DETAILED ACTION
Status of the Claims
1. Claims 1-11 are pending.
Election/Restrictions
2. Applicant’s election without traverse of claims 1-11 with election of specie of “thioredoxin” of claim 6, “NADPH-thioredoxin reductase” of claim 7 and “nicotinamide adenine dinucleotide phosphate” in the reply filed on 12/24/2025 is acknowledged.
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)(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.
Claim(s) 1, 5-6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hulko et al. (EP 2172769).
Claims 1 and 6. Hulko et al. teach an allergen inactivation method comprising (method of detecting analyte which undergoes redox state change; [0021][0006] and Fig 1) comprising :
inactivating an allergen present in a reaction system by reduction via a reduced redox protein (analyte present in the sample is reduced by redox active protein such as thioredoxin; [0006][0011]); and
reducing an oxidized redox protein produced by oxidation of the reduced redox protein in the inactivating to the reduced redox protein by donating an electron from an electrode connected to an external power supply outside the reaction system to the oxidized redox protein (the oxidized redox active protein is recycled back to reduced redox active protein with electron from electrode connected to power supply; [0010][0030][0061]).
Claim 5. Hulko et al. teach the allergen includes a disulfide bond (analyte is comprised of dithiothreitol (DTT); [0062] which inherently is comprised of disulfide bond).
Claim 11. Hulko et al. teach a voltage applied to the electrode by the external power supply is between -1.0 V and 0 V, inclusive (voltage of 80 mV (0.08V) is applied; Fig 5 in col. 17).
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.
Claim(s) 2-3 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulko et al. as applied to claim 1 above, and further in view of Heifetz et al. (US 20230071765).
Claim 2-3 and 7-8. Hulko et al. teach redox active protein (e.g. thioredoxin) reversibly reduce and oxidized by transferring electrons to or from a reaction partner [0030] but do not explicitly teach in the reducing, an electron is donated from the electrode to a redox enzyme, and an electron is donated from the redox enzyme to the oxidized redox protein OR an electron is donated from the electrode to a redox molecule, an electron is donated from the redox molecule to a redox enzyme, and an electron is donated from the redox enzyme to the oxidized redox protein.
However, Heifetz et al. teach thioredoxin protein which could be reduced from the oxidized form by the flavoenzyme thioredoxin reductase (TrxR) and the cofactor NADPH, together these three components form thioredoxin system thereby making thioredoxin protein reducing ability many times more potent [0069].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Heifetz et al. teaching to employ thioredoxin system in Hulko et al. reducing step of oxidizing redox protein i.e. thioredoxin because thioredoxin system has higher reducing ability compared to thioredoxin and thereby would yield better detection of analyte.
Combined teachings of Heifetz and Hulko et al. would yield electron donated from electrode to NADPH (redox molecule) then to redox enzyme (thioredoxin reductase) and then to thioredoxin (redox protein) as further evidenced by Holmgren (see equations 1 and 2).
Claim(s) 4 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulko et al. as applied to claim 1 above, and further in view of Heifetz et al. (US 20230071765) and Huff et al. (US 2018/0275088).
Claims 4 and 9. Hulko et al. teach redox active protein (e.g. thioredoxin) reversibly reduce and oxidized by transferring electrons to or from a reaction partner [0030] but do not explicitly teach in the reducing, an electron is donated from the electrode to an electron mediator, an electron is donated from the electrode mediator to a redox molecule, an electron is donated from the redox molecule to a redox enzyme, and an electron is donated from the redox enzyme to the oxidized redox protein.
However, Heifetz et al. teach thioredoxin protein which could be reduced from the oxidized form by the flavoenzyme thioredoxin reductase (TrxR) and the cofactor NADPH, together these three components form thioredoxin system thereby making thioredoxin protein reducing ability many times more potent [0069]. Moreover, Huff et al. teach redox mediator such as osmium with bipyridine complex are used with enzymes to amplify electrical signal generated by electrochemical species for analyte detectio [0450][0468][0461].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Heifetz et al. and Huff et al. teachings to employ thioredoxin system and electron mediator in Hulko et al. reducing step of oxidizing redox protein i.e. thioredoxin because thioredoxin system has higher reducing ability compared to thioredoxin and utilizing mediator would produce amplified signal for better detection of the analyte.
Combined teachings of Heifetz, Hulko et al. and Huff et al. would yield electron donated from electrode to electron mediator to NADPH (redox molecule) then to redox enzyme (thioredoxin reductase) and then to thioredoxin (redox protein) as further evidenced by Holmgren (see equations 1 and 2).
The allergen inactivation method according to claim 1, wherein in the reducing, an electron is donated from the electrode to an electron mediator, an electron is donated from the electrode mediator to a redox molecule, an electron is donated from the redox molecule to a redox enzyme, and an electron is donated from the redox enzyme to the oxidized redox protein.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulko et al. (EP 2172769).
Claim 10. Hulko et al. teach experimental conditions comprises parameters for operating the sensor such as operating temperature [0061]. Hulko do not explicitly teach reaction temperature in the reaction system is greater than or equal to 4 *C and less than 60 *C. However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (see MPEP 2144.05 II A).
Conclusion
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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