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 .
The response dated 4/30/2026 is acknowledged. Claims 1-5 are elected. Claims 6-12 are withdrawn. Claims 1-5 are considered on the merits below.
Response to Amendment
Applicant's remarked filed 4/30/2026 are acknowledged.
Claimed filed 12/30/2025 are being considered.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (CN 109596606 A, translation attached and cited) in view of Han et al. (CN111330643A·2020-06-26, translation attached and referenced).
Regarding claim 1, Sun describes a white nanozymes test strip (abstract “nano-enzyme test paper sheets” and claim 4 “white reference cell”) comprising
a substrate (page 2 “test-paper”), and
a manganese compound (page 2 “hydroxyl manganese oxide (MnOOH) nanomaterial solution”),
wherein the manganese nanozyme is fixed on the substrate (page 2 “hydroxyl manganese oxide (MnOOH) nanomaterial solution uniformly penetrating on test-paper,”)
However, Sun is silent to an organic developer and the manganese-based metal-organic framework nanozyme.
Han describes an organic developer (page 3 “organic developer”), and a manganese-based metal-organic framework nanozyme (page 3 “monometallic and bimetallic two dimensional MOFs nanozymes,.. Mn -MOF,”) for use in colorimetric detection (page 3 “bimetallic two-dimensional MOFs nanozymes are used as catalysts for colorimetric detection”). Han describes “MOFs-based mimic enzymes have many advantages, such as high stability, low cost, and easy storage” (page 3) and “preferably, an organic color developer is added” (page 3). This suggest motivation to incorporate both these components into the test strip detection method because they advantageously improve the detection.
Therefore it would have been obvious for one skilled in the art before the effective filing date of the claimed invention to incorporate an organic developer and a manganese-based metal-organic framework nanozyme into the test strip of Sun as suggested by Han because this would advantageously improve the detection capabilities.
Regarding claim 2, the combination described above describes the white nanozymes test strip according to claim 1, wherein the substrate is any one of an absorbent paper, a cellulose membrane, or a nitrocellulose membrane (Sun: page 4 “the round test-paper for using cellulosic filter paper”).
Regarding claim 3, the combination described above describes the white nanozymes test strip according to claim 1, wherein the organic developer is any one of 3,3’,5,5’-tetramethylbenzidine (TMB), 2,2’-azino-bis(3-ethylbenzothiazole-6-sulphonic acid) diammonium salt (ABTS), o-phenylenediamine (OPD), 3,3-diaminobenzidine (DAB), 4-aminoantipyrine, 5-aminosalicylic acid, 3-amino-9-ethylcarbazole, and 4-chloro-1-naphthol (Han: page 3 “organic developer includes but is not limited to 3,3',5,5'-tetramethylbenzidine {TMB), o-phenylenediamine {OPD) or 2,2'-azido- Bis{3-ethylbenzothiazoline-6-sulfonic acid)diamine salt (ABTS).”).
Regarding claim 4, the combination described above describes the white nanozymes test strip according to claim 1, wherein the manganese-based metal-organic framework nanozyme comprises terephthalic acid and MnCl2·4H2O (Han: page 4 “ Synthesis of different monometallic and bimetallic 20 MOFs nanoenzyme materials: (1) ultrasonically dissolving 0. 75mmol of terephthalic acid in a solvent consisting of DMF, secondary water and ethanol in a volume ratio of 16:1 :1 to obtain a colorless clear solution, then add 0.375mmol of any two different The metal salt is in the above-mentioned clear solution;” and page 3 “manganese salts including but not limited to one or two mixtures of manganese chloride”).
Examiner’s note: claim 5 is a product-by-process claim. “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” MPEP 2113.
Regarding claim 5, the combination described above describes the white nanozymes test strip according to claim 4, wherein the manganese-based metal-organic framework nanozyme is prepared as follows:
(1) dissolving 0.7-0.8 mmol of terephthalic acid in a mixture containing 30-35 mL of N,N-dimethylformamide, 1-3 mL of ethanol, and 1-3 mL of water to obtain a first resulting solution (Han: page 4 “ultrasonically dissolving 0. 75mmol of terephthalic acid in a solvent consisting of DMF, secondary water and ethanol”);
(2) adding 0.35-0.4 mmol of MnCl2·4H2O to the first resulting solution obtained in step (1) under sonication to obtain a second resulting solution (Han: page 4 “add 0.375mmol of any two different The metal salt is in the above-mentioned clear solution;”);
(3) adding 0.5-1 mL of triethylamine to the second resulting solution obtained in step (2) rapidly and stirring for 5-10 min to obtain a white suspension (Han: page 4 “inject 0.8 ml of triethylamine into the solution of (1) adding the metal salt, and stir at room temperature for 5 min”); and
(4) sonicating the white suspension obtained from step (3) continuously at 30-60 kHz for 8-10 h and then centrifuging at 3000-5000 rpm to obtain the manganese-based metal-organic framework nanozyme (Han: page4 “Put the colloidal suspension mixed solution into a polytetrafluoroethylene tube, seal the mouth of the tube, carry out ultrasonic reaction at 2s•c and ultrasonic power of 80KHz for 3h, and then centrifuge with ethanol at 5000r/min for 3min. After washing three times, and finally drying under vacuum at 60 ·c, different bimetallic twodimensional MOFs nanoenzyme materials were obtained.”).
Response to Arguments
Applicant's arguments filed 4/30/2026 have been fully considered but they are not persuasive.
The applicant argues that (1) Sun is not merely silent as to an organic developer in the abstract but Sun teaches a different arrangement in which TMB is added during the detection procedure, and it is not pre-immobilized on the test paper, (2) Han does not teach or suggest a preassembled test strip in which the organic developer is immobilized on a substrate, and (3) the combination does not teach or suggests preassembly of the organic developer with the nanozyme on the substrate of the claimed white nanozyme test strip.
In response to the applicant’s argument that (1) Sun teaches a different arrangement in which TMB is added during the detection procedure, and it is not pre-immobilized on the test paper, it is noted that the features upon which applicant relies (i.e., pre-immobilized on the test paper) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case the claim only requires that they are fixed on the substrate. As indicated in the rejection above, “fixed” can have a broad reasonable interpretation to include penetrating (fixed within) a test paper/substrate.
In response to the applicant’s argument that (2) Han does not teach or suggest a preassembled test strip in which the organic developer is immobilized on a substrate, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to the applicant’s argument that (3) the combination does not teach or suggests preassembly of the organic developer with the nanozyme on the substrate of the claimed white nanozyme test strip, it is noted that the features upon which applicant relies (i.e., preassembly) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
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 EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY R. BERKELEY/
Examiner
Art Unit 1796
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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