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
The claim set submitted on 25 SEPTEMBER 2024 is acknowledged and considered. In the claim set, Claims 1-20 are submitted and are considered on the merits below.
Specification
The disclosure is objected to because of the following informalities:
The use of the term BLUETOOTH®, ANDROID™, iOS®, WEBVIEW®, SUPER●SAL™, OASIS DIAGNOSTICS® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See [0098].
In [00109], at the end of the paragraph , it ends with ‘transmitted over comm’, is this supposed to be ‘transmitted over communications’?
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 5, character 540; Figure 6, character 602, 611, 621; Figure 7, character 750; Figure 28, character 2880; Figure 34, character 3440, 3450, 3460; Figure 41, character 4140; Figure 43B, character 4362; Figure 45B, character 4570 4572, 4574; Figure 47B, character 4750; Figure 49A, character 4906; Figure 50B, character 5084; Figure 62, character 6411, 6412; Figure 63, character 6510, 6511, 6512, 6513, 6507, 6508, 6509; Figure 64, character 6635. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 17 is objected to because of the following informalities: In the instant claim, ‘conductive’ is misspelled. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 9 and 15 recites the limitation "the fluid test sample" and "the plurality of interdigitated electrodes (IDEs)", "the primer probe", "the conductive fluid sensor surface". There is insufficient antecedent basis for this limitation in the claim.
In Claims 1, 9 and 15, initially what is claim is a ‘plurality of conductive fluid sensors’; however later in the claim in the measuring step, there is ‘the conductive fluid sensor’. The language in the claim goes from plural to singular. It is unclear whether a plurality or a singular conductive fluid sensor is claimed.
To remedy the language the Examiner suggests changing the instance in the measuring step to be ‘at least one of the plurality of conductive fluid sensors’.
Dependent Claims 2-8, 10-14, and 16-20 are also rejected under 112(b) as being dependent upon a rejected claim.
Regarding Claims 2 and 10, it is unclear to the Examiner when the ‘further comprising measuring’ step is occurring. Can it occur at any time or is it meant to be occurring before the measuring step in Claim 1 or after the measuring step in Claim 1? Clarification is requested.
Similarly, in Claim 6, 14 and 18, when is this step collecting occurring before the method is performed or after the method is completed?
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, 9 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
The claim(s) recite(s) at least in Claim 1, a method for detecting biologic analytical target pathogens of a fluid sample, comprising:
providing on a plurality of conductive fluid sensors a primer/probe solution having a single-stranded DNA reconstituted from aliquoted DNA stock;
depositing the fluid test sample on a plurality of conductive fluid sensors coupled to the plurality of interdigitated electrodes (IDEs) ;
using a plurality of selective binding properties of the primer/probe solution to lift off the primer/probe from the conductive fluid sensors surface when a select single-stranded RNA/DNA of a pathogen binds to the single-stranded DNA;
measuring with a measurement device coupled to the IDEs a change in at least one of resistance and conductivity upon presenting the fluid test sample to the conductive fluid sensor;
reading, with a reader coupled to the measurement device configured, any changes in at least one of resistance and conductivity test data;
analyzing, with a processor coupled to the reader, a feature vector of the measurements of the test to determine test results; reporting a positive result if at least one of resistance decreases and conductivity increases of the fluid test sample is detected based on the feature vector of the measurements of the test; and
storing, in a reader log memory device, operational parameters, intermediate test data, and completed test results.
Independent Claims 9 and 15 also generally claim the same thing including steps of “providing”, “depositing”, “using”, “measuring”, “reading”, “analyzing” and “storing”. Independent Claims 9 and 15 further defines the feature vector and includes a step of “reporting a positive result”. In addition, independent Claim 15 includes a second measuring step.
The limitation of steps of “reading” and “analyzing” , as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. Nothing in the claim element precludes the step from practically being performed in the mind. In addition, the language in the storing step “in a reader log memory device”, the “reading” and “analyzing” in the context of this claim encompasses the user manually performing these steps.
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. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application.
In particular, the claim only recites an additional element – “analyzing, with a processor coupled to the reader” to perform both the step. The processor in the step is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both analyzing and the storing steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claim is not patent eligible.
Claims 2, 3, 10 and 11 are directed towards measuring steps measuring steps of parameters which are at least obvious as a matter of design choice for the method as a means for characterizing the analyte.
Claims 4, 12 and 16 are directed towards using a power source, which not an additional element that is sufficient to amount to significantly more than the judicial exception and are WURC in the art of analyte analysis.
Claims 5, 13, and 17 are directed to providing operating access, which not an additional element that is sufficient to amount to significantly more than the judicial exception and are WURC in the art of analyte analysis. It is well known in the art that providing an operator access is known in the art and expected to change/add the sample and to possible fix the system.
Claims 6, 14 and 18 are directed to a step of collecting the fluid sample which is not an additional element that is sufficient to amount to significantly more than the judicial exception and are WURC in the art of analyte analysis. Furthermore, it is well known that a fluid sample must be collected by some sort of system.
Claims 7, 8, 19 and 20 are directed to addition steps of incubating and comparing which do not include additional elements that are sufficient to amount to significantly more than the judicial exception and are WURC in the art of analyte analysis.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by SCHWOEBEL, US Patent 8,216,797 B2.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference SCHWOEBEL discloses a method for detecting biologic analytical target pathogens of a fluid sample, abstract, Column 2 line 35-41, comprising:
providing on a plurality of conductive fluid sensors a primer/probe solution having a single-stranded DNA reconstituted from aliquoted DNA stock, Claim 1, Column 34 line 18-37, Column 71 line 54-Column 72 line 4;
depositing the fluid test sample on a plurality of conductive fluid sensors coupled to the plurality of interdigitated electrodes (IDEs), Column 16 line 45-48, Column 57 line 3-33, Column 34 line 18-37, the filter is considered to be the IDEs;
using a plurality of selective binding properties of the primer/probe solution to lift off the primer/probe from the conductive fluid sensors surface when a select single-stranded RNA/DNA of a pathogen binds to the single-stranded DNA, Column 34 line 18-37, unattached cells are washed off, ‘lifted off’;
measuring with a measurement device coupled to the IDEs a change in at least one of resistance and conductivity upon presenting the fluid test sample to the conductive fluid sensor, Column 2 line 4-32, Column 57 line 46-49;
reading, with a reader coupled to the measurement device configured, any changes in at least one of resistance and conductivity test data, Column 2 line 4-32, Column 55 line 46-62, Figure 4;
analyzing, with a processor coupled to the reader, a feature vector of the measurements of the test to determine test results, Column 6 line 38-51;
reporting a positive result if at least one of resistance decreases and conductivity increases of the fluid test sample is detected based on the feature vector of the measurements of the test, Column 6 line 38-51; and
storing, in a reader log memory device, operational parameters, intermediate test data, and completed test results, Column 6 line 38-51.
Additional Disclosures Included are: Claim 2: wherein the method of claim 1, further comprising measuring an electrical field and ionic strength of the fluid test sample, Column 55 line 46-62. ; Claim 3: wherein the method of claim 1, further comprising measuring a first measurement of at least one of resistance and conductivity prior to placing the fluid test sample onto the plurality of conductive fluid sensors coupled to the plurality of interdigitated electrodes (IDEs) to confirm a stable baseline of at least one of resistance and conductivity, Column 15 line 59-Column 16 line 6, Figure 5.; Claim 4: wherein the method of claim 1, further comprising using at least one power source to deliver a predetermined power level through the plurality of interdigitated electrodes and plurality of conductive fluids sensors, Column 17 line 37-41, Column 65 line 23-28.; Claim 5: wherein the method of claim 1, further comprising providing operator access to apply fluid test samples to the plurality of conductive fluid sensors and interdigitated electrodes (IDEs), Figure 4.; Claim 6: wherein the method of claim 1, further comprising collecting the fluid sample using a test sample collection system, Figure 4, syringe module, Column 12 line 19-28.; Claim 7: wherein the method of claim 1, further comprising incubating the fluid sample prior to depositing the fluid sample on the plurality of conductive fluid sensors and plurality of interdigitated electrodes (IDEs), Column 43 line 23-40, Column 45 line 47-60. ; and Claim 8: wherein the method of claim 1, further comprising comparing signatures of biological pathogens with stored data of known biological pathogen signatures to identify a type of test result of the biological pathogen detected with a positive result, Column 63 line 4-12.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over SCHWOEBEL, US Patent 8,216,797 B2.
Applicant’s invention is directed towards a method.
Regarding Claim 9, the reference SCHWOEBEL discloses a method for detecting biologic analytical target pathogens of a fluid sample, abstract, Column 2 line 35-41, comprising:
providing on a plurality of conductive fluid sensors a primer/probe solution having a single-stranded DNA reconstituted from aliquoted DNA stock, Claim 1, Column 34 line 18-37, Column 71 line 54-Column 72 line 4;
depositing the fluid test sample on a plurality of conductive fluid sensors coupled to the plurality of interdigitated electrodes (IDEs), Column 16 line 45-48, Column 57 line 3-33, Column 34 line 18-37, the filter is considered to be the IDEs;
using a plurality of selective binding properties of the primer/probe solution to lift off the primer/probe from the conductive fluid sensors surface when a select single-stranded RNA/DNA of a pathogen binds to the single-stranded DNA, Column 34 line 18-37, unattached cells are washed off, ‘lifted off’;
measuring with a measurement device coupled to the IDEs a change in at least one of resistance and conductivity upon presenting the fluid test sample to the conductive fluid sensor, Column 2 line 4-32, Column 57 line 46-49;
reading, with a reader coupled to the measurement device configured, any changes in at least one of resistance and conductivity test data, Column 2 line 4-32, Column 55 line 46-62, Figure 4;
analyzing, with a processor coupled to the reader, a feature vector representation of time-series data, Column 6 line 38-51;
reporting a positive result if at least one of resistance decreases and conductivity increases of the fluid test sample is detected based on the feature vector representation, Column 6 line 38-51; and storing, in a reader log memory device, operational parameters, intermediate test data, and completed test results, Column 6 line 38-51.
The SCHWOEBEL discloses the claimed invention, but is silent in regards to the wherein the vector representation of time-series data includes a minimum relative value, a maximum relative value, positive area under the baseline relative domain curve, negative area under the baseline relative domain curve, and average value of all values in the baseline relative domain curve .
However, since SCHWOEBEL discloses in the graphs presented in the drawings include characterizations of the DNA including time series data, it would be have been obvious to one having ordinary skill in the art before the effective filing date to modify the SCHWOEBEL so that the feature vector representation of time-series data includes minimum relative value, a maximum relative value, positive area under the baseline relative domain curve, negative area under the baseline relative domain curve, and average value of all values in the baseline relative domain curve as this would be a normal statistical characterization technique of data when describing data in a graphical sense. The other test data is further characterization of analytes/components in the sample which can help characterize analyte/components with higher confidence.
Additional Disclosures Included are: Claim 10: wherein the method of claim 9, further comprising measuring an electrical field and ionic strength of the fluid sample, Column 55 line 46-62. ; Claim 11: wherein the method of claim 9, further comprising measuring a first measurement of at least one of resistance and conductivity prior to placing the fluid sample onto the conductive fluid sensors coupled to the plurality of interdigitated electrodes (IDEs) to confirm a stable baseline of at least one of resistance and conductivity, Column 15 line 59-Column 16 line 6, Figure 5.; Claim 12: wherein the method of claim 9, further comprising using a power source to deliver a predetermined power level through the plurality of interdigitated electrodes and plurality of conductive fluid sensors, Column 17 line 37-41, Column 65 line 23-28.; Claim 13: wherein the method of claim 9, further comprising providing operator access to apply fluid samples to the plurality of conductive fluid sensors and plurality of interdigitated electrodes (IDEs), Figure 4.; and Claim 14: wherein the method of claim 9, further comprising collecting the fluid sample using a test sample collection system, Figure 4, syringe module, Column 12 line 19-28.
Applicant’s invention is directed towards a method.
Regarding Claim 15, the reference SCHWOEBEL discloses method for detecting biologic analytical target pathogens of a fluid sample, abstract, Column 2 line 35-41, comprising:
providing on a plurality of conductive fluid sensors a primer/probe solution having a single-stranded DNA reconstituted from aliquoted DNA stock, Claim 1, Column 34 line 18-37, Column 71 line 54-Column 72 line 4;
depositing the fluid test sample on a plurality of conductive fluid sensors coupled to the plurality of interdigitated electrodes (IDEs), Column 16 line 45-48, Column 57 line 3-33, Column 34 line 18-37, the filter is considered to be the IDEs;
using a plurality of selective binding properties of the primer/probe solution to lift off the primer/probe from the conductive fluid sensors surface when a select single-stranded RNA/DNA of a pathogen binds to the single-stranded DNA, Column 34 line 18-37, unattached cells are washed off, ‘lifted off’;
measuring an electrical field and ionic strength of the fluid sample to calibrate the fluid sensors to the fluid sample, Column 2 line 4-32, Column 35 line 6-18;
measuring with a measurement device coupled to the IDEs a change in at least one of resistance and conductivity upon presenting the fluid test sample to the conductive fluid sensor, Column 2 line 4-32, Column 57 line 46-49;
reading, with a reader coupled to the measurement device configured, any changes in at least one of resistance and conductivity test data, Column 2 line 4-32, Column 55 line 46-62, Figure 4;
analyzing, with a processor coupled to the reader, a feature vector of the measurements of the test, Column 6 line 38-51;
reporting a positive result if at least one of resistance decreases and conductivity increases of the fluid test sample is detected based on the feature vector of the measurements of the test, Column 6 line 38-51; and
storing, in a reader log memory device, operational parameters, intermediate test data, and completed test results, Column 6 line 38-51.
The SCHWOEBEL discloses the claimed invention, but is silent in regards to the wherein the feature vector of the measurements of the test data includes a minimum relative value, a maximum relative value, positive area under the baseline relative domain curve, negative area under the baseline relative domain curve, and average value of all values in the baseline relative domain curve.
However, since SCHWOEBEL discloses in the graphs presented in the drawings include characterizations of the DNA including time series data, it would be have been obvious to one having ordinary skill in the art before the effective filing date to modify the SCHWOEBEL so that wherein the feature vector of the measurements of the test data includes a minimum relative value, a maximum relative value, positive area under the baseline relative domain curve, negative area under the baseline relative domain curve, and average value of all values in the baseline relative domain curve as this would be a normal statistical characterization technique of data when describing data in a graphical sense. The other test data is further characterization of analytes/components in the sample which can help characterize analyte/components with higher confidence.
Additional Disclosures Included are: Claim 16: wherein the method of claim 15, further comprising using at least one of an internal or external power source to deliver a predetermined power level through the plurality of interdigitated electrodes and plurality of conductive fluid sensors, Column 17 line 37-41, Column 65 line 23-28.; Claim 17: wherein the method of claim 15, further comprising providing operator access to apply fluid samples to the plurality of [[conductive]] conductive fluid sensors and plurality of interdigitated electrodes (IDEs), Figure 4.; Claim 18: wherein the method of claim 15, further comprising collecting the fluid sample using a sample collection system, Figure 4, syringe module, Column 12 line 19-28.; Claim 19: wherein the method of claim 15, further comprising incubating the fluid sample prior to deposition onto the plurality of conductive fluid sensors and plurality of interdigitated electrodes (IDEs), Column 43 line 23-40, Column 45 line 47-60. ; and Claim 20: wherein the method of claim 15, further comprising comparing signatures of biological pathogens with stored data of known biological pathogen signatures to identify a type of test result of the biological pathogen detected with a positive result, Column 63 line 4-12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Publication No. 2010/0260679 A1 to SCHACHAR a method of detection of vascular endothelial growth factor (VEGF) hybridization uses an array of parallel capacitors to detect electrochemical binding of circulating VEGF to immobilized anti-VEGF monoclonal half-antibodies (a-VEGF mhAb) where the resistance of an interdigitated electrode is measured.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797