DETAILED ACTION
Notice of AIA Status
The present application, filed on 5/9/24, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-2 and 4-12 are rejected.
Claims 1-20 are objected to.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Each claimed element in claims 1-20 is not separated by a line indentation. Consider separating individual claim elements by appropriate line indentation, consistent with MPEP 601.01(m), which states “[[w]here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i)”).
Claim 1 recites “A test device for detecting an analyte in a liquid sample, comprising”. For clarity consider rephrasing to ‘A test device for detecting an analyte in a liquid sample, the test device comprising’.
Claim 1 recites “a transparent non-absorbent membrane covers the nitrocellulose membrane to prevents the nitrocellulose membrane from being moistened in advance by the liquid sample in a testing process”. For clarity consider rephrasing to ‘a transparent non-absorbent membrane covers the nitrocellulose membrane and prevents the nitrocellulose membrane from being moistened in advance by the liquid sample during a testing process’.
Claim 4 recites “the end of the non-absorbent membrane”. For clarity consider rephrasing to ‘a first end of the transparent non-absorbent membrane’ or ‘one end of the transparent non-absorbent membrane’.
Claim 1 recites “a lateral flow testing element and claims 4, 7, 9, 14, 17 and 18 each recite instances of “the testing element”. For consistency in claim terminology, consider rephrasing each instance of “the testing element” to ‘the lateral flow testing element’.
Claim 1 recites “a label-containing label pad’ and claims 3, 7, 14, 15, 17, 18, 19 and 20 each recite instances of “the label pad”. For consistency in claim terminology, consider rephrasing “a label-containing label pad”in claim 1 to ‘a label pad containing a label’.
Claim 5 recites “the ne end of the non-absorbent membrane”. For clarity consider rephrasing to ‘the end of the transparent non-absorbent membrane’.
Claim 6 recites “such bonding is made through a self-adhesive covering a filter paper. For clarity consider rephrasing to ‘the one end of the non-absorbent membrane overlapped on the filter paper pad is bonded to the filter paper pad by a bonding made through a self-adhesive covering a filter paper’.
Claim 12 recites “claim11”. For clarity consider rephrasing to ‘claim 11’.
Claim 18 recites “and the time when the liquid from the diversion element directly flows to the label pad is earlier than the time when the liquid from the sample application pad flows to the label pad”. For clarity consider rephrasing ‘such that, in operation, liquid from the diversion element directly reaches the label pad before liquid from the sample application pad reaches to the label pad’.
Claims dependent on objected claim are objected because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 13-20 are 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.
Appropriate correction is required.
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 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mak (EP3561512) in view of Keren (US20080038759).
With respect to claim 1, Mak (EP3561512) teaches a test device (lateral-flow test in [0003]) for detecting an analyte in a liquid sample (see [0007], which recites “the collected fluid is then drawn by capillary action into the conjugation pad 3, which is pre-loaded with biolabels 8 (mainly for visual or optical detection) that are specific for the target analytes 7 in the sample”), comprising
a label-containing label pad (conjugate pad 3 in [0007], which recites “the conjugation pad 3, which is pre-loaded with biolabels 8”), and
a lateral flow testing element (biorecognition molecules 9 in [0007]) having a nitrocellulose membrane (nitrocellulose membrane 4 in [0003]) in a testing area (test zone in [0007]), wherein one end of the label pad (conjugate label 3) is overlapped on the nitrocellulose membrane (nitrocellulose membrane 4) (see Fig. 1).
Mak fails to teach a transparent non-absorbent membrane covers the nitrocellulose membrane to prevents the nitrocellulose membrane from being moistened in advance by the liquid sample in a testing process.
In the analogous art of analytical devices, Keren (US20080038759) teaches a transparent non-absorbent membrane (top laminate 25 in [0022], which recites “back and top laminate 15 and 25 are non-absorbing films”) (see also [0008], which recites “top laminate is transparent”) covers the nitrocellulose membrane (specific membrane 4 in [0022]) (see also [0022], which recites “top laminate 25 is configured to fully cover membrane 4”) (see also [0032], which recites “the reaction membrane (Nitrocellulose…”). With respect to the functional language “prevents the nitrocellulose membrane from being moistened in advance by the liquid sample in a testing process”, under the broadest reasonable interpretation a laminate that physically covers the membrane naturally shields the membrane from unintended contact with a liquid sample in a testing process (see Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Mak by incorporating the transparent non-absorbent membrane (top laminate 25) as disclosed by Keren with a reasonable expectation of success for the benefit of shielding the membrane from unintended liquid contact while permitting visual observation thereof (see Fig. 1 of Keren).
With respect to claim 4, Mak in view of Keren teaches the device according to claim 1. Keren teaches an absorbent pad (absorbent pad 6 in [0022] of Keren) overlapped on the first end of the nitrocellulose membrane (specific membrane 4) (see Fig. 1 of Keren), and the end of the non-absorbent membrane (top laminate 25) is overlapped on a filter paper pad (matrix 2 in [0022], which recites “matrix 2 may be … a filter paper”) (see Fig. 1 of Keren).
With respect to claim 5, Mak in view of Keren teaches the device according to claim 4, wherein the ne end of the non-absorbent membrane overlapped on the filter paper pad is bonded to the filter paper pad (see [0022] of Keren, which recites “for ease of fabrication laminates 15 and 25 are preferably one-side adhesive plastic films protected by a release liner … to complete the assembly laminate 25 is placed on top with its adhesive side downward”) (see Fig. 1 of Keren).
With respect to claim 6, Mak in view of Keren teaches the device according to claim 5, wherein such bonding is made through a self-adhesive covering a filter paper (see [0022] od Keren, which recites “For ease of fabrication laminates 15 and 25 are preferably one-side adhesive plastic films protected by a release liner … to complete the assembly laminate 25 is placed on top with its adhesive side downward”) (see Fig. 1 of Keren).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Mak (EP3561512) in view of Keren (US20080038759) in view of Kato (US20200038854).
With respect to claim 2, Mak in view of Keren teaches the device according to claim 1 including the transparent non-absorbent membrane and the nitrocellulose membrane as previously recited; however, the combination fails to teach the claimed width relationship between the transparent non-absorbent membrane being wider than the nitrocellulose membrane.
In the analogous art of analytical devices, Kato (US20200038854A1)
teaches a non-absorbent membrane (top laminate sheet in [0125], which recites “top laminate sheet (60 mm), which was a PET sheet”) (Polyethylenterephthalate PET sheets are known to be transparent and non-absorbent, as evidenced by PET Clear Data, see pages 1-2) being wider than a nitrocellulose membrane (membrane in [0121], which recites “the membrane (support) (30 mm wide)”) (see also [0040], which recites “the material used for the support include …, nitrocellulose”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Mak in view of Keren by incorporating Kato’s transparent non-absorbent membrane (top laminate PET sheet) and nitrocellulose membrane and the relative widths thereof with a reasonable expectation of success such that the transparent non-absorbent membrane is wider than the nitrocellulose membrane for the benefit of improving detection sensitivity (see [0022] of Kato).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mak (EP3561512) in view of Keren (US20080038759) in view of Wu (US20090232702).
With respect to claim 7, Mak in view of Keren teaches the device according to claim 6.
Mak in view of Keren fails to teach a housing having an upper housing and a lower housing, wherein the testing element is located between the upper housing and the lower housing, one end of the housing is provided with an opening in which a part of a diversion element is located, and a liquid outlet end of the diversion element is in contact with the label pad on the testing element in the housing so that the liquid sample from the diversion element is capable of directly flowing to a label area.
In the analogous art of analytical devices, Wu (US20090232702) teaches
a housing (casing 304 in [0094]) having an upper housing (upper portion of the casing 3043 in [0114]) and
a lower housing (lower portion of the casing 3045 in [0114]), wherein
the testing element (test strip 131 in [0033]) is located between the upper housing (upper portion of the casing 3043) and the lower housing (lower portion of the casing 3045) (see Fig. 8 which illustrates the lateral flow testing element 10-1) (see [0094], which recites “FIG. 8 in detail the casing 304 has a result reading window 3041 which is opposite to the test result zone of test element 10”), one end of the housing (casing 304) is provided with an opening (sample leading port 306-1 in [0114]) in which a part of a diversion element (sample leading port 306-1 in [0033]) is located (see Fig. 8) (see [0111], which recites “sample receiving pad can be made of glass fiber”), and a liquid outlet end (defined by an end of the sample receiving part 111 in Fig. 1A) of the diversion element (sample receiving part 111) is in contact with the label pad (label pad 121) on the testing element (test strip 131) in the housing (casing 304) so that the liquid sample from the diversion element (sample receiving part 11) is capable of directly flowing to a label area (label zone 12 in [0035], which recites “a sample receiving zone 11, label zone 12, test result zone 13 and an absorbent zone 14 that are arranged in the direction of the liquid flow”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test device disclosed by Mak in view of Keren by incorporating the housing as disclosed by Wu with a reasonable expectation of success for the benefit of protecting internal testing components of the device, directing the liquid sample through the testing element and facilitating handling and use of the device.
With respect to claim 8, Mak in view of Keren in view of Wu (US20090232702) teaches the device according to claim 7, wherein
the upper housing (upper portion 3043 of Wu) further comprises
a window (window 3041 in [0104] of Wu (US20090232702)) for observing a testing area (which corresponds a test zone) (see [0003] of Wu (US20090232702), which recites “The test zone 13 can contain a test result zone 132”) (see [0104] of Wu (US20090232702), which recites “If a drug molecule is not present in the sample, a negative test result can be observed through the window 3041 of the casing 304, which can be uncovered or covered by a transparent material”) , and (wherein)
the non-absorbent membrane (top laminate 25 of Keren) is located between the window and a window area (see [0007] of Keren, which recites “the nitrocellulose membrane 4, which includes a test zone”) (in the proposed combination of Mak in view of Keren in view of Wu (US20090232702), the transparent non-absorbent membrane (top laminate 25 of Keren) would be located between the window (window 3041 of Wu) and a window area (testing zone) because the transparent non-absorbent membrane (top laminate 25 of Keren) overlies the nitrocellulose membrane 4 of Keren while the observation window 3041 of Wu overlies the testing membrane of Wu) (in other words, in the proposed combination, Wu teaches a housing with an observation window; Karen teaches a transparent non-absorbent membrane over the testing membrane; and combination of teachings relied upon in the rejection of claim 7 places Keren’s testing element inside Wu’s housing. Accordingly, with the device assembled, the transparent non-absorbent membrane lies between the observation window and the window area corresponding to the test zone).
Claims 9-10 is rejected under 35 U.S.C. 103 as being unpatentable over Mak (EP3561512) in view of Keren (US20080038759) in view of Wu (US20090232702) in view of Wu (US20240189812).
With respect to claim 9, Mak in view of Keren in view of Wu (US20090232702) teaches the device according to claim 8.
Mak in view of Keren in view of Wu (US20090232702) fails to teach the testing element is located in a groove of the lower housing, and the upper housing comprises a liquid retention chamber configured to receive a part of liquid sample from a surface of the diversion element.
In the analogous art of analytical devices, Wu (US20240189812) teaches
a (lateral flow) testing element (testing element 108 in [0090]) located in a groove (groove structure 1014) of a lower housing (bottom plate 101 in [0090], which recites “the bottom plate 101 is provided with a structure for placing the testing element, such as a groove structure 1014 for placing a test strip 108, so that the test strip 108 can be placed on the groove structure”), and
an upper housing (cover plate 102 in [0090]) comprising a liquid retention chamber (chamber in [0090], which recites “the testing element is located in a chamber formed by the bottom plate and the cover plate, or located between the bottom plate and the cover plate”) configured to receive a part of liquid sample from a surface of a diversion element (diversion element in [0090], which recites “the diversion element is an element used for allowing a treatment liquid to flow on to the testing element 108”) (in operation, when the diversion element delivers a liquid sample onto the testing element located within the chamber, the chamber receives at least a portion of the liquid sample because the diversion element discharges the liquid into the chamber containing the testing element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed Mak in view of Keren in view of Wu (US20090232702) by incorporating the groove disclosed by Wu (US20240189812) with a reasonable expectation of success for the benefit of securely positioning the lateral flow element within the housing and ensuring consistent capillary contact for reliable liquid transfer.
With respect to claim 10, Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) teaches the device according to claim 9, wherein
the liquid retention chamber has an opening, the diversion element has an upper surface for receiving the liquid sample, and the opening is covered by an upper surface of the part of the diversion element. Wu (US20240189812) teaches that the liquid retention chamber (chamber of Wu) has an opening (which corresponds to the opening at the limit of the upper side of the chamber and a lower side of an adjacent chamber on the cover plate 102), the diversion element (diversion element 1084) has an upper surface (see the upper surface of diversion element 1084 in Fig. 5.1 of Wu) for receiving the liquid sample (in operation, the upper surface of the diversion element receives a liquid sample), and the opening is covered by an upper surface of the part of the diversion element (diversion element 1084) (see Fig. 3 of Wu, which illustrates the diversion element 1084 overlying the chamber opening such that the upper surface covers the opening while permitting liquid to pass through the diversion element and into the chamber).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mak (EP3561512) in view of Keren (US20080038759) in view of Wu (US20090232702) in view of Kim (US20150251177).
With respect to claim 11, Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) teaches the device according to claim 10.
Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) fails to teach the liquid retention chamber is composed of compartment chambers formed by protruding plastic press strips set on an inner surface of the housing, and a surface of the press strip is in contact with the upper surface of the diversion element.
In the analogous art of providing analytical devices, Kim (US20150251177) teaches a liquid retention chamber (which corresponds to the sample well 12 in [0070] extending to the measurement window 34 in [0067], see Fig. 11A) composed of compartment chambers formed by protruding plastic press strips (first guide 36 a, second guide 36 b and third guide 36 d and fourth guide 36 d) (see [0022], which recites “the guides take the form of a dam or a protrusion”) set on an inner surface of the housing (housing cover 30) (see[0078], which recites “the present cartridge may be made by fabrication methods known in the art using a variety of thermoplastic or thermosetting plastics”) (see [0020], which recites “at least one guide formed at a position inside or underneath of the cover member facing the strip”, the cover is a part of the housing), and a surface of the press strip strips (first guide 36 a, second guide 36 b and third guide 36 d and fourth guide 36 d) is in contact with an upper surface of a diversion element (sub pad 21 in [0045], see Fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) by incorporating the plastic protruding press strips disclosed by Kim with a reasonable expectation of success for the benefit of effectively preventing movement of the strip (see [0067] of Kim, which recites “guide to accommodate plurality of strips and to hold the strip in place preventing the movement of the strip”).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mak (EP3561512) in view of Keren (US20080038759) in view of Wu (US20090232702) in view of Wan (US20100009430).
With respect to claim 12, Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) in view of Kim teaches the device according to claim11.
Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) in view of Kim fails to teach that the liquid retention chamber comprises one or more non-capillary grooves or non-capillary chambers.
In the analogous art of analytical devices, Wan (US20100009430) teaches one or more non-capillary chambers (non-capillary adjacent lateral space in [0018], which recites “a fluid flowing from the first chamber flows along the flow path, but surface tension of the fluid does not allow the fluid to flow laterally out from the flow path … the fluid flow path is configured so that the fluid flows along the path by capillarity but a contact angle of the fluid at a lateral edge of the path prevents the fluid from flowing laterally from the flow path. The increased contact angle at the lateral edge of the flow path can result from an enlarged, non-capillary adjacent lateral space”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) in view of Kim by incorporating the one or more non-capillary chambers disclosed by Wan with a reasonable expectation of success for the benefit of effectively improving fluid flow control by preventing fluid from laterally flowing away from the capillary flow path direction while maintaining capillary flow through the intended capillary flow.
Allowable Subject Matter
Claims 3 and 13-20 are 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.
With respect to claim 3, Mak in view of Keren fails to teach or suggest one end of the non-absorbent membrane is bonded to a first end of the nitrocellulose membrane, and the other end of the non-absorbent membrane movably covers a second end of the non-absorbent membrane, wherein the second end of the non-absorbent membrane is overlapped with the label pad.
With respect to claim 13, Mak in view of Keren in view of Wu (US20090232702) in view of Wu (US20240189812) in view of Kim in view of Wan fails to teach or suggest a blocking element for blocking liquid at an end portion of the liquid outlet end of the diversion element from flowing to the label area, wherein the blocking element is disposed in the housing, and the end portion of the liquid outlet end of the diversion element is in contact with the blocking element.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
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