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 .
Priority
The present application was filed on 11/30/2022. This application is a DIV of 16/689,530 filed 11/20/2019, which claims benefit of U.S. Provisional Patent Application 62/770,056 filed on 11/20/2018.
Status of Claims
Claims 1-6 are withdrawn. Claims 13-15 are new. Claims 1-15 are pending.
Claims 7-12 are examined.
Objection/rejection status
The objection of drawing and specification is withdrawn in view of the amendment of the drawings and specification.
The rejection of claim 7-12 under 35 USC 112(b) is withdrawn in view of the amendment of the claims.
The rejection of claims 7 and 10 under 35 USC 112(f) is updated in view of the amendment of the claims.
The rejection of claims 7-12 under 35 USC 103 is new in view of the amendment of the claims.
Claim Objections
Claim 13 is objected to because of the following informalities: spelling mistake in line 2 “patten”. It should be read as “pattern”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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: “a data processing unit” in claims 7 and 14; "a delivery device for delivering a sample solution including procalcitonin (PCT) to the sensor" in claim 10.
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.
Claim limitation “data processing unit” is disclosed in the specification in page 4 paragraph 2, page 10 paragraph 3, page 11 paragraphs 1-2, which is processor, or software to analyze data.
Claim limitation "a deliver device" is disclosed in the specification in page 10 lines 21-22 in the specification, which can be any device for introducing a fluidic sample to sensor.
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 § 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(s) 7-8 and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zybin (US20110311962) in view of Hinman et al. (Surface Plasmon Resonance: Material and Interface Design for Universal Accessibility, Anal Chem. 2018 January 02; 90(1): 19–39) and Ikeda (US20090238413).
Zybin teaches a system for detection of an analyte comprising: a sensor, a radiation source, and a detector (see Title and par(s).2-13).
The sensor has a reflective metal surface and a plurality of capture antibodies (Zybin teaches a surface plasmon resonance spectrometer comprising a sensor surface (see Abstract). The surface has a strong change in reflectivity because it is coated with metallic nanoparticles (see par.35). The sensor surface can be selectively coated with receptors or antibodies selectively binding target analyte (see par.9)).
The radiation source (i.e., light source) is located at an incident angle with respect to the reflective metal surface (see Fig.1, par.31 and 44)).
The detector (i.e., camera) is positioned to receive scattered and reflected light from the sensor and configured to produce a plurality of raw images (see Abstract: teaching that the detector has a plurality of image elements and observation optics for depicting the radiation reflected by the sensor surface on the detector; see Fig.1, par(s).27 and 43-47: teaching that the detector is Charge Coupled Device (CCD) camera that can detect a surface plasmon spectrometer).
Zybin teaches an image system comprising a data processing unit coupled to the camera and configured to generate a plurality of processed images by removing background noise from the plurality of raw plasmonic images using differential imaging algorithms executed by the data processing unit, where each processed image of the plurality of processed images is generated from a corresponding unique one raw plasmonic image of the plurality of raw plasmonic images (Zybin teaches the CCD is used for the optoelectronic detection, i.e., raw plasmonic images (see Abstract, par.13). The CCD also detects a plurality of time subsequent intensity signals for each pixel (see Abstract, par.13, claim 10 of Zybin). The images captured by the system are stored for further image processing (see par.49) by image processing means (see par.27 and 49, claim 10 of Zybin). The processing means in the system can normalize the signal with respect to a reference image which is obtained by calculating the average image over a period of time before the particle is bound (see par.26 and 50). The background noise from the plurality of raw plasmonic images is removed in order to avoid a situation where the signal disappears in the noise (see par.25-26). The system of Zybin can detect individual nanoparticles bound to the sensor surface over a period of time (see par.8, par.27-29, and Fig.5). Zybin also teaches that the images of the plasmonic sensor are monitored over a period of time (i.e., real-time analysis), so the system provides the possibility to detect very low particle concentrations (see Fig.5 and par.28). The system can be used for highly sensitive clinical diagnostics (see par.28)).
Zybin does not teach, each antibody being tethered by a linker, where each tethered antibody is spaced apart from each other tethered antibody by at least one spacer.
Zybin does not teach that the data processing unit is configured to execute an automated particle counting algorithm to detect a number of single gold nanoparticles. Zybin does not teach processing the image based on pattern detection of binding events and unbinding events as well as tracking of binding events and unbinding events over time, to detect gold nanoparticles immobilized by the tethered antibodies of the plurality of tethered antibodies.
Hinman discloses a surface plasmon resonance (SPR) technique that monitors biomolecular reactions in a real-time and label free manner (see Abstract). The technique requires a gold coated sensor chip, a light source, polarizer, a detector …(see page 2 par.2). The SPR-based biosensors commonly consist of a sandwich immunoassay, whereby a recognition antibody is bound to the sensor surface, and following antigen binding, the signal is further increased through the addition of a detection antibody (see page 18 par.2). The recognition antibodies are attached to the sensor via a functional group (i.e., linker) (page 12 par.3). The antibodies are apart from each other by spacer molecules (page 12 par.3). This teaching encompasses the limitation: each antibody being tethered by a linker on the sensor, where each tethered antibody is spaced apart from each other tethered antibody by at least one spacer.
This sensor is used to monitor concentrations and binding kinetics of target molecules in real time (see page 2 par.2). Binding events appear as bright points in the image, connected to significantly larger parabolic tails resulting from scattering of SPPs in the direction of their propagation. These tails allow for indirect visualization of objects and events beyond the diffraction limit. See page 5 paragraph 2. The image is analyzed by software (e.g., Fourie) (see page 5 par.3, page 8 par.1). This teaching encompasses the limitation: processing the image based on pattern detection of binding events and unbinding events, as well as tracking of binding events and unbinding events over time.
When analyzing smaller molecular weight analytes or those that are present in low quantities, enhancement mechanisms can be employed to boost the signal achieved upon biomolecular binding events. In a sandwich immunoassay, whereby a recognition antibody is bound to the sensor surface, and following antigen binding, the signal is further increased through the addition of a detection antibody (see page 18 par.2). Plasmonic enhancement using gold nanoparticles in place of, or in combination with, a detection antibody is also practiced. See page 18 paragraphs 2-3. The binding of these nanoparticles provides a significantly increased refractive index near the sensor surface, and given that SPR is a refractive index-based technique, accordingly, increased signals are obtained (see page 18 par.3). Therefore, processing the image based on pattern detection of binding events and unbinding events over time can also detect gold nanoparticles immobilized by the tethered antibodies because the gold nanoparticles are in the complex of the tethered antibodies, the antigens, and the detection antibodies.
Ikeda teaches the system for quantifying metal colloidal particles comprising a microscope, a camera, an image processor and a measuring device (see Fig.1). The system detects trace substances using a local plasmon resonance scattering phenomenon of metal colloid particles when irradiating light (see Abstract and par.3). The camera converts an image signal to digital data (see par.38). The image processor reads the digital image data and subjects the image data to comparison operation (see par.38). The measuring device counts the number of metal colloidal particles based on the image data processed with the image processor (see par.38). The number of particles reflects to the content of the specific trace substances in the original specimen sample (see par.14-15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the sensor in the system of Zybin with the sensor taught by Hinman for detecting the analyte of interest, because Zybin is generic to the sensor for SPR technique and Hinman is specific to the sensor for SPR technique that can boost the signal achieved upon biomolecular binding events. The combined system of Zybin and Hinman provides the best result with a larger measurement range and the lowest detection limit in analyte detection (see page Hinman 18 par.3, page 19 par.2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to integrate the system of Zybin with the image processing unit of Ikeda so that the system can detect and quantify small molecules or post-translational modification of proteins without labels (see Hinman Abstract, Ikeda par.14-15). The modified system provides high throughput and sensitive detection and study of molecular interactions (see Ikeda par.14).
Zybin is directed to the surface plasmon resonance system for imaging the radiation reflected by the sensor surface on the detector, which is used for detecting and analyzing the change of plasmonic images of individual nanoparticles on the sensor surface over a period of time. Hinman provides the plasmonic nanoparticle enhancement sensor for analyte detection specifically used for SPR technique. Ikeda provides the SPR imaging software for analyzing the plasmonic images of particles. Therefore, one having an ordinary skill in the art would have had a reasonable expectation of success in combining Zybin, Hinman, and Ikeda because they are directed to the system of detecting analyte using surface plasmon resonance technique comprising the sensor (taught by Hinman), the surface plasmon resonance spectrometer (taught by Zybin), and the surface plasmon resonance imaging software (taught by Ikeda), wherein the system of Zybin can detect the plasmonic images on the sensor of Hinman, and then the imaging software of Ikeda can analyze the plasmonic images to detect and quantify the analyte of interest via detecting the number of nanoparticles.
For claim 8, Zybin, Hinman, and Ikeda teach the system of claim 7. Zybin does not teach the gold nanoparticles comprising streptavidin coated gold nanoparticles.
Hinman provides a plasmonic nanoparticle enhancement sensor comprising a sensor surface coated with recognition antibodies for analytes of interest. The analytes of interest are detected by biotinylated detection antibodies, which are linked to the streptavidin-coated gold nanoparticles. (See page 18 last 2 sentences, page 19 par.1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use streptavidin coated gold nanoparticles in the sensor of Zybin, because the streptavidin AuNPs can be conjugated with the detection antibodies to enhance the SPR signal in the detection of the analyte of interest as taught by Hinman. The combined system of Zybin and Hinman increases the signal significantly in comparison to an assay using only detection antibodies (see page Hinman 19 par.1).
One having an ordinary skill in the art would have had a reasonable expectation of success in combining Zybin and Hinman because they are directed to the system of detecting analyte using surface plasmon resonance technique comprising the sensor (taught by Hinman), the surface plasmon resonance spectrometer (taught by Zybin). While Zybin is generic to the sensor for SPR technique, Hinman is specific to the sensor for SPR technique that can boost the signal achieved upon biomolecular binding events.
For claim 11, Zybin, Hinman, and Ikeda teach the system of claim 7. Zybin does not teach the linker comprising a polyethylene glycol (PEG) linker.
Hinman teaches the sensor used in the system of Zybin as discussed above. Hinman teaches that PEG linker is a popular choice to attach the capture antibody to the sensor (see page 12 par.3, page 15 par.3)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use PEG linker to attach the capture antibody to the sensor in the system of Zybin because it is a popular choice linker and it can easily be used alongside SPR (see Hinman page 15 par.3).
For claim 12, Zybin, Hinman, and Ikeda teach the system of claim 7.
Zybin teaches that the radiation source is a super luminescent diode because it has no irregularities on the illuminated surface (speckles) like the laser source (see par.44). Zybin teaches that optical microscopy is used to observe small objects and immersion oil is used for fixing and improving the optical contact (see par.10 and par.43).
For claim 13, Zybin, Hinman, and Ikeda teach the system of claim 7. Zybin does not teach the particle counting algorithm is configured to utilize a distinct parabolic pattern and autocorrelation pattern recognition to search and identify all single gold nanoparticles immobilized by the tethered antibodies.
Hinman discloses that computational methods allow for greater spatial resolution and the ability to resolve binding events that are in close proximity. In particular, a digital method based on image processing in Fourier space and deconvolution of the complex field, which minimizes the parabolic tails within collected SPR images and yields transverse and longitudinal resolutions close to the limit of diffraction. See page 5 paragraph 3.
Ikeda teaches the system detects trace substances using a local plasmon resonance scattering phenomenon of metal particles when irradiating light (see Abstract and par.3). The camera converts an image signal to digital data (see par.38). The image processor reads the digital image data and subjects the image data to comparison operation (see par.38). The measuring device counts the number of particles based on the image data processed by the image processor (see par.38). The number of particles reflects the content of the specific trace substances in the original specimen sample (see par.14-15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the appropriate algorithm or software (e.g., Fourier) in the modified system of Zybin to generate a distinct parabolic pattern and autocorrelation pattern recognition of the nanoparticles captured on the sensor. By doing that, the system can generate greater spatial resolution plasmonic images of the particles and resolve binding events that are in close proximity (see Hinman page 5-6 SPR Microscopy). The algorithm will help to increase the accuracy in counting the number of particles based on the processed images, thereby the concentration of the analyte in the sample, because the measuring device counts the number of particles based on the image data processed by the image processor (see Ikeda par.38).
One having an ordinary skill in the art would have had a reasonable expectation of success in combining Zybin, Hinman, and Ikeda because Zybin, Hinman, and Ikeda are directed to the system of detecting analyte using surface plasmon resonance technique. The surface plasmon resonance spectrometer (taught by Zybin) can take a plurality of plasmonic images of the nanoparticles in the SPR sensor, the computational method that can resolve the parabolic tails of the nanoparticles on the plasmonic images (taught by Hinman), and the surface plasmon resonance imaging software (taught by Ikeda) can count the number of particles based on the image data processed by the image processor.
For claim 14, Zybin, Hinman, and Ikeda teach the system of claim 7. Claim 14 recites the system of claim 7, wherein the differential imaging algorithms executed by the data processing unit are configured to subtract a preceding image from a subsequent image frame to generate time sequence differential images, and wherein the plurality of processed images comprise the time sequence differential images.
Zybin teaches that a reference image is generated by averaging over a period of time where there is no particle suspension (see par.50). The intensity of each pixel in the subsequent images is normalized with the average value in the reference image for each pixel (see par.50). The processing means in the system can normalize the signal with respect to a reference image (see par.26, 50: teaching that the intensity of each pixel in the subsequent images is normalized with the average value in the reference image for each pixel to achieve the corrected image). The time dependence of a signal in a period of time, where a particle is bound, is shown in Fig. 3. The plurality of processed images in various observation periods are analyzed in Fig. 5. In order to quantify the signal of a particle, the time dependence of the intensity in the vicinity of the particle is measured (see par.55).
This teaching encompasses the limitation of the claim.
For claim 15, Zybin, Hinman, and Ikeda teach the system of claim 7. Claim 15 recites wherein the removing of background noise from the plurality of raw plasmonic images further comprises implementing a moving average over time of images of the plurality of raw plasmonic images.
Zybin teaches removing the background noise to avoid a situation where the signal disappears in the noise. The reference signal can be generated by calculating the average of the images, which are detected before binding a particle at the sensor surface. The background is corrected by applying a reference image. See paragraph 26. Zybin does not teach the removing process comprising implementing a moving average over time of images of the plurality of raw plasmonic images.
Ikeda teaches a process of removing the background noise comprising removing a signal component derived from an impurity existing on the substrate from the image data by comparing the plurality of image data (see Abstract, par.52). The process also comprises setting a voltage of electrodes to a value by which the moving distance of the metal colloid is not more than optical spatial resolution; setting the second voltage for acquisition of the second image data larger than the first voltage in absolute value to subject the particle to electrophoretic migration; tracing the moving of the metal colloidal particle in the second image data obtained for a given exposure time (see par.60). The metal colloidal particles moving in the solution can be discriminated from the impurity existing on the substrate by changing the applied voltage and exposure time. Accordingly, the colloidal particles can be quantified by counting the colloidal particles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement a moving average over time of images of the plurality of raw plasmonic images into the modified system of Zybin. By doing that, the background noise or the impurity existing on the sensor is removed, and the analyte of interest can be accurately detected via counting the interaction between particles and analyte (see Ikeda Abstract, par.14, 52, 60).
One having an ordinary skill in the art would have had a reasonable expectation of success in implement a moving average over time of images of the plurality of raw plasmonic images into the modified system of Zybin because Zybin, Hinman, and Ikeda are directed to the system of detecting analyte using surface plasmon resonance technique comprising the sensor (taught by Hinman), the surface plasmon resonance spectrometer (taught by Zybin), and the surface plasmon resonance imaging software (taught by Ikeda). The Hinman sensor can be used in electrochemical SPR (see page 25 par.2), so it can work with electrodes to trace the movement of the particles in the sensor. The system of Zybin can detect the plasmonic images on the sensor of Hinman, and then the imaging software of Ikeda can analyze the plasmonic images to detect and quantify the analyte of interest via detecting the number of nanoparticles.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zybin (US20110311962) in view of Hinman et al. (Surface Plasmon Resonance: Material and Interface Design for Universal Accessibility, Anal Chem. 2018 January 02; 90(1): 19–39), and Ikeda (US20090238413), as applied in claim 8, and further in view of Zhou et al. (Detection of procalcitonin (PCT) using the double antibody sandwich method based on fluorescence resonance energy transfer between upconversion nanoparticles and quantum dots, Anal. Methods, 2018, 10, 1015–1022).
For claim 9, Zybin, Hinman, and Ikeda teach the system of claim 8. Zybin in view of Hinman teaches the gold nanoparticles comprise streptavidin-coated gold nanoparticles (see discussion in claim 8 above).
Zybin does not teach the capture antibodies, which bind to procalcitonin, having a bound detection antibody, and the bound detection antibody is configured to bind the streptavidin-coated gold nanoparticles.
Hinman teaches a method of detecting analytes comprising capture antibodies tethered to the sensor, the capture antibodies bind to analytes of interest, and the analytes of interest are detected by biotinylated detection antibodies which are linked to streptavidin-coated gold nanoparticles (see page 18 last 2 sentences, page 19 par.1).
Zhou teaches a method of detecting procalcitonin (PCT) using a nanoparticle-based method (see Abstract). Zhou teaches that procalcitonin (PCT) plays a crucial role in providing a promising biomarker for monitoring bacterial infections because the PCT concentration increases to several thousand times higher in the case of severe parasitic, bacterial or fungal infection than normal physiological concentrations (see page 1015 col.1 par.1). The detection of PCT comprises a capture antibody and a detection antibody that can bind to PCT (see Schemes 1-2, page 1017 col.1 par.3-4: teaching 3D3-antibody as a capture antibody and 2E6-antibody as a detection antibody, the detection antibody is coated on nanoparticle, the detection is based on the antibody–antigen–antibody “sandwich” immunoassay).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the modified system of Zybin to detect PCT in the test sample, because detecting PCT can help the diagnosis of parasitic, bacterial or fungal infection in a subject as taught by Zhou. Accordingly, it would have been obvious to use the capture and detection antibodies that can bind to PCT to form a complex of antibody-PCT-antibody coupled to gold nanoparticles to detect PCT in the sample. This technique would increase the signal significantly in comparison to an assay using only detection antibodies (see page Hinman 19 par.1), so it can improve the sensitivity of detecting PCT in the sample.
One having an ordinary skill in the art would have had a reasonable expectation of success in detecting PCT using the modified system of Zybin because the teaching of Zybin in view of Hinman, and the teaching of Zhou are directed to a method of detecting an analyte using a nanoparticle-based sandwich immunoassay as discuss above. The reagents of the immunoassay are selected depending on the user preference to detect an analyte of interest. The modified system of Zybin can detect the interaction between nanoparticles and the analyte of interest.
For claim 10, Zybin, Hinman, Ikeda and Zhou teach the system of claim 9. Zybin does not teach a delivery device for delivering a sample.
Ikeda teaches an injector to inject the solution on the sensor (see par.35 and 40, Fig.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an injector taught by Ikeda to deliver the assay solutions to the modified system of Zybin, so that the analytes in the sample can be contacted with the assay reagents and can be measured. One having an ordinary skill in the art would have had a reasonable expectation of success in combining Zybin and Ikeda because they are directed to the SPR system to detect an analyte of interest.
Response to Arguments
Applicant’s arguments, in the Remarks filed 04/03/2026 with respect to claim(s) 7-12 have been considered but are moot because the new ground of rejection is made in view of the amendment of the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAU N.B. TRAN whose telephone number is (571)272-3663. The examiner can normally be reached on Mon-Fri 8:30-6:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L 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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/CHAU N.B. TRAN/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 October 1, 2026
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