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 Status
Claims 1-7 are currently pending and under examination herein.
Claims 1-7 are rejected.
Claim 1 is objected to.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202011550421.3, filed on 12/24/2020. Therefore, the effective filing date of claims 1-7 is 12/24/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/28/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. A signed copy of a list of references cited from each IDS is included in this Office Action.
The Examiner notes that the WIPO publication numbers between the uploaded WIPO document and the IDS citation do not match. Appropriate correction is required. The cited document has been provided.
Drawings
The drawings submitted on 8/10/2023 is accepted.
Specification
The specification submitted on 8/10/2023 is accepted.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites that the input signal “is concentrations or activities of a substance and enzyme” when it should be are. 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.
Claim 3-5 and 7 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.
Regarding claims 3-5 and 7, the claims are to a product, the biochemical reaction logic gate, but these claims include limitations that are method steps or uses of the components of the logic gate. According to MPEP 2173.05(p)(II), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) as it is unclear where infringement occurs. (See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)).
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 1-7 are non-statutory as they recite " a biochemical reaction logic gate". The claims do not fall within at least one of the four categories of patent eligible subject matter because under the broadest reasonable interpretation, the recited logic gate is a written set of enzymatic reactions that represent something which is equivalent to data and does not have a tangible embodiment. As such, claims 1-7 fail to claim statutory subject matter.
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 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.
The present rejection(s) reference specific passages from cited prior art. However,
Applicant is advised that the rejections are based on the entirety of each cited prior art. That is,
each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI))
Therefore, Applicant is advised to review all portions of the cited prior art if traversing a
rejection based on the cited prior art.
Claims 1, 2, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO2011116151) in view of Filipov et al (Y. Filipov, P. Bollella, E. Katz, “Not-XOR (NXOR) Logic Gate Realized with Enzyme-Catalyzed Reactions: Optical and Electrochemical Signal Transduction”, ChemPhysChem 2019, 20, 2082.) as filed in the IDS on 8/10/2023.
Regarding claim 1, Wang teaches:
A biochemical reaction logic gate based on an enzymatic reaction, wherein the biochemical reaction logic gate is based on a plurality of enzymatic reactions carried out in the same solution (cardiac logic unit 1310 analyzes a blood sample and has the function of logic processing of four biochemical signals which are related to enzymes; see lines 7-16 on page 36; see also Figures 13-15);
an input signal of the biochemical reaction logic gate is concentrations or activities of a substance and an enzyme (myeloperoxidase (MPO), lactate dehydrogenase (LDH), creatine kinase (CDK) generates the two outputs of NADH and oxidized redox mediator (Mox); see lines 7-16 on page 36; see also Figures 13-15);
Wang does not disclose an output signal of the biochemical reaction logic gate is the concentrations or activities of the substance and the enzyme and a logic and a cascade of the biochemical reaction logic gate are implemented by a change in concentrations of a corresponding substrate and a product caused by a change in the activity of the enzyme. Filipov discloses an enzyme-catalyzed reaction-based biochemical reaction logic gate, which is based on three enzyme-catalyzed reactions catalyzed by the enzymes esterase, urease, and PQQ-GDH in the same solution wherein the output signal generated is a result of the catalyzed reaction and the signal production reduction cascade is under control of the two other reactions shifting pH in situ (see “Abstract” on page 2082; see first paragraph of “2.1 NXOR Gate Realized with Soluble Enzymes and Optical Transduction of Output Signals”; see also page 2084 where in Figure 3, the concentration of the input signals (e.g. the enzymatic reactions) change the pH value which will affect the activity of the enzyme also known as the reaction rate; see also Figure 4 where the activity of an enzyme is a logic gate output signal as 1 or 0 based on threshold). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Filipov’s enzyme-catalyzed reaction-based biochemical reaction logic gate into Wang’s existing biochemical reaction logic gate in order to provide an addition to the “toolbox” of biomolecular computing systems, which already includes many other Boolean and none-Boolean molecular “devices” (see page 2089 with “3. Conclusions”). This could have been accomplished with reasonable expectation of success as both inventions operate in the same field of endeavor.
Regarding claim 2, Wang as modified teaches:
The biochemical reaction logic gate based on the enzymatic reaction according to claim 1, wherein the change in the concentration or activity of the substance is affected by the concentration or activity of one or more enzymes (discussed throughout; see Fig. 4A where enzymes such as LDH are responsible for determining the behavior of biochemical reactions, see also 2A where tyrosinase is responsible for change in substance).
Regarding claim 4, Wang as modified teaches:
The biochemical reaction logic gate based on the enzymatic reaction according to claim 1, wherein the concentration or activity of the substance for the output signal of the biochemical reaction logic gate is detected and converted into an electrical signal in real time (explicitly disclosed on page 8 describing Fig. 3A where amperometric signals corresponding to the in situ production of NQ obtained for different combinations of the input signals; see Fig. 3A-3B where current is detected in real time; see also page 37 lines 27-29).
Regarding claim 6, Wang as modified teaches:
The biochemical reaction logic gate based on the enzymatic reaction according to claim 1, wherein when the activity of the enzyme changes, the concentrations of the substrate and product of the enzymatic reaction also change accordingly (explicitly disclosed; see on page 14 lines 28-30, where Fig. 49A-C shows the absorbance of the GSH output generated in situ by the GSSG/GR biocatalytic cascade changes upon different input signals; other examples also present where the enzymatic reactions produce a measurable change in concentration of substrate and product (e.g. Fig. 4B with NADH/NAD)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO2011116151) as filed in the IDS on 8/10/2023 in view of Filipov et al (Y. Filipov, P. Bollella, E. Katz, “Not-XOR (NXOR) Logic Gate Realized with Enzyme-Catalyzed Reactions: Optical and Electrochemical Signal Transduction”, ChemPhysChem 2019, 20, 2082), as applied in claim 1 and filed in the IDS on 8/10/2023, further in view of Smit et al. (Reagentless enzyme electrode for the determination of manganese through biocatalytic enhancement. Anal. Chem. 1 February 1992; 64 (3): 245–249.).
Regarding claim 3,
Wang as modified by Filipov teaches the claimed invention substantially as claimed above.
Wang as modified does not teach the biochemical reaction logic gate based on the enzymatic reaction according to claim 1, wherein the concentration or activity of the substance for the input signal of the biochemical reaction logic gate is changed and controlled in real time via an electrical signal. Smit teaches that the electrochemical control of enzyme activity can be achieved through substrate promotion of catalysis and that enzyme modulation by manganese can be switched on and off or adjusted through the appropriate selection of the applied potential (see “Abstract on page 245). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in order to incorporate Smit’s electrochemical control method into Wang as modified’s existing biochemical reaction logic gate pipeline in order to achieve a greater degree of control over amperometric sensing devices as they have selectivity and rapid turnover (see first paragraph of “Introduction” on page 245). The incorporation would have been accomplished with reasonable expectation of success as Wang as modified’s existing pipeline already makes use of amperometric signals and has the existing architecture to support the incorporation (Filipov: see “Abstract” where electrode support already exists).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO2011116151) as filed in the IDS on 8/10/2023 in view of Filipov et al (Y. Filipov, P. Bollella, E. Katz, “Not-XOR (NXOR) Logic Gate Realized with Enzyme-Catalyzed Reactions: Optical and Electrochemical Signal Transduction”, ChemPhysChem 2019, 20, 2082.), as applied in claim 1 and filed in the IDS on 8/10/2023, further in view of Molinnus et al. (Towards an adrenaline biosensor based on substrate recycling amplification in combination with an enzyme logic gate. Sensors and Actuators B: Chemical, 237, 190–195.)
Regarding claim 5,
Wang as modified by Filipov teaches the claimed invention substantially as claimed above.
Wang as modified does not teach the biochemical reaction logic gate based on the enzymatic reaction according to claim 1, wherein another reaction is present in a solution, in which the enzymatic reaction is conducted, and consumes a product of the enzymatic reaction and generate a substrate of the enzymatic reaction. Molinnus teaches a two-enzyme recycling system in which laccase converts adrenaline to adenochrome, PQQ-GDH converts adenochrome to adrenaline which is cyclical (see “3.1 Substrate recycling principle”; see also Fig. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Molinnus’s two enzyme recycling system. This incorporation would have been accomplished with reasonable expectation of success as Wang as modified by Filipov’s disclosure already includes an output producing signal reaction that is catalyzed by PQQ-GDH (Filipov: “Abstract” on page 2082).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO2011116151) as filed in the IDS on 8/10/2023 in view of Filipov et al (Y. Filipov, P. Bollella, E. Katz, “Not-XOR (NXOR) Logic Gate Realized with Enzyme-Catalyzed Reactions: Optical and Electrochemical Signal Transduction”, ChemPhysChem 2019, 20, 2082), as applied in claim 1 and filed in the IDS on 8/10/2023, further in view of Hu et al. (CN110672695A) as filed in the IDS on 8/10/2023.
Regarding claim 7,
Wang as modified by Filipov teaches the claimed invention substantially as claimed above.
Wang as modified does not teach that the biochemical reaction logic gate based on the enzymatic reaction according to claim 1, wherein the substrate and product of the enzymatic reaction are used as enzymes to catalyze another enzymatic reaction. Hu teaches that G4 formed on the basis of terminal deoxynucleotidyl transferase (TdT) in his logic gate pipeline has catalytic activity on H2O2 (explicitly recited in [0004]; it is mentioned that G4 is prepared via TdT which is used subsequently by H2O2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Hu’s cascade into Wang as modified’s existing biochemical reaction logic gate in order to make use of a known technique to improve the devices as it is known that the G4 reactant is stable under physiological conditions and is becoming popular to use in nucleic acid research and biological analyses (see [0003]). This incorporation would have been accomplished with reasonable expectation of success as both disclosures operate in the same field of endeavor of biochemical reaction logic gates.
Conclusion
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/P.N./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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