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 .
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.
Claim 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20100248258 (herein after “Lee”) in view of US 10,822,379 (hereinafter “Dimitrov”), and further in view of US 20130273524 (hereinafter “Ehrenkranz”), and US 20150298118 (hereinafter “Chard”) and US 20170113223 (hereinafter “Immink”), and US 6,884,357 (hereinafter “Siddiqi”) in view of US 20020031839 (hereinafter “McNeirney”), and WO 2011156713 (hereinafter “Bornhop”), and US 20130157892 (hereinafter “Grunert”), and further in view of Buechler (WO 99/35486).
As to claim 1, Lee discloses the limitations as follows:
a cartridge [biochip, see para. 0011 or 0012 in Lee] configured to receive a test sample from the person, the cartridge comprising at least one chamber [storage chamber, or alternatively, first fluidic channel, para. 0011, 0012, 0040 or claim 14 of Lee, or alternatively, the purification chamber which receives the sample after attachment to the magnetic beads, para. 0040] configured to receive the test sample;
a first reagent reactive to presence of a pathogen, [see capture antibody binding the target, para. 0011, 0012, 0040, or claim 14];
first apparatus [mixer, or alternatively the magnetic beads, see para. 0011, 0012, 0040, or claim 14 of Lee] configured to mix [i.e., capable of mixing] at least one first reagent reactive to the primary antibodies to the pathogen or the pathogen with the test sample so as to cause the first reagent to react to primary antibodies to the pathogen or the pathogen that are present in the test sample [para. 0040];
a second reagent including a fluorescent compound reactive to the presence of the pathogen [see antibody labeled with fluorescent molecule, paras. 0011, 0012, 0040, or claim 14] [see especially paragraph 0040 disclosing that if a fluorescent antibody binds to the target, a bound form of magnetic bead-capture antibody-target-fluorescent antibody complex will be formed];
second apparatus [i.e., fluidic channel control unit which moves fluid into mixing chamber, paras. 0011, 0012, 0040, or claim 14] configured to mix [i.e., capable of mixing] at least one second reagent with the test sample mixed with the first reagent [see paras. 0011, 0012, 0040, or claim 14];
and circuitry [fluorescence detection unit detecting fluorescence intensities, para. 0012 and 0061, which is understood by one skilled in the art to include circuitry] configured to determine [capable of determining; Examiner notes again that Applicant is not positively reciting the reagents as part of the claimed device] presence of primary antibodies to the pathogen or the pathogen by detecting reaction of the second reagent by determining fluorescence of the fluorescent compound [para. 0048; Examiner notes that the fluorescence detection unit is capable of determining fluorescence from a fluorescent compound that is bound to primary antibodies to a pathogen or the pathogen, where the proper reagents are provided including fluorescent compound that is bound to primary antibodies to a pathogen or pathogen ].
However Lee does not disclose that the first reagent is reactive to a pathogen that is SARS-CoV-2, and that the second reagent is reactive to the presence of the pathogen that is SARS-CoV-2.
Lee however does refer to the desirability of diagnosing diseases such as SARS (severe acute respiratory syndrome). Paragraph 0004.
However, Dimitrov discloses a binder such as an antibody that can be used to detect the presence or absence of SARS-CoV-2 which can allow clinicians, health professionals, and patients to make better decisions about possible quarantine and/or treatment options. Col. 2, lines 54-67.
The Dimitrov binder (antibody that binds SARS-CoV-2) is equivalent to Applicant’s first reagent. It would have been obvious to one skilled in the art to utilize the binder of Dimitrov to detect the presence or absence of SARS-CoV-2 for the benefit of allowing clinicians, health professionals, and patients to make better decisions about possible quarantine and/or treatment options, as taught by Dimitrov.
Moreover, given that Lee teaches that the fluorescently labeled antibody also binds to the target [paras. 0011, 0012, 0040, or claim 14], it would have been obvious to one skilled in the art that the fluorescently labeled antibody to be used in the modification above would be a fluorescently labeled antibody that detects [reactive to the presence of] SARS-CoV-2.
Applicant has amended claim 1 to recite that the second reagent is stored in a blister reservoir of the cartridge, and the second apparatus is configured to move the second reagent from the blister reservoir to a mixer chamber. Lee does not disclose these limitations.
However, Ehrenkranz discloses these limitations as follows.
Ehrenkranz discloses in paragraph 0090 a microfluidic device that may include a number of
fluid reservoirs (e.g., blister packs) configured for diluting the sample, staining cells in the sample, and washing away excess stain, unadhered cells, etc. In one embodiment, the testing apparatus may include one or more pressure applying members (e.g., rollers) for successively introducing each of the dilution buffer, the stain, and the wash buffer from the blister packs into the at least one fluid channel. In one embodiment, such pressure applying members may be positioned in or around the microfluidic device insertion port of the testing apparatus. Paragraph 0090.
Ehrenkranz further discloses in paragraph 0102 a microfluidic device 700 that includes a body 710, a blood port 720, a dilution chamber 740, a counting chamber 780, and a waste chamber 790. Instead of ports, there is a series of reservoirs include a dilution buffer reservoir 730, a stain reservoir 750, a first wash reservoir 760, and an optional second wash reservoir 770. These reservoirs, which may, for example, be provided as blister packs that can be punctured to deliver their fluid, can be used to introduce dilution buffer, stain, and wash buffer. As such, the device 700 illustrated in FIG. 7 is self-contained. Thus, there is no reason for a user to carry separate containers of buffer and stain. Instead, the only thing that need be added to the microfluidic device 700 is blood or another fluid of interest (via the blood port). The sample can be diluted, washed, and stained by successively introducing the buffers and stains from the reservoirs. Paragraph 0102.
It would have been obvious to one skilled in the art to modify the Lee device to provide blister packs in a reservoir and a pressure applying members, such as rollers, for successively introducing any reagent from the blister packs into a channel or chamber, because Ehrenkranz teaches that providing such blister reservoir allows for a self-contained device so that there is no reason to carry separate containers for the reagents. The rollers are equivalent to Applicant’s second apparatus configured to move the second reagent from the blister reservoir to a mixer chamber [chamber or channel of the Lee device containing the sample and first reagent].
Furthermore, Examiner notes that “first apparatus configured to mix” and “second apparatus configured to move…and to mix” are interpreted to invoke 35 USC 112(f) since they do not recite structure. Thus, the first apparatus and second apparatus are interpreted to compass what Applicant discloses and their equivalences.
Also, Applicant has added to claim 1 the following limitations: “a movable permanent magnet configured to move the test sample mixed with the first reagent to a mixer chamber”.
Examiner acknowledges that Lee does not disclose a permanent magnet nor a magnet that moves a mixed sample to another chamber. Instead, Lee teaches an electromagnet to immobilize the magnetic beads during purification (para. 0012), and a pumping action to move the sample solution in between chambers (para. 0012 and 0029).
More specifically, Lee discloses the following in paragraph 0012:
“In an additional aspect, the present invention provides a method of using the immunoassay biochip of the present invention, including the steps of: (a) loading a sample and a solution containing a magnetic bead into the mixing chamber and then operating the mixer to mix the sample with the solution in the mixing chamber, wherein the magnetic bead is conjugated with a capture antibody for identifying and capturing a target; (b) operating the first bidirectional fluidic channel control unit so that the fluid mixed in step (a) flows into the purification chamber; (c) switching on the magnetic field generating unit so that the magnetic bead contained in the fluid in the purification chamber of step (b) is attracted onto the inner wall of the purification chamber; (d) operating the waste fluidic channel control unit so that the fluid in the purification chamber of step (c) flows off via the waste fluidic channel; (e) loading a resuspension solution into the purification chamber and switching off the magnetic field generating unit so that the magnetic bead is resuspended in the resuspension solution; (f) operating the first bidirectional fluidic channel control unit so that the resuspension solution flows into the mixing chamber via the first fluidic channel; (g) loading a solution containing a fluorescent antibody into the mixing chamber and operating the mixer to mix the solution with the resuspenstion solution in the mixing chamber, wherein the fluorescent antibody is labeled with a fluorescent molecule and can bind to the target; (h) operating the first bidirectional fluidic channel control unit so that the fluid mixed in step (g) flows from the mixing chamber into the purification chamber; (i) switching on the magnetic field generating unit so that the magnetic bead contained in the fluid in the purification chamber of step (h) is attracted onto the inner wall of the purification chamber; (j) operating the waste fluidic channel control unit so that the fluid in the purification chamber flows off via the waste fluidic channel; (k) loading a resuspension solution into the purification chamber and switching off the magnetic field generating unit so that the magnetic bead is resuspended in the resuspension solution; (l) operating the unidirectional fluidic channel control unit of the fluorescence detection unit so that the resuspension solution flows from the purification chamber into the fluorescence detection area via the fluorescence detection fluidic channel; and (m) conducting a fluorescence detection to determine whether the sample contains a target.” Paragraph 0012 (emphasis added).
Thus Lee teaches use of an electromagnet (not permanent magnet) for immobilizing magnetic beads during purification and a fluidic channel control unit (para. 0012), for example a pump (see para. 0029) to move the mixed solution of magnetic beads with bound target from once chamber to another, such as from the purification chamber to a mixing chamber.
However Chard teaches use of an electromagnet or permanent magnet to mix a solution (see para. 0216).
More specifically, Chard discloses in paragraph 0216 the following.
“If a magnetic/electromagnetic field has been used to aid mixing, the field is switched off, for example by moving the permanent magnet away for the detection chamber for a predetermined delay to allow complexes to form in the detection chamber.”
See similar disclosure regarding mixing in paragraph 0214.
Thus Chard shows that a permanent magnet is an alternative to an electromagnet for mixing.
Moreover Immink teaches the following.
“The aforementioned purification-particle storage chamber may preferably be coupled to the purification chamber via a (second) valve, particularly a (second) magneto-capillary valve. This allows for a controlled transfer of purification particles into the purification chamber when they are required there (typically after introduction of the sample). In case of magneto-capillary valves and magnetic purification particles, the same magnetic field generator (e.g. a movable permanent magnet) can optionally be used for moving purification particles from their storage chamber into the purification chamber and thereafter (with bound interfering components) from the purification chamber into the waste chamber.” Para. 0026 (emphasis added).
“The purification particles may particularly comprise magnetic particles such as magnetizable beads. Magnetic purification particles can controllably be moved by magnetic means, for example by a magnetic field generator such as a permanent magnet.” Para. 0034 (emphasis added).
Thus Immink teaches that a magnet, such as a permanent magnet, can be used to move magnetic particles from one chamber to another chamber.
It would have been obvious to one of ordinary skills in the art to provide a permanent magnet in the modified Lee invention in order to mix reagents, as taught by Chard, and to move the particles from chamber to chamber, as taught by Immink, as an alternative to pumping the fluid from chamber to chamber in the Lee invention. Thus these limitations are known for performing an assay as taught by Chard and Immink, and incorporating these limitations into the invention Lee involves only routine skills in the art since it involves providing known elements for a known use with a predictable outcome.
Examiner notes that Applicant’s earliest effective filing date for claim 1 appears to be 3/19/20 from provisional application number 62991906.
However, neither Chard nor Immink teach that the movable permanent magnet is attached to a rack moved by a pinion gear.
However Siddiqi discloses a test container for a binding reaction which is used with a permanent magnet (see abstract), and further discloses the following.
“Generally the permanent magnet assembly is placed in close proximity to the container without the magnet extending to the bottom of the container. The distance between each magnet and the container shown in FIGS. 1 through 6 and 12 is adjustable between about 1 mm to about 20 mm to create a desired magnetic field strength within the magnetic field cavity of the test medium. The apparatus shown in these figures includes a means for adjusting the distance between each magnet assembly and the container. An adjusting means is shown in FIG. 12. Lateral (or horizontal) movement of magnets is provided by a linear motion mechanism. Linear motion mechanisms are well known in the art. A simple linear motion mechanism comprises a slider with a rectangular notch or groove, riding on rail with corresponding rectangular shape. Such linear motion mechanisms exist in common furniture drawers. Multiple rails can be provided, as well as ball bearings and rollers if desired. A gear rack and pinion mechanism comprising of a rectangular gear teeth bar (rack) and a mating gear teeth pulley is advantageous when accuracy in the distance between magnet assembly and the container is desired. Suitable gear racks and pinions are available from Designatronics Inc., 2101 Jericho Turnpike, New Hyde Park, N.Y. 11042-5416. Lateral movement of magnet assembly can also be changed by attaching it to an electromagnetic actuator or plunger and such lateral movement may be synchronized with the rotary motion of the container or magnet assembly. Electromagnetic actuators or plungers are also well known in motion control art. While FIG. 12 shows six cylindrical containers, obviously the number can be increased, or decreased to one. FIG. 12 further shows vertical movements of magnets driven by screw 116. Obviously structures shown in FIG. 1 and FIG. 4 can be moved by FIG. 12 mechanisms. For instance, the stationary containers of FIGS. 2 and 3 or the stationary magnet of FIG. 1 could be made movable using a screw mechanism, or similar mechanical means, like the one shown in FIG. 12. The magnet position can also be changed by fastening the magnet assembly at a desired position by various male and female fasteners.” Col. 13, line 36 to column 14, line 7 (emphasis added).
It would have been obvious to one skilled in the art to provide the movable permanent magnet suggested by Chard and Immink such that it is attached to a rack moved by a pinion gear, since Siddiqi teaches that this mechanism is a well known mechanism for moving a permanent magnet in relation to a test container. Siddiqui further teaches a motivation for utilizing this particular mechanism, more specifically that “[a] gear rack and pinion mechanism comprising of a rectangular gear teeth bar (rack) and a mating gear teeth pulley is advantageous when accuracy in the distance between magnet assembly and the container is desired.”
However, Lee and the other cited references above do not disclose that the circuitry is “configured to determine an emission spectrum of the light emitted by fluorescence of the fluorescent compound by performing wavelength and amplitude analysis on the emitted light to determine absence, presence, and quantity and isotype of the primary antibodies to the pathogen or the pathogen” as recited by Applicant in claim 1.
However McNeirney discloses labeling analytes with fluorescents tags to detect the presence or concentration of the analytes (see abstract and paras. 0012-0013, 0026, 0029, 0031) using wavelength and amplitude data determined using standard signal processing “means well known to those in the art” (para. 0035). It would have been obvious to one of ordinary skills in the art to use in the modified Lee invention wavelength and amplitude data from fluorescent tags to determine presence or concentration of the analytes since such technique is well known in the art as shown by McNeirney.
The claims now recite determining absence, presence, and quantity and isotype of the primary antibodies to the pathogen or the pathogen.
Regarding isotype, Grunert teaches the following in paragraph 0028:
“For the differential diagnostics of many diseases, it is important to detect the antibodies of one or more particular class of immunoglobulin. A satisfactory diagnosis in the case of viral, bacterial and parasitic infection can only be ensured by means of a class-specific antibody detection and/or by excluding the interfering measurement of certain other immunoglobulin classes (e.g., detection of IgG and IgA antibodies but no detection of IgM antibodies). This is particularly important for differentiating between fresh or acute infections and older infections as well as to clinically monitor the course of an infection. The class-specific detection of antibodies is especially important for HIV, hepatitis A, hepatitis B, toxoplasmosis, rubella and chlamydia infections. The class-specific detection of antibodies that are specific for a certain antigen is also necessary when determining the titer of protecting antibodies, for example in determining if an immunization has been successful.” Para. 0028.
Thus, it would have been obvious to one skilled in the art to utilize labeled secondary antibodies that comprise IgG, IgA, and IgM, as taught by Grunert, in the modified Lee sandwich assay as modified by Johnson in detecting infection by detecting the antigen/virus in the sample, since Grunert teaches that it is known that for viral infections, a satisfactory diagnosis involves detection of IgG, IgA, and IgM antibodies [i.e., detecting isotype], which also allows for differentiating between fresh or acute infections and older infections as well as clinically monitoring the course of an infection.
Moreover, McNeirney teaches detecting and quantitating the analyte (see paras. 0003, 0013, 0014). Examiner notes that quantitating necessarily encompasses detecting the absence or presence of the analyte since the quantity detected can be zero or higher than zero. In any case, detecting the absence, presence, and quantity of the analyte as well as isotype (as taught by Grunert) would have required ordinary skills in the art utilizing known means such as shown by McNeirney and Grunert, as may be desirable for study or diagnosis. Moreover, utilizing the known means to determine absence, presence, quantity and isotype of the analyte would have resulted in a predictable outcome since it merely utilizes known elements in a familiar manner for the same purposes.
With respect to the limitation regarding the circuitry being configured to use wavelength backscattering with a plurality of wavelengths of light for the detection, this limitation is taught by Bornhop.
More specifically, Bornhop teaches the following.
Bornhop teaches multiplexed backscattering interferometric detection system for detection along a capillary channel (paras. 0014-016).
The disclosed detection system and methods are capable of measuring multiple signals, for example, along a length of a capillary channel, simultaneously or substantially simultaneously. Para. 0043.
The disclosed “detection system has numerous applications, including the observation and quantification of molecular interactions, molecular concentrations, bioassays, universal/RI detection for CE (capillary electrophoresis), CEC (capillary electrochromatography) and FIA (flow injection analysis), physiometry, cell sorting/detection by scatter, ultra micro calorimetry, flow rate sensing, and temperature sensing. One of the advantages of the systems and methods of the present invention is that a sample measurement and reference measurement can be acquired simultaneously or substantially simultaneously from the same channel. As both measurements occur in the same capillary and, in one aspect, in immediately adjacent portions of the capillary, the thermal properties attributable to each measurement will be uniform, resulting in higher signal to noise levels.” Para. 0044 (emphasis added).
“In one aspect, the detection systems and methods described herein can be useful as a bench-top molecular interaction photometer. In another aspect, the detection systems and methods described herein can be useful for performing near patient diagnostics.” Para. 0045.
The system includes a source of light, an optional optical element capable of at least one of spreading, splitting, rastering, or a combination thereof the light from the light source, a channel of capillary dimensions in a substrate for reception of a sample to be analyzed, and a photodetector for detecting scattered light from the sample at a detection zone. Para. 0046.
The substrate and channel together comprise a capillary tube, and can together comprise a microfluidic device. Para. 0048.
“A microfluidic channel, if present, can hold and/or transport the same or varying samples, and a mixing zone. The design of a mixing zone can allow at least initial mixing of, for example, one or more binding pair species. The at least initially mixed sample can then be subjected to a stop-flow analysis, provided that the reaction and/or interaction between the binding pair species continues or is not complete at the time of analysis. The specific design of a microfluidic channel, mixing zone, and the conditions of mixing can vary, depending on such factors as, for example, the concentration, response, and volume of a sample and/or species.” Para. 0049 (emphasis added)
“In yet another aspect, a channel can be divided into two, three, or more regions, wherein each region is separated from other regions by a separator. In one aspect, a separator can prevent a fluid in one region of a channel from contacting and/or mixing with a fluid from another region of the channel. In another aspect, any combination of regions or all of the regions can be positioned such that they will be impinged with at least a portion of the light beam. In such an aspect, multiple regions of a single channel can be used to conduct multiple analyses of the same of different type in a single instrumental setup. In one aspect, a channel has two regions, wherein a separator is positioned in the channel between the two regions, and wherein each of the regions are at least partially in an area of the channel where the light beam is incident. Para. 0052.
In one aspect, if multiple regions are present, each region can have an input and an output port. In one aspect, the input and/or output ports can be configured so as not to interfere with the generation of scattered light, such as, for example, backscattered light, and the resulting measurements. In one aspect, a single channel can allow for analysis of multiple samples simultaneously in the same physical environment. Para. 0053.
Any one or more of the individual zones along a channel can optionally comprise a marker compound positioned within the path of the channel. In another aspect, at least one discrete zone comprises a marker compound and an adjacent discrete zone serves as a reference. In yet another aspect, at least two discrete zones comprise marker compounds. In other aspects, each of at least two discrete zones can comprise marker compounds. In another aspect, each of the discrete zones either comprise a marker compound or serve as a reference. In yet another aspect, each of the discrete zones comprise a marker compound. If multiple marker compounds are present, any individual discrete zone can comprise the same or a different marker compound than any other discrete zone. For example, multiple zones can comprise the same marker compound so as to, for example, obtain multiple measurements for increased accuracy, signal averaging, or to measure flow rates. In another exemplary aspect, separate marker compounds can be used in different zones, with alternating reference zones therebetween, so as to provide multiple simultaneous measurements and reference values from a single sample in a single channel. In another aspect, measurements can be made simultaneously in multiple discrete zones and no marker compounds are present. Para. 0055.
“A marker compound, if present, can comprise any compound capable of reacting or interacting with a sample or an analyte species of interest. In one aspect, a marker compound can comprise a chromophore. In another aspect, a marker compound can comprise a ligand that can interact with a species of interest to provide a detectable change in refractive index. In yet another aspect, a marker compound can comprise an aptamer. In still another aspect, a marker compound can comprise an antigen, such as, for example, a prostate specific antigen and/or a syphilis antibody. In still another aspect, a marker compound can be DNA and/or R A. In still another aspect, a marker compound can comprise a marker protein, such as, for example, a cardiac marker protein. Other exemplary marker compounds and uses thereof are described herein with respect to various applications for the multiplexed interferometric detection systems, apparatuses, and methods of the present invention.” Para. 0056 (emphasis added).
In one aspect, the light source generates an easy to align optical beam that is incident on the etched channel for generating scattered light... In one aspect, at least a portion of the light beam incident on the channel covers at least two discrete zones. In another aspect, at least a portion of the light beam is incident on the channel such that the intensity of the light on each of at least two zones is the same or substantially the same. In yet another aspect, at least a portion of the light beam is incident on the channel such that the each of the zones along the channel receive the same or substantially the same intensity of light… Para. 0057.
The light source can comprise any suitable equipment and/or means for generating light, provided that the frequency and intensity of the generated light are sufficient to interact with a sample and/or a marker compound and provide elongated fringe patterns as described herein…In another aspect, a light source can comprise two or more laser, each generating a beam that can impinge one or more zones of a channel. In another aspect, if two or more lasers are present, any individual laser can be the same as or different from any other laser. For example, two individual laser can be utilized, each producing a light beam having different properties, such as, for example, wavelength, such that different interactions can be determined in each zone along a channel. Para. 0058.
Thus, Bornhop teaches a detection system and method that uses wavelength backscattering with a plurality of wavelengths. It would have been obvious to one skilled in the art to utilize backscattering detection technique using a plurality of wavelengths in the modified Lee technique since Bornhop teaches that it is a known detection technique for detecting molecular interactions, including antigen and antibody interaction, which provides the benefit of simultaneous assay measurements and reference values from a single sample in a single channel.
Claim 1 further recites that the cartridge comprises an authentication chip, wherein the authentication chip is configured to provide a microcontroller access to information including testing information and patient information, and wherein the microcontroller is operable to configure a mode of the device based on the information.
Examiner notes that the microcontroller is not positively recited as part of the claimed invention. Also, the authentical chip “configured to provide….” is interpreted to mean –is capable of providing--.
Lee is silent as to the above limitations.
However, Buechler teaches these limitations as follows.
Buechler teaches an energy source such as a laser for illumination of the sample and an energy detector (page 27, lines 3-16).
Buechler teaches that an encoder such as a magnetic strip encoder [equivalent to an authentication chip] encodes information on an assay device [equivalent to a cartridge], such that when the user inserts the assay device into the fluorometer [equivalent to circuitry configured to determine the presence of primary antibodies to the pathogen], a reader reads the information on the assay device and combines the assay results with the encoded information. See page 6 of Buechler, at lines 11-19. The encoder encodes information such as patient information, tests to be performed and the like that can be entered through a keypad or computer that downloads the information to the fluorometer (page 6, lines 11-15.)
It would have been obvious to one skilled in the art to provide this mechanism in the Lee invention for the benefits disclosed by Buechler, to read information on the assay device upon insertion into an apparatus such as a fluorometer, as would be desirable for ease of use or for convenience. As taught by Buechler the encoder encodes information such as patient information, tests to be performed and the like (page 6, lines 11-15.) Thus, the encoder of Buechler is equivalent to Applicant’s authentication chip that is configured to provide [capable of providing] a microcontroller [computer] access to information including testing information and patient information, and wherein the microcontroller is operable to configure a mode of the device based on the information.
Claims 2-5 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20100248258 (herein after “Lee”) in view of US 10,822,379 (hereinafter “Dimitrov”), and US 20130273524 (hereinafter “Ehrenkranz”), and US 20150298118 (hereinafter “Chard”) and US 20170113223 (hereinafter “Immink”) and US 6,884,357 (hereinafter “Siddiqi”), and US 20020031839 (hereinafter “McNeirney”), and WO 2011156713 (hereinafter “Bornhop”), and US 20130157892 (hereinafter “Grunert”), and Buechler (WO 99/35486), as applied to claim 1 above, and further in view of US 20080160277 (hereinafter “Tamoris”) and US 20150038347 (hereinafter “Johnson”).
As to claim 2, Lee, discussed above, teaches use of magnetic beads for immobilization of a binding reagent (see paragraphs 0011, 0012, 0040, or claim 14 of Lee.)
However, Lee, discussed further above, is silent as to the first apparatus comprising a plurality of magnetic particles upon which at least one antigen to primary antibodies to the pathogen has been immobilized, wherein the at least one first reagent comprises the at least one antigen to primary antibodies that has been immobilized on the plurality of magnetic particles.
Tamoris discloses in paragraph 0083 that magnetic particles can be carrier particles for diagnoses by bonding an antibody or an antigen to the magnetic particles. Paragraph 0082.
Thus Tamori discloses that antibodies or antigen can be bound to magnetic particles for binding and diagnosis. It would have been obvious to one of ordinary skills in the art to modify the Lee invention such that the magnetic beads are provided with antigen (instead of antibodies) for binding and diagnosis.
Moreover, Johnson discloses magnetic particles specifically for detection of antibodies to viruses and virus antigens. Paragraph 0093.
Johnson teaches that assays for detection of antigens may provide detection of viremic infections in drawn blood. Paragraph 0119.
While Johnson uses a different kinds of detection, nevertheless Johnson teaches that antibodies to viruses and virus antigens can be detected to provide detection of infections. Thus it would have been obvious to one skilled in the art that the modified Lee invention can be further modified to provide bound antigens, as taught by Tamoris, for detection of antibodies to viruses and virus antigens for detection of infection, as taught by Johnson. In this modification, given that Dimitrov teaches SARS-CoV-2 [antigen] detection for detecting the virus that causes covid-19 (see abstract in Dimitrov), the bound antigen would be SARS-CoV-2. In view of Johnson, the modification would result in detection of the antibodies to SARS-CoV-2 and thus detecting the infection with the virus.
As to claim 3, see mixer in paragraphs para. 0011, 0012, 0040, or claim 14 of Lee.
As to claim 4, see mixing chamber and/or fluidic channel control unit which moves fluid into mixing chamber, para. 0011, 0012, 0040, or claim 14. Examiner notes that Applicant does not disclose particular features of the first or second apparatus, here, other than that it is configured to mix the recited elements. The mixing chamber and/or fluidic channel control unit are part of what allows the two reagents to be introduced and/or contact and therefore mix.
As to claim 5, see fluorescent antibody labeled with fluorescent molecule, para. 0011, 0012, 0040, or claim 14.
As to claim 12, with respect to limitations regarding the secondary antibodies comprise IgA, IgM, and IgG, Grunert teaches in paragraph 0028 the following:
“For the differential diagnostics of many diseases, it is important to detect the antibodies of one or more particular class of immunoglobulin. A satisfactory diagnosis in the case of viral, bacterial and parasitic infection can only be ensured by means of a class-specific antibody detection and/or by excluding the interfering measurement of certain other immunoglobulin classes (e.g., detection of IgG and IgA antibodies but no detection of IgM antibodies). This is particularly important for differentiating between fresh or acute infections and older infections as well as to clinically monitor the course of an infection. The class-specific detection of antibodies is especially important for HIV, hepatitis A, hepatitis B, toxoplasmosis, rubella and chlamydia infections. The class-specific detection of antibodies that are specific for a certain antigen is also necessary when determining the titer of protecting antibodies, for example in determining if an immunization has been successful.” Para. 0028.
Thus, it would have been obvious to one skilled in the art to utilize labeled secondary antibodies that comprise IgG, IgA, and IgM, as taught by Grunert, in the modified Lee sandwich assay as modified by Johnson in detecting infection by detecting the antigen/virus in the sample, since Grunert teaches that it is known that for viral infections, a satisfactory diagnosis involves detection of IgG, IgA, and IgM antibodies, which also allows for differentiating between fresh or acute infections and older infections as well as clinically monitoring the course of an infection.
Claims 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20100248258 (herein after “Lee”) in view of US 20080160277 (hereinafter “Tamoris”) and US 20130273524 (hereinafter “Ehrenkranz”) and US 20150298118 (hereinafter “Chard”) and US 20170113223 (hereinafter “Immink”), US 6,884,357 (hereinafter “Siddiqi”), and US 20020031839 (hereinafter “McNeirney”), and WO 2011156713 (hereinafter “Bornhop”), and US 20130157892 (hereinafter “Grunert”), and Buechler (WO 99/35486), as applied to claim 1 above, and further in view of US 20090042237 (hereinafter “Smith”).
Regarding claim 6, the references cited above with respect to claim 1 is silent as to a fluorometer for determining fluorescence. While Lee teaches use of a fluorescence detection unit (para. 0012 and 0061), Lee does not specifically mention a fluorometer.
However use of a fluorometer for fluorescence detection is known in the art, as shown by Smith (para. 0035), and its use as the fluorescence detection unit in the Lee invention would have required ordinary skills in the art since Smith discloses that it is a device for detecting fluorescence in an assay.
AS to claim 7, see Smith in paragraph 0041 disclosing a fluorescence detector [optical sensor] and a light emitter [light source].
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20100248258 (herein after “Lee”) in view of US 20080160277 (hereinafter “Tamoris”) and US 20130273524 (hereinafter “Ehrenkranz”) and US 20150298118 (hereinafter “Chard”) and US 20170113223 (hereinafter “Immink”), US 6,884,357 (hereinafter “Siddiqi”), and US 20020031839 (hereinafter “McNeirney”), and WO 2011156713 (hereinafter “Bornhop”), d anUS 20130157892 (hereinafter “Grunert”), and Buechler (WO 99/35486), as applied to claim 1 above, and further in view of US 20150293093 (hereinafter “Charles”).
As to claim 8, Lee, discussed above, is silent as to a display circuitry configured to display an indication of presence or absence of primary antibodies to the pathogen.
However, providing such a display for indicating the results of an assay, or the detection of the analyte, is known in the art, as shown by Charles (para. 0131). It would have been obvious to one skilled in the art to provide such a display in the modified Lee invention in order to indicate the results of an assay or detection of the analyte, as shown by Charles.
Response to Arguments
Applicant’s arguments have been considered but are not found to be persuasive.
Applicant has amended claim 1 to further recite that the cartridge comprises an authentication chip, wherein the authentication chip is configured to provide a microcontroller access to information including testing information and patient information, and wherein the microcontroller is operable to configure a mode of the device based on the information.
Applicant argues that Ehrenkranz does not disclose an authentication chip operable to provide access to a microcontroller for information and a microcontroller operable to configure a mode of a testing device based on information from an authentication chip. Applicant points to paragraph 0090 of the specification for support of an authentication chip and a microcontroller.
Examiner notes that the microcontroller is not positively recited as part of the claimed invention. Also, the authentical chip “configured to provide….” is interpreted to mean –is capable of providing--.
As mentioned in the amended grounds for rejection (and provided below for convenience), Lee is silent as to the above limitations.
However, Buechler teaches these limitations as follows.
Buechler teaches an energy source such as a laser for illumination of the sample and an energy detector (page 27, lines 3-16).
Buechler teaches that an encoder such as a magnetic strip encoder [equivalent to an authentication chip] encodes information on an assay device [equivalent to a cartridge], such that when the user inserts the assay device into the fluorometer [equivalent to circuitry configured to determine the presence of primary antibodies to the pathogen], a reader reads the information on the assay device and combines the assay results with the encoded information. See page 6 of Buechler, at lines 11-19. The encoder encodes information such as patient information, tests to be performed and the like that can be entered through a keypad or computer that downloads the information to the fluorometer (page 6, lines 11-15.)
It would have been obvious to one skilled in the art to provide this mechanism in the Lee invention for the benefits disclosed by Buechler, to read information on the assay device upon insertion into an apparatus such as a fluorometer, as would be desirable for ease of use or for convenience. As taught by Buechler the encoder encodes information such as patient information, tests to be performed and the like (page 6, lines 11-15.) Thus, the encoder of Buechler is equivalent to Applicant’s authentication chip that is configured to provide [capable of providing] a microcontroller [computer] access to information including testing information and patient information, and wherein the microcontroller is operable to configure a mode of the device based on the information.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Ann Montgomery/Primary Examiner, Art Unit 1678