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
Applicant’s election without traverse of Group II: Claims 284-294 in the reply filed on 20 July 2026 is acknowledged.
Claims 272-283 of Group I are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 07/20/2026.
Claim Objections
Claims 272-283 are objected to because of the following informalities: The claim status designators should be changed from “Previously Presented” to “Withdrawn” in view of the election of Claims 284-294 discussed above.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 284-294 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 284 recites the limitation "the microfluidic network". There is insufficient antecedent basis for this limitation in the claim. Applicant is suggested to amend the claim to recite “the microfluidic channel network”.
Claim 284 recites the limitation "the fully compressed state". There is insufficient antecedent basis for this limitation in the claim. Applicant is suggested to amend the claim to recite “a fully compressed state”.
Claim 284 recites the limitation "the step of decompressing the wall of the gas bladder". There is insufficient antecedent basis for this limitation in the claim. Applicant is suggested to amend the claim to recite “Claims 285, 289-290, and 293 wherein “the step of” is provided without first designating the processes thereto as “a step of”. Applicant is suggested to remove the “the step of” designator for clarity.
Claim 284 recites the limitation "the presence of the liquid sample". There is insufficient antecedent basis for this limitation in the claim. Applicant is suggested to amend the claim to recite “a presence of the liquid sample”. See also the same issue in Claim 293.
Claim 284 recites “applying a liquid sample to an application zone” in line 17. However, the application zone was introduced previously to this instance in line 4. It appears Applicant does not intend to provide an additional application zone; therefore, it is suggested Applicant amend line 17 to recite “the application zone”.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 284-294 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keatch et al. (WO 2018/002668 A1), hereinafter “Keatch”, in view of Marchant (US PAT 5,225,643 A), hereinafter “Marchant”.
Regarding Claim 1, Keatch teaches a method of operating a microfluidic device ([0001]: “methods of conducting assays”), comprising:
placing the microfluidic device 1 in an operative position with respect to a diagnostic reader 100 ([0250]: “In use, the cartridge (1) is inserted into a reader (100) as shown in FIG. 3.”),
the microfluidic device 1 comprising:
(a) a microfluidic channel network (Fig. 1 and [0253]: “The sample fills the channels (4, 5, and 7)”), the microfluidic network comprising an application zone 3 (Fig. 1 and [0253]: “A sample is contacted with and introduced into the cartridge (1) by way of the input port (3). The sample fills the channels (4, 5, and 7) by capillary action...”), a microchannel 4 configured to receive a liquid applied to the application zone ([0248]: “upon application of a sample to the cartridge by a capillary application, the sample fills the channel (4)”), and a gas bladder 10 in gaseous communication with the microchannel 4 (Fig. 1 and [0247]: “The cartridge (1) comprises a liquid sample input port (3) connected to a microfluidic channel (4) which splits into a plurality of separate channels (5 and 7). Each channel (5) extends within the cartridge (1) and is fluidly connected to gas filled chambers (10).”), and
(b) (i) a first electrical contact disposed on the microfluidic device 1 outside of the microfluidic channel network ( [0252]: “Correct insertion of the cartridge (1) is detected by electrodes which are present on the cartridge with corresponding contacts which are present in the reader.”) and in electrical communication with a first lead portion disposed within or adjacent the gas bladder ( [0059]: “Electrodes may also be provided to the gas filled chamber in order to signal the degree of compression of each/said chamber.”.) and a first liquid sensing electrode disposed to contact liquid within the microchannel at a first location, a second liquid sensing electrode disposed to contact liquid within the microchannel at a second location spaced apart from the first location ([0051]: “the position of fluid within each channel can optionally be detected by the reader by means, such as electrodes, positioned along the microfluidic channels”), and
compressing a wall of the gas bladder 10 until the gas bladder 10 is in the fully compressed state ([0053]: “Initial maximum compression of the/said gas filled chamber, prior to liquid sample application, ensures that it is not possible to push the sample beyond the sample input port.”),
applying a liquid sample to an application zone 3 of the microfluidic channel network ([0253]: “A sample is contacted with and introduced into the cartridge (1) by way of the input port (3).”); decompressing the wall of the gas bladder 10 thereby moving the liquid sample within the microfluidic channel network ([0022]: “...decompressing said chamber causes gas to be expelled from or drawn into the chamber, which in turn causes movement of the liquid sample within said/each microfluidic channel.”); and
after the step of decompressing the wall of the gas bladder 10, sensing the presence of the liquid sample at the first liquid sensing electrode by detecting a first electrical signal at the first electrical contact and sensing the presence of the liquid sample at the second liquid sensing location by detecting a second electrical signal at the second electrical contact ([0051]: “...the position of fluid within each channel can optionally be detected by the reader by means, such as electrodes, positioned along the microfluidic channels that are in contact with the reader and can feedback the position of any liquid and/or fluid in each/said microfluidic channel thereby permitting the reader to very carefully determine the position and/or rate of fluid movement through application of force/pressure to the gas/air filled chamber.”),
as in Claim 284.
Further regarding Claim 284, Keatch does not specifically teach the method above further comprising (ii) a second electrical contact disposed on the microfluidic device outside of the microfluidic channel network and in electrical communication with a second lead portion disposed within or adjacent the gas bladder and, wherein the first and second electrical contacts are in electrical communication with one another when the gas bladder is in a fully compressed state, as in Claim 284.
However, Marchant teaches a fluidic device where a sealed gas chamber 12 is bound by two electrically conductive flexible diaphragms 14/16 (See Fig. 2.) comprising opposing contact portions acting as separate electrical leads (See also the lead wires 28 and 30 seen in Fig. 2 such that when the chamber 12 is internally pressurized, the diaphragms 14/16 bow apart and the circuit is open (Fig. 7), and when outside pressure compresses the chamber 12, the diaphragms 14/16 bow inward toward one another such that the opposing lead portions touch and establish electrical connection (Fig. 6) (col. 5, lines 35-40: “When the diaphragms 14 and 16 are pressurized internally, as herein disclosed, with low pressure on the outside, that is externally thereof, the diaphragms 14 and 16 do not make electrical contact. When the diaphragms 14 and 16 are pressurized externally, electrical contact between them is made.”). Therein, this arrangement provides the benefit of ensuring a known pressure is achieved, alerting operators if a desired pressure falls out of the desired range and alleviating errors due to improper pressure within a system (col. 3, lines 19-42).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Keatch further comprising (ii) a second electrical contact disposed on the microfluidic device outside of the microfluidic channel network and in electrical communication with a second lead portion disposed within or adjacent the gas bladder and a second liquid sensing electrode disposed to contact liquid within the microchannel at a second location spaced apart from the first location, wherein the first and second electrical contacts are in electrical communication with one another when the gas bladder is in a fully compressed state, such as suggested by Marchant, so as to provide a mechanism for confirming the compressed/decompressed state of the gas bladder in Ketach, thereby alleviating errors due to improper pressure control.
Keatch provides that electrodes may be provided to the gas bladder to monitor the compression ([0059]), thus the implementation of Marchant in Ketach has a reasonable expectation of success, and one of ordinary skill in the art would have been motivated to seek a particular mechanism for providing such monitoring as in Keatch.
Regarding Claim 285, the prior art meets the limitations of Claim 284 as discussed above. Further, Keatch teaches the method discussed above wherein the step of decompressing the wall of the gas bladder is performed after the step of applying the liquid sample to the application zone ([0108]), as in Claim 285.
Regarding Claim 286, the prior art meets the limitations of Claim 284 as discussed above. Further, Keatch teaches the method discussed above wherein the microfluidic device comprises a supply electrode disposed to contact liquid sample within the microfluidic channel network at a third location spaced apart from the first and second locations and further wherein the first and second electrical signals each comprise an electrical signal emitted by the supply electrode (Given that electrical detection in the case of Keatch detecting a liquid presence is achieved by an electrode arrangement, the device must necessarily supply a current to the first/second liquid sensing electrodes (through the liquid by contacting with the liquid) so as to provide a circuit to be completed or interrupted when liquid flows therethrough. As such, Keatch must necessarily comprise a supply electrode so as to enable the detection of fluid within the channel by electrode means as in Keatch so as to supply the first/second electrical signals.), as in Claim 286.
Regarding Claims 287 and 288, the prior art meets the limitations of Claim 284 as discussed above. Further, Keatch does not specifically teach the method discussed above wherein the first and second lead portions define a plurality of interposed first and second lead portions, nor wherein the lead portions of the first and second interposed lead portions are spaced apart from one another along a longitudinal axis of the gas bladder, as in Claims 287 and 288 respectively.
However, as discussed above regarding Claim 284, one of ordinary skill in the art would find it obvious to modify the microfluidic device of the method of Keatch such that the gas bladder 10 comprises opposing electrical leads to confirm pressurization or depressurization of said gas bladder 10, such as suggested by Marchant. Therein, one of ordinary skill in the art would find it obvious to provide additional replicates of the lead portions to the gas bladder so as to further ensure the electrical contact is valid through redundancy -- mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Further, interposing the leads spaced apart from one another along a longitudinal axis of the gas bladder is a mere matter of design choice -- mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Whether the electrical leads are longitudinally interposed as claimed or arranged in some other configuration does not affect their fundamental function of contacting and separating upon deflation and inflation of the gas bladder respectively, absent evidence of an unexpected result or criticality associated therewith.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Keatch wherein the first and second lead portions define a plurality of interposed first and second lead portions, and wherein the lead portions of the first and second interposed lead portions are spaced apart from one another along a longitudinal axis of the gas bladder, such as suggested by Marchant and as would be ordinary matters of design choice to one of ordinary skill in the art, so as to increase the redundancy of gas bladder inflation measurement so as to reduce errors related to false electrode reading, and so as to cover a greater surface area of the gas bladder to ensure electrical contact is achieved.
Further, it appears Applicant may intend these recitations to mean the electrical leads as having a comb-like shape with short branches extending from a backbone, such as seen through Applicant’s instant drawings fig 13b showing the short branches 648a’ of the electrical lead. To this end, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). The seemingly intended branching electrical leads would not perform differently from non-branching leads as both serve the identical fundamental purpose of contacting and forming a circuit.
Regarding Claim 289, the prior art meets the limitations of Claim 288 as discussed above. Further, Keatch teaches the method discussed above wherein the wall of the gas bladder 10 is a first wall and the gas bladder 10 comprises a second wall opposing the first wall (The walls being formed by the upper and lower layers of the laminated device – see para. [0022]: “the system is formed from three layers, which are sandwiched together to define each/said microfluidic channel(s) and said gas filled chamber”), as in Claim 289.
Further as in Claim 289, Keatch does not specifically teach the method discussed above wherein the first and second lead portions are each disposed on an interior surface of one of the first and second walls of the gas bladder, an interior of the other of the first and second walls of the gas bladder comprises an electrically conductive bridging member, and the step of compressing the first wall of the gas bladder comprises bringing the bridging member and the first and second lead portions into electrical communication with one another, as in Claim 289.
However, as discussed above regarding Claim 284, one of ordinary skill in the art would find it obvious to modify the microfluidic device of the method of Keatch such that the gas bladder 10 comprises opposing electrical leads to confirm pressurization or depressurization of said gas bladder 10, such as suggested by Marchant. Therein Marchant, the first and second lead portions 14/16 are each disposed on an interior surface of one of the first and second walls of the chamber 12 (Fig. 2), an interior of the other of the first and second walls of the gas bladder comprises an electrically conductive bridging member 18a/20a (Fig. 5), and the step of compressing the first wall of the gas bladder comprises bringing the bridging member and the first and second lead portions into electrical communication with one another (col. 4, lines 32-37: “Optionally, electrically conductive beads 18a and 20a may be provided at the center of the central region of the diaphragms 14 and 16, respectively...” – See also col. 4, lines 10-13.). Therein, this arrangement assists in ensuring an electrical contact is achieved by providing protruding electrode members oriented toward one another, thereby reducing errors due to insufficient electrical contact.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the method of Keatch wherein the first and second lead portions are each disposed on an interior surface of one of the first and second walls of the gas bladder, an interior of the other of the first and second walls of the gas bladder comprises an electrically conductive bridging member, and the step of compressing the first wall of the gas bladder comprises bringing the bridging member and the first and second lead portions into electrical communication with one another, such as suggested by Marchant, so as to assist in ensuring an electrical contact is achieved by providing protruding electrode members oriented toward one another, thereby reducing errors due to insufficient electrical contact.
Regarding Claim 290, the prior art meets the limitations of Claim 289 as discussed above. Further, as discussed above regarding Claims 287 and 288, one of ordinary skill in the art would find it an obvious matter of design choice to provide additional interpolating, or comb-shaped interpolating, electrodes. Therein, as the gas bladder of Marchant provides a step wherein compressing the chamber 12 brings the bridging member into communication with the first and second electrical leads, one would similarly expect such contact to be achieved in interpolated leads as discussed.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the method of Keatch wherein the step of compressing the first wall of the gas bladder comprises bringing the bridging member into electrical communication with each of a plurality of the first and second interposed lead portions, such as suggested by Marchant, as an obvious similar arrangement of Marchant achieving the identical fundamental function of providing a completed circuit for detection.
Regarding Claim 291, the prior art meets the limitations of Claim 284 as discussed above. Further, Keatch teaches the method discussed above wherein the method comprises performing a diagnostic assay to detect a target present in the liquid sample ([0032]: “The cartridge design of the present invention may easily be adapted to carry out a number of different assays and hence can be considered as an assay platform for a variety of similar and/or different assays.”), as in Claim 291.
Regarding Claim 292, the prior art meets the limitations of Claim 291 as discussed above. Further, Keatch teaches the method discussed above wherein performing the diagnostic assay comprises contacting the liquid sample with a reagent disposed in the microchannel ([0022]: “a sample input port for receiving the liquid sample, the sample input port connected to at least one microfluidic channel, wherein each/said microfluidic channel(s) comprises one or more reagents deposited therein for use in conducting the assay...” – See also para. [0248].), as in Claim 292.
Regarding Claim 293, the prior art meets the limitations of Claim 292 as discussed above. Further, Keatch teaches the method discussed above wherein the step of contacting the liquid sample with the reagent is performed after sensing the presence of the liquid sample at the first liquid sensing electrode ([0321]: “Summary Test Sequence: ...3. Sample application to the cartridge, filling by capillary action or by reader controlled filling. 4. Wetting of the cartridge fill detect electrodes determines the test start timing 5. The sample rehydrates the dried reagents...”) and prior to sensing the presence of the liquid sample at the second liquid sensing location (Fig. 1, [0248]: “Located distal/proximal to zones (28, 30) is a detection zone (32) where label/analyte/magnetic particle complexes can be detected.”, [0059]: “The electrode(s) may also be used to confirm that the removal of the sample from the detection area...”. By this, the recitation of para. [0248] and Fig. 1 show the detection area 32 as being downstream the electrodes positioned on the channel 4, and the recitation of para. [0059] indicates there is an electrode in the detection area 32. As the reagent zones 28 and 30 are upstream the detection area 32, the step of contacting the liquid sample with the reagent is thereby performed prior to sensing the presence of the liquid sample at the second liquid sensing location, where the second sensing location is the detection area 32.), as in Claim 293.
Regarding Claim 294, the prior art meets the limitations of Claim 292 as discussed above. Further, Keatch teaches the method discussed above wherein the reagent is selected from the group consisting of a lysing reagent for lysing a cell, a buffering reagent ([0298]), a detectably labeled reagent ([0072-0073]), a reagent configured to specifically bind the target ([0067]: “the present system may be adapted to detect any type of analyte that can bind a suitable binding agent”), a magnetically labeled reagent ([0098]: “the binding agent is bound to the surface of magnetic agents, such as magnetic beads”), OR a combination thereof (As Applicant has provided an alternative/“or”-type listing (A or B or C), only one of the alternatives need be identified by the prior art.), as in Claim 294.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (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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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
