DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the claims
The amendment filed 07/22/25 is acknowledged and has been entered. Claims 16 and 21-22 have been amended. Claims 1-15 and 24 remain withdrawn as being directed to non-elected inventions. New claims 25-26 have been added. Accordingly, claims 16-23 and 25-26 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
Claim Interpretation
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.
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.
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:
“lateral flow test strip configured to retain blood cells while allowing a fluid of the blood, serum or plasma..” in claim 16.
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
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 16-23 and 25-26 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 16 is vague. In line 3 the recitation “configured to” is not clear as to how the test strip has been structurally or materially modified to retain the blood cells.
Claim 16, line 11 is vague and indefinite in reciting “the amino acids of NT-proBNP because it is unclear which amino acids the applicant is referring to. It is unclear if the applicant intends the antibodies bind to all amino acids of NT-proBNP or if the applicant is trying to claim the antibodies bind to a specific epitope of NT-proBNP consisting of specific amino acids or if the applicant intends something else. Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims.
Claim 16 is confusing in reciting “fluorescently labeled monoclonal antibodies conjugated to fluorescent microparticles” is confusing because it is unclear if the applicant intends the antibodies are labeled by the conjugation to a microparticle comprising the label, if the applicant intends the antibody is fluorescently labeled and also conjugated to a micorparticle comprising a label (ie. Both the antibody and microparticle are fluorescently labeled or if the applicant intends something else. The specification. The specification on page 17 discloses an antibody conjugated to a europium chelate polystyrene microparticle (fluorescent microparticle). Applicant is reminded that although the claims are read in light of the specification limitations from the specification are not read into the claims. Please clarify.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Jena et al. (US 2014/0072189) and Gruler et al. (US 2010/0110439, Ids Reference) in view of Katruka et al (US 2009-0163415, IDS Reference), Millipore Guide (2002;retrieved from http://www.millipore.com/publications.nsf/a73664f9f981af8c852569b9005b4eee/348ee7096d93729b85256bf40066a40d/$FILE/tb500en00.pdf).and Molecular Probes (2009, retrieved from https://assets.thermofisher.com/TFS-Assets/LSG/manuals/mp20880.pdf), Hunter et al (US 2010/0135857), Booker et al (US 2017/0177724) and further in view of Liang et al (Analytica Chimica Acta 891, 2015, pages 277-283).
Jena et al. disclose an optoelectronic reader accessory to analyze test strips with a mobile device (Fig. 1) ,the mobile device including a central processing unit (Fig. 27) , the system comprising: an optoelectronic reader accessory configured to be coupled to the mobile device, the accessory including – structure defining an aperture configured to permit light to pass into and out of the optoelectronic reader at a defined viewing axis [0023], structure defining a slot for operable insertion of the test strip, the slot being configured to orient the test strip to intersect the defined viewing axis [0023]at least one light source configured to emit light i.e. a light emitting diode [0023) a mechanism i.e. element 102(Fig.6) for to control configured to control electronic components on a circuit (Fig.8) within the optoelectronic reader and to operably communicate with the central processing unit of the mobile device [0086] when for example an out of range condition has occurred as for example low battery or out of range temperature [0078]-[0086] a control "circuit including a colored light source arranged to illuminate the in situ calibration target when activated." and [0125-0126] "a color intensity value in one color channel. ... ") at least one light source configured to emit light direct light from the at least one light source to a surface of a test zone of the test strip [0013] [0025], (figure 8 "plurality of light-emitting diodes (LEDs) 124" and [0023] "the at least one light source being arranged for illumination of the colorimetric test strip when the colorimetric test strip is registered within the slot. The at least one light source can be a light emitting diode.");an optical system configured to detect optical signals from the test strip(Fig 32) as for example a light box accessory that covers the mobile phone camera and restricts or eliminates light and aids in the alignment of the colorimetric strip with the camera, wherein the light box accessory can include a macro lens [0025];a light sensor within said housing to sense light reflected from the test strip when positioned in the test strip receiving channel ([0009] "the camera of the mobile device can be used to automatically detect the color of one or several reagent areas of the colorimetric strip." and [0023] "the at least one light source being arranged for illumination of the colorimetric test strip when the colorimetric test strip is registered within the slot.") a power source disposed within the optoelectronic reader and operatively coupled with the microcontroller, at least one light source, and the optical system [0024][0025][0070], 6Application No. 16/222,463 "the power source 57 includes a battery holder 58 that accommodates button- or coin-type batteries" and [0077]"An alternative embodiment may eliminate the power switch 52. Instead, the plurality of LEDs 124 can be activated by a switch that is internal to the light box accessory 30 and senses the presence of the colorimetric strip 56(for example, by a roller lever arm toggle micro switch or an optical path detection switch). Such an arrangement can provide the advantage of assuring that the colorimetric strip 56 is properly loaded into the light box accessory 30 before analysis images can be acquired. The arrangement can also prevent inadvertent activation of the LEDs that could drain the batteries.") The optoelectronic reader of Jena et al., is configured to communicate signals representative of optical signals from the optical system to the central processing unit of the mobile device to be analyzed to provide quantitative color values as compared to calibration color which reads on a an estimate of a concentration of an analyte as the mobile device is equipped with a software for the analysis of the colorimetric strip (Fig 1; figures 36 and 37 and [0021] "an analysis of the colorimetric strip using a software application loaded into the processor of the mobile device).
Jena et al differs from the instant invention in failing to teach a reflective surface to direct light from source to the strip for determining analyte concentration.
Gruler et al. describes an optoelectronic reader [0019] and strips [0029] for determining analyte concentration ([0206]) with reflective surfaces to direct light ([0106]). Gruler et al. further suggests that the reflective mirrors are advantageous due to providing precise light directing ([0106]), suggesting motivation to incorporate reflective surfaces. Additionally, Gruler et al. suggest that colorimetric or fluorescence data and concentration can be used to determine each other ([0139]) which can provide a quantitative measurement for the analyte for subsequent diagnostic purposes, suggesting motivation to use the data collected to determine the analyte concentration.
It would have been obvious, before the effective filing of the claimed invention to a person having ordinary skill in the art to incorporate reflective surfaces and concentration determination into the optoelectronic reader of Jena et al as suggest by Gruler et al. because this would provide for a precise light directing and a quantitative measurement for the analyte for subsequent diagnostic purposes.
As Jena et al teach the test strip comprises a reference or calibration color that can be used for calibration of the camera [0010]and therefore at the test line [0018] and Gruler et al teach quantification can be performed using an internal standard [0155][0151, one of ordinary skill would have found it obvious to assay fluorescent i.e. europium internal standard at the test line for convenience and for calibration purposes and it would have been with expectation of success that a reference measurement can be obtained when europium internal standard at the test line is measured prior to performing the lateral flow assay, wherein the reference measurement can be can used to account for a path length and light intensity as claimed as the system of the prior art is the same as claimed and therefore capable to perform the same functions (instant claims 17,21)..
The system of Jena et al and Gruler et al. is silent regarding the analyte is NT-proBNP in the blood, serum, or plasma and regarding strip component i.e. a sample pad configured to retain blood cells while allowing fluid to pass through passive wicking on the test strip, 5Application No. 16/222,463 a conjugate pad configured to release fluorescently labeled antibodies upon contact with fluid wicking on the test strip, and wherein at least one light source is configured to emit light at a wavelength between 300-400nm.
Katruka et al. discloses a fluoroimmunoassay method for measuring a NT-proBNP concentration in a plasma wherein the fluoroimmunoassay comprises monoclonal antibodies used for capture, such as 15F11 or 15C4, and monoclonal antibodies used for detection, such as Eu-labeled 24Ell or 16E6 (see paragraphs [0058], [0086], [0173]; table l; claims 52-58; figures 12, 25).
Millipore Guide teaches throughout the publication key aspects of immunochromatographic test strip design that need to be optimized for a specific analyte. Millipore Guide teaches immunochromatographic test strips are modeled after existing immunoassay formats wherein immunochromatographic test strips comprise a sample pad a conjugate pad and a test line comprising a capture reagent for the analyte i.e. antibody (Fig.1; page 1), wherein the test strip can be integrated in hand held readers (page 1 left column).. For analytes found in serum, porous media the sample pad can contain a filter that can separate cells from serum or plasma that enough volume is loaded on the immunodiagnostic test (pages 22, 36-38) which reads on configured to retain blood cells while allowing fluid to pass through passive wicking on the test strip. The conjugate pad is configured to release labeled antibodies upon contact with fluid wicking on the test strip (page 19), wherein the label can be fluorescent (page 2). The test strips of Millipore comprise a porous membrane and an absorbent pad for helping wick the sample through the porous membrane and thus Millipore is teaching a wicking membrane.
It would have been obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to have used a test strip as taught in Millipore to test for NT-proBNP analyte with the optoelectronic reader of Jena et al as suggest by Gruler et al., wherein the strip is modeled after the immunoassay formats of Katruka et al. i.e. capture antibodies are printed on the membrane and detector europium labeled anti-proBNP antibodies are placed in the conjugated pad. One would be motivated to do so as Millipore Guide teaches immunochromatographic test strips are modeled after existing immunoassay formats and reagent and because the NT-proBNP analyte concentration in serum/plasma has clinical relevance as taught in Katruka et al.
Hunter et al teaches that it is known and conventional in the art to excite europium with a wavelength of 340-360 nm and that the light emitted by the europium would be at 615 nm (e.g. para’s 0093, 0095).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the LED in the modified system of Jena et al to excite the europium label at 340-360 nm because Hunter et al shows that it is known and conventional in the art to excite europium at 340-360 nm to have it emit detection at 615 nm and also it would have been obvious to have customized the wavelengths in the UV range of 300-400 nm for application in the fluorescence mode in the optoelectronic reader of Jena et al as suggest by Gruler et al because light source/filters are available as taught in Gruler et al [0124] and thus suitable for the excitation of europium chelated taught in Katruka et al. as disclosed in Molecular Probes, see Fig. 1
One would be motivated to do so because replacing gold beads in lateral flow assays with fluorescence labels allows for a more sensitive readouts as taught in Gruler et al [0147].
Jena et al., Gruler et al., Katruka, Millipore and Hunter differ from the instant invention in failing to teach the light source is an ultraviolet light emitting diode.
Booker et al teaches that it is known and conventional in the art to illuminate a test strip with an ultraviolet light-emitting diode (UV-LED) particularly when a europium label is used (e.g. para 0076).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a UV-LED into the modified method of Jena et al because Booker shows that it is known and conventional in the art. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a UV-LED into the modified method of Jena et al.
The system of Jena et al., Gruler et al., Katruka, Millipore, Hunter and Booker is silent regarding the fluorescent Eu label being a microparticle.
Liang et al teaches that it is known and conventional in the art to utilize Europium chelate microparticles as labels in lateral flow test strips (abstract, pgs 279-280) and teaches that this allows for a lateral flow immunoassay system which provides a rapid, sensitive and reliable method for determining an analyte and is advantageous not only for the relatively low cost, simplicity and rapidity of conventional lateral flow strips, but also for the high sensitivity and photostability afforded by the EU chelate microparticles.
(e.g. abstract, Conclusion-p.282).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate Eu chelate microparticles for the Eu label in the modified system and method of Jena et al because Liang et al teaches that it is known and conventional in the art to utilize Europium chelate microparticles as labels in lateral flow test strips and teaches that this allows for a lateral flow immunoassay system which provides a rapid, sensitive and reliable method for determining an analyte and is advantageous not only for the relatively low cost, simplicity and rapidity of conventional lateral flow strips, but also for the high sensitivity and photostability afforded by the EU chelate microparticles. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating Eu chelate microparticles for the Eu label in the modified system and method of Jena et al.
Regarding claim 18, Millipore, the strip can be encased in a cassette (Fig.1), Jena et al teach the test strip is encased in an adaptor structure [0090], Fig 11; Gruler et al teach a cassette [0143].
Regarding claims 19-20, Jena et al the optoelectronic reader comprises a circuit to detect an out of range condition [0014].
Regarding claim 22, providing a filter after emission of light would have been obvious for color selection or to selectively transmit light in the emission peak of europium chelate as Gruler et al teach at least one filter is provided within the device for signal processing [0032][0044][0049][0059], wherein such filters are available to customize the wavelength range [0125] .
Regarding claim 23, providing an end pad as claimed would it would have been obvious and conventional, as taught in Millipore.
Claims 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Depa et al. (US 20170234858, published August, 2017, IDS Reference) in view of Gruler et al Katruka et al. Millipore Guide and Molecular Probes, Hunter et al (US 2010/0135857), Booker et al (US 2017/0177724) and further in view of Liang et al (Analytica Chimica Acta 891, 2015, pages 277-283).
Depa et al. teach throughout the patent and especially in abstract, a system to test for analyte in whole blood, serum, or plasma using an optoelectronic reader accessory to analyze test strips with a mobile device, the mobile device including a central processing unit (Fig.1), the system comprising:
a test strip (Fig 5) comprising reaction pad that comprises a reagent that selectively capture the analyte at the reactive zone to develop a color that can be detected by the reader for measuring the concentration of an analyte in a bodily fluid sample [0006] as for example blood [0050]-[0051](claim 13). The test strip can be housed within an adapter [0049] which reads on the instant cassette (instant claim 18).
an optoelectronic reader accessory configured to be coupled to the mobile device (Fig.1) structure defining an aperture configured to permit light to pass into and out of the optoelectronic reader at a defined viewing axis (see fig 3B, optical aperture “26”; [0036] and having a structure defining a slot for operable insertion of the test strip, the slot being configured to orient the test strip to intersect the defined viewing axis, see Fig.3b “rails 40,41”[[0037]; at least one light source configured to emit light (fig 4c, “62”, a reflective surface configured to direct light from the at least one light source to a surface of a test zone of the test strip (Fig 4c,”68”) [0042]-[0047] an optical system configured to detect optical signals from the test strip (Fig 4c,”60”) [0042]-[0047].
a microcontroller configured to control electronic components on a circuit within the optoelectronic reader and to operably communicate with the central processing unit of the mobile device [0037], a power source disposed within the optoelectronic reader and operatively coupled with the microcontroller, at least one light source, and the optical system [0037], 6Application No. 16/222,463 wherein the optical path includes a filter to detect the level of incoming lights at different wavelengths [0054](instant claim 22) suitable for the analysis of the analyte [0060].
The optoelectronic reader accessory is configured to communicate signals representative of optical signals from the optical system to the central processing unit of the mobile device to be analyzed to provide an estimate of a concentration of an analyte[0009][0010] (claim 15). The optoelectronic reader accessory can comprise a circuit sensor configured to detect an out of range condition i.e. low battery or temperature [0054][0062](Instant claims 19-20).
Depa et al. differs from the instant invention in failing to teach the analyte is NT-proBNP in the blood, serum, or plasma.and regarding strip component i.e. a sample pad configured to retain blood cells while allowing fluid to pass through passive wicking on the test strip, 5Application No. 16/222,463 a conjugate pad configured to release fluorescently labeled antibodies as claimed and wherein at least one light source is configured to emit light at a wavelength between 300-400nm.
Gruler et al , Katruka et al. Millipore Guide and Molecular Probes are relied upon as in the 103 rejection above.
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have used a test strip as taught in Millipore to test for NT-proBNP analyte with the optoelectronic reader of Depa et al. wherein the strip is modeled after the immunoassay formats of Katruka et al. i.e. capture antibodies are printed on the membrane and detector europium labeled anti-proBNP antibodies are placed in the conjugated pad and wherein optoelectronic reader is modified to comprise light source/filters for fluorescence detection as taught in Gruler et al [0124] and thus suitable for the excitation of europium chelated taught in Katruka et al. as disclosed in Molecular Probes, see Fig. 1
One would be motivated to do so as Millipore Guide teaches immunochromatographic test strips are modeled after existing immunoassay formats and reagent and because the NT-proBNP analyte concentration in serum/plasma has clinical relevance as taught in Katruka et al. and because replacing colorimetric labels in lateral flow assays with fluorescence labels allows for a more sensitive readouts as taught in Gruler et al [0147].
As Depa et al. teach mock test strips comprise a reference or calibration color that can be used for calibration of the camera and therefore at the test line [0052] and Gruler et al teach quantification can be performed using an internal standard [0155][0151, one of ordinary skill would have found it obvious to assay fluorescent i.e. europium internal standard at the test line for convenience and for calibration purposes and it would have been with expectation of success that a reference measurement can be obtained when europium internal standard at the test line is measured prior to performing the lateral flow assay, wherein the reference measurement can be can used to account for a path length and light intensity as claimed as the system of the prior art is the same as claimed and therefore capable to perform the same functions (instant claims 17,21)..
Hunter et al teaches that it is known and conventional in the art to excite europium with a wavelength of 340-360 nm and that the light emitted by the europium would be at 615 nm (e.g. para’s 0093, 0095).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the LED in the modified system of Jena et al to excite the europium label at 340-360 nm because Hunter et al shows that it is known and conventional in the art to excite europium at 340-360 nm to have it emit detection at 615 nm and also it would have been obvious to have customized the wavelengths in the UV range of 300-400 nm for application in the fluorescence mode in the optoelectronic reader of Depa et al. because light source/filters are available and can be customized to the application as taught in Depa et al. (page 12, middle paragraph)and Gruler et al and one would motivated to optimize for excitation of europium chelated taught in Katruka et al., wherein UV range of 300-400 nm is needed as disclosed in Molecular Probes, see Fig. 1.
Depa et al., Gruler et al., Katruka, Millipore and Hunter differ from the instant invention in failing to teach the light source is an ultraviolet light emitting diode.
Booker et al teaches that it is known and conventional in the art to illuminate a test strip with an ultraviolet light-emitting diode (UV-LED) particularly when a europium label is used (e.g. para 0076).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a UV-LED into the modified method of Depa et al because Booker shows that it is known and conventional in the art. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a UV-LED into the modified method of Depa et al.
The system of Depa et al., Gruler et al., Katruka, Millipore, Hunter and Booker is silent regarding the fluorescent Eu label being a microparticle.
Liang et al teaches that it is known and conventional in the art to utilize Europium chelate microparticles as labels in lateral flow test strips (abstract, pgs 279-280) and teaches that this allows for a lateral flow immunoassay system which provides a rapid, sensitive and reliable method for determining an analyte and is advantageous not only for the relatively low cost, simplicity and rapidity of conventional lateral flow strips, but also for the high sensitivity and photostability afforded by the EU chelate microparticles.
(e.g. abstract, Conclusion-p.282).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate Eu chelate microparticles for the Eu label in the modified system and method of Depa et al because Liang et al teaches that it is known and conventional in the art to utilize Europium chelate microparticles as labels in lateral flow test strips and teaches that this allows for a lateral flow immunoassay system which provides a rapid, sensitive and reliable method for determining an analyte and is advantageous not only for the relatively low cost, simplicity and rapidity of conventional lateral flow strips, but also for the high sensitivity and photostability afforded by the EU chelate microparticles. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating Eu chelate microparticles for the Eu label in the modified system and method of Depa et al.
Claim 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Jena et al in view of Gruler et al., Katruka et al ., Millipore Guide, Hunter et al., Booker et al Liang et al as applied to claims 16-23 above, and further in view of Zhou et al (US 2003/0032196).
See above for the teachings of Jena et al., Gruler et al., Katruka et al ., Millipore Guide, Hunter et al., Booker et al., and Liang et al.
Jena et al., Gruler et al., Katruka et al ., Millipore Guide, Hunter et al., Booker et al., and Liang et al. differ from the instant invention in failing to teach the test strip comprises a mesh pad wherein the mesh pad has a particle retention size of 1 to 4 microns.
Zhou et al teaches that it is known and conventional in the art to have a sample filter as part of an application pad wherein the sample filter is comprised of microfiber filters and having various pores sizes that retain blood cells while allowing liquid to pass (thus teaching a mesh pad)(e.g. para’s 0006, 0009, 0014, 0017, 0058, 0069-0070). Zhou et al discloses that the pores of sizes of 5 microns or less (e.g. para 0070).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a microfiber sample filter with the sample pad in the modified method of Jena et al because Zhou et al shows that it is known and conventional in the art. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a microfiber sample filter with the sample pad in the modified method of Jena et al. Further, the optimum pore size could be determined by routine experimentation. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Regardless, Zhou et al teaches 5 microns or less which reads on 1-4 microns.
Claim 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Depa et al in view of Gruler et al., Katruka et al ., Millipore Guide, Hunter et al., Booker et al Liang et al as applied to claims 16-23 above, and further in view of Zhou et al (US 2003/0032196).
See above for the teachings of Depa et al., Gruler et al., Katruka et al ., Millipore Guide, Hunter et al., Booker et al., and Liang et al.
Depa et al., Gruler et al., Katruka et al ., Millipore Guide, Hunter et al., Booker et al., and Liang et al. differ from the instant invention in failing to teach the test strip comprises a mesh pad wherein the mesh pad has a particle retention size of 1 to 4 microns.
Zhou et al teaches that it is known and conventional in the art to have a sample filter as part of an application pad wherein the sample filter is comprised of microfiber filters and having various pores sizes that retain blood cells while allowing liquid to pass (thus teaching a mesh pad)(e.g. para’s 0006, 0009, 0014, 0017, 0058, 0069-0070). Zhou et al discloses that the pores of sizes of 5 microns or less (e.g. para 0070).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a microfiber sample filter with the sample pad in the modified method of Depa et al because Zhou et al shows that it is known and conventional in the art. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a microfiber sample filter with the sample pad in the modified method of Depa et al. Further, the optimum pore size could be determined by routine experimentation. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation.” Application of Aller, 220 F.2d 454,456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation .” Id. At 458,105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Application of Boesch, 617 F.2d 272,276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Regardless, Zhou et al teaches 5 microns or less which reads on 1-4 microns.
Response to Arguments
Applicant’s arguments filed 07/22/25 have been considered but are moot in view of the new grounds of rejection.
Conclusion
No claims are allowed.
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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/GARY COUNTS/ Primary Examiner, Art Unit 1678