DETAILED ACTION
Applicant’s amendments to the claims filed September 16, 2025 were received. Claims 2, 3, and 5 were amended.
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 Status
Claims 1-9 are pending and are examined.
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 1-9 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 1 recites the terms “large” and “small” in the expressions “large end” and “small end”. The terms “large” and “small” in claim 1 are relative terms which render the claim indefinite. The terms “large” and “small” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. If applicant intends to convey that a first end of the tube is larger (or smaller) than a second end of the tube, then it needs to be explicitly recited in the claim for clarity.
Regarding Claim 2, the limitation in line 3, “the compressible chamber” lacks antecedent basis since claim 1 previously states “a depressible chamber”.
Additionally, is applicant interchanging the claim terms “compressible” with “depressible”? Applicant argues on page 4 in remarks in the section under rejection under 112b that “amended claim 2 specifies that the buffer well is in fluid communication with the compressible chamber.” However, claim 2 states in the claims filed 9/16/25, “a buffer well in fluid communication with the depressible chamber”.
Which chamber should the buffer well be in communication with? Additionally, claim 2 states “compressible chamber”, yet claim 1 only recites a “depressible chamber”. How many chambers are there? Please clarify how many chambers there are and which of these chambers communicates with the buffer well.
The examiner notes the specification mentions three chambers: 1) “depressible chamber”; 2) “depressible air chamber”; and 3) “compressible chamber”. Are 1) and 2) different or the same and should that be specified in the claims? The “compressible chamber” is listed as ref. no. “206” in applicant’s drawings, however no “depressible chamber” is shown in the drawings.
Dependent claims are rejected by virtue of being dependent on a rejected base claim.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Collavati (US Pub 2020/0345286) in view of Lauks (US Patent 5,096,669).
Regarding Claim 1, Collavati teaches an assay device comprising: a lateral flow assay test strip; a capillary tube comprising a large end, a center portion, and a small end; a sample collection port in fluid communication with the small end of the capillary tube; a buffer well in fluid communication with the large end of the capillary tube and with the lateral flow assay test strip; a depressible chamber in fluid communication with the center portion of the capillary tube, wherein the depressible chamber is adapted to move a sample in the capillary tube into the buffer well ([0064] FIG. 1 shows a deconstructed view of the rapid diagnostic test cassette device of the invention, all of its components being represented, namely: a lower cassette (1), test strip (2), a first absorbent pad (3), a second absorbent pad (4), a buffer solution containing capsule (5), a spear-shaped structure (6) an upper cassette (7), a capillary-tube-shaped structure (8), a movable cover (9), a region that receives the blood sample (10) and an upper cross bar (11).).
Collavati is silent to a depressible chamber in fluid communication with the center portion of the capillary tube, wherein the depressible chamber is adapted to move a sample in the capillary tube into the buffer well.
Lauks teaches in the related art of a sensor for samples. In the Abstract, Next an air bladder located in the device is depressed, forcing the sample across the sensors where measurements are performed and read by the reader which performs the calibrations. A third conduit 228 (FIG. 2) leads from the capillary break 222 past the sensing arrays 66 to a second cavity 20 which serves as a sink. The first conduit enters the third conduit between the capillary break and the sensing arrays. A third cavity 22 serves as an air bladder 229. When the air bladder 229 is depressed, air is forced down a fourth conduit 234 into the second conduit 224. Col. 4, lines 45-47.
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 depressible chamber in fluid communication with the center portion of the capillary tube, wherein the depressible chamber is adapted to move a sample in the capillary tube into the buffer well, as taught by Lauks, to the device of Collavati, for forcing a sample across sensors where measurements are made, as taught by Lauks, in the Abstract.
Claims 2, 3, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Collavati (US Pub 2020/0345286) in view of Lauks (US Patent 5,096,669) as applied to claim 1 above, and further in view of Cho (WO 2011/102563).
Regarding Claims 2, 3, 4, and 5, modified Collavati teaches the assay device of claim 1.
Modified Collavati is silent to a housing comprising a signal window through which is visible at least a portion of the capillary tube; a transfer button coupled to the compressible chamber; a buffer well in fluid communication with the buffer well; and a test results viewing window through which is visible at least a portion of the lateral flow test strip, depressing the depressible chamber moves a metered sample in the capillary tube into the buffer well, the depressible chamber in an expanded state comprises air and the depressible chamber in a depressed state displaces air into the capillary tube to move the sample to the buffer well, and providing a buffer into the buffer well provides a buffer in the buffer well, said buffer in the buffer well mixes with the sample to provide a buffered sample, and said buffered sample contacts the lateral flow assay test strip to initiate a lateral flow assay.
Cho teaches in the related art of an immunoassay device. Fig. 2 result confirmation window. The test strip would be visible through the window. The chamber 72 is pressurized to apply the pretreated sample (sample, liquid buffer and detector mixture) to the nozzle. It may have elasticity to discharge through 76. The diaphragm 74 may seal the chamber 72 to prevent leakage of the liquid buffer, evaporation, and the like, and may be made of a material that is torn and opened by the protrusion 64. For example, it may be made of aluminum foil, plastic, rubber, or the like (See paragraph 11 under BEST MODE section). Fig. 2 Using the immunoassay device according to the present invention, in order to detect analytes in a sample, the sample must be mixed with the liquid buffer and the detector and then introduced into the sample reservoir 52. (See paragraph 9 under BEST MODE section). The chamber 72 is a cylindrical space in which the liquid buffer is accommodated, and the liquid buffer, the sample and the detector can be mixed. The chamber 72 is pressurized to apply the pretreated sample (sample, liquid buffer and detector mixture) to the nozzle. (See paragraph 11 under BEST MODE section).
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 a housing comprising a signal window through which is visible at least a portion of the capillary tube; a transfer button coupled to the compressible chamber; a buffer well in fluid communication with the buffer well; and a test results viewing window through which is visible at least a portion of the lateral flow test strip, depressing the depressible chamber moves a metered sample in the capillary tube into the buffer well, the depressible chamber in an expanded state comprises air and the depressible chamber in a depressed state displaces air into the capillary tube to move the sample to the buffer well, and providing a buffer into the buffer well provides a buffer in the buffer well, said buffer in the buffer well mixes with the sample to provide a buffered sample, and said buffered sample contacts the lateral flow assay test strip to initiate a lateral flow assay, as taught by Cho, to the device of modified Collavati, to allow for using a single membrane strip, which can improve the accuracy of sample analysis by maintaining a constant amount of absorption and antigen-antibody reaction time of the sample, as taught by Cho, in paragraph 2.
Claims 6, 7, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Collavati (US Pub 2020/0345286) in view of Lauks (US Patent 5,096,669) as applied to claim 1 above, and further in view of Bunce (US Pub 2012/0220049).
Regarding Claims 6, 7, 8, and 9, modified Collavati teaches the assay device of claim 1, wherein the lateral flow assay test strip comprises a labeled recombinant antigen ([0046] In an embodiment of the invention, one or more antigens present in the test strip are complementary to one or more antibodies present in the capillary blood sample.).
Modified Collavati is silent an anti-human antibody, the anti-human antibody is immobilized on the lateral flow test strip, the lateral flow assay test strip comprises a first antibody and a second antibody, and the first antibody is immobilized on the lateral flow test strip and the second antibody comprises a label.
Bunce teaches in the related art of detecting the presence of an analyte. See Abstract. See Claim 26. (i) a detection zone comprising an immobilised a first antibody configured to bind to complexes formed between the analyte and the conjugated detection means to produce a detection signal, and (ii) a control zone within which is immobilised a second antibody, which provides a control signal when contained within the control zone. See Claim 26. [0021] Biological fluids containing relevant antibodies flow along the device and are contacted by antigen ligand conjugated to coloured, fluorescent and/or gold micro particles. Detection of analyte-bound antibody occurs at the test line whereby the same or similar antigen is immobilised: the antibody-antigen-particle aggregate is immobilised by binding of the antibody to the antigen at both locations (bead and strip) and the positive test is indicated by the visual presence of the coloured beads. [0100] The bead-antibody complex then comes into contact and binds with anti-human antibody either in a separate buffer or in the conjugation pad.
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 an anti-human antibody, the anti-human antibody is immobilized on the lateral flow test strip, the lateral flow assay test strip comprises a first antibody and a second antibody, and the first antibody is immobilized on the lateral flow test strip and the second antibody comprises a label, as taught by Bunce, to the device of modified Collavati, to allow for specific detection of an analyte, as taught by Bunce, in [0001].
Response to Arguments
Applicant’s arguments, see page 4, filed 9/16/25, with respect to the claim objection have been fully considered and are persuasive. The claim objection has been withdrawn.
Applicant’s arguments, see page 4, filed 9/16/25, with respect to the 112b rejections have been fully considered and are persuasive. The 112b rejections has been withdrawn.
The examiner notes a new 112b rejection is applied in light of the amendment.
Applicant’s arguments with respect to the 102 and 103 rejections have been considered and a new reference is applied in light of Applicant’s remarks regarding the limitation “a depressible chamber”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 8-6.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798