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 Claims
Claims 1-22 are pending and examined on the merits.
Priority
The instant application filed on 5/4/2022 is a continuation-in-part of Application No. 17/074,274 filed 10/19/2020 and issued as US Patent No. 11,327,014 on 5/10/2022, which itself is a continuation of Application No. 16/423,733 filed 5/28/2019 and issued as US Patent No. 10,809,194 on 10/20/2020. Application 16/423,733 is also a continuation of PCT/US19/34087 filed 5/27/2019 which claims the benefit of priority to US Provisional Patent Application No. 62/676,983 filed on 5/27/2018. Thus, the effective filing date of the claims is 5/27/2018.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/13/2022, 6/27/2023, and 9/11/2023 have been entered and considered. A signed copy of the corresponding 1449 form has been included with this Office action.
Specification
The disclosure is objected to because of the following informalities:
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. The abstract filed 5/4/2022 contains 176 words.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 13 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 13 rejected as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Claims 2 and 13 recite "preparing the biosensor device; and after preparing the biosensor device, using the biosensor device to measure the plurality of ROIs to obtain the respective biosensor response signal or the respective biosensor reflectivity signal for each of the plurality of ROIs", which does not further limit claims 1 or 12 because there are no further limitations of what "preparing the biosensor device" entails, and it is already being "used" in claims 1 and 12 for measuring the plurality of ROI response or reflectivity signals.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1 and 12: “determining a sample group and a reference group for the plurality of ROIs” provides an evaluation (determining groupings for samples or references involves evaluations) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“generating one or more sample data distributions based on one or more respective sample group binding parameters for each of the sample group ROIs derived from the respective biosensor response data for the each of the sample group ROIs; and generating one or more reference data distributions based on one or more respective reference group binding parameters for each of the reference group ROIs derived from the respective biosensor response data for the each of the reference group ROIs” provides a mathematical relationship (generating binding parameter data distributions involves determining mathematical relationships of parameter values) that is considered a mathematical concept, which is an abstract idea.
Claims 3 and 14: “determining a respective ROI sensitivity for the each ROI of the plurality of ROIs at each incident angle of a predetermined range of incident angles to the plurality of ROIs” provides an evaluation (determining a sensitivity involves evaluation of the biosensor response at each incident angle) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“determining a respective ROI count at each incident angle of the predetermined range of incident angles, wherein the respective ROI count is a count of ROIs of the plurality of ROIs for which the respective ROI sensitivity at the each incident angle is no less than a predetermined sensitivity threshold; and determining a selected incident angle of the predetermined range of incident angles for the biosensor device, wherein the respective ROI count at the selected incident angle is no less than another respective ROI count at any other incident angle of the predetermined range of incident angles” provides a comparison (determining counts below or above certain thresholds involves comparing values to thresholds) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claims 4 and 15: “determining a respective biosensor signal change and a respective biosensor angle change for the each ROI at the each incident angle based on: (a) the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle, and (b) the respective biosensor profile curve for the each ROI” provides a comparison (determining changes involves evaluating values against one another) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“determining the respective ROI sensitivity for the each ROI at the each incident angle based at least in part on the respective biosensor angle change and the respective biosensor signal change” (specification para.0048 “change in reflectivity signal divided by SPR angle change”) provides a mathematical calculation (determining sensitivities requires mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claims 5 and 16: “generating the respective biosensor profile curve for the each ROI based on the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle” provides a mathematical relationship (generating the "angle-response profile curves" [figure 6 of Drawings] involves determining the mathematical relationship of the angle of incident light and the response) that is considered a mathematical concept, which is an abstract idea.
Claims 6 and 17: “a respective slope of the respective biosensor profile curve at the each incident angle; a respective function value of a curve fitting function for the each ROI based at least in part on the each incident angle, the respective biosensor signal change, and the respective biosensor angle change” provides a mathematical calculation (determining sensitivities by the slope or curve fitting requires mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claims 7 and 18: “determining the respective ROI sensitivity for the each ROI at the each incident angle based on (a) the respective biosensor response signal or the respective biosensor reflectivity signal and (b) the respective biosensor angle change” provides a mathematical calculation (determining sensitivities requires mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
Claims 8 and 19: “identifying the one or more samples from an optical image of the sensor surface taken by the biosensor device; and automatically mapping a respective location of each of the one or more samples to the sample group ROIs” provides an evaluation (identifying sample groups involves an evaluation of the optical image) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claims 9 and 20: “eliminating a noise from the respective biosensor response data of the each ROI of the plurality of ROIs based at least in part on the respective biosensor response data of a representative reference group ROI of the reference group ROIs” provides an evaluation and comparison (eliminating noise by evaluation of sample and reference signals involves comparing data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claims 10 and 21: “subtracting the respective biosensor response data of the representative reference group ROI from the respective biosensor response data of the each ROI” provides a mathematical calculation (subtraction of reference data from sample data requires mathematical calculations) that is considered a mathematical concept, which is an abstract idea.
“determining a respective fit error for each of the one or more respective sample group binding parameters and the one or more respective reference group binding parameters” provides a mathematical relationship (determining a fit involves determining a mathematical relationship) that is considered a mathematical concept, which is an abstract idea.
“removing a group ROI of the plurality of ROIs from a group of the sample group ROIs or the reference group ROIs when the respective fit error for the group ROT is at least as great as a predetermined cutoff error” provides an evaluation and comparison (comparing fit errors to a predetermined cutoff value involves an evaluation) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claims 11 and 22: “eliminating an error for each of the sample group ROIs caused by one or more unwanted effects based on the one or more sample data distributions and the one or more reference data distributions” provides an evaluation and comparison (eliminating errors by evaluation of sample and reference distributions involves comparing data) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, while claims 1-22 recite performing some aspects of the analysis “via execution of computing instructions configured to run at one or more processors and stored at one or more non-transitory computer-readable media” (claim 1) and on “one or more processors; and one or more non-transitory computer-readable media storing computing instructions that, when executed on the one or more processors” (claim 12), there are no additional limitations that indicate that this requires anything other than carrying out the recited mental processes or mathematical concepts in a generic computer environment. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental processes” grouping of abstract ideas. As such, claims 1-22 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claims 1 and 12: “the method being implemented via execution of computing instructions configured to run at one or more processors and stored at one or more non-transitory computer-readable media” (claim 1) and “the system comprising: one or more processors; and one or more non-transitory computer-readable media storing computing instructions that, when executed on the one or more processors” (claim 12) provides insignificant extra-solution activities (running instructions on generic computer components) that do not serve to integrate the judicial exceptions into a practical application.
“receiving respective biosensor response data for each ROI of the plurality of ROIs, wherein the respective biosensor response data for the each ROI include a respective biosensor response signal or a respective biosensor reflectivity signal for the each ROI measured by the biosensor device over a predetermined period of time” provides insignificant extra-solution activities (receiving data is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claims 4 and 15: “obtaining a respective biosensor profile curve for the each ROI of the plurality of ROIs” provides insignificant extra-solution activities (obtaining data is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“detecting, by the biosensor device, the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle” provides insignificant extra-solution activities (detecting a signal from a biosensor is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claims 5 and 16: “measuring the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle of the predetermined range of incident angles” provides insignificant extra-solution activities (measuring a signal from a biosensor is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“retrieving the respective biosensor profile curve, pre-measured for the each ROI, from a non-transitory computer-readable media or a remote database” provides insignificant extra-solution activities (retrieving data is a post-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claims 6 and 17: “a respective table value of a look-up table based at least in part on the respective biosensor signal change and the respective biosensor angle change” provides insignificant extra-solution activities (retrieving data is a post-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claims 7 and 18: “introducing a standard calibration fluid onto the each ROI, wherein a respective biosensor angle change for the standard calibration fluid on the each ROI at the each incident angle is predetermined” provides insignificant extra-solution activities (applying a standard is a pre-solution activity involving sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
“detecting, by the biosensor device, the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle” provides insignificant extra-solution activities (detecting a signal from a biosensor is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claims 8 and 19: “obtaining predetermined ROI grouping information, wherein the predetermined ROI grouping information comprises a predetermined mapping of sample group ROIs and reference group ROIs” provides insignificant extra-solution activities (obtaining data is a pre-solution activity involving sample gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
The steps for obtaining, measuring/detecting, and retrieving data; and applying standards for calibration are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data gathering, data manipulation, and sample manipulation steps (see MPEP 2106.04(d)(2)).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
As discussed above, there are no additional elements to indicate that the claimed “execution of computing instructions configured to run at one or more processors and stored at one or more non-transitory computer-readable media” (claim 1) or “one or more processors; and one or more non-transitory computer-readable media storing computing instructions that, when executed on the one or more processors” (claim 12) requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. Additionally, the limitations for obtaining, measuring/detecting, and retrieving data; and applying standards for calibration are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are demonstrated to be well-understood, routine, and conventional: Wong et al., Page 5 col 1 paragraph 2 "Conventional phase SPR imaging sensors mainly relied on interference fringe analysis, and a large portion of spatial information has been sacrificed in the phase extraction process [44, 63, 64, 71, 74–76]. Wong et al. presented a 2D SPR phase imaging sensor technique [43]. A piezoelectric transducer was used to modulate the phase of the interference image in the time domain, which allowed every pixel on the SPR image to be converted into corresponding phase shift values, and a 2D SPR phase map could be obtained without the use of expensive electro-optical modulators. In 2008, they applied a differential phase measurement scheme together with the 2D phase mapping technique for bio-molecular array detection [45]" (Wong et al. "Surface plasmon resonance imaging sensors: a review." Plasmonics 9.4 (2014): 809-824).
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-22 are not patent eligible.
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.
Claims 1-2, 8-9, 12-13, and 19-20 rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (US-20140185051) in view of Indermuehle et al. (US-20080204713).
Regarding claims 1-2 and 12-13, Guan teaches receiving respective biosensor response data for each ROI of the plurality of ROIs, wherein the respective biosensor response data for the each ROI include a respective biosensor response signal or a respective biosensor reflectivity signal for the each ROI measured by the biosensor device over a predetermined period of time (Para.0063 "The SPR analysis apparatus 101 is configured to detect and/or characterize molecular binding interactions in a label-free format. The optics assembly 108 may simultaneously address thousands of spots on the microarray" and para.0082 "the reflectivity may be monitored vs. time to detect the rate of analyte binding characterized by an association constant ka or a rate of analyte unbinding characterized by a dissociation constant kd. Similarly, the reflectivity of the ROI may indicate an equilibrium constant Ka=ka/kd").
Guan also teaches taking measurements from one or more groups of pixels during an experimental run (Para.0103 "The sensorgram may be generated by monitoring changes in brightness of one or more groups of pixels during an experimental run, the one or more groups of pixels corresponding each of one or more ROIs on a microarray. An ROI selection module 804 is operable to receive user selection of ROIs within the video display, or alternatively may automatically select ROIs for display").
Guan also teaches generating one or more sample data distributions based on one or more respective sample group binding parameters for each of the sample group ROIs derived from the respective biosensor response data for the each of the sample group ROIs; and generating one or more reference data distributions based on one or more respective reference group binding parameters for each of the reference group ROIs derived from the respective biosensor response data for the each of the reference group ROIs (Para.0016 "The SPR analysis software application may measure changes in brightness of regions of interest in the SPR video image and compute one or more kinetics parameters corresponding to the association and dissociation" and para.0113 "Multiple sensorgram plots of different spot collections and analyte series is provided for comparison and inclusion in reports", which supports plotting data from sample or reference pixel groups).
Guan does not explicitly teach determining a sample group and a reference group for the plurality of ROIs, wherein: the sample group comprises sample group ROIs of the plurality of ROIs; each of the sample group ROIs is supporting one or more samples for the molecular interactions to be measured; the reference group comprises reference group ROIs of the plurality of ROIs; the sample group ROIs are absent from the reference group; and the reference group ROIs are absent from the sample group.
However, Indermuehle teaches predetermining groups on the surface of a biosensor (Para.0029 "Surface treatments associated with specific binding of selected analyte molecules can be applied to a variety of surfaces. For example, a surface can be treated to specifically bind a selected analyte, while other analytes do not bind to the surface. A surface can be provided with one or more such surface treatments for one or more analytes. [] depressions or wells can be provided in a substrate, and bottom surfaces of the wells can be similarly treated. Typically, pillars, wells, or activated areas on a planar surface are arranged in arrays, and are conveniently separated by intermediate areas that are not provided with such surface treatments. In some examples, the intermediate areas are treated to reduce or minimize any type of binding" suggests that if the surface is configured for a control, then it cannot also be a sample, and vice versa).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Guan as taught by Indermuehle in order to control and specifically bind an analyte for calibration or verification (Para.0029 "For example, a surface can be configured with specific surface regions configured for different analytes and/or some surface regions can be configured to provide controls for calibration and verification of binding of one or more analytes"). One skilled in the art would have a reasonable expectation of success because both methods are operating using principles of optical sensing of biomolecules at an illuminated surface.
Regarding claims 8 and 19, Guan in view of Indermuehle teach the methods of Claims 1 and 12 on which this claim depends/these claims depend, respectively. Guan also teaches determining the sample group and the reference group for the plurality of ROIs further comprises: (a) identifying the one or more samples from an optical image of the sensor surface taken by the biosensor device; and automatically mapping a respective location of each of the one or more samples to the sample group ROIs; or (b) obtaining predetermined ROI grouping information, wherein the predetermined ROI grouping information comprises a predetermined mapping of sample group ROIs and reference group ROIs (Para.0103 "The sensorgram may be generated by monitoring changes in brightness of one or more groups of pixels during an experimental run, the one or more groups of pixels corresponding each of one or more ROIs on a microarray. An ROI selection module 804 is operable to receive user selection of ROIs within the video display, or alternatively may automatically select ROIs for display").
Regarding claims 9 and 20, Guan in view of Indermuehle teach the methods of Claims 8 and 19 on which this claim depends/these claims depend, respectively. Guan also teaches eliminating a noise from the respective biosensor response data of the each ROI of the plurality of ROIs based at least in part on the respective biosensor response data of a representative reference group ROI of the reference group ROIs (Para.0133 "Video frame averaging may be useful for reducing processing time and/or for averaging noisy data. The user may also load and/or revise a calibration table in a calibration table field 1420 and load and/or revise a spot location table in a spot location table field 1422").
Claims 3-7 and 14-18 rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (US-20140185051) in view of Indermuehle et al. (US-20080204713) as applied to claims 1-2, 8-9, 12-13, and 19-20 above, and further in view of Niskanen et al. (US-20120100626).
Guan et al. in view of Indermuehle et al. are applied to claims 1-2, 8-9, 12-13, and 19-20.
Regarding claims 3 and 14, Guan in view of Indermuehle teach the method of Claims 2 and 13 on which this claim depends/these claims depend. Guan also teaches determining a respective ROI sensitivity for the each ROI of the plurality of ROIs at each incident angle of a predetermined range of incident angles to the plurality of ROIs (Para.0021 "FIG. 4 is a plot of a surface plasmon resonance signal while modifying the angle of incidence" suggests measurements from a range of incident angles).
Guan nor Indermuehle explicitly teach determining a respective ROI count at each incident angle of the predetermined range of incident angles, wherein the respective ROI count at the each incident angle is no less than a predetermined sensitivity threshold.
However, Niskanen teaches each sensor element being sensitive to radiation only above a particular threshold (Para.0047 "each sensor element 201 may be configured to detect radiation above a particular threshold (which may be different for each sensor element 201). Below this threshold, the sensor element 201 may be insensitive to variations in wavelength”
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the multiple angle methods of Guan and Indermuehle as taught by Niskanen in order to control the intensity of each pixel or group of pixels independently (para.0047 "it would be most beneficial if the intensity of each pixel 208, or groups of pixels, could be controlled independently. This is because the sensitivity of each sensor element 201 to a particular intensity might be different. For example, each sensor element 201 may be configured to detect radiation above a particular threshold (which may be different for each sensor element 201). Below this threshold, the sensor element 201 may be insensitive to variations in wavelength"). One skilled in the art would have a reasonable expectation of success because both methods are operating using the same principles of SPR.
Regarding claims 4 and 15, Guan in view of Indermuehle teach the method of Claims 3 and 14 on which this claim depends/these claims depend. Guan also teaches obtaining a respective biosensor profile curve for the each ROI of the plurality of ROIs (Para.0021 "FIG. 4 is a plot of a surface plasmon resonance signal while modifying the angle of incidence" suggests measurements from a range of incident angles).
Guan also teaches detecting, by the biosensor device, the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle; and determining a respective biosensor signal change and a respective biosensor angle change for the each ROI at the each incident angle based on: (a) the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle, and (b) the respective biosensor profile curve for the each ROI (para.0038 "FIG. 19 is a screen shot of an SPR data analysis application spot details screen illustrating measurement configuration and SPR response curves from a partially played video file, according to an embodiment").
Niskanen also teaches determining the respective ROI sensitivity for the each ROI at the each incident angle based at least in part on the respective biosensor angle change and the respective biosensor signal change (para.0047 "it would be most beneficial if the intensity of each pixel 208, or groups of pixels, could be controlled independently. This is because the sensitivity of each sensor element 201 to a particular intensity might be different. For example, each sensor element 201 may be configured to detect radiation above a particular threshold (which may be different for each sensor element 201). Below this threshold, the sensor element 201 may be insensitive to variations in wavelength").
Regarding claims 5 and 16, Guan in view of Indermuehle teach the method of Claims 4 and 15 on which this claim depends/these claims depend. Guan also teaches measuring the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle of the predetermined range of incident angles; and generating the respective biosensor profile curve for the each ROI based on the respective biosensor response signal or the respective biosensor reflectivity signal for the each ROI at the each incident angle (Para.0021 "FIG. 4 is a plot of a surface plasmon resonance signal while modifying the angle of incidence" suggests measurements from a range of incident angles).
Alternatively, Guan and Niskanen also teach retrieving the respective biosensor profile curve, pre-measured for the each ROI, from a non-transitory computer-readable media or a remote database (Guan, Para.0101 "An SPR database module 704 may be configured to receive and respond to queries, and store data from the graphical user interface module 702. The SPR database module 704 may include one or more of at least one data storage table 706, at least one kinetics formulae module 708, at least one fluidics recipe module 710, and at least one relationship diagram module"; and Niskanen, para.0056 "The light patterns and electrical responses can then be stored in a database for use in subsequent sensing experiments").
Regarding claims 6 and 17, Guan in view of Indermuehle teach the method of Claims 5 and 16 on which this claim depends/these claims depend. Guan also teaches the respective ROI sensitivity for the each ROI of the plurality of ROIs at the each incident angle of the predetermined range of incident angles is determined by a respective function value of a curve fitting function for the each ROI based at least in part on the each incident angle, the respective biosensor signal change, and the respective biosensor angle change (Para.0061 "plotting the intensity of light at the detector against the magnitude of the displacement of the linear actuator to give a curve comprising a linear slope (50 in (FIG. 4))").
Or alternatively, Guan also teaches the respective ROI sensitivity for the each ROI of the plurality of ROIs at the each incident angle of the predetermined range of incident angles is determined by a respective table value of a look-up table based at least in part on the respective biosensor signal change and the respective biosensor angle change (Para.0104 "A curve fit module 824 may allow a user to map association and/or dissociation curves to the data" and Para.0109 "A kinetic table display module 846 may be configured to assemble information from the kinetic analysis results file, a GAL file, an analyte file, and/or other data sources, and output a report including the assembled data").
Regarding claims 7 and 18, Guan in view of Indermuehle teach the method of Claims 3 and 14 on which this claim depends/these claims depend. Indermuehle also teaches introducing a standard calibration fluid onto the each ROI, wherein a respective biosensor angle change for the standard calibration fluid on the each ROI at the each incident angle is predetermined Para.0042 "at least some sensor ROIs can be provided for calibration, and the signal processor can determine analyte response parameters such as slope and offset based on these ROIs"), and detecting and determining sensitivity are covered above.
Claims 10-11 and 21-22 rejected under 35 U.S.C. 103 as being unpatentable over Guan et al. (US-20140185051) in view of Indermuehle et al. (US-20080204713) as applied to claims 1-2, 8-9, 12-13, and 19-20 above, and further in view of Bosmans et al. (US-20180003631).
Guan et al. in view of Indermuehle et al. are applied to claims 1-2, 8-9, 12-13, and 19-20.
Regarding claims 10 and 21, Guan in view of Indermuehle teach the method of Claims 9 and 20 on which this claim depends/these claims depend. Indermuehle also teaches removing a group ROI of the plurality of ROIs from a group of the sample group ROIs or the reference group ROIs when the respective fit error for the group ROT is at least as great as a predetermined cutoff error (Applying the threshold of Niskanen from claims 3 and 14 would effectively remove ROI groups by rendering them before the threshold of sensitivity).
Guan nor Indermuehle explicitly teach: subtracting the respective biosensor response data of the representative reference group ROI from the respective biosensor response data of the each ROI; nor after subtracting, determining a respective fit error for each of the one or more respective sample group binding parameters and the one or more respective reference group binding parameters
However, Bosmans teaches subtracting the respective biosensor response data of the representative reference group ROI from the respective biosensor response data of the each ROI (Para.0049 "In all SPR experiments, nonspecific binding obtained in the control flow cell was subtracted from the signal obtained in the experimental flow cell").
Bosmans also teaches after subtracting, determining a respective fit error for each of the one or more respective sample group binding parameters and the one or more respective reference group binding parameters (Para.0049 "The bulk signal caused by refractive index differences between the flow buffer and the buffer containing the analyte was systematically excluded from the data-fitting process").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Guan and Indermuehle as taught by Bosmans in order to fit data to a heterogeneous surface ligand model (para.0053 "Colored traces represent toxin binding obtained after subtraction of the signal from the control flow cell. Green dotted lines depict a fit of the data to a heterogeneous surface ligand model). One skilled in the art would have a reasonable expectation of success because both methods are operating using the same principles of SPR.
Regarding claims 11 and 22, Guan in view of Indermuehle teach the method of Claims 9 and 20 on which this claim depends/these claims depend. Indermuehle and Bosmans also teach eliminating an error for each of the sample group ROIs caused by one or more unwanted effects based on the one or more sample data distributions and the one or more reference data distributions (the calibration of Indermuehle from claims 7 and 18 and the subtracted signal from the control flow cell of Bosmans from claims 10 and 21 fairly teaches or suggests this limitation).
Conclusion
No claims are allowed.
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/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686