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 .
Claims 1-15 are pending.
Claims 12-15 are new.
Applicant’s election without traverse of Group III, claims 7-15 in the reply filed on 12/22/2025 is acknowledged.
Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups/Inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/22/2025.
Newly submitted claims 11-14 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims are directed to limitations for the method of making the nanosheet which are encompassed by non-elected Group II (having been presented in claims 1-6). Since Applicant elected a method of using (Group III) in response to the Restriction Requirement dated 10/27/2025, claims 11-14 are withdrawn from consideration as being directed to a non-elected invention (specifically, a method of making the nanosheet (non-elected Group II) where the only limitations recited pertain to different product-by-process of manufacturing steps). See 37 CFR 1.142(b) and MPEP § 821.03. This is consistent with the claim interpretation (see below) presumed in good faith based upon the present claim drafting and in an effort to promote compact prosecution through interpreting Applicant’s response to the restriction requirement as a bona fide response, which requires that, in the reply to the restriction requirement, applicant must elect one invention for examination (see MPEP §818) where all claims that the Examiner finds are not directed to the elected invention are withdrawn from further consideration by the examiner in accordance with 37 CFR 1.142(b) (see MPEP §821).
Claims 7-10 and 15 are under examination on the merits.
Priority
Applicant’s claim of priority to CN 202111244546 A, filed 10/26/2021, is acknowledged.
IDS
The information disclosures statement (IDS) filed 10/12/2022 and 01/22/2024 have been considered.
Notice and Claim Interpretation
Claims directed to a method(s) comprising use of a recited Ti3-C2-MXene nanosheet produced by a recited method are being examined for the recited use of a Ti3-C2-MXene nanosheet irrespective of the method of making said nanosheet in accordance with the restriction requirement dated 10/27/2025 as well as established practice that a prior art product, appearing to be structurally/functionally indistinguishable from the claimed product, is presumed to have the same characteristics and functionality irrespective of the method by which is was made, absent a clear, evidenced showing to the contrary (see MPEP §§2112.01(II) and 2113(I-III)).
Claims 7-10 and 15 are being interpreted as requiring a N,S-Ti3-C2-MXene nanosheet, where the nanosheet is being interpreted as a product-by-process limitation (see MPEP §2113) as is consistent with the combined claim drafting and Applicant’s stated election in view of the restriction requirement dated (10/27/2025).
Claim Rejections - 35 USC § 112
35 USC § 112(b)
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 7-8 and 15 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.
Claims 7-8 and 15 provide for the use of a nitrogen-sulfur co-doped Ti3C2-MXene nanosheet to detect uric acid, but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. See MPEP § 2173.05(q). The only recited step is “…the use of a…” N,S-Ti3-C2-MXene nanosheet. Artisans are left to arrive at their own, potentially conflicting, understanding of what active steps are encompassed within said recited use such that the metes and bounds of the claim are indefinite as presently drafted.
35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 depends from claim 7, but only reiterates the substance of the limitations recited in claim 7 (namely that the nanosheet has peroxidase-like activity, which is already recited in and required for claim 7). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al (Analytica Chimica Acta 1103 (2020) 134e142; https://doi.org/10.1016/j.aca.2019.12.069) in view of SJU (CN110190184A; citation 1 under Foreign Patent Documents on the 01/22/2024 IDS; Note that the appended English translation of the claims from Espace.net and the English translation from Google Patents are being relied upon by the Examiner), Li et al (Microchemical Journal 166 (2021) 106238; https://doi.org/10.1016/j.microc.2021.106238), and Tripathi et al (PLOSONE16(10):e0257777.https://doi.org/10.1371/journal.pone.0257777 (pub/ 10/12/2021)) as evidenced by Habib et al (Sci Rep 9, 16489 (2019). https://doi.org/10.1038/s41598-019-52972-2).
Regarding claim 7, Liu et al teach a ’’naked-eye’’ colorimetric and ratiometric fluorescence probe for uric acid (UA) using glutathione functionalized Ti3C2 MXene quantum dots (GSH-Ti3C2 MQDs) to detect UA using uricase and HRP (peroxidase) and FRET/UV absorption of oxOPD (see for example, the abstract and title at 134 and scheme 1 and its caption at page 135). Liu et al teach that MXenes have gained significant attention owing to its unique structure, fascinating optical and electronic properties and tunable work function for various applications and, having good photoelectric properties, MXenes are well suited to analytical methods such as electrochemical techniques (see for example, pages 134-135). Liu et al further teach that UA in body fluids is an important biomarker for numerous diseases like gout, obesity, hypertension, fatty liver, arthritis, renal disorder, kidney stones and diabetes no matter excess or insufficient supply of UA in urine and blood. Therefore, monitoring the level of UA is quite important for the early diagnosis of diseases related to its activity (see for example, column 1 of page 135).
Liu et al do not teach the use of nitrogen and sulfur co-doped Ti3C2MXenes (NS-Ti3-C2-MXenes).
However, SJU teach methods for producing nitrogen, sulfur co-doped Ti3C2MXene nanomaterial as dialectric layers (see for example, the title, abstract, and claims 1-2 at page 1 of the Google Patents English Translation as well as claims 1-2 of the Espacenet English Translation; note that Habib et al evidence that MXenes are a family of 2D nanosheets discovered in 2011 which support that the recited MXene of SJU is a nanosheet). It is noted that there is no definition provided for what an organ-like shape is intended to mean within the instant disclosure. The only hint as to what Applicant intended to convey with said recitation is the SEM schematic of instant figure 1, which shows an accordion-like/multilayered structure, which appears to be consistent with the state of the art regarding organ-like MXenes. SJU teach that their N,S-Ti3-C2-MXENE is in an accordion-like/multilayered arrangement which appears to be approximately 10µm thick (see for example, the SEM schematic of figure 2 of the untranslated version of SJU).
Liu et al and SJU as evidenced by Habib et al do not teach that the N,S-Ti3-C2-MXene nanosheet would be expected to mimic/simulate peroxidase activity.
However, Li et al teach that MXenes are attractive for various biosensors owning to their tunable versatile properties. Herein, Ti3C2 nanosheets were found to possess intrinsic peroxidase-like activity (see for example, the abstract at page 1).
Liu et al, SJU, and Li et al as evidenced by Habib et al do not teach a reaction by which UA may be colorimetrically detected using a N,S-Ti3-C2-MXene nanosheet and TMB.
However, Tripathi et al teach that UA may be detected using a substrate with peroxidase-like activity and hydrogen peroxide (H2O2) to oxidize TMB (colorless) to oxTMB (blue) where, once UA contacts oxTMB solution, the blue color faded in proportion to UA concentration (see for example, the abstract, Fig 1 and its caption and pages 1/17-3/17 and 11/17).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of the prior art references. The artisan would have been motivated to make and use the invention as claimed because Liu et al teach that UA detection is desirable for diagnosis of a variety of diseases. Li et al teach that Ti3-C2-MXenes have intrinsic peroxidase activity and would be obvious to use in a method, such as the method of Liu et al, using a nanomaterial to simulate peroxidase activity for UA detection with a reliable expectation of the N,S-Ti3-C2-MXene of SJU expected to have peroxidase-like activity (see MPEP §2143(I)(B), 2144.06(II) and 2141(I)). The artisan would have found it obvious to substitute the N,S-Ti3-C2-MXene of SJU for HRP in the method of Tripathi et al as the stand in nanoenzyme because it is nitrogen-doped and would therefore be expected to possess the enhanced catalytic properties which Tripathi et al teach are ideal for their colorimetric method (see for example, the title and abstract of Tripathi et al at page 1/17)(noting also that the artisan would have understood OPD and TMB to be functionally equivalent reagents for colorimetric detection of UA using peroxidase or peroxidase-like activity; see MPEP §2143(I)(B), 2144.06(II) and 2141(I)). The Office, being unable to test the prior art products, presumes that the doped elements of the N,S-Ti3-C2-MXene nanosheet of SJU are evenly dispersed/distributed in light of SJU’s silence regarding the distribution of said doped elements. Alternatively, the nanosheet of SJU is presumed to be an obvious, art-known equivalent of the claimed nanosheet which the artisan would have found obvious to use in the method of Liu et al in place of Liu et al’s disclosed Ti3-C2-MXene quantum dots, particularly in view of the cited teachings of Li et al and Tripathi et al (see above). While SJU is deemed to teach an organ-like nanosheet having a thickness 6-10µm, it is noted that the thickness and shape of the nanosheet are result-effective variables which the artisan would have, alternatively, found obvious to modify in the process of routine optimization (see MPEP §2144.05). The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Regarding claim 8, as discussed above, the combined references make obvious a method of colorimetric detection of UA using a N,S-Ti3-C2-MXene nanosheet that has peroxidase-like activity (see above).
Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al in view of SJU, Li et al, and Tripathi et al as evidenced by Habib et al, as applied to claims 7-8 above, in further view of BTLab Systems (Water Bath or Heat Blocks (Dry Bath)-What Wins?; obtained from: https://blog.btlabsystems.com/blog/heat-block-or-waterbath (posted online 01/16/2018)) as evidenced by Wikipedia (McIlvaine buffer; obtained from: https://en.wikipedia.org/wiki/McIlvaine_buffer#:~:text=McIlvaine%20buffer%20-%20Wikipedia,13.56; available as of 2019 as evidenced by Wayback Machine).
Regarding claim 9, as discussed above, Liu et al, Li et al, Tripathi et al, and SJU as evidenced by Habib et al teach the methods of instant claims 7-8. It is noted that the instant claim 9 recites adding the enumerated reagents/elements successively. The Examiner notes that the order in which the reagents/elements are added appears to be inconsequential as the reaction described in the instant specification (see for example, paragraph 0009 (lines 20-25) of page 2) proceeds by an order which is limited by the creation of certain intermediate products (such as OH radicals and oxTMB, whereby the order of adding reagents would not appear to impact the reaction process). The instant claim 9 further recites incubating the mixture in a water bath. The Examiner notes that the only mention/purpose of the water bath pertains to controlling the temperature of the incubation (30-50°C; see for example, paragraph 0026 (lines 24-31) at page 3 of the specification).
Tripathi et al teach that colorimetric investigations of the peroxidase-like catalytic performances were conducted using the chromogenic TMB-H2O2 reaction in phosphate citrate buffer (pH5) (which is also understood to be synonymous or at least functionally equivalent in the art with disodium hydrogen phosphate citrate buffer which is also understood to be synonymous or at least functionally equivalent in the art McIlvaine buffer and citrate-phosphate buffer; see for example Wikipedia available as of 2019 as evidenced by Wayback Machine which supports that the recited phosphate citrate buffer is also known in the art as disodium hydrogen phosphate citrate buffer, McIlvaine buffer, and citrate-phosphate buffer), TMB, and H2O2, where the oxTMB was further used as an optical sensor for UA (necessitating adding UA (presumably as a solution see for example, pages 1/17-2/17 and 11/17-13/17) where incubation of the peroxidase-like simulator, TMB, H2O2, and buffer lasted 15 minutes. Tripathi et al teach recording and measuring absorbance at 652 nm by UV-Vis (see for example, pages, 5/17-7/17).
Tripathi et al as evidenced by Wikipedia do not teach that the reaction occurs at a temperature different than room temperature (necessitating a temperature control means such as a water bath), but does generally teach that enzymatic activity tends to be higher under conditions of temperatures at 37°C (see for example, page 9/17 bridging page 10/17).
However, Li et al teach that peroxidase-like activity and kinetic studies using Ti3-C2-MXene nanosheets were carried out at 40°C (a temperature warmer than room temperature indicating the need for a means of temperature control) for 20 min using a mixed solution (held to read upon the recited even mixing) of Ti3-C2-MXene nanosheet, OPD (art-known equivalent of TMB), buffer, and H2O2 where colorimetric detection by recorded absorbance occurred after said incubation step (see for example, the title and abstract at page 1 and section 2.4 at column 1 of page 3).
The combined references do not teach the use of a water bath as a means for temperature control during incubation.
However, BTLab Systems teaches that water baths are typically used for routine laboratory applications such as warming reagents, melting substrates and/or incubating cell cultures, with little ignition risk.
It is noted that there is no definition provided for what an organ-like shape is intended to mean within the instant disclosure. The only hint as to what Applicant intended to convey with said recitation is the SEM schematic of instant figure 1, which shows an accordion-like/multilayered structure, which appears to be consistent with the state of the art regarding organ-like MXenes (such that any other interpretation would be unsupported and insufficiently described by the instant disclosure and the state of the art). SJU teach that their N,S-Ti3-C2-MXENE is in an accordion-like/multilayered arrangement which appears to be approximately 10µm thick (see for example, the SEM schematic of figure 2 of the untranslated version of SJU).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of the combined references. The artisan would have been motivated to make and use the invention as claimed because Li et al teach detection of UA at 40°C and BTLab Systems teach the use of a water bath as a common means for controlling temperature of incubations, where the references combine to make obvious the particular claimed parameters (such as the disodium hydrogen phosphate citrate buffer used) as obvious to use in the prior art method with a predictable expectation of successful UA detection. The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Regarding claim 15, the combined prior art references make obvious a N,S-Ti3C2-MXene nanosheet for use in detecting UA wherein the nanosheet has peroxidase-like activity (see above).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al in view of SJU, Li et al, and Tripathi et al, BTLab Systems as evidenced by Habib et al and Wikipedia, as applied to claims 9 and 15 above, in further view of Metto et al (International Journal of Electrochemistry, 2019, 6318515, 8 pages, 2019. https://doi.org/10.1155/2019/6318515).
Regarding claim 10, as discussed above, Li et al teach that peroxidase-like activity and kinetic studies using Ti3-C2-MXene nanosheets were carried out at 40°C (see for example, the title and abstract at page 1 and section 2.4 at column 1 of page 3) with the incubation time being 20 min (wherein the reaction time is presumed to be the same as the incubation time). Liu et al additionally teach creation of a calibration curve comprising contacting the reaction the nanosheet/buffer/TMB/ H2O2 solution (interpreted to be the reaction system Applicant refers to in the recitation of claim 10) with uric acid solution at a concentration of 0-200µM (see for example, pages 138-140). The Examiner believes that the upper limit of 400µM UA would have been obvious optimization for producing a more comprehensive calibration curve for comparison to unknown/test samples for determination of the amount of detected UA in the unknown/test sample(s).
However, Metto et al teach determination of UA in clinical samples using a calibration curve prepared with UA concentrations in serial dilutions ranging in concentration from 0-1,000µM UA, making obvious a curve using any range of concentrations within the 0-1,00µM range (see for example, section 2.4 at column 2 of page 2; note Figure 4C and its caption further suggesting a range of 0-500µM of UA for the calibration curve).
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of the combined references. The artisan would have been motivated to make and use the invention as claimed because Lui et al and Metto et al both teach detection of UA involving production of a calibration curve with 0-1,000µM UA in contact with the reaction system where the calibration curve may be compared to unknown/test samples to determine the amount/concertation of UA in the unknown/test sample. The artisan would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Elumalai et al (Microchim Acta 187, 33 (2020), https://doi.org/10.1007/s00604-019-4018-0), Da Chen et al (Analytica Chimica Acta 1197 (2022) 339520, https://doi.org/10.1016/j.aca.2022.339520), Zeng et al (Journal of Alloys and Compounds 869 (2021) 159335, https://doi.org/10.1016/j.jallcom.2021.159335), and Lorencova et al (Electrochim Acta. 2017 May 1;235:471-479. doi: 10.1016/j.electacta.2017.03.073. PMID: 29109588; PMCID: PMC5669457), Li et al (Mater Sci Eng C Mater Biol Appl. 2019 Nov;104:110000. doi: 10.1016/j.msec.2019.110000. Epub 2019 Jul 19), and Lian et al (Journal of Electroanalytical Chemistry 904 (2022) 115849, https://doi.org/10.1016/j.jelechem.2021.115849) are deemed relevant.
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/Ashley Gao/
Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678