Has 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 .
Claims 1, 4, 6-8, 10-12, 16-22, and 25-26 are being prosecuted. Claim 27 is withdrawn. Claims 2, 3, 5, 9, 13-15, 23, and 24 are cancelled.
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/1/25 has been entered.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
KR 10-2017-0182705 has been received.
Claim Interpretation
4. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
5. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
6. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a.) the “diagnosis unit” is a generic placeholder and is “configured to” perform to make a diagnosis in claim 1 and output information in claims 6-8 and 16-18.
b.) the first test portion is a generic placeholder and is “configured to” to increase the color intensity thereof as a concentration of an analyte increases in claim 1
c.) the second test portion is a generic placeholder and is “configured to” decrease the color intensity thereof as the concentration of the analyte increases in claim 1
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 4, 6-8, and 22 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 4 is vague because it recites sandwich and competitive immunoassay schemes but claim 4 and previous claims do not provide reagents for sandwich and competitive immunoassay schemes in the device.
Claims 6 is vague because the terms “normal” and “abnormal” are relative terms and the claims do not recite a frame of reference to define what is considered “normal” versus “abnormal”. While claim 6 has been amended to indicate what the “normal state” and “abnormal state” indicate, the claim still does not define what constitutes a “normal state” and an “abnormal state”. Claims 7 and 8 define the “normal state” and “abnormal state” in terms of ratios. Applicants are encouraged to combine claims 6 and 7 and 6 and 8 to define the “normal state” and “abnormal state”.
Claim 22 is vague because claim 1 appears to determine pregnancy state by ratios of color intensity in the test portions but the assay formats recited in claim 22 is not clear how they are related to determination of pregnancy state.
9. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
10. Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 does not recite any limitations that further limit the components that comprise the device of claim 1. The listed methods for diagnosis do not limit the components of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
11. Claim limitation “diagnosis unit is configured to diagnose” in claim 1 and configured to output a normal or abnormal state in claims 6-8 and 16-18 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claims are not clear as to how the diagnostic unit has been modified/configured to perform the claimed functions/intended uses. There are no structural features or components recited on the diagnostic unit for performing the claimed functions/intended uses. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
12. Claim limitation “the first test portion is configured to increase the color intensity thereof as a concentration of an analyte increases, and the second test portion is configured to decrease the color intensity thereof as the concentration of the analyte increases” in claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claims are not clear as to how the test portions have been modified/configured to perform the claimed functions. There are no structural features or component recited on the diagnostic unit for performing the claimed functions/intended uses. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites
what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the
structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly
recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which
are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
13. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
14. Claim(s) 1, 4, 6-8, 10-12, 16-22, 25, and 26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Beckley (US 2020/0141953).
Beckley claims priority to provisional applications 62/503,223 (filed on 5/8/2017) and 62/460,307 (filed on 2/17/2017).
Beckley discloses devices, systems, and kits, for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect at least progesterone or analytes of progesterone in a sample (see Abstract).
In the disclosed methods, a test strip 3001 configured to evaluate urine for the presence of at least progesterone or an analyte of progesterone (e.g., PdG) optionally is configured such that the first capture region is configured such that, when used with a base unit, a first optical signal (e.g., a fluorescent signal) is capable of being detected at the first capture region. The first optical signal may be a readout for the amount of progesterone analyte (e.g., PdG) in the sample, for example, by detecting the amount of first detection reagent bound to the first capture reagent. In such cases, the first optical signal increases when the amount of first analyte present in the sample is low, and the first optical signal decreases when the amount of first analyte present in the sample is high. The optical signal at the first capture region may be proportional to the amount of first analyte present in the sample. In various aspects, the capture zone further comprises a second capture region configured to produce an optical signal likewise corresponding to the presence or absence of a second analyte. In various aspects of the systems and methods herein, the test strip 3001 is configured for utilization in conjunction with a base unit 4001, optionally configured to evaluate a test strip 3001 contained within a cartridge 4002, together comprising a diagnostic test system (see paragraph [0027]).
A diagnostic test system is provided comprising: a housing, comprising: a) a port for receiving an assay device, said assay device comprising two or more capture regions; b) a reader comprising: i) one or more light sources for illuminating said two or more capture regions; ii) one or more light detectors for detecting optical signals from said two or more capture regions; and c) a data analyzer having one or more processors configured to: A) receive said optical signals; and determine an amount of at least a first analyte and a second analyte present in a biological sample based on said optical signals, wherein an optical signal of a first of said two or more capture regions increases with decreasing amounts of said first analyte present in said biological sample, and an optical signal of a second of said two or more capture regions increases with increasing amounts of said second analyte present in said biological sample; wherein in an embodiment at least one of the said first capture region or the said second capture regions is configured to detect PdG present in a biological sample.
The diagnostic test system may include a housing for containing the components of the system. The housing can be constructed of any suitable material. The housing may be configured to receive an immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte of the disclosure. For example, the housing may include a port or opening for receiving the immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. The system may further include, contained within the housing, a reader device. The reader device may include one or more light sources for illuminating the immunoassay device or a region of the immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. In one non-limiting example, the one or more light sources are configured to illuminate the capture zone of an immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte of the disclosure. The type of light source suitable for use with the immunoassay devices will depend on the chemistry of the immunoassay device. In one particular example, the one or more light sources are used to illuminate a detectable label provided by the immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. In a particular example, the detectable label provided on the immunoassay device is a fluorophore, and therefore, the one or more light sources of the reader device should include a fluorescent light source (e.g., a light-emitting diode (LED)). It is to be understood that the wavelength of light provided by the light source of the reader device should be selected based on the excitation wavelength of the detectable label, and can readily be selected by a person of skill in the art.
The reader may be configured to illuminate the capture zone and/or the control zone of an immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte (e.g. PdG) of the disclosure. For example, the reader may be configured to illuminate the first capture region configured to signal the presence or absence of progesterone or a progesterone analyte (e.g. PdG), the second capture region, the first control region, the second control region, or any combination thereof. In some cases, the reader is configured to scan across the test strip of an immunoassay device. In such cases where the immunoassay device utilizes a single fluorophore, the reader may contain a single fluorescent light source. In cases where the immunoassay device utilizes more than one fluorophore, the reader may contain more than one fluorescent light source.
The reader may further comprise one or more light detectors (e.g., a photodetector) for detecting optical signals from the immunoassay device. Generally speaking, the one or more light detectors should be capable of distinguishing between emitted light at a first discrete position and a second discrete position on the immunoassay device. This may be accomplished by, e.g., the one or more light sources scanning across the test strip of the immunoassay device and determining the position of the emitted light on the immunoassay device.
The diagnostic test device may further comprise a data analyzer. The data analyzer may have one or more processors configured to receive an optical signal. In some cases, the data analyzer is in operable communication with a reader device. The data analyzer may be configured to determine an amount of analytes present in a sample, for example, by measuring an amount of optical signal produced at the capture zone of an immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. For example, the data analyzer may be configured to calculate the area under the curve of a signal intensity plot. The data analyzer may further be configured to determine the differences between signal intensities among the multiple discrete regions on the test strip. For example, the data analyzer may be configured to determine the difference between the signal intensity at the first capture region and the signal intensity at the second control region. The data analyzer may further be configured to determine the difference between the signal intensity at the second capture region and the signal intensity at the first control region. The data analyzer may further be configured to calculate an amount or concentration of the analytes present in the sample, in one aspect at least one of the analytes present being an analyte of progesterone (e.g. PdG). The data analyzer may be further configured to detect a binary optical pattern. The binary optical pattern can be generated by two fluorescent materials which excitation and/or emission spectrum differs in wavelength. In some cases, the binary optical pattern can be generated by one fluorescent material and one light absorbent material. The detection reagents may be conjugated with the two types of materials respectively and can be captured in the same capture zone, such that the capture zone may generate two different optical signal patterns in the data analyzer.
In various aspects, the system may comprise a housing for containing the electronic components of the system such as that shown in FIGS. 5A, 5B, and 6. The system may have a top housing and a bottom housing. The top housing may comprise a display module for displaying the results of an immunoassay configured to detect for at least the presence or absence of progesterone or a progesterone analyte as described herein. The system may further comprise a display cover. The system may further comprise a battery. The system may further comprise an optomechanics module. The optomechanics module may comprise the one or more light sources and one or more light detectors as described above. The system may further comprise a circuit board containing electronic components. The cassette or housing of the immunoassay test device configured to detect for at least the presence or absence of progesterone or a progesterone analyte may include a cavity. The chamber or receiving port of the diagnostic test system may include a ball bearing contained within the inner wall of the chamber. The ball bearing may hook or latch into the cavity of the test device, thereby locking the immunoassay test device configured to detect for at least the presence or absence of progesterone or a progesterone analyte into the receiving chamber of the diagnostic test system.
The diagnostic test system may include an optomechanics module comprising the one or more light sources for illuminating the test strip of the immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. The optomechanics module may be movable across an optical axis such that the optomechanics module moves laterally across the test strip of the immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte, thereby scanning the test strip. The diagnostic test system may further comprise an actuation module. The actuation module may comprise one or more motors configured to actuate/move the optomechanics module. In some embodiments, the motors may be coupled to a rack and pinion mechanism that is configured to translate the optomechanics module along one or more directions. For example, the optomechanics module can be translated along a longitudinal axis of the test strip of the immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. The direction(s) of translation may or may not be orthogonal to an optical axis of the optomechanics module. The direction(s) of translation may be parallel to the longitudinal axis of the test strip, and the optical axis may be orthogonal to the longitudinal axis or a planar surface of the test strip. In some cases, the direction(s) of translation need not be parallel to the longitudinal axis of the test strip, and the optical axis need not be orthogonal to the longitudinal axis (or a planar surface) of the test strip. For example, the direction(s) of translation and/or the optical axis may be at an oblique angle relative to the longitudinal axis of the test strip.
In various aspects, the diagnostic test system may include an optical configuration suitable for use with the diagnostic test system and positioning of the optics above a test strip of an immunoassay device configured to detect for at least the presence or absence of progesterone or a progesterone analyte. The optical configuration may include a light source (e.g., a light-emitting diode (LED) for illuminating the test strip. The optical configuration may further include one or more lens, a filter, optical beamsplitters, or any combination thereof. The optical configuration may further include a photodetector for detecting an optical signal from the immunoassay device configured to detect for at least the presence of progesterone or a progesterone analyte. In an example, the system is configured to an excitation/emission spectra with an excitation wavelength of 492 nm and an emission wavelength of 512 nm.
In some cases, the diagnostic test device generates measurement results (e.g., concentration or relative amounts of analytes present in the sample) from a completed assay performed on the test device, as described throughout. In some cases, the diagnostic test device displays the measurement results on a screen contained within the device. Data containing the measurement results can be transmitted from the diagnostic test device to a mobile device and/or to a server. The data may be transmitted via one or more wireless or wired communication channels. The wireless communication channels may comprise Bluetooth®, WiFi, 3G, and/or 4G networks. The data containing the measurement results may be stored in a memory on the diagnostic test device when the diagnostic test device is not in operable communication with the mobile device and/or the server. The data may be transmitted from the diagnostic test device to the mobile device and/or the server when operable communication between the diagnostic test device and the mobile device and/or the server is re-established (See paragraphs [0028] to [0035]).
Samples that can be assayed include saliva (See paragraph [0041]) and urine (see paragraph [0043]).
In embodiments of the invention, the tests utilized (optionally a “single test” which as used herein comprises one or more test strips 3001 that are disposable and altogether intended to be utilized one time to evaluate a single non-serum bodily fluid sample) incorporate a pre-defined threshold of PdG correlating in a positive result to at least the lowest amount of progesterone present and necessary to support conception. In embodiments of the invention, the tests utilized (optionally a single test) incorporate a pre-defined threshold of LH correlating in a positive result to at least the lowest amount of LH necessary to fully mature a follicle and cause rupture). In an embodiment of the invention, the pre-defined threshold of PdG is determined by a fixed amount of PdG antibody on the conjugate pad and the amount of PdG conjugate impregnated on the membrane in competitive assay form. In an embodiment of the invention, the pre-defined threshold of LH is determined by a fixed amount of LH antibody on the conjugate pad and the amount of LH antibody on the membrane in sandwich assay form. In an embodiment of the invention, the sandwich assay form and the competitive assay form are integrated together into a single test. In an embodiment of the invention, the receiving zones containing the LH antibody and the PdG antibody, and optionally antibodies of other hormones or analytes including FSH, Estrogen analyte, and hCG, are incorporated into a single conjugate pad within a single test. In an alternative embodiment of the invention, the receiving zones containing the LH antibody and the PdG antibody, and optionally antibodies of other hormones or analytes including FSH, Estrogen analyte, and hCG, are incorporated into at least two discrete conjugate pads within a single test. In an embodiment of the invention, the test strip 3001 is configured to incorporate multiple visual labels, including a test line 3003 and a visual label indicating the absence or presence of PdG 3006, a visual label indicating the absence or presence of LH, 3007, and a visual label indicating the absence or presence of estrogen or an analyte of estrogen 3008, as depicted in FIG. 4B. In an embodiment of the invention, the pre-defined threshold of PdG and/or the pre-defined threshold of LH is determined by a percentage difference from a previous test, optionally indicating a trend or fold change. In an embodiment, the test is contained within a cartridge (See paragraph [0055]).
Referring now to FIG. 4, a test strip 3001 of the present invention is shown wherein an end with a sample pad is dipped into a urine sample such that the urine sample flows up the test strip 3001 in a direction depicted by an arrow and is stopped by an adsorbent pad (i.e. a wicking pad) at an end opposite the sample pad. The sample pad is readily available from various supplies, such as SureWick Pad Materials from Millipore Sigma. The test strip 3001 includes a conjugate pad that can be a glass fiber conjugate pad saturated with colloidal gold, colored latex beads or other visual dye particles that are conjugated to anti-pregnanediol gluconoride mouse monoclonal antibodies. A membrane of the test strip 3001 can be a nitrocellulose membrane with pore size between 3 to 20 μm. At least a test line configured to detect for the presence or absence of PdG in the tested fluid 3006 and a control line 3003 are impregnated on the membrane. The membrane is supported by a backing card (See paragraph [0056]).
With respect to claim 1, the test lines for detecting multiple analytes read on the “first test portion” and “second test portion” of the instant invention.
With respect to a “diagnosis unit”, Beckley teaches a reader with one or more light sources and one or more light detectors and a data analyzer with processors to receive an optical signal and determine an amount of analyte present, including determining the differences between signal intensity (see paragraphs [0028] to [0032]). The reader and data analyzer read on the instant “diagnosis unit”. With respect to claim 1, taking ratios of the detected light is an intended use and thus does not provide a structural limitation of the claimed diagnostic unit that distinguishes over the instant claims. With respect to claims 6-8 and 16-18, using the ratio of detected light is an intended use and thus does not provide a structural limitation of the claimed diagnostic unit that distinguishes over the conflicting claims. Conversely, the determination of ratios could also be considered a functional limitation. If so, given the lack of specific components recited in the instant claims, the data analyzer of Beckley appears to be capable of analyzing data in the form of calculating ratios of the detected signal from each test portion.
With respect to the limitations from cancelled claim 3 which have been incorporated into claim 1, Beckley teaches a sandwich assay and a competitive assay on the same test strip. In a sandwich assay, the amount of signal is a direct indication of how much analyte is bound. Thus, the amount of signal increase as the amount of analyte increase. In a competitive assay, the amount of signal is inversely proportional to the amount of analyte that is present. Thus, the amount of signal decreases as the amount of the amount of analyte increases.
With respect to claims 4 and 22, Beckley teaches sandwich and competitive immunoassay schemes on the same test strip.
15. The 102(a)(2) rejection over Nahm et al (US Patent 7,371,582) is withdrawn in view of Applicant’s amendments.
Double Patenting
16. The nonstatutory double patenting rejection over claims 1-13 of U.S. Patent No. 10,254,232 is withdrawn in view of Applicant’s amendments.
Response to Arguments
17. Applicant's arguments filed 12/1/25 have been fully considered but they are not persuasive.
Applicant’s argue that Beckley fails to show all of the claimed features in amended claim 1.
Applicant’s amendments have been considered but are not convincing to distinguish the instant invention over Beckley for the reasons set forth above.
Conclusion
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
2/21/2026