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
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/AU202/051396, filed 12/18/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2019904865, filed on 12/20/2019 in Australia.
Information Disclosure Statement
The information disclosure statements (IDS) entered 02/13/2026 is considered, initialed and is attached hereto.
The information disclosure statement filed 12/01/2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
See Non-patent literature documents 6 and 7 are lined through, as Applicant has provided no translation or concise explanation of relevance.
Status of the Claims
Claims 1-32 are pending; claims 26-32 are withdrawn; claim 8 is amended. Claims 1-25 are examined below.
Withdrawn Objections/Rejections
The previous objection to claim 8 is withdrawn in response to the amendments to the claim.
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.
(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.
Claim(s) 1-7, 9-12 and 14 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Cheng et al., US PG Pub No. 2010/0216256A1 (IDS entered 01/23/2023).
Cheng et al. teach (see e.g., para [0010]) a biosensor (sensor for detection a bioanalyte), comprising a substrate, a pair of terminal electrodes on the substrate (see para [0010], a source electrode and a drain electrode), the pair of electrodes shown as in mutually spaced apart and opposing relation to one another (see for example Figures 1 and 9), and a non-insulating sensing element applied to the surface of the substrate between and in contact with the pair of terminal electrodes wherein the sensing element provides a conduction path between the terminal electrodes, wherein the sensing element comprises an oxygen deficient metal oxide layer and a bioanalyte binding site (see Cheng at para [0010], a functionalized nanobelt on the substrate, the nanobelt having functionalized surface linked to one or more detector molecules for binding a biological analyte, see para [0042], the nanobelt comprising an oxide such as ZnO, thereby also addressing claim 2). The device of Cheng et al. such that when a voltage is applied across the sensor, an electrical signal is generated proportional to a change in conductance of the sensing element corresponding to binding of a bioanalyte to the binding site (see as cited above, and paras [0035], Fig. 9).
Regarding claim 3, Cheng teach the nanobelt structural component is not longer than 100 µm, the cross section on the order of tens of nanometers (see para [0043]), given this description and the figures, and considering Cheng’s nanobelt is a nanometer sized rectangular structure, Cheng appears to anticipate the claimed range.
Regarding claim 4, Cheng is teaching metal oxide layers formed using sputtering for deposition (see for example, paras [0057], [0072]).
Regarding claims 5-7, the bioanalyte binding site of Cheng et al. is anchored to the nanobelt (the oxygen deficient metal oxide layer) via and intermediate layer, a layer produced by silanization with a silanizing agent having a terminal functionality as claimed, specifically see Cheng teach APTES (Figures 5 and 15, for example; see also para [0044], APTES with terminal NH2 active end for binding).
Regarding claims 9-12 and 14, Cheng is teaching a bioanalyte binding site that is a biomolecule (e.g., antibodies, paras [0036], [0046]-[0050], see para [0048] including antibody fragments).
Regarding claim 20, see Cheng teach contacting the sensor with sample solution (see para [0015], and also Examples, and further para [0066], Cheng teach sample solutions, such as blood or other biological fluids), applying a voltage across the sensor (see Figure 9 for example), detecting an electrical signal generated that is proportional to a change in conductance corresponding to detection of bioanalyte upon binding (para [0010], [0015], [0034]; see also para [0004]).
Regarding claim 21, see as cited above, Cheng teaches binding site that is a biomolecule (see as cited above).
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.
Claim(s) 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (cited previously above).
Although Cheng is considered to anticipate the claim, see further regarding claim 3, the claimed range of 50nm to 200µm as thickness is further obvious over the cited prior art because “on the order of tens of nanometers” encompasses a range thickness that substantially overlaps the claimed range, specifically because a cross section on the order of tens of nanometers is a range of anywhere from 10-90 nm, which falls within (and as such, addresses) the claimed range. See MPEP 2144.05. Specifically, it would have been obvious to have arrived at thicknesses within the claimed range by trying from the values disclosed within the prior art range, on the order of tens of nanometers (10-90nm thickness), since the prior art is teaching these dimensions as suitable for the nanobelt material of Cheng.
Regarding claim 8, although Cheng teach a biosensor substantially as claimed (see as cited in detail previously above).
Cheng does teach, semiconducting nanobelts are advantageously used in the sensors because of their small size and their electrical conductivity being sensitive to the type and concentration of molecules absorbed on their surfaces (para [0037]). Cheng et al. teach having “a suitable conductivity (or resistivity) for use in FET device (para [0042]).
Further, see Applicant’s originally filed specification at para [0084], which teaches sputtering as a way to create ZnO thin films (paras [0083]-[0084], sputtering parameters selected to engineer thin films with electrical conductivities in the range of 0.08-0.6 S/m2, the instant specification indicates this range of conductivity gives maximum sensitivities.
Cheng is teaching metal oxide layers formed using sputtering for deposition (see for example, paras [0057], [0072]).
Therefore, although Cheng fails to teach that the nanobelt material (the oxygen-deficient metal oxide layer) has a conductance that falls within the range of about 0.08-0.6 siemens/m2, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the conductance of the nanobelt material of Cheng fall within this claimed range (the claimed range considered a sensitive conductance) because Cheng is teaching the same type of metal oxide material encompassed by Applicant’s disclosed suitable materials (e.g., ZnO), and is teaching forming nanobelt materials with techniques comprising sputter deposition, which Applicant’s originally filed specification supports is responsible for conductivity with maximum sensitivity. As a result, although not specifically disclosing the same values, it would be expected that since Cheng’s device appears structurally consistent with that which is presently claimed, it would be expected that this component of the biosensor exhibit the same functional ability in terms of conductance.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. in view of Yi Toh et al., Aptamers as a replacement for antibodies in enzyme-linked immunosorbent assay, Biosensors and Bioelectronics, 64, (2015), p. 392-403 (5 pages).
Cheng et al. teach a biosensor substantially as claimed (see as cited above, for example, teaching antibody), however, fails to teach protein-binding scaffold as the capture protein (see species, at claim 13).
Yi Toh teach compared to antibodies, aptamers are smaller in size, can be easily modified, are cheaper to produce and can be generated against a wide array of target molecules (see abstract, page 5, Section 3.), see further Yi Toh teach aptamers are applicable in different sensing tools, including biosensors (see page 6).
It would have been further prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheng et al. in order to provide aptamer as the ligand at the biosensor instead of antibody as an obvious matter of a simple substitution of one art recognized binding partner for targeting an analyte for another, one motivated to rely on an aptamers because of the advantages of aptamers over antibodies (advantages regarding size, easily modified, cheaper to produce). One having ordinary skill in the art would have a reasonable expectation of success because Yi Toh teach aptamers as usable for different sensing tools, including biosensors (the device of Cheng is a biosensor device).
Claim(s) 15, 16 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. in view of Spanuth, US PG Pub No. US PG Pub No. 2006/0234300A1.
Cheng et al. teach bioanalyte binding site comprising an antibody for an antigen (see Cheng, paras [0013], [0035], [0046], [0047] detecting protein biomarkers, for example cardiac biomarker cTnI).
However, Cheng fails to teach binding site that binds IL-6 (claims 15 and 22), binding site that binds CRP (claim 16).
Spanuth et al. teach detecting biomarkers in an effort to assess cardiovascular risk in a patient with respect to administration of an anti-inflammatory drug, particularly NSAIDs or steroids (para [0002]). Spanuth teach measuring the level of markers, such as markers indicative of an inflammatory process, teaching examples of such markers include IL-6 and CRP (see para [0082]).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have modified the biosensor of Cheng et al., in order to target IL-6, and alternatively also CRP (claims 15, 16, 22 and 24), as an obvious matter of a simple substitution of one known biomarker of interest for another. In particular, the prior art (Cheng et al.) is not particularly limited to any one biomarker, the biosensor taught as applicable for detection of bioanalyte (antibody detection of an antigen), Cheng teaching as an example, a cardiovascular biomarker (cTnI). Other known biomarkers of interest include each of IL-6 and CRP, both art recognized markers indicative of inflammatory processes, one further motivated to detect either of these markers for the purpose of assessing cardiovascular risk related to administration of NSAIDs or steroids. One having ordinary skill would have found it obvious to modify the biosensor to detect either of IL-6 or CRP for the protein bioanalyte of Cheng, and the results would have been predictable (predictably achieved detection).
One having ordinary skill in the art would have had a reasonable expectation of success because each of IL-6 and CRP are protein biomarkers of interest in the prior art, and because Cheng is not particularly limited to a particular bioanalyte (would be expected usable, based on Cheng, for detection of other targeted protein analytes).
Regarding claim 23, the claim recites “wherein the change in conductance detected in a sample solution with a concentration of IL-6 of 4 femtomolar is about 9.2%”, it is noted that the recited functional language does not appear to recite or suggest any additional structure, other than that specific to the biosensor at claim 1 (claim 20 recites the biosensor of claim 1), targeting IL-6 (claims 22). As such, the claimed limitations at claim 23 read as a natural consequence of performing the method of claims 20 and 22, for example the “wherein” clause recited at claim 23 does not recite language that limits the claim to any particular structure/structural feature, rather reads as the result observed when the device is used on a sample with 4 femtomolar IL6. Because the limitation does not impart any specific additional claimed steps/elements to the method claimed, or structure to the claimed biosensor, it appears the cited prior art addresses the claim.
Regarding claim 25, the claim similarly recites “wherein the change in conductance detected in a sample solution with a concentration of CRP of 13 femtomolar is about 12.5%”, the same reasoning as applied in detail above also applies presently. Because the limitation does not impart any specific additional claimed steps/elements to the method claimed, or structure to the claimed biosensor, it appears the cited prior art addresses the claim.
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. in view of Choong et al., WO0142508A2.
Regarding claim 17 and 19, see Cheng teach a ceramic substrate (Si3N4, paras [0039], [0041], [0050] and [0054]).
Although Cheng does teach substrate material that is silicon based, such as Si3N4, Cheng does not specifically refer to the material as “silicon wafer” (claims 17 and 19); further fails to teach polymer substrate (claim 17), such as polyimide (claim 18).
Choong et al. teach solid substrate material (for supporting electrodes), including silicon wafer, ceramics, polymer such as polyimide material (e.g., see page 18, lines 13-27, page 24, lines 27 to page 25, line 4).
Regarding claims 17 and 18, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the Si3N4 material in the form of a silicon wafer material as an obvious matter of applying a known materials for its art recognized purpose, see specifically Choong et al., solid substrates can be made from a wide variety of materials, preferred including silicon, such as silicon wafers. Cheng et al. teach silicon based substrates, however, is silent as to whether or not that material is provided as a “silicon wafer”. Considering it was known in the art to provide, as a substrate material supporting electrodes, silicon material that is a silicon wafer, it would have been obvious to have applied the known technique of Choong to the known product of Cheng.
Additionally, the modification is considered an obvious matter to try, namely selecting from the known list of suitable materials (Choong disclosed silicon wafer as an art recognized substrate materials).
One having ordinary skill would have a reasonable expectation of success applying a known material for its art recognized, intended purpose.
Further, regarding claims 17 and 18, for the same reasons as applied above, it would be further obvious to have modified Cheng et al. in order to provide the substrate as a polymer material, namely polyimide also as in Choong et al., this modification additionally an obvious matter of a simple substitution of one know substrate material for another, both recognized in the prior art as usable for the same purpose (both known substrate materials for supporting an electrode). As indicated above, one having ordinary skill would have a reasonable expectation of success applying a known material for its art recognized, intended purpose.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive for the following reasons:
Applicant argues Cheng et al. fails to teach "a non-insulating sensing element" and fails to teach "sensing element provides a conduction path between the terminal electrodes". Applicant asserts that Cheng indicates a proposed sensor that is a FET based biosensor, however the present claimed biosensor is based on conductometry (remarks page 6). Applicant argues the claims recite a "pair of terminal electrodes", whereas Cheng uses a 3 electrode system (source, drain and gate). Applicant remarks that in Cheng, the external bias is applied between the gate and source my measuring current flow across source and drain electrodes upon binding of target cTnI biomarkers to the cTnI antibodies on the sensor, arguing the claimed invention, the external bias is applied across the two electrodes and the current flow is measured across the same two electrodes upon binding of target biomarkers to the antibodies on the sensor.
Applicant's remarks are not persuasive as the cited prior art structure appears to be indistinct from the structure as claimed. Applicant's arguments are not limited to structures recited at the claims (arguments are not commensurate in scope, in that the claimed structures do not appear limited to biosensors based on conductometry as claimed, as the FET biosensor structure of Cheng does appear to read on the claims). For example, consistent with the claims, Cheng's biosensor includes a nanobelt structure that appears to address the claimed invention in that it is a "non-insulating sensing element", this structure is applied to the substrate surface between and in electrical contact with the terminal (source and drain) electrodes, and does include the same material consistent with the present claims (ZnO, as recited at claim 2). The bioanalyte binding site is present on the sensing element of Cheng, and when voltage is applied across the sensor, and electrical signal is generated as claimed (see for example the citations as in the pending rejection, and further para [0036] "conductance of the FET channel changes upon binding... electrical conductance modification is through electric field gating rather than direct exchange of charge carriers". See para [0037], "their electrical conductivity being sensitive to the type and concentration of molecules adsorbed on their surface". The claimed structure does not appear to exclude FET based biosensor structures.
Applicant further asserts structural distinctions between the claimed biosensor and the FET based biosensor of Cheng, specifically referring to how Cheng includes a gate (remarks pages 7-8), however, notably the claimed biosensor recites the open transitional language "comprising" and as such does not clearly exclude other structural components, such as a Gate as in Cheng (for example, the claim does not recite structure consisting of/limited to two electrodes). Applicant argues points 1-15 (through page 9), however these arguments refer to particular structures and the instant claims are not restricted to these particular structure (the argued features of Cheng are not clearly excluded as a result of the broad claim language).
Regarding remarks at page 9, specific to instant claim 2, Applicant argues the ZnO layer of Chen does not address "oxygen deficient metal oxide" as claimed, arguing that Cheng discloses using oxygen-deficiency terminology to explain the possible conductivity observed across electrodes. Claim 2 of the instant application recites "oxygen deficient metal oxide layer formed from a metal oxide selected from the group consisting of zinc oxide (ZnO)", oxygen deficiency is considered in reference to "oxygen vacancies" in this oxide system. Cheng appears to be teaching the same material, referring to para [0042], Zinc oxide- para [0084] appears to refer to conductivity of the nanobelt material, from the surface oxygen deficiency. The structure claimed does not appear distinct from that taught by Cheng in terms materials/structure that make up the biosensor.
Regarding claim 3, Applicant argues the Examiner has mischaracterized the reference in terms of Cheng's reported thickness, however, this is not persuasive. Referring to the rejection (page 4), Cheng is cited as teaching a length not longer than 100 micrometers, and cross-section (i.e., thickness) on the order of tens of nanometers. From this description, and the figures of Cheng, one having ordinary skill in the art would consider the thickness of this structure to be nanometer sized rectangular structure, i.e. tens of nanometers reads on thickness within the claimed range.
Applicant's arguments that Cheng used complicated procedure to modify the metal oxide layer with APTES, whereas the claimed invention uses GPS silane to functionalize the device by simply exposing to GPS vapor, which takes less than 1 hour, is not persuasive that the claimed biosensor is distinct from the prior art. This argument is directed to a method of making a biosensor, and does not appear to distinguish the biosensor itself from the prior art. For example, in terms of claim 5, Cheng's biosensor comprises bioanalyte anchored via intermediate layer physically or chemically absorbed.
Additionally, regarding remarks at page 10 specific to claims 9-12, these claims are not limited to antibodies for capturing IL-6 and CRP, respectively. This is not a limitation of these claims (IL6 and CRP are not recited until claims 15 and 16, see under 35 U.S.C. 103, the rejection further cites Spanuth et al.).
At remarks pages 10-12 Applicant refers to reasons discussed previously above (see remarks page 11, "for the reasons given above in relation to novelty, the Applicant considers the presently claimed sensor is non-obvious in view of Cheng et al..."). Applicant remarks Cheng's sensor fabrication is difficult, time-consuming, and expensive, as compared to the fabrication of the present sensor, however, this is not persuasive as the claimed invention is not a method of making a biosensor (claim 26 is directed to a method of fabrication and is withdrawn as a result of election). The claimed invention under examination is a product, namely the biosensor.
For all of these reasons, Applicant's arguments are not persuasive, and the rejections are maintained.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677
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