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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/10/2026 has been entered.
Response to Amendment
The Amendment filed 02/13/2026 has been entered. Claims 1-27 remain pending in the application. Claims 10-20 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-9, 21-23, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Fei et al. (US 20200150048 A1) in view of Meissner et al. (Meissner PE, Musoke P, Okwera A, Bunn JE, Coulter JB. The value of urine testing for verifying adherence to anti-tuberculosis chemotherapy in children and adults in Uganda. Int J Tuberc Lung Dis, Jan. 2002; 6(10): 903-8; cited in the IDS filed 02/21/2023).
Regarding claim 1, Fei teaches a test apparatus (abstract; paragraphs [0097],[0099]; Figs. 5-8) for detecting a drug metabolite (paragraphs [0097],[0099]), the test apparatus comprising:
a control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17) including a control substrate (gas generating pad 16), the control strip including at least two reagents on the control substrate (paragraph [0024] teaches ammonium salt and alkaline buffer salt treated on the same pad, i.e. gas generating pad, with a distance between both), the at least two reagents configured to make a reactive gas upon mixing (paragraph [0137] teaches the ammonium salt and alkaline buffer salt reacts to generate a gas); and
an indicator strip (Figs. 5-8, symbol display layer 2) including an indicator substrate (indicator 21), the indicator strip including a color change reagent on the indicator substrate (paragraphs [0006],[0100],[0105] teaches the indicator 21 is capable of changing color to display a symbol; paragraph [0107] teaches the indicator is an acid-base indicator, i.e. color change reagent), the color change reagent configured to form a colored compound upon reaction with a biomarker and the reactive gas (paragraph [0006],[0100],[0104]-[0105],[0128] teaches ammonia gas contacts the indicator to change the color of the indicator; paragraph [0105] teaches the detection line exhibits a color that can be recognized, such as a positive result after detection; paragraph [0124] teaches when HcG content is higher than a lowest detection value, a color line becomes visible; therefore, the indicator 21 forms a colored compound upon reaction with a target analyte and the reactive gas);
wherein the control substrate (Figs. 5-8, gas generating pad 16) is distinct and separate from the indicator substrate (Figs. 5-8, indicator 21) and the control substrate is spaced from the indicator substrate by a distance (Figs. 5-8);
wherein the test apparatus exhibits a length measured in a longitudinal direction (Fig. 5, interpreted as the length in the longitudinal direction from the left and right of Fig. 5, i.e. from element 12 towards element 8) , a width measured is a transverse direction that is perpendicular to the longitudinal direction (Fig. 5, interpreted as the width in the transverse direction, i.e. vertical direction, from element 11 towards element 2, which is perpendicular to the longitudinal direction from the left and right of Fig. 5, i.e. from element 12 towards element 8), and a thickness measured perpendicular to the longitudinal direction and the transverse direction (Figs. 6-7, interpreted as the thickness measured along line 171, which is perpendicular to the directions of Fig. 5), wherein the length is greater than the width (Fig. 5, the left and right length of Fig. 5 is less than the up and down width of Fig. 5); and
wherein the indicator strip (Figs. 5-8, symbol display layer 2) is spaced from the control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17) in the transverse direction (Fig. 5 shows element 2 is spaced in a transverse direction from elements 13,16,18; the transverse direction, i.e. vertical direction, being from element 11 towards element 2).
While Fei teaches detection of drug or drug metabolites (paragraph [0097], [0099], [0103]), and gas from the gas generating reagent can be generated by mixing different substances with the liquid sample (paragraph [0108]), Fei fails to teach: the control strip including at least three reagents on the control substrate, the at least three reagents configured to make a reactive gas upon mixing; and the width is greater than the thickness.
Meissner teaches a test apparatus (abstract teaches a urine dipstick for detection of INH; page 904, Figure) for detecting a drug metabolite (abstract teaches a urine dipstick for detection of INH), the test apparatus comprising: a control strip (page 904, Figure, interpreted as the strips or bands of chloramine T and potassium thiocyanate in citric acid) including at least three reagents (page 904, Figure , chloramine T, potassium thiocyanate, citric acid) formulated to make a reactive gas upon mixing (page 904, section “Detection of isoniazid” teaches cyanogen chloride, i.e. reactive gas, is produced by mixing the potassium thiocyanate in citric acid with chloramine T); and an indicator strip (page 904, Figure, interpreted as the strip or band of barbituric acid) spaced from the control strip by a distance (page 904, Figure shows the strip of barbituric acid is spaced from the strips of chloramine T and potassium thiocyanate in citric acid), the indicator strip including a color change reagent (page 904, Figure, barbituric acid; page 904, section “Detection of isoniazid” teaches barbituric acid changes to form a dark blue color, i.e. color change reagent) formulated to form a colored compound upon reaction with a biomarker and the reactive gas (page 904, section “Detection of isoniazid” teaches barbituric acid changes to form a dark blue polymethine dye upon reaction with INH and the cyanogen chloride). Meissner teaches an aim to study usefulness of urine tests for monitoring drug treatment of patients with tuberculosis (page 903, right column, first full paragraph). Meissner teaches to detect INH metabolites, the Arkansas method was used which includes three reagents: chloramine-T, potassium thiocyanate, and citric acid; which causes barbituric acid to change to a clear blue color in positive samples (page 904, section “detection of isoniazid”). Meissner teaches the test strips can be produced easily and have high sensitivity and specificity (page 907, conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control substrate and color change reagent of Fei to incorporate the teachings of the use of three reagents chloramine-T, potassium thiocyanate, and citric acid which mix to form cyanogen chloride to cause a color change in an indicator to indicate a positive sample of Meissner (page 904, section “detection of isoniazid”; page 904, Figure) to provide: the control strip including at least three reagents on the control substrate, the at least three reagents configured to make a reactive gas upon mixing. Doing so would have a reasonable expectation of successfully utilizing known reagents for detection of drug metabolites with high sensitivity and specificity (Meissner, page 907, conclusion).
Furthermore, since Meissner teaches the use of three reagents (i.e. chloramine-T, potassium thiocyanate, and citric acid) and an color change reagent (barbituric acid) for the function of detection of drug metabolites are known (page 904, section “detection of isoniazid”; page 904, Figure), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the control substrate and color change reagent of Fei to incorporate the teachings of the use of three reagents chloramine-T, potassium thiocyanate, and citric acid which mix to form cyanogen chloride to cause a color change in a color change reagent to indicate a positive sample of Meissner (page 904, section “detection of isoniazid”; page 904, Figure) to provide: the control strip including at least three reagents on the control substrate, the at least three reagents configured to make a reactive gas upon mixing. I.e. It would have been obvious to have substituted one known element (Fei’s control substrate and color change reagent) for another (Fei’s control substrate, which includes chloramine-T, potassium thiocyanate, and citric acid, and Fei’s color change reagent), and the results of the substitution would have been predictable (detection of drug metabolites with high sensitivity and specificity as discussed by Meissner, page 907, conclusion). See MPEP 2143(I)(B).
Modified Fei fails to teach: the width is greater than the thickness.
MPEP 2144.04(IV)(A) discusses where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the width and or thickness of the test apparatus of modified Fei to provide: the width is greater than the thickness. Doing so would have been an obvious change in size/proportion which would not perform differently than the prior art device (In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Additionally, MPEP 2144.05 (II)(B) holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the design and fabrication of Fei’s detection device includes a transverse width (Fig. 5 shows element 2 is spaced in a transverse direction from elements 13,16,18; the transverse direction, i.e. vertical direction, being from element 11 towards element 2) between the indicator strip (Figs. 5-8, symbol display layer 2) and control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17), which would affect the area and volume of the reaction between the indicator and control strip. Additionally, the detection device includes a thickness (Fig. 6, interpreted as the dimension along line 171), which would affect the volume and area of detection of a sample. Thus, the width and thickness are result effective variables.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the width and or thickness of the test apparatus of modified Fei to provide: the width is greater than the thickness through routine experimentation (see MPEP 2144.05 (II)). I.e., it would have been obvious to design and adjust the test apparatus to modify the result-effective variables (e.g. width and thickness), and arrive at the claimed width is greater than the thickness through routine optimization of workable dimensions to optimize the area and volume of reaction space between the indicator and control strip, and volume and area of detection of a sample.
Regarding claim 2, modified Fei further teaches wherein the at least three reagents include sodium chloro(4-methylbenzene-1-sulfonyl)azanide, 2-hydroxypropane-1,2,3-tricarboxylic acid, and potassium thiocyanate (see above claim 1; modified Fei in combination of Meissner teaches three reagents of chloramine-T, i.e. chloro(4-methylbenzene-1-sulfonyl)azanide, potassium thiocyanate, and citric acid, i.e. 2-hydroxypropane-1,2,3-tricarboxylic acid; Meissner, page 904, section “detection of isoniazid”).
Regarding claim 4, Fei further teaches the test apparatus of claim 1, further comprising a test packaging at least partially sealing one or more portions of the control strip and indicator strip from an external environment (Figs. 5-8 and paragraph [0117] teaches the gas channel 22 is closed, and structural elements, such as elements 2 and 11, which at last partially seals one or more portions of elements 16 and 21 from an external environment).
Regarding claim 5, modified Fei fails to teach: wherein: the test packaging includes a base having a control strip channel formed therein and an indicator strip channel formed therein and spaced the distance from the control strip channel; the control strip is disposed in the control strip channel; and the indicator strip is disposed in the indicator strip channel.
Fei teaches embodiments (Figs. 18-22) comprising test packaging (detection cassette 40) comprising a bottom plate (41) and cover plate (41). Fei’s test packaging (Figs. 19-20) includes a control strip channel formed therein (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1) and an indicator strip channel formed therein (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2) and spaced the distance from the control strip channel (Figs. 19-20); the control strip is disposed in the control strip channel (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1); and the indicator strip is disposed in the indicator strip channel (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2). Fei teaches a strip channel in a base of a test packaging (Figs. 23-25, channel of support surface 61) for carrying a strip (Figs. 23-25; paragraphs [0156]-[0158]). Fei teaches the space for gas can be closed (paragraph [0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the test packaging of modified Fei to incorporate the teachings of a test packaging including a cover and bottom with channels that enclose and support various strips of Fei (Figs. 18-25) to provide: wherein: the test packaging includes a base having a control strip channel formed therein and an indicator strip channel formed therein and spaced the distance from the control strip channel; the control strip is disposed in the control strip channel; and the indicator strip is disposed in the indicator strip channel. Doing so would have a reasonable expectation of successfully improving enclosure, support, and handling of the control strip and indicator strip for use by an operator.
Regarding claim 6, modified Fei fails to teach: wherein the test packaging includes a cover sized and shaped to seal around at least a portion of a periphery of the base to at least partially seal one or more portions of the control strip and indicator strip therebetween and the cover includes an access port in an initial region thereof and a window in a terminal region thereof.
Fei teaches embodiments (Figs. 18-22) comprising test packaging (detection cassette 40) comprising a bottom plate (41) and cover plate (41). Fei’s test packaging (Figs. 19-20) includes a control strip channel formed therein (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1) and an indicator strip channel formed therein (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2) and spaced the distance from the control strip channel (Figs. 19-20); the control strip is disposed in the control strip channel (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1); and the indicator strip is disposed in the indicator strip channel (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2). Fei teaches a strip channel in a base of a test packaging (Figs. 23-25, channel of support surface 61) for carrying a strip (Figs. 23-25; paragraphs [0156]-[0158]). Fei teaches the space for gas can be closed (paragraph [0117]). Fei teaches the cover plate (Fig. 19) includes an access port (45) for adding a sample in an initial region (paragraph [0144]) and a window (43) for observing the final detection results in a terminal region (paragraph [0144]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the test packaging of modified Fei to incorporate the teachings of a test packaging including a cover with a window and a bottom with channels that enclose and support various strips of Fei (Figs. 18-25) to provide: wherein the test packaging includes a cover sized and shaped to seal around at least a portion of a periphery of the base to at least partially seal one or more portions of the control strip and indicator strip therebetween and the cover includes an access port in an initial region thereof and a window in a terminal region thereof. Doing so would have a reasonable expectation of successfully improving enclosure, support, and handling of the control strip and indicator strip for use by an operator and additionally improving sample addition and observing of results of the test apparatus as discussed by Fei (paragraph [0144]).
Regarding claim 7, modified Fei fails to teach: wherein the cover includes one or more of an orientation marker or a test identifier.
Fei teaches embodiments (Figs. 18-22) comprising test packaging (detection cassette 40) comprising a bottom plate (41) and cover plate (41). Fei’s test packaging (Figs. 19-20) includes a control strip channel formed therein (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1) and an indicator strip channel formed therein (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2) and spaced the distance from the control strip channel (Figs. 19-20); the control strip is disposed in the control strip channel (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1); and the indicator strip is disposed in the indicator strip channel (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2). Fei teaches a strip channel in a base of a test packaging (Figs. 23-25, channel of support surface 61) for carrying a strip (Figs. 23-25; paragraphs [0156]-[0158]). Fei teaches the space for gas can be closed (paragraph [0117]). Fei teaches the cover plate (Fig. 19, element 42) comprises one or more of an orientation marker or a test identifier (Fig. 19 shows an arrow adjacent to element 45 and markers “C” and “T” adjacent to the window 43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cover of modified Fei to incorporate the teachings of various orientation markers and test identifiers of Fei (Fig. 19) to provide: wherein the cover includes one or more of an orientation marker or a test identifier. Doing so would have a reasonable expectation of successfully improving ease of operability and identification of desired areas of the test apparatus by a user.
Regarding claim 8, Fei further teaches wherein the indicator strip (Figs. 5-8, symbol display layer 2) is substantially parallel to the control strip (Figs. 5-8, shows element 2 is parallel to the control strip, i.e. labelled pad 13, gas generating pad 16, and detecting pad 17).
Regarding claim 9, modified Fei fails to teach: wherein the biomarker includes one or more of 4-pyridinecarboxylic acid hydrazide, 4-pyridinecarboxylic acid, or derivatives thereof.
Meissner teaches detection of INH metabolites (abstract; page 94, section “Detection of isoniazid”). Note that instant specification, paragraph [0024] describes 4-pyridinecarboxylic acid hydrazide as "INH”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control substrate and color change reagent of Fei to incorporate the teachings of the use of three reagents chloramine-T, potassium thiocyanate, and citric acid which mix to form cyanogen chloride to cause a color change in an indicator to indicate a positive sample of Meissner (page 904, section “detection of isoniazid”; page 904, Figure) to provide: wherein the biomarker includes one or more of 4-pyridinecarboxylic acid hydrazide, 4-pyridinecarboxylic acid, or derivatives thereof. Doing so would have a reasonable expectation of successfully utilizing known reagents for detection of drug metabolites, such as INH metabolites, with high sensitivity and specificity (Meissner, page 907, conclusion).
Furthermore, since Meissner teaches the use of three reagents (i.e. chloramine-T, potassium thiocyanate, and citric acid) and an color change reagent (barbituric acid) for the function of detection of drug metabolites are known (page 904, section “detection of isoniazid”; page 904, Figure), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control substrate and color change reagent of Fei to incorporate the teachings of the use of three reagents chloramine-T, potassium thiocyanate, and citric acid which mix to form cyanogen chloride to cause a color change in a color change reagent to indicate a positive sample of Meissner (page 904, section “detection of isoniazid”; page 904, Figure) to provide: wherein the biomarker includes one or more of 4-pyridinecarboxylic acid hydrazide, 4-pyridinecarboxylic acid, or derivatives thereof. I.e. It would have been obvious to have substituted one known element (Fei’s control substrate and color change reagent) for another (Fei’s control substrate, which includes chloramine-T, potassium thiocyanate, and citric acid, and Fei’s color change reagent), and the results of the substitution would have been predictable (detection of the biomarker including 4-pyridinecarboxylic acid hydrazide or derivatives thereof). See MPEP 2143(I)(B).
Regarding claim 21, Fei further teaches wherein the indicator strip is free of one or more of the at least three reagents (paragraphs [0006],[0100],[0105] teaches the indicator 21 is capable of changing color to display a symbol; paragraph [0107] teaches the indicator is an acid-base indicator, i.e. color change reagent; Figs 5-8 shows indicator 21 is spaced from the gas generating pad 16; therefore, the indicator 21 is free of the reagents of the control substrate since they are separated and comprise different reagents).
Regarding claim 22, Fei teaches a test apparatus (abstract; paragraphs [0097],[0099]; Figs. 5-8) for detecting a drug metabolite (paragraphs [0097],[0099]), the test apparatus comprising:
a control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17) including a control substrate (gas generating pad 16), the control strip including at least two reagents on the control substrate (paragraph [0024] teaches ammonium salt and alkaline buffer salt treated on the same pad, i.e. gas generating pad, with a distance between both), the at least two reagents configured to make a reactive gas upon mixing, the control strip including a control section (paragraph [0137] teaches the ammonium salt and alkaline buffer salt reacts to generate a gas); and
an indicator strip (Figs. 5-8, symbol display layer 2) including an indicator substrate (indicator 21), including a color change reagent on the indicator substrate (paragraphs [0006],[0100],[0105] teaches the indicator 21 is capable of changing color to display a symbol; paragraph [0107] teaches the indicator is an acid-base indicator, i.e. color change reagent), the color change reagent configured to form a colored compound upon reaction with a biomarker and the reactive gas (paragraph [0006],[0100],[0104]-[0105],[0128] teaches ammonia gas contacts the indicator to change the color of the indicator; paragraph [0105] teaches the detection line exhibits a color that can be recognized, such as a positive result after detection; paragraph [0124] teaches when HcG content is higher than a lowest detection value, a color line becomes visible; therefore, the indicator 21 forms a colored compound upon reaction with a target analyte and reactive gas), the indicator strip including a test section (Figs. 5-8, interpreted as the area or section of indicator 21) configured to indicate the presence of a biomarker in a biological sample (paragraph [0105] teaches the detection line exhibits a color that can be recognized, such as a positive result after detection; paragraph [0124] teaches when HcG content is higher than a lowest detection value, a color line becomes visible);
wherein the control substrate (Figs. 5-8, gas generating pad 16) is distinct and separate from the indicator substrate (Figs. 5-8, indicator 21) and the control substrate is spaced from the indicator substrate by a distance (Figs. 5-8);
wherein the control strip is free of the test section and the indicator strip is free of the control section (paragraphs [0006],[0100],[0105] teaches the indicator 21 is capable of changing color to display a symbol; paragraph [0107] teaches the indicator is an acid-base indicator, i.e. color change reagent; Figs 5-8 shows indicator 21 is spaced from the gas generating pad 16; therefore, the indicator 21 is free of the reagents of the control substrate);
wherein the test apparatus exhibits a length measured in a longitudinal direction (Fig. 5, interpreted as the length in the longitudinal direction from the left and right of Fig. 5, i.e. from element 12 towards element 8) , a width measured is a transverse direction that is perpendicular to the longitudinal direction (Fig. 5, interpreted as the width in the transverse direction, i.e. vertical direction, from element 11 towards element 2, which is perpendicular to the longitudinal direction from the left and right of Fig. 5, i.e. from element 12 towards element 8), and a thickness measured perpendicular to the longitudinal direction and the transverse direction (Figs. 6-7, interpreted as the thickness measured along line 171, which is perpendicular to the directions of Fig. 5), wherein the length is greater than the width (Fig. 5, the left and right length of Fig. 5 is less than the up and down width of Fig. 5); and
wherein the indicator strip (Figs. 5-8, symbol display layer 2) is spaced from the control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17) in the transverse direction (Fig. 5 shows element 2 is spaced in a transverse direction from elements 13,16,18; the transverse direction, i.e. vertical direction, being from element 11 towards element 2).
While Fei teaches detection of drug or drug metabolites (paragraph [0097], [0099], [0103]), and gas from the gas generating reagent can be generated by mixing different substances with the liquid sample (paragraph [0108]), Fei fails to teach: the control strip including at least three reagents on the control substrate, the at least three reagents configured to make a reactive gas upon mixing; and the width is greater than the thickness.
Meissner teaches a test apparatus (abstract teaches a urine dipstick for detection of INH; page 904, Figure) for detecting a drug metabolite (abstract teaches a urine dipstick for detection of INH), the test apparatus comprising: a control strip (page 904, Figure, interpreted as the strips or bands of chloramine T and potassium thiocyanate in citric acid) including at least three reagents (page 904, Figure , chloramine T, potassium thiocyanate, citric acid) formulated to make a reactive gas upon mixing (page 904, section “Detection of isoniazid” teaches cyanogen chloride, i.e. reactive gas, is produced by mixing the potassium thiocyanate in citric acid with chloramine T); and an indicator strip (page 904, Figure, interpreted as the strip or band of barbituric acid) spaced from the control strip by a distance (page 904, Figure shows the strip of barbituric acid is spaced from the strips of chloramine T and potassium thiocyanate in citric acid), the indicator strip including a color change reagent (page 904, Figure, barbituric acid; page 904, section “Detection of isoniazid” teaches barbituric acid changes to form a dark blue color, i.e. color change reagent) formulated to form a colored compound upon reaction with a biomarker and the reactive gas (page 904, section “Detection of isoniazid” teaches barbituric acid changes to form a dark blue polymethine dye upon reaction with INH and the cyanogen chloride). Meissner teaches an aim to study usefulness of urine tests for monitoring drug treatment of patients with tuberculosis (page 903, right column, first full paragraph). Meissner teaches to detect INH metabolites, the Arkansas method was used which includes three reagents: chloramine-T, potassium thiocyanate, and citric acid; which causes barbituric acid to change to a clear blue color in positive samples (page 904, section “detection of isoniazid”). Meissner teaches the test strips can be produced easily and have high sensitivity and specificity (page 907, conclusion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control substrate and color change reagent of Fei to incorporate the teachings of the use of three reagents chloramine-T, potassium thiocyanate, and citric acid which mix to form cyanogen chloride to cause a color change in an indicator to indicate a positive sample of Meissner (page 904, section “detection of isoniazid”; page 904, Figure) to provide: the control strip including at least three reagents on the control substrate, the at least three reagents configured to make a reactive gas upon mixing. Doing so would have a reasonable expectation of successfully utilizing known reagents for detection of drug metabolites with high sensitivity and specificity (Meissner, page 907, conclusion).
Furthermore, since Meissner teaches the use of three reagents (i.e. chloramine-T, potassium thiocyanate, and citric acid) and an color change reagent (barbituric acid) for the function of detection of drug metabolites are known (page 904, section “detection of isoniazid”; page 904, Figure), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control substrate and color change reagent of Fei to incorporate the teachings of the use of three reagents chloramine-T, potassium thiocyanate, and citric acid which mix to form cyanogen chloride to cause a color change in a color change reagent to indicate a positive sample of Meissner (page 904, section “detection of isoniazid”; page 904, Figure) to provide: the control strip including at least three reagents on the control substrate, the at least three reagents configured to make a reactive gas upon mixing. I.e. It would have been obvious to have substituted one known element (Fei’s control substrate and color change reagent) for another (Fei’s control substrate, which includes chloramine-T, potassium thiocyanate, and citric acid, and Fei’s color change reagent), and the results of the substitution would have been predictable (detection of drug metabolites with high sensitivity and specificity as discussed by Meissner, page 907, conclusion). See MPEP 2143(I)(B).
Modified Fei fails to teach: the width is greater than the thickness.
MPEP 2144.04(IV)(A) discusses where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the width and or thickness of the test apparatus of modified Fei to provide: the width is greater than the thickness. Doing so would have been an obvious change in size/proportion which would not perform differently than the prior art device (In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Additionally, MPEP 2144.05 (II)(B) holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the design and fabrication of Fei’s detection device includes a transverse width (Fig. 5 shows element 2 is spaced in a transverse direction from elements 13,16,18; the transverse direction, i.e. vertical direction, being from element 11 towards element 2) between the indicator strip (Figs. 5-8, symbol display layer 2) and control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17), which would affect the area and volume of the reaction between the indicator and control strip. Additionally, the detection device includes a thickness (Fig. 6, interpreted as the dimension along line 171), which would affect the volume and area of detection of a sample. Thus, the width and thickness are result effective variables.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the width and or thickness of the test apparatus of modified Fei to provide: the width is greater than the thickness through routine experimentation (see MPEP 2144.05 (II)). I.e., it would have been obvious to design and adjust the test apparatus to modify the result-effective variables (e.g. width and thickness), and arrive at the claimed width is greater than the thickness through routine optimization of workable dimensions to optimize the area and volume of reaction space between the indicator and control strip, and volume and area of detection of a sample.
Regarding claim 23, Fei further teaches wherein each of the control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 17) and the indicator strip (Figs. 5-8, symbol display layer 2) includes material configured to move a biological sample therethrough (paragraph [0115] teaches a sample flows through the labelled pad 13, gas generating pad 16, and detecting pad 17, therefore the control strip includes a material capable of moving a biological sample therethrough; paragraph [0112] teaches the symbol display layer 2 can include a gas and/or water-permeable layer, therefore the control strip includes a material capable of moving a biological sample therethrough, since a biological sample can move through a gas or water-permeable layer).
Regarding claim 25, Fei further teaches the test apparatus of claim 23, wherein: the material configured to move the biological sample therethrough of the control strip includes a wicking material (paragraph [0115] teaches a sample flows through the labelled pad 13, gas generating pad 16, and detecting pad 17); therefore, the material is interpreted as a wicking material since sample flows sequentially between the pads) and extends substantially along an entire length of the control strip (Fig. 5 and [0115] teaches a sample sequentially flows from the labelled pad 13, gas generating pad 16, and detecting pad 17; therefore, the wicking material extends substantially along the entire length of the control strip); the material configured to move the biological sample therethrough of the indicator strip includes a wicking material and extends substantially along an entire length of the indicator strip (paragraph [0112] teaches the symbol display layer 2 can include a gas and/or water-permeable layer, therefore the control strip is interpreted as a wicking material capable of moving a biological sample therethrough, since a biological sample can move through a gas or water-permeable layer; and the symbol display layer 2 can include a gas and/or water-permeable layer is interpreted as a material that extends along the entire length of symbol display layer 2, i.e. indicator strip).
Regarding claim 27, modified Fei fails to teach: wherein the window is positioned above at least the control section of the control strip and the test section of the indicator strip, the control section proximate to one side of the window and the test section proximate to an opposing side of the window.
Fei teaches embodiments (Figs. 18-22) comprising test packaging (detection cassette 40) comprising a bottom plate (41) and cover plate (41). Fei’s test packaging (Figs. 19-20) includes a control strip channel formed therein (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1) and an indicator strip channel formed therein (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2) and spaced the distance from the control strip channel (Figs. 19-20); the control strip is disposed in the control strip channel (Figs. 19-20 teaches a channel in the bottom plate 41 which is shaped to hold the strip 1); and the indicator strip is disposed in the indicator strip channel (Fig. 20 teaches a channel or groove formed in cover plate 42 which hold layer 2). Fei teaches a strip channel in a base of a test packaging (Figs. 23-25, channel of support surface 61) for carrying a strip (Figs. 23-25; paragraphs [0156]-[0158]). Fei teaches the space for gas can be closed (paragraph [0117]). Fei teaches the cover plate (Fig. 19) includes an access port (45) for adding a sample in an initial region (paragraph [0144]) and a window (43) for observing the final detection results in a terminal region (paragraph [0144]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the test packaging of modified Fei to incorporate the teachings of a test packaging including a cover with a window and a bottom with channels that enclose and support various strips of Fei (Figs. 18-25) to provide: wherein the window is positioned above at least the control section of the control strip and the test section of the indicator strip, the control section proximate to one side of the window and the test section proximate to an opposing side of the window. Doing so would have a reasonable expectation of successfully improving observing of results of the control section and test section of the test apparatus as discussed by Fei (paragraph [0144]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fei in view of Meissner as applied to claim 1 above, and further in view of Lim et al. (US 20210164974 A1).
Regarding claim 3, while Fei teaches a detection pad with a detection line and quality control line (Figs. 5-8 and paragraph [0095], elements 171, 172), modified Fei fails to teach: wherein the control strip includes an additional color change reagent configured to form an additional colored compound upon reaction with the biomarker or a biomarker analogue.
Lim teaches a chromatographic strip comprising a plurality of test lines and a control line for qualitatively or quantitatively analyzing a target material (abstract; Figs. 3-4). Lim teaches that by having additional test lines to allow multiple competition reactions to take place, the chromatographic strip allows the intensity of test line signals to be compared among the test lines or with the intensity of a control line signal can be used to quantify the analyte over a wide dynamic range of analyte concentration (paragraph [0007]). Lim teaches in order to determine the analyte contained in a sample not only qualitatively but also quantitatively, two or more test lines have been immobilized to the detection pad to form “multiple competition assay test lines” (paragraph [0028]). Lim teaches the test lines comprises a predetermined amount of an analyte or analyte analog (paragraph [0032]). Lim teaches the strip improved sensitivity to an analyte and improved quantitative analytical capabilities compared to conventional chromatographic analysis methods (paragraph [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control strip of modified Fei to incorporate the teachings of a chromatographic strip comprising multiple test lines of Lim (Figs. 3-4; paragraphs [0007],[0028],[0032]) and the teachings of a detection pad with a detection line and quality control line of Fei (Figs. 5-8 and paragraph [0095], elements 171, 172) to provide: wherein the control strip includes an additional color change reagent configured to form an additional colored compound upon reaction with the biomarker or a biomarker analogue. Doing so would have a reasonable expectation of successfully improving sensitivity to an analyte and allowing for improved quantitative analysis of the analyte on the control strip (Lim, paragraphs [0028],[0043]).
Allowable Subject Matter
Claims 24 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is suggested to incorporate all of the limitations of claim 24 or claim 26, and any intervening claims, into the independent claims 1 and 22.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 24, the closest prior art of Fei et al. (US 20200150048 A1) in view of Meissner et al. (Meissner PE, Musoke P, Okwera A, Bunn JE, Coulter JB. The value of urine testing for verifying adherence to anti-tuberculosis chemotherapy in children and adults in Uganda. Int J Tuberc Lung Dis, Jan. 2002; 6(10): 903-8; cited in the IDS filed 02/21/2023) fails to teach: the test apparatus of claim 23, wherein: the material configured to move the biological sample therethrough of the control strip extends from a portion of the control strip adjacent to an access port to the control section; the material configured to move the biological sample therethrough of the indicator strip extends from a portion of the indicator strip adjacent to the access port to the test section; and the access port is configured to allow the biological sample to the control strip and the indicator strip.
A reference Zuaretz et al. (US 20100173423 A1; cited in the OA filed 08/04/2025) teaches two test strips with equal lengths (Fig. 1), the two test strips extending from an access port (sample application site 40). However, Zuaretz fails to teach or suggest all of the limitations of claim 24 and fails to teach or suggest motivation to have modified Fei’s control strip and/or indicator strip to arrive at the limitations of claim 24.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 24. Therefore, claim 24 is deemed allowable.
Regarding claim 26, the closest prior art of Fei et al. (US 20200150048 A1) further teaches wherein each of the control strip and the indicator strip exhibit a length measured in the longitudinal direction (Fig. 5). The closest prior art of Fei et al. (US 20200150048 A1) in view of Meissner et al. (Meissner PE, Musoke P, Okwera A, Bunn JE, Coulter JB. The value of urine testing for verifying adherence to anti-tuberculosis chemotherapy in children and adults in Uganda. Int J Tuberc Lung Dis, Jan. 2002; 6(10): 903-8; cited in the IDS filed 02/21/2023) fails to teach: the length of the control strip is equal to the length of the indicator strip. None of the prior art teaches or suggest motivation to have modified the length of Fei’s control strip (Figs. 5-8, interpreted as labelled pad 13, gas generating pad 16, and detecting pad 18) and/or indicator strip (Figs. 5-8, symbol display layer 2) to be equal in length.
A reference Deutsch (US 3011874 A; cited in the OA filed 08/04/2025) teaches an indicator strip (Figs. 1-2), where the length of the gas liberation band is the same as that of the reaction band (column 5, lines 12-14). However, Deutsch fails to teach or suggest all of the limitations of claim 26 and fails to teach or suggest motivation to have modified the length of Fei’s control strip and/or indicator strip to have equal lengths.
A reference Zuaretz et al. (US 20100173423 A1; cited in the OA filed 08/04/2025) teaches two test strips with equal lengths (Fig. 1), the two test strips extending from an access port (sample application site 40). However, Zuaretz fails to teach or suggest all of the limitations of claim 26 and fails to teach or suggest motivation to have modified the length of Fei’s control strip and/or indicator strip to have equal lengths.
None of the prior art teaches or fairly suggests, alone or in combination, all of the limitations of claim 26. Therefore, claim 26 is deemed allowable.
Response to Arguments
Applicant’s arguments, see pages 8-10, filed 02/13/2026, with respect to rejections under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejections under 35 U.S.C. 112(a) of 12/16/2025 have been withdrawn.
Applicant’s arguments, see pages 10-11, filed 02/13/2026, with respect to the rejection(s) of claims 1-2, 4-9, and 21-22 under 35 U.S.C. 103, specifically regarding amended claims 1 and 22, 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 Fei et al. (US 20200150048 A1) in view of Meissner et al. (Meissner PE, Musoke P, Okwera A, Bunn JE, Coulter JB. The value of urine testing for verifying adherence to anti-tuberculosis chemotherapy in children and adults in Uganda. Int J Tuberc Lung Dis, Jan. 2002; 6(10): 903-8; cited in the IDS filed 02/21/2023).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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