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 .
Response to Amendment
Applicant amendments filed 01/08/2026 have been entered. Applicant amendments overcomes the previous claim objections and 112(b) rejections set forth in the Office Action mailed 09/10/2025, the previous claim objections and 112(b) rejections are withdrawn.
Status of Claims
Claims 1-20 remain pending in the application.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0011] recites “The test strip has a leukocytes and nitrite test pad” where it is believed that “nitrite” should instead be “nitrate” as this is the only occurrence where “nitrite” appears. All other paragraphs describe “nitrate”
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 1-20 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 “a user.” on line 16, where it is unclear if the user is the same or different from the wearer described on line 8.
For examination, it will be interpreted that they are the same.
Claims 2-10 are rejected by virtue of being dependent on a rejected claim.
Claim 8 recites “in a sample.” on line 2, where it is unclear if a sample in claim 8 is the same or different from the drops of urine described on line 9 of claim 1.
For examination it will be interpreted that they are the same.
It is suggested to amend claim 8 to recite “in the urine
Claim 11 recites “a user” on line 19, where it is unclear if the user is the same or different from the wearer described on line 8.
For examination, it will be interpreted that they are the same.
Claims 12-18 are rejected by virtue of being dependent on a rejected claim.
Claim 16 recites ““in a sample.” on line 2, where it is unclear if a sample in claim 16 is the same or different from the drops of urine described on line 9 of claim 11.
For examination it will be interpreted that they are the same.
It is suggested to amend claim 16 to recite “in the urine
Claim 19 recites “a user.” on line 20, where it is unclear if the user is the same or different from the wearer described on line 8.
For examination, it will be interpreted that they are the same.
Claim 20 is rejected by virtue of being dependent on a rejected claim.
Claim 20 recites “in a sample.” on line 2, where it is unclear if a sample in claim 20 is the same or different from the drops of urine described on line 9 of claim 19.
For examination it will be interpreted that they are the same.
It is suggested to amend claim 20 to recite “in the urine
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (US-2015/0025347-A1) in view of Kobayashi (US-2016/0274100-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Regarding claim 1, Song teaches a urinary tract infection (UTI) detection device (lateral flow assay detection device 10) for detecting a possibility of a UTI, the UTI detection device (10) comprising ([0022], Figure 1):
an indicator strip (chromatographic material 14) on a first surface ([0022], Figure 1); and
an adhesive (adhesive layer 24) on an opposing second surface ([0068], Figures 1, 2);
wherein said adhesive (24) releasably adheres said UTI detection (10) device to an inner surface of an undergarment ([0068] see when the user is preparing to adhere device 10 to the absorbent article);
wherein said UTI detection device (10) is a liner positioned between the undergarment and a wearer of the undergarment ([0005] see lateral flow device attached to bodyside liner of the absorbent article, [0051] describes other absorbent articles including absorbent underpants, [0054] see bodyside liner 102 employed to help isolate the wearer’s skin from liquids held in the absorbent core, Figure 4);
wherein said indicator strip (14) having a detection portion (detection zone 20) for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes ([0028], [0034], [0048], Figure 1);
wherein said detecting the presence of at least one of leukocytes above a first threshold value indicates a possible UTI and above a second threshold value indicates a definitive UTI ([0034]);
The limitations “wherein said adhesive releasably adheres said UTI detection device to an inner surface of an undergarment”, “a detection portion for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes or nitrates”, and “further wherein said detecting the presence of at least one of leukocytes or nitrates above a first threshold value indicates a possible UTI and above a second threshold value indicates a definitive UTI.” 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 Song and the apparatus of Song is capable of adhering the device to an inner surface of an undergarment, receiving drops of urine for detecting the presence of at least one of leukocytes, and detecting leukocytes above a first threshold and above a second threshold. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
Additionally, the undergarment nor urine are positively recited, and are thus not a part of the UTI detection device.
[0019] describes the invention is a lateral flow device for testing a body fluid such as urine that can be attached to an absorbent article, [0020] describes that the device may be attached to a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. [0034] describes that when leukocytes are present in urine, leukocyte esterase is produced and is used as a biomarker for the presence of leukocytes. [0048] describes where device 10 detects the presence of leukocyte esterase, where the enzyme and substrate react to release an aromatic product that subsequently couples with a diazonium ion to form a colored aromatic azo compound in the detection zone 20. With the description from [0048], it is clear that different concentrations of leukocyte esterase will lead to different amounts of formed colored aromatic azo compound that will impact color, and therefore different thresholds can be indicated with different shades/intensities of color development.
Again, it is noted that detecting the presence of leukocytes or nitrates is directed to the intended use of the device, see supra.
[0023] of Song describes that the thickness of the chromatographic medium 14 may be less than about 500 micrometers, and [0024] describes that the support 12 that holds the chromatographic medium 14 to have a thickness of about 125 micrometers. [0068] of Song does describe an adhesive layer 24 applied to the backside of support 12, however Song does not teach a specific thickness of the adhesive.
In the analogous art of testing devices, Kobayashi teaches a testing device with a substrate and flow path member (Kobayashi; [0003], [0036]).
Specifically, Kobayashi teaches where an adhesive layer is formed on substrate 11, where the adhesive layer is 50 micrometers, where flow path member 12 is then applied over the adhesive layer (Kobayashi; [0110]).
Song is silent with regards to specific adhesive thickness, therefore, it would have been necessary and thus obvious to look to the prior art for conventional adhesive thicknesses. Kobayashi provides this conventional teaching showing that it is known in the art to use adhesives with a thickness of 50 micrometers. Therefore, it would have been obvious to one having ordinary skill in the art to make the adhesive layer on the support 50 micrometers because it is taught by Kobayashi that this is an effective thickness for adhesives applied to a support member.
Therefore, the overall thickness of the lateral flow assay detection device will be 500 micrometers (chromatographic medium) + 125 micrometers (support) + 50 micrometers (adhesive) = 675 micrometers = 0.675 mm.
While Song does describe that urine testing can be used to detect dehydration, and that the present invention is not limited to the diagnosis of a urinary tract infection (Song; [0002], [0049]), Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
In the analogous art of disposable absorbent garments that include reagents that can detect the presence of one or more medical conditions through the detection of various substances in urine, Long teaches that the medical conditions include urinary tract infection or dehydration (Long; abstract, [0005]).
Specifically, Long teaches where a disposable absorbent article may be a diaper 10 (figure 1) and pant 120 (figure 2), where a test panel 320 may contain test results for one or more substances and may be of any shape (Long; [0065]). As seen in Figure 3 of Long, the test panel 320 includes a hydration detection that indicates the urine concentration and if hydration is at an acceptable level and a bilirubin detection area (Long; [0067]). Additionally, [0072] of Long describes that each garment may detect one or more of the following substances or physical conditions: bilirubin, urobilinogen, leukocytes, nitrites, red blood cells, glucose, protein, ketones, hydrogen ions, ion concentrations, phenylalanine, and the remaining liquid-capacity of the garment. [0073] describes a garment having a first reagent that detects in urine an abnormal level of a substance associated with a first medical condition, that medical condition may be a urinary tract infection.
It would have been obvious to one skilled in the art to modify the lateral flow assay detection device of Song such that it further detects dehydration as taught by Long because it is taught by Howell that it is desirable to determine the hydration of a user because dehydration can lead to shock and loss of control of bodily functions (Howell; [0006]).
Regarding claim 2, modified Song teaches the UTI detection device of claim 1. Song further teaches wherein said UTI detection device (10) having a selectively releasable protection layer (peel strip 26) to expose said adhesive (24) prior to adhering inside the undergarment (Song; [0068], Figures 1, 2).
Regarding claim 3, modified Song teaches the UTI detection device of claim 1. The limitations of claim 3 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 Song and the apparatus of modified Song is capable of indicating a lack of a UTI when detecting the presence of at least one of leukocytes below said first threshold value. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
[0034] of Song states that leukocytes are normally present in urine and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine. As such, below this level would not indicate a UTI.
Regarding claim 4, modified Song teaches the UTI detection device of claim 1. The limitations of claim 4 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 Song and the apparatus of modified Song is capable of changing the indicator strip to a first color above the first threshold value. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
From [0034] and [0048] of Song, if there are more than 1*104 leukocytes per milliliter of uncentrifuged urine this will cause a color change to indicate a possible UTI.
Regarding claim 5, modified Song teaches the UTI detection device of claim 4. The limitations of claim 5 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 Song and the apparatus of modified Song is capable of having the first color be yellow. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
From [0034] and [0048] of Song, different concentrations of leukocytes will impact the color shade/intensity. The more leukocyte esterase is present, the more colored aromatic azo compound will form to intensify the color. The different shades of color are being considered different colors.
Regarding claim 6, modified Song teaches the UTI detection device of claim 5. The limitations of claim 6 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 Song and the apparatus of modified Song is capable of changing the indicator strip to a second color for the second threshold value. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
From [0034] and [0048] of Song, different concentrations of leukocytes will impact the color shade/intensity. The more leukocyte esterase is present, the more colored aromatic azo compound will form to intensify the color. The different shades of color are being considered different colors.
Regarding claim 7, modified Song teaches the UTI detection device of claim 6. The limitations of claim 5 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 Song and the apparatus of modified Song is capable of having the second color be red. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
From [0034] and [0048] of Song, different concentrations of leukocytes will impact the color shade/intensity. The more leukocyte esterase is present, the more colored aromatic azo compound will form to intensify the color. The different shades of color are being considered different colors.
Regarding claim 8, modified Song teaches the UTI detection device of claim 6. The limitations of claim 8 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 Song and the apparatus of modified Song is capable of having the second threshold value be detection of leukocytes over 100,000 units in a sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
However, please note [0034] of Song describes that leukocytes are normal in urine, and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine.
Converting to liters of uncentrifuged urine:
1*104 leukocytes/1 milliliter * 1000 mL/1 L = 10000000 leukocytes per liter
Therefore, the second threshold value will be detection of leukocytes over 100,000 units because Song teaches that 10000000 leukocytes per liter (units) is the threshold limit for pathological levels.
Regarding claim 9, modified Song teaches the UTI detection device of claim 1. The limitations of claim 9 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 Song and the apparatus of modified Song is capable of the indicator strip changing to a third color below the first threshold. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
See [0034] and [0048] of Song where different shades of colors are being considered different colors.
Regarding claim 10, modified Song teaches the UTI detection device of claim 1. The limitations of claim 10 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 Song and the apparatus of modified Song is capable of being disposed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (US-2015/0025347-A1) in view of Feaster (US-2006/0205087-A1), Kobayashi (US-2016/0274100-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
If it is determined that the thresholds and different colors are not the intended use of the detection device, the following rejections below are set forth.
Regarding claim 1, Song teaches a urinary tract infection (UTI) detection device (lateral flow assay detection device 10) for detecting a possibility of a UTI, the UTI detection device (10) comprising ([0022], Figure 1):
an indicator strip (chromatographic material 14) on a first surface ([0022], Figure 1); and
an adhesive (adhesive layer 24) on an opposing second surface ([0068], Figures 1, 2);
wherein said adhesive (24) releasably adheres said UTI detection (10) device to an inner surface of an undergarment ([0068] see when the user is preparing to adhere device 10 to the absorbent article);
wherein said UTI detection device (10) is a liner positioned between the undergarment and a wearer of the undergarment ([0005] see lateral flow device attached to bodyside liner of the absorbent article, [0051] describes other absorbent articles including absorbent underpants, [0054] see bodyside liner 102 employed to help isolate the wearer’s skin from liquids held in the absorbent core, Figure 4);
wherein said indicator strip (14) having a detection portion (detection zone 20) for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes ([0028], [0034], [0048], Figure 1); and
Note the limitations “wherein said adhesive releasably adheres said UTI detection device to an inner surface of an undergarment”, “a detection portion for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes or nitrates” 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 Song and the apparatus of Song is capable of adhering the device to an inner surface of an undergarment and receiving drops of urine for detecting the presence of at least one of leukocytes. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
Additionally, the undergarment nor urine are positively recited, and are thus not a part of the UTI detection device.
[0019] describes the invention is a lateral flow device for testing a body fluid such as urine that can be attached to an absorbent article, [0020] describes that the device may be attached to a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. [0034] describes that when leukocytes are present in urine, leukocyte esterase is produced and is used as a biomarker for the presence of leukocytes. [0048] describes where device 10 detects the presence of leukocyte esterase, where the enzyme and substrate react to release an aromatic product that subsequently couples with a diazonium ion to form a colored aromatic azo compound in the detection zone 20.
However, Song does not teach said detecting the presence of at least one of leukocytes above a first threshold value indicates a possible UTI and above a second threshold value indicates a definitive UTI.
In the same problem solving area of lateral flow assay devices for detecting the quantity of an analyte, Feaster teaches zones of an assay device that convey that the analyte level is within acceptable, borderline, or high range by producing green, yellow, and red colors (Feaster; abstract, [0004], [0005]).
Specifically, Feaster teaches a lateral flow device for cholesterol that has five reaction zones, the first, third, and fifth zones correspond to current medical guidelines of less than 200, 200-239, and greater than 240 mg/dL total cholesterol where each of the zones are designed to be an all or none response which means they will only indicate if cholesterol or a derivative penetrates the zone and the second and fourth reaction zones are designed to destroy excess cholesterol or derivative (Feaster; [0028]). It is further described by [0029] that when a sample containing 250 mg/dL cholesterol is applied to the device and converted to peroxide, the peroxide then travels through the lateral flow membrane until it reaches zone one indicating less than 200 mg/dL, where at this point zone one will turn green and excess peroxide will enter zone two, a scavenging zone. [0029] describes that in the scavenging zone only the amount greater than 200 mg/dL cholesterol enters zone three, and when the sample enters zone three it turns yellow to indicate cholesterol between 200 and 239 mg/dL. The same concept applies for the following scavenging zone and zone five, which turns red to indicate cholesterol greater than 240 mg/dL.
It would have been obvious to one skilled in the art to modify the detection zone of Song such that it determines the concentration of leukocytes in the sample and creates different colors based on the measured concentration as taught by Feaster because Feaster teaches that the colors convey when analyte level is within acceptable, borderline, or high range (Feaster; [0005]).
As such, there will be two thresholds on the lateral flow assay detection device 10 of Song. The first one would be borderline amounts of leukocytes, and the second would be high range amounts of leukocytes. Where if the amount of leukocytes is below the borderline amount, the area will be green. If it is borderline, the yellow color will appear, and if it is high range the red color will appear.
[0023] of Song describes that the thickness of the chromatographic medium 14 may be less than about 500 micrometers, and [0024] describes that the support 12 that holds the chromatographic medium 14 to have a thickness of about 125 micrometers. [0068] of Song does describe an adhesive layer 24 applied to the backside of support 12, however Song does not teach a specific thickness of the adhesive.
In the analogous art of testing devices, Kobayashi teaches a testing device with a substrate and flow path member (Kobayashi; [0003], [0036]).
Specifically, Kobayashi teaches where an adhesive layer is formed on substrate 11, where the adhesive layer is 50 micrometers, where flow path member 12 is then applied over the adhesive layer (Kobayashi; [0110]).
Song is silent with regards to specific adhesive thickness, therefore, it would have been necessary and thus obvious to look to the prior art for conventional adhesive thicknesses. Kobayashi provides this conventional teaching showing that it is known in the art to use adhesives with a thickness of 50 micrometers. Therefore, it would have been obvious to one having ordinary skill in the art to make the adhesive layer on the support 50 micrometers because it is taught by Kobayashi that this is an effective thickness for adhesives applied to a support member.
Therefore, the overall thickness of the lateral flow assay detection device will be 500 micrometers (chromatographic medium) + 125 micrometers (support) + 50 micrometers (adhesive) = 675 micrometers = 0.675 mm.
Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
While Song does describe that urine testing can be used to detect dehydration, and that the present invention is not limited to the diagnosis of a urinary tract infection (Song; [0002], [0049]), Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
In the analogous art of disposable absorbent garments that include reagents that can detect the presence of one or more medical conditions through the detection of various substances in urine, Long teaches that the medical conditions include urinary tract infection or dehydration (Long; abstract, [0005]).
Specifically, Long teaches where a disposable absorbent article may be a diaper 10 (figure 1) and pant 120 (figure 2), where a test panel 320 may contain test results for one or more substances and may be of any shape (Long; [0065]). As seen in Figure 3 of Long, the test panel 320 includes a hydration detection that indicates the urine concentration and if hydration is at an acceptable level and a bilirubin detection area (Long; [0067]). Additionally, [0072] of Long describes that each garment may detect one or more of the following substances or physical conditions: bilirubin, urobilinogen, leukocytes, nitrites, red blood cells, glucose, protein, ketones, hydrogen ions, ion concentrations, phenylalanine, and the remaining liquid-capacity of the garment. [0073] describes a garment having a first reagent that detects in urine an abnormal level of a substance associated with a first medical condition, that medical condition may be a urinary tract infection.
It would have been obvious to one skilled in the art to modify the lateral flow assay detection device of Song such that it further detects dehydration as taught by Long because it is taught by Howell that it is desirable to determine the hydration of a user because dehydration can lead to shock and loss of control of bodily functions (Howell; [0006]).
Regarding claim 2, modified Song teaches the UTI detection device of claim 1. Song further teaches wherein said UTI detection device (10) having a selectively releasable protection layer (peel strip 26) to expose said adhesive (24) prior to adhering inside the undergarment (Song; [0068], Figures 1, 2).
Regarding claim 3, modified Song teaches the UTI detection device of claim 1. [0034] of Song states that leukocytes are normally present in urine and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine, where therefore it is understood that 1*104 leukocytes per milliliter of uncentrifuged urine is the first threshold and that below this value it will not indicate a UTI.
Regarding claim 4, modified Song teaches the UTI detection device of claim 1. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 1 supra where the first threshold is borderline amounts of leukocytes that will change the zone to a yellow color.
Regarding claim 5, modified Song teaches the UTI detection device of claim 4. Modified Song further teaches wherein said first color is yellow, please see claim 4 supra.
Regarding claim 6, modified Song teaches the UTI detection device of claim 5. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 1 supra where the second threshold is high range amounts of leukocytes that will change the zone to a red color.
Regarding claim 7, modified Song teaches the UTI detection device of claim 6. Modified Song further teaches wherein said second color is red, please see claim 6 supra.
Regarding claim 8, modified Song teaches the UTI detection device of claim 6. Song further teaches wherein above said second threshold value is detection of leukocytes over 100,000 units in a sample.
[0034] of Song describes that leukocytes are normal in urine, and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine.
Converting to liters of uncentrifuged urine:
1*104 leukocytes/1 milliliter * 1000 mL/1 L = 10000000 leukocytes per liter
Therefore, the second threshold value will be detection of leukocytes over 100,000 units because Song teaches that 10000000 leukocytes per liter (units) is the threshold limit for pathological levels.
Regarding claim 9, modified Song teaches the UTI detection device of claim 1. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 1 supra where below the first threshold the color will be green.
Regarding claim 10, modified Song teaches the UTI detection device of claim 1. The limitations of claim 10 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 Song and the apparatus of modified Song is capable of being disposed. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
Claim(s) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (US-2015/0025347-A1) in view of Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Regarding claim 11, Song teaches a UTI detection device (lateral flow assay detection device 10) for detecting a possibility of a UTI, the UTI detection device (10) comprising ([0022], Figure 1):
an indicator strip (chromatographic material 14) on a first surface ([0022], Figure 1); and
an adhesive (adhesive layer 24) on an opposing second surface ([0068], Figures 1, 2);
wherein said adhesive (24) releasably adheres said UTI detection (10) device to an inner surface of an undergarment ([0068] see when the user is preparing to adhere device 10 to the absorbent article);
wherein said UTI detection device (10) is a liner positioned between the undergarment and a wearer of the undergarment ([0005] see lateral flow device attached to bodyside liner of the absorbent article, [0051] describes other absorbent articles including absorbent underpants, [0054] see bodyside liner 102 employed to help isolate the wearer’s skin from liquids held in the absorbent core, Figure 4);
wherein said indicator strip (14) having a detection portion (detection zone 20) for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes ([0028], [0034], [0048], Figure 1);
wherein said detecting the presence of at least one of leukocytes above a first threshold value indicates a possible UTI and above a second threshold value indicates a definitive UTI ([0034]);
wherein above said first threshold value changes said indicator strip (10) to a first color ([0048]);
wherein above said second threshold value changes said indicator strip (10) to a second color ([0048]);
wherein the first color is indicated on a portion of the indicator strip (10) and the second color is indicated on a nonoverlapping portion of the indicator strip (10) ([0033] see lateral flow assay device 10 may provide any number of distinct detection regions so a user may better determine the concentration of the analyte and that each region may contain the same or different materials, where the zones include two or more distinct regions (lines, dots, etc.));
The limitations “wherein said adhesive releasably adheres said UTI detection device to an inner surface of an undergarment”, “a detection portion for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes and nitrates”, “further wherein said detecting the presence of at least one of leukocytes and nitrates above a first threshold value indicates a possible UTI and above a second threshold value indicates a definitive UTI.”, “wherein above said first threshold value changes said indicator strip to a first color”, and “further wherein above said threshold value changes said indicator strip to a second color” 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 Song and the apparatus of Song is capable of adhering the device to an inner surface of an undergarment, receiving drops of urine for detecting the presence of at least one of leukocytes, detecting leukocytes above a first threshold and above a second threshold, and changing to a first or second color. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
Additionally, the undergarment nor urine are positively recited, and are thus not a part of the UTI detection device.
[0019] describes the invention is a lateral flow device for testing a body fluid such as urine that can be attached to an absorbent article, [0020] describes that the device may be attached to a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. [0034] describes that when leukocytes are present in urine, leukocyte esterase is produced and is used as a biomarker for the presence of leukocytes. [0048] describes where device 10 detects the presence of leukocyte esterase, where the enzyme and substrate react to release an aromatic product that subsequently couples with a diazonium ion to form a colored aromatic azo compound in the detection zone 20. With the description from [0048], it is clear that different concentrations of leukocyte esterase will lead to different amounts of formed colored aromatic azo compound that will impact color, and therefore different thresholds can be indicated with different shades/intensities of color development. The different shades/intensities are being considered different colors. Additionally, from [0033] of Song there may be different detection regions that are distinct from each other and may have the same or different material, where the zones include two or more distinct regions (e.g. lines, dots, etc.). Additionally, it is described that in one example the lines are disposed in a direction that is substantially perpendicular to the flow of the test sample. It is therefore understood that having distinct regions would mean that the lines/dots will not overlap each other, because if there were any overlap occurring it would not be a distinct region.
Again, it is noted that detecting the presence of leukocytes or nitrates is directed to the intended use of the device, see supra.
Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
While Song does describe that urine testing can be used to detect dehydration, and that the present invention is not limited to the diagnosis of a urinary tract infection (Song; [0002], [0049]), Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
In the analogous art of disposable absorbent garments that include reagents that can detect the presence of one or more medical conditions through the detection of various substances in urine, Long teaches that the medical conditions include urinary tract infection or dehydration (Long; abstract, [0005]).
Specifically, Long teaches where a disposable absorbent article may be a diaper 10 (figure 1) and pant 120 (figure 2), where a test panel 320 may contain test results for one or more substances and may be of any shape (Long; [0065]). As seen in Figure 3 of Long, the test panel 320 includes a hydration detection that indicates the urine concentration and if hydration is at an acceptable level and a bilirubin detection area (Long; [0067]). Additionally, [0072] of Long describes that each garment may detect one or more of the following substances or physical conditions: bilirubin, urobilinogen, leukocytes, nitrites, red blood cells, glucose, protein, ketones, hydrogen ions, ion concentrations, phenylalanine, and the remaining liquid-capacity of the garment. [0073] describes a garment having a first reagent that detects in urine an abnormal level of a substance associated with a first medical condition, that medical condition may be a urinary tract infection.
It would have been obvious to one skilled in the art to modify the lateral flow assay detection device of Song such that it further detects dehydration as taught by Long because it is taught by Howell that it is desirable to determine the hydration of a user because dehydration can lead to shock and loss of control of bodily functions (Howell; [0006]).
Regarding claim 12, modified Song teaches the UTI detection device of claim 11. Song further teaches wherein said UTI detection device (10) having a selectively releasable protection layer (peel strip 26) to expose said adhesive layer (24) prior to adhering inside the undergarment (Song; [0068], Figures 1, 2).
Regarding claim 13, Song teaches the UTI detection device of claim 11. The limitations of claim 11 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 Song and the apparatus of modified Song is capable of indicating a lack of a UTI when detecting the presence of at least one of leukocytes below said first threshold value. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
[0034] of Song states that leukocytes are normally present in urine and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine. As such, below this level would not indicate a UTI.
Regarding claim 14, modified Song teaches the UTI detection device of claim 11. The limitations of claim 14 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 Song and the apparatus of modified Song is capable of having the first color be yellow. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
From [0034] and [0048] of Song, different concentrations of leukocytes will impact the color shade/intensity. The more leukocyte esterase is present, the more colored aromatic azo compound will form to intensify the color. The different shades of color are being considered different colors. Additionally, from [0033] of Song there may be different detection zones that are distinct from each other and may have the same or different material.
Regarding claim 15, modified Song teaches the UTI detection device of claim 14. The limitations of claim 15 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 Song and the apparatus of modified Song is capable of having the second color be red. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
From [0034] and [0048] of Song, different concentrations of leukocytes will impact the color shade/intensity. The more leukocyte esterase is present, the more colored aromatic azo compound will form to intensify the color. The different shades of color are being considered different colors. Additionally, from [0033] of Song there may be different detection zones that are distinct from each other and may have the same or different material.
Regarding claim 16, modified Song teaches the UTI detection device of claim 11. The limitations of claim 16 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 Song and the apparatus of modified Song is capable of having the second threshold value be detection of leukocytes over 100,000 units in a sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
However, please note [0034] of Song describes that leukocytes are normal in urine, and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine.
Converting to liters of uncentrifuged urine:
1*104 leukocytes/1 milliliter * 1000 mL/1 L = 10000000 leukocytes per liter
Therefore, the second threshold value will be detection of leukocytes over 100,000 units because Song teaches that 10000000 leukocytes per liter (units) is the threshold limit for pathological levels.
Regarding claim 17, modified Song teaches the UTI detection device of claim 11. The limitations of claim 17 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 Song and the apparatus of modified Song is capable of the indicator strip changing to a third color below the first threshold. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
See [0034] and [0048] of Song where different shades of colors are being considered different colors. Additionally, from [0033] of Song there may be different detection zones that are distinct from each other and may have the same or different material.
Regarding claim 18, modified Song teaches the UTI detection device of claim 17. The limitations of claim 18 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 Song and the apparatus of modified Song is capable of having the third color be green. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
From [0034] and [0048] of Song, different concentrations of leukocytes will impact the color shade/intensity. The more leukocyte esterase is present, the more colored aromatic azo compound will form to intensify the color. The different shades of color are being considered different colors. Additionally, from [0033] of Song there may be different detection zones that are distinct from each other and may have the same or different material.
Claim(s) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (US-2015/0025347-A1) in view of Feaster (US-2006/0205087-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
If it is determined that the thresholds and different colors are not the intended use of the detection device, the following rejections below are set forth.
Regarding claim 11, Song teaches a UTI detection device (lateral flow assay detection device 10) for detecting a possibility of a UTI, the UTI detection device (10) comprising ([0022], Figure 1):
an indicator strip (chromatographic material 14) on a first surface ([0022], Figure 1); and
an adhesive (adhesive layer 24) on an opposing second surface ([0068], Figures 1, 2);
wherein said adhesive (24) releasably adheres said UTI detection (10) device to an inner surface of an undergarment ([0068] see when the user is preparing to adhere device 10 to the absorbent article);
wherein said UTI detection device (10) is a liner positioned between the undergarment and a wearer of the undergarment ([0005] see lateral flow device attached to bodyside liner of the absorbent article, [0051] describes other absorbent articles including absorbent underpants, [0054] see bodyside liner 102 employed to help isolate the wearer’s skin from liquids held in the absorbent core, Figure 4);
wherein said indicator strip (14) having a detection portion (detection zone 20) for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes ([0028], [0034], [0048], Figure 1); and
Note the limitations “wherein said adhesive releasably adheres said UTI detection device to an inner surface of an undergarment”, “a detection portion for receiving drops of urine of the wearer for detecting the presence of at least one of leukocytes or nitrates” 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 Song and the apparatus of Song is capable of adhering the device to an inner surface of an undergarment and receiving drops of urine for detecting the presence of at least one of leukocytes. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
Additionally, the undergarment nor urine are positively recited, and are thus not a part of the UTI detection device.
[0019] describes the invention is a lateral flow device for testing a body fluid such as urine that can be attached to an absorbent article, [0020] describes that the device may be attached to a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. [0034] describes that when leukocytes are present in urine, leukocyte esterase is produced and is used as a biomarker for the presence of leukocytes. [0048] describes where device 10 detects the presence of leukocyte esterase, where the enzyme and substrate react to release an aromatic product that subsequently couples with a diazonium ion to form a colored aromatic azo compound in the detection zone 20.
However, Song does not teach:
wherein said detecting the presence of at least one of leukocytes above a first threshold value indicates a possible UTI and above a second threshold value indicates a definitive UTI;
wherein above said first threshold value changes said indicator strip to a first color; and further wherein above said second threshold value changes said indicator strip to a second color;
wherein the first color is indicated on a portion of the indicator strip and the second color is indicated on a nonoverlapping portion of the indicator strip.
In the same problem solving area of lateral flow assay devices for detecting the quantity of an analyte, Feaster teaches zones of an assay device that convey that the analyte level is within acceptable, borderline, or high range by producing green, yellow, and red colors (Feaster; abstract, [0004], [0005]).
Specifically, Feaster teaches a lateral flow device for cholesterol that has five reaction zones, the first, third, and fifth zones correspond to current medical guidelines of less than 200, 200-239, and greater than 240 mg/dL total cholesterol where each of the zones are designed to be an all or none response which means they will only indicate if cholesterol or a derivative penetrates the zone and the second and fourth reaction zones are designed to destroy excess cholesterol or derivative (Feaster; [0028]). It is further described by [0029] that when a sample containing 250 mg/dL cholesterol is applied to the device and converted to peroxide, the peroxide then travels through the lateral flow membrane until it reaches zone one indicating less than 200 mg/dL, where at this point zone one will turn green and excess peroxide will enter zone two, a scavenging zone. [0029] describes that in the scavenging zone only the amount greater than 200 mg/dL cholesterol enters zone three, and when the sample enters zone three it turns yellow to indicate cholesterol between 200 and 239 mg/dL. The same concept applies for the following scavenging zone and zone five, which turns red to indicate cholesterol greater than 240 mg/dL.
It would have been obvious to one skilled in the art to modify the detection zone of Song such that it determines the concentration of leukocytes in the sample and creates different colors based on the measured concentration as taught by Feaster because Feaster teaches that the colors convey when analyte level is within acceptable, borderline, or high range (Feaster; [0005]).
As such, there will be two thresholds on the lateral flow assay detection device 10 of Song. The first one would be borderline amounts of leukocytes, and the second would be high range amounts of leukocytes. Where if the amount of leukocytes is below the borderline amount, the area will be green. If it is borderline, the yellow color will appear, and if it is high range the red color will appear. Further, as seen in Figure 2 of Feaster the zones do not overlap each other. Specifically, the zones 30, 32, and 34 (detection zones) are separated by zones 40 and 42 (scavenging zones) (Feaster; Figure 2), where as the detection zones are separated by scavenging zones the detection zones will not overlap each other.
While Song does describe that urine testing can be used to detect dehydration, and that the present invention is not limited to the diagnosis of a urinary tract infection (Song; [0002], [0049]), Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
In the analogous art of disposable absorbent garments that include reagents that can detect the presence of one or more medical conditions through the detection of various substances in urine, Long teaches that the medical conditions include urinary tract infection or dehydration (Long; abstract, [0005]).
Specifically, Long teaches where a disposable absorbent article may be a diaper 10 (figure 1) and pant 120 (figure 2), where a test panel 320 may contain test results for one or more substances and may be of any shape (Long; [0065]). As seen in Figure 3 of Long, the test panel 320 includes a hydration detection that indicates the urine concentration and if hydration is at an acceptable level and a bilirubin detection area (Long; [0067]). Additionally, [0072] of Long describes that each garment may detect one or more of the following substances or physical conditions: bilirubin, urobilinogen, leukocytes, nitrites, red blood cells, glucose, protein, ketones, hydrogen ions, ion concentrations, phenylalanine, and the remaining liquid-capacity of the garment. [0073] describes a garment having a first reagent that detects in urine an abnormal level of a substance associated with a first medical condition, that medical condition may be a urinary tract infection.
It would have been obvious to one skilled in the art to modify the lateral flow assay detection device of Song such that it further detects dehydration as taught by Long because it is taught by Howell that it is desirable to determine the hydration of a user because dehydration can lead to shock and loss of control of bodily functions (Howell; [0006]).
Regarding claim 12, modified Song teaches the UTI detection device of claim 11. Song further teaches wherein said UTI detection device (10) having a selectively releasable protection layer (peel strip 26) to expose said adhesive (24) prior to adhering inside the undergarment (Song; [0068], Figures 1, 2).
Regarding claim 13, modified Song teaches the UTI detection device of claim 11. [0034] of Song states that leukocytes are normally present in urine and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine, where therefore it is understood that 1*104 leukocytes per milliliter of uncentrifuged urine is the first threshold and that below this value it will not indicate a UTI.
Regarding claim 14, modified Song teaches the UTI detection device of claim 11. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 11 supra where the first threshold is borderline amounts of leukocytes that will change the zone to a yellow color.
Regarding claim 15, modified Song teaches the UTI detection device of claim 14. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 11 supra where the second threshold is high range amounts of leukocytes that will change the zone to a red color.
Regarding claim 16, modified Song teaches the UTI detection device of claim 11. Song further teaches wherein above said second threshold value is detection of leukocytes over 100,000 units in a sample.
[0034] of Song describes that leukocytes are normal in urine, and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine.
Converting to liters of uncentrifuged urine:
1*104 leukocytes/1 milliliter * 1000 mL/1 L = 10000000 leukocytes per liter
Therefore, the second threshold value will be detection of leukocytes over 100,000 units because Song teaches that 10000000 leukocytes per liter (units) is the threshold limit for pathological levels.
Regarding claim 17, modified Song teaches the UTI detection device of claim 11. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 11 supra where below the first threshold the color will be green.
Regarding claim 18, modified Song teaches the UTI detection device of claim 17. Song has been modified with Feaster such that the detection zone now determines concentration of leukocytes in the sample and creates different colors based on the measured concentrations as taught by Feaster, see claim 11 supra where below the first threshold the color will be green.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (US-2015/0025347-A1) in view of Jung (US-2020/0088701-A1), Mongale (US-2014/0093896-A1), Long (US-2008/0147031-A1), and Howell (US-2007/0048224-A1),
Regarding claim 19, Song teaches a UTI detection device (lateral flow assay detection device 10) for detecting a possibility of a UTI, the UTI detection device (10) comprising ([0022], Figure 1):
an indicator strip (chromatographic material 14) on a first surface ([0022], Figure 1); and
an adhesive (adhesive layer 24) on an opposing second surface ([0068], Figures 1, 2);
wherein said adhesive (24) releasably adheres said UTI detection device (10) to an inner surface of an undergarment ([0068] see when the user is preparing to adhere device 10 to the absorbent article);
wherein said disposable UTI detection device (10) is a liner positioned between the undergarment and a wearer of the undergarment ([0005] see lateral flow device attached to bodyside liner of the absorbent article, [0051] describes other absorbent articles including absorbent underpants, [0054] see bodyside liner 102 employed to help isolate the wearer’s skin from liquids held in the absorbent core, Figure 4);
wherein said indicator strip (10) having a detection portion (detection zone 20) for receiving urine of the wearer for detecting the presence of leukocytes ([0028], [0034], [0048], Figure 1); and
wherein said detecting the presence of leukocytes above a first threshold value changes said indicator strip (10) to a first color and indicates a possible UTI ([0048]);
wherein said detecting the presence of leukocytes above a second threshold value changes said indicator strip (10) to a second color and indicates a definitive UTI ([0048]); and
wherein detecting the presence of leukocytes below said first threshold value changes said indicator strip (10) to a third color and indicates a lack of a UTI ([0048]);
The limitations “said adhesive releasably adheres said disposable UTI detection device to an inner surface of an undergarment”, “said adhesive releasably adheres said disposable UTI detection device to an inner surface of an undergarment”, “a detection portion for receiving urine of the wearer for detecting the presence of leukocytes”, “wherein said detecting the presence of leukocytes above a first threshold value changes said indicator strip to a first color and indicates a possible UTI; wherein said detecting the presence of leukocytes above a second threshold value changes said indicator strip to a second color and indicates a definitive UTI; and further wherein detecting the presence of leukocytes below said first threshold value changes said indicator strip to a third color and indicates a lack of a UTI.” 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 Song and the apparatus of Song is capable of adhering the device to an inner surface of an undergarment, receiving drops of urine for detecting the presence of at least one of leukocytes, detecting leukocytes above a first threshold and above a second threshold, and changing to a first, second, or third color. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
Additionally, the undergarment nor urine are positively recited, and are thus not a part of the UTI detection device.
[0019] describes the invention is a lateral flow device for testing a body fluid such as urine that can be attached to an absorbent article, [0020] describes that the device may be attached to a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. [0034] describes that when leukocytes are present in urine, leukocyte esterase is produced and is used as a biomarker for the presence of leukocytes. [0048] describes where device 10 detects the presence of leukocyte esterase, where the enzyme and substrate react to release an aromatic product that subsequently couples with a diazonium ion to form a colored aromatic azo compound in the detection zone 20. With the description from [0048], it is clear that different concentrations of leukocyte esterase will lead to different amounts of formed colored aromatic azo compound that will impact color, and therefore different thresholds can be indicated with different shades/intensities of color development. The different shades/intensities are being considered different colors.
Again, it is noted that detecting the presence of leukocytes is directed to the intended use of the device, see supra.
While Song does teach that another analyte of interest includes nitrites, where nitrites can indicate a urinary tract infection or other bacterial infections in the body (Song; [0050]), Song does not teach where the lateral flow assay detection device detects both leukocytes and nitrates together.
In the analogous art of disposable devices for the detection of a UTI and other disorders, Jung teaches where the targeted compounds are nitrite, nitrate, and white blood cells (Jung; [0011], [0016]).
Specifically, Jung teaches a disposable device 60 that detects nitrite, nitrate, or white blood cells and includes a sensing unit 102 (Jung; [0093]). [0106] describes the sensing unit 102 including a sensing strip 124, and [0112] describes a sensing strip 124 comprises a liquid-absorbing colorimetric strip configured to display a certain color dependent upon the nitrite and/or nitrate concentration present within a substance being tested. [0136] further recites “one of the sensing strips 124 comprises a first reagent strip 124 r1 comprising UTI (e.g., nitrite or nitrate) sensing chemicals/reagents…”
It would have been obvious to one skilled in the art to modify the lateral flow assay detecting device of Song such that it detects nitrates in addition to nitrites as taught by Jung because Jung teaches that nitrates and nitrites are both detected to indicate a UTI (Jung; [0112]).
Further, it would have been obvious to one skilled in the art to have the lateral flow assay detecting device of Song to detect both leukocytes and nitrates/nitrites because it is taught by Monagle that it is desirable to detect both of these analytes when determining if a UTI is present (Monagle; [0052]).
While Song does describe that urine testing can be used to detect dehydration, and that the present invention is not limited to the diagnosis of a urinary tract infection (Song; [0002], [0049]), Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
In the analogous art of disposable absorbent garments that include reagents that can detect the presence of one or more medical conditions through the detection of various substances in urine, Long teaches that the medical conditions include urinary tract infection or dehydration (Long; abstract, [0005]).
Specifically, Long teaches where a disposable absorbent article may be a diaper 10 (figure 1) and pant 120 (figure 2), where a test panel 320 may contain test results for one or more substances and may be of any shape (Long; [0065]). As seen in Figure 3 of Long, the test panel 320 includes a hydration detection that indicates the urine concentration and if hydration is at an acceptable level and a bilirubin detection area (Long; [0067]). Additionally, [0072] of Long describes that each garment may detect one or more of the following substances or physical conditions: bilirubin, urobilinogen, leukocytes, nitrites, red blood cells, glucose, protein, ketones, hydrogen ions, ion concentrations, phenylalanine, and the remaining liquid-capacity of the garment. [0073] describes a garment having a first reagent that detects in urine an abnormal level of a substance associated with a first medical condition, that medical condition may be a urinary tract infection.
It would have been obvious to one skilled in the art to modify the lateral flow assay detection device of Song such that it further detects dehydration as taught by Long because it is taught by Howell that it is desirable to determine the hydration of a user because dehydration can lead to shock and loss of control of bodily functions (Howell; [0006]).
Regarding claim 20, modified Song teaches the UTI detection device of claim 19. The limitations of claim 20 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 Song and the apparatus of modified Song is capable of having the second threshold value be detection of leukocytes over 100,000 units in a sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
However, please note [0034] of Song describes that leukocytes are normal in urine, and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine.
Converting to liters of uncentrifuged urine:
1*104 leukocytes/1 milliliter * 1000 mL/1 L = 10000000 leukocytes per liter
Therefore, the second threshold value will be detection of leukocytes over 100,000 units because Song teaches that 10000000 leukocytes per liter (units) is the threshold limit for pathological levels.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Song (US-2015/0025347-A1) in view of Feaster (US-2006/0205087-A1), Jung (US-2020/0088701-A1), Mongale (US-2014/0093896-A1), Long (US-2008/0147031-A1), and Howell (US-2007/0048224-A1).
If it is determined that the thresholds and different colors are not the intended use of the detection device, the following rejections below are set forth.
Regarding claim 19, Song teaches a UTI detection device (lateral flow assay detection device 10) for detecting a possibility of a UTI, the UTI detection device (10) comprising ([0022], Figure 1):
an indicator strip (chromatographic material 14) on a first surface ([0022], Figure 1); and
an adhesive (adhesive layer 24) on an opposing second surface ([0068], Figures 1, 2);
wherein said adhesive (24) releasably adheres said UTI detection device (10) to an inner surface of an undergarment ([0068] see when the user is preparing to adhere device 10 to the absorbent article);
wherein said disposable UTI detection device (10) is a liner positioned between the undergarment and a wearer of the undergarment ([0005] see lateral flow device attached to bodyside liner of the absorbent article, [0051] describes other absorbent articles including absorbent underpants, [0054] see bodyside liner 102 employed to help isolate the wearer’s skin from liquids held in the absorbent core, Figure 4);
wherein said indicator strip (10) having a detection portion (detection zone 20) for receiving urine of the wearer for detecting the presence of leukocytes ([0028], [0034], [0048], Figure 1); and
Note the limitations “wherein said adhesive releasably adheres said disposable UTI detection device to an inner surface of an undergarment”, “a detection portion for receiving urine of the wearer for detecting the presence of leukocytes” 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 Song and the apparatus of Song is capable of adhering the device to an inner surface of an undergarment and receiving urine for detecting the presence of leukocytes. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Song (see MPEP §2114).
Additionally, the undergarment nor urine are positively recited, and are thus not a part of the UTI detection device.
[0019] describes the invention is a lateral flow device for testing a body fluid such as urine that can be attached to an absorbent article, [0020] describes that the device may be attached to a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. [0034] describes that when leukocytes are present in urine, leukocyte esterase is produced and is used as a biomarker for the presence of leukocytes. [0048] describes where device 10 detects the presence of leukocyte esterase, where the enzyme and substrate react to release an aromatic product that subsequently couples with a diazonium ion to form a colored aromatic azo compound in the detection zone 20.
However, Song does not teach:
wherein said detecting the presence of leukocytes above a first threshold value changes said indicator strip to a first color and indicates a possible UTI;
wherein said detecting the presence of leukocytes above a second threshold value changes said indicator strip to a second color and indicates a definitive UTI; and
further wherein detecting the presence of leukocytes below said first threshold value changes said indicator strip to a third color and indicates a lack of a UTI.
In the same problem solving area of lateral flow assay devices for detecting the quantity of an analyte, Feaster teaches zones of an assay device that convey that the analyte level is within acceptable, borderline, or high range by producing green, yellow, and red colors (Feaster; abstract, [0004], [0005]).
Specifically, Feaster teaches a lateral flow device for cholesterol that has five reaction zones, the first, third, and fifth zones correspond to current medical guidelines of less than 200, 200-239, and greater than 240 mg/dL total cholesterol where each of the zones are designed to be an all or none response which means they will only indicate if cholesterol or a derivative penetrates the zone and the second and fourth reaction zones are designed to destroy excess cholesterol or derivative (Feaster; [0028]). It is further described by [0029] that when a sample containing 250 mg/dL cholesterol is applied to the device and converted to peroxide, the peroxide then travels through the lateral flow membrane until it reaches zone one indicating less than 200 mg/dL, where at this point zone one will turn green and excess peroxide will enter zone two, a scavenging zone. [0029] describes that in the scavenging zone only the amount greater than 200 mg/dL cholesterol enters zone three, and when the sample enters zone three it turns yellow to indicate cholesterol between 200 and 239 mg/dL. The same concept applies for the following scavenging zone and zone five, which turns red to indicate cholesterol greater than 240 mg/dL.
It would have been obvious to one skilled in the art to modify the detection zone of Song such that it determines the concentration of leukocytes in the sample and creates different colors based on the measured concentration as taught by Feaster because Feaster teaches that the colors convey when analyte level is within acceptable, borderline, or high range (Feaster; [0005]).
As such, there will be two thresholds on the lateral flow assay detection device 10 of Song. The first one would be borderline amounts of leukocytes (possible UTI), and the second would be high range amounts of leukocytes (definitive UTI). Where if the amount of leukocytes is below the borderline amount (no UTI), the area will be green. If it is borderline, the yellow color will appear, and if it is high range the red color will appear.
While Song does teach that another analyte of interest includes nitrites, where nitrites can indicate a urinary tract infection or other bacterial infections in the body (Song; [0050]), Song does not teach where the lateral flow assay detection device detects both leukocytes and nitrates together.
In the analogous art of disposable devices for the detection of a UTI and other disorders, Jung teaches where the targeted compounds are nitrite, nitrate, and white blood cells (Jung; [0011], [0016]).
Specifically, Jung teaches a disposable device 60 that detects nitrite, nitrate, or white blood cells and includes a sensing unit 102 (Jung; [0093]). [0106] describes the sensing unit 102 including a sensing strip 124, and [0112] describes a sensing strip 124 comprises a liquid-absorbing colorimetric strip configured to display a certain color dependent upon the nitrite and/or nitrate concentration present within a substance being tested. [0136] further recites “one of the sensing strips 124 comprises a first reagent strip 124 r1 comprising UTI (e.g., nitrite or nitrate) sensing chemicals/reagents…”
It would have been obvious to one skilled in the art to modify the lateral flow assay detecting device of Song such that it detects nitrates in addition to nitrites as taught by Jung because Jung teaches that nitrates and nitrites are both detected to indicate a UTI (Jung; [0112]).
Further, it would have been obvious to one skilled in the art to have the lateral flow assay detecting device of Song to detect both leukocytes and nitrates/nitrites because it is taught by Monagle that it is desirable to detect both of these analytes when determining if a UTI is present (Monagle; [0052]).
While Song does describe that urine testing can be used to detect dehydration, and that the present invention is not limited to the diagnosis of a urinary tract infection (Song; [0002], [0049]), Song does not teach wherein the detection portion of the indicator strip is further configured to detect dehydration in a user.
In the analogous art of disposable absorbent garments that include reagents that can detect the presence of one or more medical conditions through the detection of various substances in urine, Long teaches that the medical conditions include urinary tract infection or dehydration (Long; abstract, [0005]).
Specifically, Long teaches where a disposable absorbent article may be a diaper 10 (figure 1) and pant 120 (figure 2), where a test panel 320 may contain test results for one or more substances and may be of any shape (Long; [0065]). As seen in Figure 3 of Long, the test panel 320 includes a hydration detection that indicates the urine concentration and if hydration is at an acceptable level and a bilirubin detection area (Long; [0067]). Additionally, [0072] of Long describes that each garment may detect one or more of the following substances or physical conditions: bilirubin, urobilinogen, leukocytes, nitrites, red blood cells, glucose, protein, ketones, hydrogen ions, ion concentrations, phenylalanine, and the remaining liquid-capacity of the garment. [0073] describes a garment having a first reagent that detects in urine an abnormal level of a substance associated with a first medical condition, that medical condition may be a urinary tract infection.
It would have been obvious to one skilled in the art to modify the lateral flow assay detection device of Song such that it further detects dehydration as taught by Long because it is taught by Howell that it is desirable to determine the hydration of a user because dehydration can lead to shock and loss of control of bodily functions (Howell; [0006]).
Regarding claim 20, modified Song teaches the UTI detection device of claim 19. The limitations of claim 20 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 Song and the apparatus of modified Song is capable of having the second threshold value be detection of leukocytes over 100,000 units in a sample. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Song (see MPEP §2114).
However, please note [0034] of Song describes that leukocytes are normal in urine, and that the threshold limit for pathological levels is about 1*104 leukocytes per milliliter of uncentrifuged urine.
Converting to liters of uncentrifuged urine:
1*104 leukocytes/1 milliliter * 1000 mL/1 L = 10000000 leukocytes per liter
Therefore, the second threshold value will be detection of leukocytes over 100,000 units because Song teaches that 10000000 leukocytes per liter (units) is the threshold limit for pathological levels.
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 8, filed 01/08/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102(a)(1) and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of:
For claims 1-10 Song (US-2015/0025347-A1) in view of Kobayashi (US-2016/0274100-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Claims 1-10 in the alternative if the thresholds and different colors are not the intended use Song (US-2015/0025347-A1) in view of Feaster (US-2006/0205087-A1), Kobayashi (US-2016/0274100-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Claims 11-18 Song (US-2015/0025347-A1) in view of Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Claims 11-18 in the alternative if the thresholds and different colors are not the intended use Song (US-2015/0025347-A1) in view of Feaster (US-2006/0205087-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Claims 19-20 Song (US-2015/0025347-A1) in view of Jung (US-2020/0088701-A1), Mongale (US-2014/0093896-A1), Long (US-2008/0147031-A1), and Howell (US-2007/0048224-A1),
Claims 19-20 in the alternative if the thresholds and different colors are not the intended use Song (US-2015/0025347-A1) in view of Feaster (US-2006/0205087-A1), Jung (US-2020/0088701-A1), Mongale (US-2014/0093896-A1), Long (US-2008/0147031-A1) and Howell (US-2007/0048224-A1).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Song (US-2010/0159611-A1) teaches a fluidic assay device or test format that regulates/controls the sample flow rate and modulates the manifestation of test results to reduce or eliminate errors, where the device monitors dehydration or tests ion strength of a urine sample (Song; abstract).
Sageder (US-2019/0008439-A1) teaches detection of nitrite/nitrate in urine, where a nitrate sensor enables the early detection of infections (Sageder; [0166]).
Odorzynski (US-2006/0069362-A1) teaches an absorbent article that contains a colorant that detects blood, protein, nitrate, ketones, glucose, leukocytes, urobilinogen, bilirubin and combinations comprising at least one of those substances (Odorzynski; [0004]).
Burg (US-2020/0225166-A1) teaches dipsticks used for the diagnosis of dehydration (Burg; [0033]).
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.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759