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 .
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.
Priority
This is a U.S. application filed on 03/22/2022 which claims priority to U.S. Provisional Application No. 63/165,372 filed on 03/24/2021.
Claim Status
The Applicant amended claims 1, 6 and 13 and noted that no new matter is added. The Applicant cancelled claims 2 and 5. Claims 3-4 and 7-12 are original. The Applicant withdrew claims 14-19. Claims 20-21 are new and the Applicant notes that no new matter is added.
Thus, claims 1, 3-4, 6-13 and 20-21 are pending and are under examination.
Withdrawn Objections and Rejections
The previous objection to claim 13 objection, regarding informalities is withdrawn in light of Applicant’s amendments of the claim.
The previous rejection of claim 2 under 35 U.S.C. 112(b), regarding indefiniteness, is withdrawn in lights of Applicant’s cancellation of the claim.
The previous rejection of claims 2 and 5 under 35 U.S.C. 102(a)(2), as being anticipated by Muthukumar et al. (US 2021/0325380 A1, Priority Date 04/20/2020), is withdrawn in lights of Applicant’s cancellation of the claims.
Maintained Rejections
Claim Rejections - 35 USC § 102
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)(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, 3-4, 6-10 and 12-13, 20-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Muthukumar et al. (US 2021/0325380 A1, Priority Date 04/20/2020).
Regarding claim 1, Muthukumar teaches a system for detecting inflammation (Abstract; page 18, [0194]).
Muthukumar teaches at least one sensor (Abstract; page 1, [0006-0007]; page 2, [0012]).
Muthukumar teaches at least one port for receiving a biological sample (Page 6, [0047]; page 11, [0150]; page 35, claim 15).
Muthukumar teaches at least one electrochemical cell that is in fluid communication with said at least one port for receiving a biological sample (Page 9, [0130]; page 19, [0197]).
Muthukumar teaches an electrochemical cell comprising at least two conductive electrodes (Page 9, [0130]; page 19, [0197]).
Muthukumar teaches that at least one of the electrodes is functionalized with at least one molecular recognition probe such as an antibody exhibiting specific binding to at least one inflammatory target biomarker, inflammation biomarker or genetic component associated with an inflammatory target biomarker (Page 2, [0017]; page 8, [0119]; page 18, [0194]; page 19, [0201]; page 27, [0268]; page 32, [0317]).
Muthukumar teaches a plurality of channels providing fluid communication between a respective electrochemical cell or sensor of the plurality of electrochemical cells and at least one port or base module (Page 28, [0273]; page 29, [0282]).
Muthukumar teaches a circuitry for detecting electron changes through at least one electrode or an electrical impedance across electrodes in response to interaction of functionalized electrode with a sample and generating detection signals in response to such detection (Page 1, [0006-0007]; page 2, [0012] and [0017]).
Regarding claim 1, Muthukumar teaches at least one electrochemical cell (Page 9, [0130]; page 19, [0197]).
Muthukumar teaches a first sensing device functionalized with a probe exhibiting specific binding to said inflammation biomarker such as IL-6 (Page 19, [0197-0200]; page 32, [0318]).
Muthukumar teaches a second sensing device functionalized with a probe exhibiting specific binding to said genetic component associated with the inflammation biomarker (Page 19, [0197-0200]; page 16, [0171], “The sensing device 100 may be an electrochemical sensing device configured for both catalytic and affinity based detection of one or more target analytes in a sample.”; page 31, [0303], “Biomarkers exist in a variety of different forms, including antibodies, enzymes, microbes, DNA, RNA, lipids, metabolites, and proteins”; page 31, [0304]).
Muthukumar teaches that a genetic component could be part of the molecular signature for a certain malady or disease (Page 31, [303]).
Regarding claim 3, Muthukumar teaches that a probe comprises an antibody specific to a target of interest (page 8, [0119]; page 11, [0144]).
Regarding claim 4, Muthukumar teaches an analyzer that is in communication with a circuitry for receiving signals and processing the received signals to identify an onset and/or an occurrence of a cytokine storm (Sheet 23 of 29, FIG. 23, “Pathogen Detection ”, “+”, “Immune Response”; page 5, [0041]; page 6, [0046]; page 21, [0213]; page 33, [0321]; page 34, claim 11).
Regarding claim 6, Muthukumar teaches an analyzer configured to receive the detection signals generated by first and second electrochemical cells (Sheet 14 of 29, “1422”, “Analyzer”; page 1, [0009]; page 4, [0029] and [0033]; page 7, [0107]). Muthukumar teaches processing the generated detection signals to determine if the biomarker is present in the biological sample (Sheet 14 of 29, “1422”, “Analyzer”; page 1, [0009]; page 7, [0107]).
Regarding claims 7-9, Muthukumar teaches the presence or absence of at least a first analyte and a second analyte (Page 15, [0168]). Muthukumar teaches that a particular combinations of biomarker may be adopted to achieve a particular diagnostic function such as diagnosing a patient with cytokine storm (Sheet 23 of 29, FIG. 23, “Pathogen Detection ”, “+”, “Immune Response”; page 33, [0321]; page 34, [0326]). A skilled artisan would have known that when two biomarkers are needed to make a diagnosis on a condition, a positive result for only one biomarker is an inconclusive result whereas a positive result for the two biomarkers is indicative of the condition. Furthermore, a complete absence of signals for the two biomarkers is indicative of a lack of the condition.
Regarding claim 10, Muthukumar teaches that an inflammation biomarker can be a cytokine and a chemokine (Page 32, [0318]).
Regarding claim 12, Muthukumar teaches that a chemokine is induced by interferon-γ such as IP10 (Page 32, [0318]).
Regarding claim 13, Muthukumar teaches that a biological sample can be a fluid sample (Page 33, [0323] and [0325]; page 34, claim 9).
Regarding claim 20, Muthukumar teaches that the biological sample comprises any of: blood and urine (Page 33, [0323] and [0325]; page 34, claim 9).
Regarding claim 21, Muthukumar teaches a third electrochemical cell functionalized with a probe exhibiting specific binding to a CRP biomarker (Page 34, [0326] and claim 2; page 17, [0185], page 18, [0194]).
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 (PHOSITA) 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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Muthukumar et al. (US 2021/0325380 A1) as applied to claim 1 above, and further in view of Liu et al. (Anal. Chem. 2010, 82, 8131–8136).
Regarding claim 11, Muthukumar teaches all of the limitation of claim 11 but fails to teach that the inflammation biomarker can be interferon-γ.
Regarding claim 11, Liu teaches that the inflammation biomarker is interferon-γ (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to modify the testing method of Muthukumar with Liu’s teachings to include interferon-γ because Liu suggested the important role of interferon-γ in immunology, cancer research and infectious disease monitoring (Abstract) and Muthukumar further noted the antagonism of interferon by SARS-CoV-2 in viral infections (Page 33, [0321]). Muthukumar warned against the use of interferons in later stages of a viral infection with SARS-CoV-2 due to the risk of a cytokine storm (Page 33, [0321]). A skilled artisan is motivated to test for interferon-γ to predict the possibility of a cytokine storm in a patient with SARS-CoV2 infection. A PHOSITA would have had a reasonable expectation of success in combining the methods of Liu and Muthukumar because both are methods directed to detecting biomarkers of inflammation by immunoassays.
It would have been obvious for a PHOSITA to test for the presence of interferon-γ in a patient to predict the response of the patient to treatment.
Response to Arguments
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive. The Applicant alleged that two limitations of the amended claim 1 are not taught by Muthukumar.
The Applicant alleged that Muthukumar does not teach plurality of channels providing fluid communication between a respective one of the plurality of electrochemical cells and the at least one port. The Applicant further alleged that Muthukumar does not teach combination of first and second electrochemical cells functionalized with a probe exhibiting specific binding to the inflammation biomarker and a genetic component associated with the inflammation biomarker.
This argument is not persuasive because the two limitations of claim 1 are taught by Muthukumar. Muthukumar teaches plurality of channels providing fluid communication between a respective electrochemical cell or sensor of the plurality of electrochemical cells and at least one port or base module (Page 28, [0273]; page 29, [0282]).
Muthukumar further teaches first sensing device functionalized with a probe exhibiting specific binding to said inflammation biomarker such as IL-6 (Page 19, [0197-0200]; page 32, [0318]).
Muthukumar teaches a second sensing device functionalized with a probe exhibiting specific binding to said genetic component associated with the inflammation biomarker (Page 19, [0197-0200]; page 16, [0171], “The sensing device 100 may be an electrochemical sensing device configured for both catalytic and affinity based detection of one or more target analytes in a sample.”; page 31, [0303], “Biomarkers exist in a variety of different forms, including antibodies, enzymes, microbes, DNA, RNA, lipids, metabolites, and proteins”; page 31, [0304]).
Muthukumar teaches that a genetic component could be part of the molecular signature for a certain malady or disease (Page 31, [303]).
Thus, the previous rejections of claims 1, 3-4, 6-10 and 12-13 under 35 U.S.C. 102(a)(2), as being anticipated by Muthukumar et al. (US 2021/0325380 A1, Priority Date 04/20/2020), is maintained and is made final.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OMAR RAMADAN whose telephone number is (571)270-0754. The examiner can normally be reached Monday-Friday 8:30 am - 5:00 pm.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678