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 .
Status of Claims
Claims 1-12 remain pending in the application.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “wherein there are as many membranes and many protrusions as the number of the specimen delivery holes” on lines 3-4, where it is suggested to amend these lines to recite “wherein there are as many membranes and as many protrusions as the number of the specimen delivery holes” to clarify the claim.
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 1-12 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 “and a protrusion which is located on the lower end of the membrane, and protrudes to a height corresponding to the depth of the specimen delivery hole so as to press the membrane into contact with the blood cell separation module by being inserted into the specimen delivery hole.” on lines 10-13, where with the way the claim is phrased it is unclear what is being inserted into the specimen delivery hole. Is it the protrusion or is it the membrane that is inserted into the specimen delivery hole?
For examination, it will be interpreted that the membrane is put into contact with the blood cell separation by the membrane itself being inserted into the specimen delivery hole.
Claims 2-12 are rejected by virtue of being dependent on a rejected claim.
Claim 5 recites “wherein there are a plurality of specimen delivery holes” on lines 1-2, where it is unclear if the plurality of specimen delivery holes includes the specimen delivery hole described in claim 1, or if they are different.
For examination, it will be interpreted that they include the specimen delivery hole described in claim 1.
It is suggested to amend lines 1-2 to recite “wherein there are a plurality of the specimen delivery holes” or similar.
Line 5 recites “wherein the number of kinds of the colorimetric reaction substances”, where there is insufficient antecedent basis for this limitation.
Claim 1 on lines 7-8 recites “a colorimetric reaction substance”, and thus it is unclear in claim 5 how there are now multiple colorimetric reaction substances.
Claim 7 recites “wherein in the blood cell separation module, the mesh is located, the blood cell separation pad for separating blood cells from a vertical blood flow is located at the lower end of the mesh,” on lines 1-3, where it sounds as though there is a word or phrase missing after “the mesh is located”. It is unclear if it was intended for more detail to be provided or if it is meaning that the mesh is placed first. Based on the phrasing of the rest of the claim and on the instant specification in particular Figure 2, the mesh will be located on the top side of the blood separation pad.
It is suggested to remove the phrasing “the mesh is located”, as the following line describes the relation between the blood cell separation pad and the mesh, and then the blood plasma spreading pad and the blood cell separation pad. Alternatively, additional phrasing could be included to describe where the mesh is located.
Claim 10 recites “further comprising a mesh between the blood separation module and the membrane.” on lines 1-2, where this is unclear because in claim 1 on lines 7-10 it describes where the membrane is put into contact with the blood cell separation module through the specimen delivery hole. If there is now a mesh in between the blood separation module and the membrane, how are they in contact with one another?
For examination, it will be interpreted that the blood separation module and membrane may be indirectly in contact with one another when the mesh is in between them.
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(s) 1, 3, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1).
Regarding claim 1, Quinlan teaches a colorimetric bio sensor comprising:
an upper housing (upper portion 71) including a blood cell separation module (filter 30) which separates blood plasma from blood injected from the outside and spreads the separated blood plasma, and a specimen delivery hole (bottom most opening where the filter 30 is seen in Figure 6) which is located on the lower end of the blood cell separation module (30) and formed to penetrate the upper housing (71), so that the lower end of the blood cell separation module (30) is exposed to the outside ([0029], Figures 5-6); and
a lower housing (lower portion 72) including a membrane (porous substrate 10) containing a colorimetric reaction substance ([0024] see visually detectable support 20, and if the sample contains the visually detectable support 20 as a complex a colored line develops at line 50 as seen in Figure 1, where the porous substrate seen in Figure 1 will be the same as the porous substrate 10 seen in Figure 5) capable of causing a colorimetric reaction with a target substance in the blood plasma by being in contact with the blood cell separation module (30) through the specimen delivery hole (bottom most opening where the filter 30 is seen in Figure 6), and a protrusion (mounting supports 74, including the vertical posts and the horizontal components connecting the vertical posts seen in Figure 5) which is located on the lower end of the membrane (10), and protrudes to a height corresponding to the depth of the specimen delivery hole so as to press the membrane (10) into contact with the blood cell separation module (30) by being inserted into the specimen delivery hole ([0029], Figure 5-6. See in particular Figure 5 where the mounting supports 74, the posts and the horizontal components, will be on the lower end of the porous substrate 10).
It would have been obvious to one skilled in the art to modify the mounting supports 74 such that they are at a height that corresponds to the depth of the bottom most opening where the filter is located (specimen delivery hole) such that they would press the porous substrate 10 up to contact the filter 30, where therefore at least some part of the porous substrate 10 would be through the bottom most opening where the filter is located (specimen delivery hole). Additionally, see [0029] which recites “The filter is housed in the diagnostic device 1 such that it may be provided in intimate contact adjacent to the porous substrate 10 to pre-filter a sample from the container 80.”
The limitation “a blood cell separation module which separates blood plasma from blood injected from the outside and spreads the separated blood plasma” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Quinlan and the apparatus of Quinlan is capable of separating blood plasma from blood injected from the outside and spreading the separated blood plasma. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Quinlan (see MPEP §2114).
See [0007] the filter removes at least some of the colored particles from blood.
Further, please note that the blood has not been positively recited in the claim, and therefore it is not a part of the claimed sensor.
Regarding claim 3, Quinlan further teaches wherein the upper housing (71) further includes a compression member at the upper portion of the specimen delivery hole (see annotated Figure 6 below, showing specifically the connection between the upper and lower portions, where there are two dashed arrows pointing to part of the upper portion 71 that protrudes downward, which are understood to go around the entirety of the upper portion and is a compression member that starts at the bottom most opening where filter 30 is located (specimen delivery hole), where this is the upper portion of the specimen delivery hole. This structure is a compression member because when the upper and lower portions are combined, the structure compresses downwardly on the corresponding surface of the lower portion).
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Regarding claim 9, Quinlan further teaches wherein the upper housing (71) includes a guide part for fixing the blood cell separation module (as seen in Figure 6 the filter 30 is held in a part of upper portion 71, where the bottom most opening is the specimen delivery hole and the top opening and sidewalls are a guide part that fix the filter 30 in the upper portion 71).
Claim(s) 2, 4, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1) in view of Kelly (US-2018/0071741-A1).
Regarding claim 2, Quinlan teaches the colorimetric bio sensor of claim 1. Quinlan does not teach wherein the upper housing includes at least one upper magnet located on the lower end of the upper housing,
wherein the lower housing includes a lower magnet located on the upper end of the lower housing to correspond to the upper magnet, and
wherein the lower housing is coupled with the upper housing by the lower magnet and the upper magnet.
In the analogous art of cassettes that removably hold assay strips, Kelly teaches a cassette that includes a cover and a base where the base has a channel that holds an assay strip (Kelly; abstract).
Specifically, Kelly teaches where the cassette includes a plurality of magnetic elements, where at least one of the magnetic elements is carried by the base and at least one of the magnetic elements is carried by the cover where the magnets retain the cover to the base (Kelly; [0011]). As seen in Figure 2, there are magnetic elements 132a and 132b positioned on base 102 and cover 104 that properly align the cover to the base and ensure correct or acceptable orientations of the cover relative to the base, where the magnets are positioned such that the cover only attaches to the base in select orientations (Kelly; [0035]).
It would have been obvious to one skilled in the art to modify the upper and lower portions of Quinlan such that they include magnets as taught by Kelly because Kelly teaches that the magnets ensure proper orientation of the cover relative to the base (Kelly; [0021], [0035]).
Regarding claim 4, Quinlan teaches the colorimetric bio sensor of claim 3. Quinlan does not teach wherein the compression member and the protrusion include magnets.
In the analogous art of cassettes that removably hold assay strips, Kelly teaches a cassette that includes a cover and a base where the base has a channel that holds an assay strip (Kelly; abstract).
Specifically, Kelly teaches where the cassette includes a plurality of magnetic elements, where at least one of the magnetic elements is carried by the base and at least one of the magnetic elements is carried by the cover where the magnets retain the cover to the base (Kelly; [0011]). As seen in Figure 2, there are magnetic elements 132a and 132b positioned on base 102 and cover 104 that properly align the cover to the base and ensure correct or acceptable orientations of the cover relative to the base, where the magnets are positioned such that the cover only attaches to the base in select orientations (Kelly; [0035]).
It would have been obvious to one skilled in the art to modify the upper and lower portions of Quinlan such that they include magnets as taught by Kelly because Kelly teaches that the magnets ensure proper orientation of the cover relative to the base (Kelly; [0021], [0035]).
One skilled in the art would find it obvious to place magnets on the part of the upper portion that protrudes downward (compression member, see claim 3 supra for more detail) as well as the corresponding magnet on the horizontal portion of the mounting supports (protrusion).
Regarding claim 8, modified Quinlan teaches the colorimetric bio sensor of claim 2. Quinlan further teaches wherein the upper housing (71) and the lower housing (72) are formed such that when being coupled to each other, one end of the upper housing (71) and the other end of the lower housing (72) protrude (Quinlan; see Figure 6 where the upper portion will protrude upwards and the lower portion will protrude downwards).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1) in view of Witchel (WO-2005/116651-A2).
Regarding claim 5, Quinlan teaches the colorimetric bio sensor of claim 1. Quinlan does not teach wherein there are a plurality of specimen delivery holes,
wherein there are as many membranes and many protrusions as the number of the specimen delivery holes, and
wherein the number of kinds of the colorimetric reaction substances corresponds to the number of the specimen delivery holes.
In the analogous art of chromatographic test strips, Witchel teaches where a housing has at least two wells capable of holding a test strip each, such that multiple test strips are run side by side where multiple reaction sites are included to detect multiple analytes of interest (Witchel; [0071], [0084], [0091], [0092]).
Specifically, Witchel teaches a housing 11 that has a center divider 12 that holds a first and second test strip 20 and 21 (Witchel; [00101], [00103], [00104], Figure 3). There is a first gap 34 that receives liquid sample and a second gap that also receives liquid sample that wet respective test strips (Witchel; [00108], [00109], Figure 4A).
It would have been obvious to one skilled in the art to modify the diagnostic device of Quinlan such that the device may hold at least two test strips each with their own respective opening for receiving sample and separated from each other as taught by Witchel because Witchel teaches that multiple analytes of interest are able to be detected when there is more than one test strip in a housing (Witchel; [0091], [0092]).
It is understood that in each section that holds a test strip and is separated from other test strips will have its own respective mounting supports (protrusion), further each opening will similarly hold its own filter.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1) in view of Anaokar (US-2003/0175153-A1).
Regarding claim 6, Quinlan teaches the colorimetric bio sensor of claim 1. While Quinlan does describe where a filter collects solid components enabling the fluid portion to progress to the porous substrate to be tested, such as filtering at least some of the colored particles in blood (Quinlan; [0007]), Quinlan does not teach wherein the blood cell separation module includes at least one mesh, at least one blood cell separation pad, and at least blood plasma spreading pad.
In the same problem solving area of multilayer vertical flow test strips that measure HDL concentration from plasma, Anaokar teaches a test strip that has a two stage blood separation mechanism that separates blood cells so that plasma is free of red blood cells (Anaokar; [0018]).
Specifically, Anaokar teaches where four layers are held by a test strip holder 22, where there is a top layer 36 is a disbursement or spreader mesh layer, then layer 38 separates blood cells from whole blood, layer 40 which traps the remainder of the red blood cells before reaching reaction layer 42 (Anokar; [0064], [0065], [0073]).
It would have been obvious to one skilled in the art to modify the filter held in the upper portion of Quinlan to include a disbursement/spreader mesh layer, followed by two layers that separates blood cells before reaching the porous substrate as taught by Anaokar because Anaokar teaches that these layers provide a more uniform distribution of blood and retain red blood cells (Anaokar; [0064], [0065], [0073]).
Regarding claim 7, modified Quinlan teaches the colorimetric bio sensor of claim 6. The filter held in the upper portion of Quinlan has been modified to have a top layer (disbursement/spreader mesh layer) and then two subsequent layers that separates red blood cells as taught by Anaokar in this order.
The limitations “the blood cell separation pad for separating blood cells from a vertical blood flow” and “the blood plasma spreading pad for secondarily separating blood cells from a horizontal blood flow” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Quinlan and the apparatus of modified Quinlan is capable of separating blood cells from a vertical and horizontal blood flow. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Quinlan (see MPEP §2114).
Further, please note that the blood has not been positively recited in the claim, and is therefore not a part of the claimed colorimetric bio sensor.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1) in view of Feldsine (US-5658747-A).
Regarding claim 10, Quinlan teaches the colorimetric bio sensor of claim 1. As seen in Figure 1 of Quinlan, the porous substrate 10 includes a filter 30 that pre-filters a sample that is a non-woven pre-filter made from a plastics material (Quinlan; [0023]). It is further seen in Figure 2 that there is a filter 30 that extends into receptacle 31 that receives a sample to be tested, where the porous substrate also includes filter 30. Therefore, in the device seen in Figures 5 and 6 there will both be a filter 30 held in the upper portion 71 as well as a filter 30 on the porous substrate. However, Quinlan does not teach that the filter on the porous substrate is a mesh.
In the same problem solving area of lateral flow membranes used for the detection of target microorganisms, Feldsine teaches a lateral flow diagnostic device with a reagent zone (Feldsine; column 4 lines 57-62, column 7 lines 57-60).
Specifically, Feldsine teaches that the reagent zone 4 comprises a porous pad 12, where the porous pad 12 is capable of accepting a significant amount of sample and then filtering and releasing the sample to the lateral flow membrane (Feldsine; column 8 lines 24-29). The porous pad is a loosely woven or non-woven material or mesh and is non absorbent (Feldsine; column 8 lines 29-31).
Examiner finds that the prior art contained a device/method/product (i.e., porous substrate) which differed from the claimed device by the substitution of component(s) (i.e., filter being non-woven material) with other component(s) (i.e., a mesh), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., substituting the non-woven material for the mesh), and the results of the substitution (i.e., filtering) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the non-woven material of reference Quinlan with the mesh of reference Feldsine, since the result would have been predictable.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1) and Kelly (US-2018/0071741-A1), and in further view of Bayloff (US-2007/0244368-A1).
Regarding claim 11, modified Quinlan teaches the colorimetric bio sensor of claim 2. Quinlan does teach a transparent portion 73 in the upper portion 71 so that the result of the test on the porous substrate 10 may be viewed (Quinlan; [0029]), however Quinlan does not teach wherein the lower housing includes a colorimetry check hole which is a through-hole formed in the center of the protrusion, so that the colorimetric reaction of the membrane can be indicated on the lower surface of the lower housing in a state where the lower housing is separated from the upper housing.
In the same problem solving area of housings with windows for observing detection zones, Bayloff teaches where a housing that has a window that allows for a color change to be visible (Bayloff; [0046], [0081]).
Specifically, Bayloff teaches where a diagnostic cap 30 comprises a housing formed of an upper part 50 and a lower part 52, where the lower surface of the upper housing part 50 comprises shallow recesses 59 for receiving test strips 64 of porous carrier materials (Bayloff; [0108], Figures 8-10). As described by [0110] and best seen in Figure 11, the lower housing part 52 comprises apertures for viewing the test strips, in particular window 56 which is disposed above the detection zone of the strip and a control window 58 above the end-of-assay indicator region of the test strip. It is recited by [0110] “It will be appreciated that the windows 56, 58 and optical indicia could alternatively be provided in the upper housing part 50 if viewing from the top of the device is preferred.”
Examiner finds that the prior art contained a device/method/product (i.e., diagnostic device) which differed from the claimed device by the substitution of component(s) (i.e., the transparent portion for viewing the porous substrate being on the upper portion) with other component(s) (i.e., transparent portion for viewing being on the lower portion), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., placement of the transparent portion on the lower portion instead of the upper portion), and the results of the substitution (i.e., viewing the results of the porous substrate) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the position of the transparent portion being on the upper portion of reference Quinlan to instead be placed on the lower portion as taught by Bayloff, since the result would have been predictable.
The transparent portion is understood to be a through-hole that will be in the center of mounting supports, as indicated by the arrow in annotated Figure 5 below. The dashed arrow is pointing to the area of the lower portion that is in the center of two of the mounting supports.
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Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quinlan (US-2007/0031978-A1), Kelly (US-2018/0071741-A1), and Bayloff (US-2007/0244368-A1) and in further view of Hatamian (US-2022/0196560-A1).
Regarding claim 12, modified Quinlan teaches the colorimetric bio sensor of claim 11. Quinlan does teach that the diagnostic device may be used with any immunochromatographic assay, lateral flow test, or strip test (Quinlan; [0039]). However, Quinlan does not teach further comprising a testing strip including a QR code and an RGB correction pad and disposed on the lower surface of the lower housing.
In the analogous art of lateral flow assay devices, Hatamian teaches a lateral flow assay device that includes markers, a color bar and/or greyscale on the housing of the lateral flow assay device as well as a barcode (Hatamian; abstract, [0027]).
Specifically, Hatamian teaches a lateral flow assay device housing 100 that includes a barcode 190, a color bar 155 and/or greyscale strip 145 in order to identify the type of the lateral flow assay devices’s enclosure and to correct the images (e.g. perspective correction and/or color and intensity correction) taken by the camera of a mobile device (Hatamian; [0026], Figure 1A). The barcode 190 may be a two-dimensional barcode such as a QR code (Hatamian; [0027]).
It would have been obvious to one skilled in the art to modify the lower portion of Quinlan to include the QR code and the color bar and greyscale strip as taught by Hatamian because Hatamian teaches that the QR code allows for the type of lateral flow assay device to be identified, types of test to be performed, and other parameters and information related to the test, and to further include the color bar and greyscale strip because they allow for color and intensity correction (Hatamian; [0026], [0027]).
Because the transparent portion for viewing the porous substrate is on the lower portion, the QR code and the color bar and greyscale of Hatamian will be placed on the lower surface of the lower portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796