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 .
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 1-3, 5-10 and 31-40 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.
Independent claims 1 and 31 recite: a test sample possibly containing at least one analyte. The word “possibly” is unclear as the claim says that the analyte may be part of the claimed invention, but also may not. The Examiner suggests amending the claim to either: remove the language “possibly containing at least one analyte”, or say “introducing a test sample to be tested for the presence of at least one analyte”.
Claims 2, 3, 5-10, and 32-40 are rejected for their respective dependencies.
Claims 7 and 37 recite: finding a correlation between said different concentrations of said analyte in said at least two control samples and said measurable indications. It is not clear as to how the correlation is found between two samples when only the same variable is being measured (e.g. it is not clear how the (quantitative) concentration of an analyte in two samples can be correlated with the (qualitative) detection of the presence of an analyte in the same samples, if the only change between the two is the concentration.).
Claim 39 is rejected for its dependence on claim 37.
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.
Claim(s) 1-3, 5, 6, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glezer et al. (US 20160356722 A1), hereinafter “Glezer”.
Regarding Claim 1, Glezer teaches a method for obtaining calibrated indicia of a level of at least one analyte in a sample comprising:
introducing a test sample possibly containing at least one analyte into a testing device; processing said test sample in a test region of said testing device (Glezer [0100] The assay cartridges of the invention may comprise a plurality of flow cells or detection chambers. In certain preferred embodiments the flow cell may comprise the same assay domains or, at least, have at least some assay domains that share specificity for the same analytes of interest. In these embodiments, the plurality of flow cells may be used to analyze a plurality of different samples or to compare samples that have been pre-treated in different ways.);
obtaining, as a result of said processing, a measurable indication of a level of said at least one analyte in said test sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest.);
processing at least one control sample containing said at least one analyte in a control region of said testing device, said processing of said at least one control sample being carried out in at least near real time with respect to said processing of said test sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.);
obtaining, as a result of said processing of said control sample, at least one measurable indication of at least one level of said at least one analyte in said at least one control sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest.); and
calibrating said indication of said level of said at least one analyte in said test sample based on said at least one measurable indication of said level of said at least one analyte in said at least one control sample, to provide a calibrated indication of said level of said at least one analyte in said test sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.).
Regarding Claim 2, Glezer further teaches wherein said control sample is separate to and different from said test sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.).
Regarding Claim 3, Glezer further teaches wherein said test sample comprises a bodily fluid obtained from a subject and said testing device is a single-use, disposable device, usable by said subject (Glezer [0012] Preferably, the electrodes are housed in a disposable assay cartridge and the optical detector(s), voltmeter(s), and/or ammeter(s) are housed in a separate re-usable cartridge reader. Also see [0002] This application relates to apparatuses, systems, kits and methods for conducting chemical, biochemical and/or biological assays on a sample. And [0102] Also depicted in this preferred embodiment are two banks of impedance sensors 172,173 that may be used fluid detection (e.g., sample, reagents, wash, buffer, etc.) and/or fluid discrimination (e.g., discriminating between sample, reagents, wash, buffer, etc. and/or sample type such as whole blood, plasma, mucous, etc.). The samples can be some kind of bodily fluid.).
Regarding Claim 5, Glezer further teaches wherein said measurable indication of said level of said at least one analyte in said test sample and said control sample comprises at least one of a colorimetric indication, an optical indication, an electrical indication and a chemical indication (Glezer [0012] In yet another embodiment, the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes.).
Regarding Claim 6, Glezer further teaches wherein said calibrating comprises at least one of:
qualitative calibrating based on relative characteristics of said measurable indications of said test sample and control sample, and quantitative calibrating based on relative concentrations of said at least one analyte as derived from said measurable indications of said test sample and control sample (Glezer [0012] In yet another embodiment, the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes. Also see [0277] In certain preferred embodiments employing ECL detection technology, data conversion/analysis operations may include one or more of: background subtraction; conversion to ECL counts; conversion of ECL counts to concentrations; and/or performance of quality checks on the acquired data. Determining the concentration of analyte is providing quantitative and qualitative measurements.).
Regarding Claim 21, Glezer teaches a testing device comprising:
a test region configured to process therein a test sample obtained from a subject (Glezer [0100] The assay cartridges of the invention may comprise a plurality of flow cells or detection chambers. In certain preferred embodiments the flow cell may comprise the same assay domains or, at least, have at least some assay domains that share specificity for the same analytes of interest. In these embodiments, the plurality of flow cells may be used to analyze a plurality of different samples or to compare samples that have been pre-treated in different ways.);
a first output region configured to display a measurable indication of a level of at least one analyte in said test sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest. Also see [0259] The embedded operator interface can preferably utilize an integrated display 2360 and/or integrated data entry device 2355 (e.g., keypad). The computerized control system may also preferably include non-volatile memory storage for storing cartridge results and instrument configuration parameters.);
a control region configured to process therein at least one control sample, said control sample being processed in at least near real time with respect to said test sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.); and
a second output region configured to display, in at least near real time with respect to said display of said measurable indication of said level of said at least one analyte in said test sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest. Also see [0259] The embedded operator interface can preferably utilize an integrated display 2360 and/or integrated data entry device 2355 (e.g., keypad). The computerized control system may also preferably include non-volatile memory storage for storing cartridge results and instrument configuration parameters.),
a measurable indication of at least one level of said at least one analyte in said at least one control sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest.), said measurable indication of said at least one level of said at least one analyte in said at least one control sample providing a basis for calibration of said measurable indication of said level of said at least one analyte in said test sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.).
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.
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.
Claim(s) 8, 9, 31-36, 38, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glezer (as stated above) in view of Reddy (US 20200337594 A1).
Regarding Claim 8, Glezer further teaches following said calibrating: rating a level of said at least one analyte in said test sample based on said calibrating (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest. Glezer provides a numerical output of the amount of analyte of interest in the sample.).
Although the disclosure of Glezer is intended to allow quicker and simpler patient diagnosis (Glezer [0003] Point of care measurements allow a care provider or patient to quickly make decisions based on diagnostic information, as opposed to having to wait hours or days to receive laboratory results from a clinical lab.), Glezer is not relied upon to further teach providing a diagnosis of a subject from whom said test sample is obtained based on said rated level of said at least one analyte in said test sample.
Reddy teaches providing a diagnosis of a subject from whom said test sample is obtained based on said rated level of said at least one analyte in said test sample (Reddy [0100] In such instances, the diagnostic module 124 can be further operable to determine, based at least in part on the processed data from the biomarker processing module 122, one or more diagnoses and/or treatments for a subject.).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instant application, to modify Glezer (as stated above) in view of Reddy to teach providing a diagnosis of a subject from whom said test sample is obtained based on said rated level of said at least one analyte in said test sample, to use the determined concentration of analytes to determine a diagnosis (Glezer [0029] Technical effects of certain embodiments of the disclosure may include providing biomarkers for diagnosis and treatment for particular health conditions related to the detection and identification of certain substances, such as chemicals, volatile organic compounds (VOCs), volatile gases (VGs), ketones, cannabis, controlled substances, pharmaceuticals, or anesthetics, in the exhaled breath of a subject or person in real-time. Also see [0108] For example, one or more signals and/or signal patterns indicating the presence of at least one or more of the substances and/or volatile organic compounds such as, ammonia and acetone, in combination with each other, can be associated with a relatively high likelihood of ulcers in a subject.).
Regarding Claim 9, Glezer in view of Reddy (as stated above) further teaches wherein said providing a diagnosis comprises providing one of a binary diagnosis and a probability of said subject having said diagnosis (Reddy [0100] In such instances, the diagnostic module 124 can be further operable to determine, based at least in part on the processed data from the biomarker processing module 122, one or more diagnoses and/or treatments for a subject. A diagnosis is a binary diagnosis.).
Regarding Claim 31, Glezer teaches a system for diagnosing a subject comprising: a testing device comprising:
a test sample receipt subsystem operative to receive a test sample from a subject (Glezer [0002] This application relates to apparatuses, systems, kits and methods for conducting chemical, biochemical and/or biological assays on a sample.), said test sample possibly containing at least one analyte (Glezer [0100] The assay cartridges of the invention may comprise a plurality of flow cells or detection chambers. In certain preferred embodiments the flow cell may comprise the same assay domains or, at least, have at least some assay domains that share specificity for the same analytes of interest. In these embodiments, the plurality of flow cells may be used to analyze a plurality of different samples or to compare samples that have been pre-treated in different ways.);
a first processing subsystem operative to process said test sample in a test region of said testing device (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest.);
a first data output subsystem operative to output, as a result of said processing by said first processing subsystem, a measurable indication of a level of said at least one analyte in said test sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest.);
a second processing subsystem operative to process, in at least near real time with respect to said processing of said test sample by said first processing subsystem, at least one control sample containing said least one analyte, in a control region of said testing device (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.); and
a second data output subsystem operative to output, as a result of said processing of said control sample, a measurable indication of at least one level of said at least one analyte in said at least one control sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest.),
an image acquisition device operative to capture said measurable indications of said levels of said at least one analyte in said test sample and said at least one control sample (Glezer [0012] In yet another embodiment, the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes.), and
a data analysis module operative to calibrate said captured measurable indication of said level of said at least one analyte in said test sample based on said captured measurable indication of said at least one level of said at least one analyte in said at least one control sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.).
Although the disclosure of Glezer is intended to allow quicker and simpler patient diagnosis (Glezer [0003] Point of care measurements allow a care provider or patient to quickly make decisions based on diagnostic information, as opposed to having to wait hours or days to receive laboratory results from a clinical lab.), Glezer is not relied upon to further teach to output a diagnosis of said subject based on said calibrated level of said at least one analyte in said test sample.
Reddy teaches to output a diagnosis of said subject based on said calibrated level of said at least one analyte in said test sample (Reddy [0100] In such instances, the diagnostic module 124 can be further operable to determine, based at least in part on the processed data from the biomarker processing module 122, one or more diagnoses and/or treatments for a subject.).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instant application, to modify Glezer (as stated above) in view of Reddy to teach to output a diagnosis of said subject based on said calibrated level of said at least one analyte in said test sample, to use the determined concentration of analytes to determine a diagnosis (Glezer [0029] Technical effects of certain embodiments of the disclosure may include providing biomarkers for diagnosis and treatment for particular health conditions related to the detection and identification of certain substances, such as chemicals, volatile organic compounds (VOCs), volatile gases (VGs), ketones, cannabis, controlled substances, pharmaceuticals, or anesthetics, in the exhaled breath of a subject or person in real-time. Also see [0108] For example, one or more signals and/or signal patterns indicating the presence of at least one or more of the substances and/or volatile organic compounds such as, ammonia and acetone, in combination with each other, can be associated with a relatively high likelihood of ulcers in a subject.).
Regarding Claim 32, Glezer in view of Reddy (as stated above) further teaches wherein said control sample is separate to and different from said test sample (Glezer [0100] Alternatively, one of the flow cells may be a control flow cell used to analyze a control sample and another of the flow cells may be a test flow cell used to analyze a test sample. The control sample may be a completely pre-defined control sample or may be a mixture comprising the test sample but spiked with added analytes of interest so as to allow for calibration of the assays by the method of standard addition.).
Regarding Claim 33, Glezer in view of Reddy (as stated above) further teaches wherein said test sample comprises a bodily fluid obtained from said subject (Glezer [0002] This application relates to apparatuses, systems, kits and methods for conducting chemical, biochemical and/or biological assays on a sample. And [0102] Also depicted in this preferred embodiment are two banks of impedance sensors 172,173 that may be used fluid detection (e.g., sample, reagents, wash, buffer, etc.) and/or fluid discrimination (e.g., discriminating between sample, reagents, wash, buffer, etc. and/or sample type such as whole blood, plasma, mucous, etc.). The samples can be some kind of bodily fluid.).
Regarding Claim 34, Glezer in view of Reddy (as stated above) further teaches wherein said testing device is a single-use, disposable device (Glezer [0012] Preferably, the electrodes are housed in a disposable assay cartridge and the optical detector(s), voltmeter(s), and/or ammeter(s) are housed in a separate re-usable cartridge reader. Also see [0002] This application relates to apparatuses, systems, kits and methods for conducting chemical, biochemical and/or biological assays on a sample. And [0102] Also depicted in this preferred embodiment are two banks of impedance sensors 172,173 that may be used fluid detection (e.g., sample, reagents, wash, buffer, etc.) and/or fluid discrimination (e.g., discriminating between sample, reagents, wash, buffer, etc. and/or sample type such as whole blood, plasma, mucous, etc.). The samples can be some kind of bodily fluid.).
Regarding Claim 35, Glezer in view of Reddy (as stated above) further teaches wherein said measurable indication of said level of said at least one analyte in said test sample and said control sample comprises at least one of a colorimetric indication, an optical indication, an electrical indication and a chemical indication (Glezer [0012] In yet another embodiment, the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes.).
Regarding Claim 36, Glezer in view of Reddy (as stated above) further teaches wherein said data analysis module is operative to perform at least one of: qualitative calibration based on relative characteristics of said measurable indications of said test sample and control sample, and quantitative calibration based on relative concentrations of said at least one analyte as derived from said measurable indications of said test sample and control sample (Glezer [0012] In yet another embodiment, the apparatus can be configured with an optical detector for detecting luminescence generated at the dedicated working and dual-role electrodes. Also see [0277] In certain preferred embodiments employing ECL detection technology, data conversion/analysis operations may include one or more of: background subtraction; conversion to ECL counts; conversion of ECL counts to concentrations; and/or performance of quality checks on the acquired data. Determining the concentration of analyte is providing quantitative and qualitative measurements.).
Regarding Claim 38, Glezer in view of Reddy (as stated above) further teaches wherein said data analysis module is also operative to: rate a level of said at least one analyte in said test sample based on said calibration, and provide said diagnosis of said subject from whom said test sample is obtained based on said rated level of said at least one analyte in said test sample (Glezer [0290] The assay modules (preferably assay cartridges) of the invention may be used to carry out a variety of different assay formats for measuring analytes interest […] The assay dependent signal is measured to determine the amounts of the analytes of interest. Glezer provides a numerical output of the amount of analyte of interest in the sample.).
Regarding Claim 40, Glezer in view of Reddy (as stated above) further teaches wherein said data analysis module is at least partially incorporated within at least one of said testing device and processing functionality in the cloud (Glezer [0259] A computerized control system 2310 is preferably utilized to selectively control operation of the cartridge-based system. The computerized control system may be fully integrated within the cartridge reader, separated from the cartridge reader in an externally housed system and/or partially integrated within and partially separated from, the cartridge reader. For example, the cartridge reader can be configured with external communications ports (e.g., RS-232, parallel, USB, IEEE 1394, and the like) for connection to a general purpose computer system (not shown) that is preferably programmed to control the cartridge reader and/or its subsystems. In one preferred embodiment, a single embedded microprocessor may be used to control the electronics and to coordinate cartridge operations. Additionally, the microprocessor may also support an embedded operator interface, connectivity and data management operations. The embedded operator interface can preferably utilize an integrated display 2360 and/or integrated data entry device 2355 (e.g., keypad). The computerized control system may also preferably include non-volatile memory storage for storing cartridge results and instrument configuration parameters.).
The Examiner notes that there are currently no prior art rejections for claims 7, 37, and 39, as the prior art of record does not seem to fairly teach or suggest said quantitative calibrating comprises finding a correlation between said different concentrations of said analyte in said at least two control samples and said measurable indications thereof, and applying said correlation to said measurable indication of said level of said analyte in said test sample.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gan et al. (US 20180259543 A1) discloses a Method Of Determining An Analyte Concentration.
Burch et al. (US 20070265509 A1) discloses Detection, Diagnosis, And Monitoring Of A Medical Condition Or Disease With Artificial Olfactometry.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN T BRYANT whose telephone number is (571)272-4194. The examiner can normally be reached Monday-Thursday and Alternate Fridays 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CATHERINE RASTOVSKI can be reached at (571) 270-0349. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTIAN T BRYANT/Primary Examiner, Art Unit 2857
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