches the device according to claim 37.
Chen is silent to the device comprises a monitoring means for monitoring operation of the device and providing a warning if incorrect operation is detected.
Dees teaches in the related art of detection of agents. Dees teaches in [0016] This switch can produce a signal to a user and/or computer indicating proper or improper placement. [0046] FIG. 17 shows a flow chart illustrating an exemplary program logic for data query and/or results display. It illustrates a logic path for real-time monitoring of the assay development, and possible immediate notification of results, e.g., positive results.
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 a monitoring means for monitoring operation of the device and providing a warning if incorrect operation is detected, as taught by Dees, to the device, of Chen, to allow for monitoring of assay development, as taught by Dee in [0046].
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Chen (US Pub 2010/0304986; previously cited), in view of Lind (WO 2019/202167).
Regarding Claim 59, Chen teaches the device according to claim 37.
Chen is silent to the lid is mounted on a guide rail for linear movement along an elongate axis of a casing of the device.
Lind teaches in the related art of a sample holder. The platform lid may comprise a guide wheel which is arranged to follow a guide rail which extends from the locked position to the loading position. See page 2, lines 5-6.
The height of the guide rail optionally increases from the locked position to the loading position, such that the platform lid is lifted upwards (by movement of the guide wheel along the guide rail) when moving from the locked position to the loading position. Correspondingly, the platform lid is guided downward (by movement of the guide wheel along the guide rail) when moving from the loading position to the locked position. See page 2, lines 9-13.
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 the lid in the device of Chen, to be mounted on a guide rail for linear movement along an elongate axis of a casing of the device, as taught by Lind, to allow for adding to or removing a sample from the device when the device is moving from one location to another location.
Response to Arguments
Applicant’s arguments, see page 8, filed 6/8/26, with respect to the objection to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant's arguments filed 6/8/26 have been fully considered. Applicant’s arguments regarding page 13, paragraph 3 (lines 4-11 in this paragraph) are persuasive. The examiner notes that the non-final rejection 12/19/25 applied a 103 rejection over claim 41, and the final rejection 4/8/26 applied a 102 rejection over independent amended claim 37 (which included claim 41). Therefore, this Office action corrects this. Further, the examiner notes that the limitation in pending claim 37 “wherein the lid is lockable following the introduction of the liquid sample to the sample receiving chamber” is directed to intended use of the device. The liquid sample is not part of the claimed device. The examiner also notes in applicant’s remarks on page 11, 1st paragraph, line 8, that the applicant refers to “a lockable lid”. However, claim 37 discloses “the lid is lockable following the introduction of the liquid sample”. Applicant may specify “a lockable lid” in an amendment.
Applicant's arguments, see pages 9-10, filed 6/8/26 have been fully considered but they are not persuasive.
Applicant argues on page 10 that present claim 37 requires a lid forming a common actuating member such that the lid itself both closes the device and performs actuation of both the flow control means and the transfer means.
In response, the examiner notes the prior art of Chen teaches [0102] a moveable actuator residing proximate to the component. At least a portion of the actuator is capable of motion relative to the component, and the actuator suitably includes one or more actuator portions capable of actuating at least one fluidic element and also being arranged such that movement of the actuator effects a prescribed sequence of actuations. The actuations may be of the deformable sealing layer, or of one or more fluidic elements, or both. Movement of the actuator is suitably capable of effecting fluid motion within at least a portion of the component. In Claim 28, the one or more actuator portions of the actuator being arranged such that movement of the actuator effects a prescribed sequence of actuations of the deformable sealing layer, of one or more fluidic elements, or both, and movement of the actuator being capable of effecting fluid motion within at least a portion of the component. The examiner notes that “the prescribed actuations of the deformable sealing” would seal (close) the device. Further, the claim does not positively recite the lid closing the device. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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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/JB/
/JOHN MCGUIRK/Examiner, Art Unit 1798
Prosecution Insights