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 Objections
Claims 1-2, 25, and 28 are objected to because of the following informalities:
Claim 1, line 1: “the presence” should read --presence--
Claim 2, line 1: “the presence” should read --presence--
Claim 25, line 2: “interact” should read --interacts--
Claim 28, line 9: “conductive material” should read --the conductive material--
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 8-9, 11, 16-17, 21-22, 25 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castro (US 20090247418) (cited by Applicant).
Regarding claim 1, Castro discloses an electrochemical sensor for determining the presence of an analyte in a liquid sample (Paragraphs [0015]-[0017]), comprising: an electrode having a surface (Fig. 3 electrodes 30/32); an active polymer brush ([Paragraphs [0034]-[0036]); an analyte recognition element (Fig. 3, affinity probes 54/56) bound to the polymer brush (Paragraphs [0034]-[0036]); and a signal transduction element comprising a reporter (Paragraphs [0037], [0043]-[0045], fig. 5), wherein the analyte recognition element specifically interacts with an analyte, when present, resulting in a detectable change in a charge transfer between the reporter and the electrode (Paragraph [0037], [0043]-[0045]; Fig. 5).
Regarding claim 3, Castro teaches wherein the electrode is carbon-based, metal-based, conductive metal oxide-based, or conductive polymer-based. (Paragraph [0053]).
Regarding claim 8, Castro teaches wherein the polymer brush is tethered to the electrode surface. (Paragraph [0035] A linker or spacer molecule typically is a molecule inserted into the growing polymer or inserted between the surface of the substrate and the probe molecule).
Regarding claim 9, Castro teaches wherein the polymer brush is end-tethered to the electrode surface. (Paragraph [0035] A linker or spacer molecule typically is a molecule inserted into the growing polymer or inserted between the surface of the substrate and the probe molecule). The claims do not define any further physical limitations on the polymer brush which would cause the functional result of it being “end-tethered”.
Regarding claim 11, Castro teaches wherein the polymer brush comprises a synthetic polymer or biopolymer. (Paragraph [0034]).
Regarding claim 16, Castro teaches wherein the analyte recognition element is a protein. (Paragraph [0023]).
Regarding claim 17, Castro teaches wherein the analyte recognition element is an antibody, a lectin, a nucleic acid, or an aptamer. (Paragraph [0023]).
Regarding claim 21, Castro teaches wherein the liquid sample is selected from blood, serum, saliva, urine, sweat, interstitial fluid, spinal fluid, cerebral fluid, tissue exudates, maccrated tissue samples, cell solutions, intracellular compartments, water, food, groundwater, or other biological and environmental samples. (Paragraphs [0005]-[0007]).
Regarding claim 22, Castro teaches wherein the liquid sample is a complex liquid sample. (Paragraphs [0005]-[0007]).
Regarding claim 25, Castro teaches a sensor device comprising at least two electrodes each having an active surface that interact with the liquid sample, wherein a first electrode contains the sensor and a second electrode provides a current and reference potential. (Figs. 2-3; Paragraphs [0040], [0043]).
Regarding claim 27, Castro teaches wherein the first and second electrode active surfaces are co-planar. (Figs. 2-3; Paragraphs [0040], [0043]).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haustein, N. et al., 'Analytical Model To Describe the Effect of Polycthylene Glycol on Ionic Screening of Analyte Charges in Transistor-Based Immunosensing', ACS sensors, 2019, vol. 4, pages 874 – 882 (cited by Applicant).
Regarding claim 2, Haustein discloses an electrochemical sensor for determining the presence of an analyte in a liquid sample (Abstract, page 874, first paragraph), comprising: an electrode (Figs. 4A-B gold extended gate); a semi-permeable, antifouling polymer brush (Figs. 4A-B PEG, page 876, last paragraph NB 'the PEG in the mixed SAM forms a brush-like layer'. The claims do not define any further physical limitations on the polymer brush which would cause the functional result of it being semi-permeable and antifouling. Therefore, these features are considered inherent in any 'polymer brush'); an analyte recognition element bound to the electrode and residing wholly within the polymer brush (Figs. 4A-B recognition molecule); and a signal transduction element comprising a reporter (page 877, Table 2), wherein the analyte recognition element specifically interacts with an analyte, when present, resulting in a detectable change in a charge transfer between the reporter and the electrode (page 877, Table 2).
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webster (US 20110079522) (cited by Applicant).
Regarding claim 28, Webster discloses a sensor device comprising at least three electrodes (Fig. 1, first/second working electrodes 118/122, counter/reference electrode layer 110), in a combination of opposing and co-planar arrangement (Fig. 1, first/second working electrodes 118/122 are coplanar, counter/reference electrode layer 110 is opposing), the sensor device comprising: at least two substrate materials (Fig. 1, insulating layers 102/112) coated with conductive material (Paragraphs [0023], [0029]); wherein at least one of the two substrate materials coated with conductive material is patterned by printing, mechanical punching or laser scoring/ablation to isolate at least two separate electrodes thereon (Paragraph [0028]), wherein at least one electrode has active chemistry deposited on it to provide sensitivity and selectivity to an analyte of interest (Fig. 1, multi-analyte reagent layer 106, Paragraph [0022]); and a nonconductive spacer material (Fig. 1, patterned spacer layer 108, Paragraph [0030] NB 'plastic') used to separate the at least two substrate materials coated with conductive material and to define a fixed volume within the sensor device (Fig. 1, single bodily fluid sample-receiving chamber 126, Paragraphs [0019]-[0020]).
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.
Claims 7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Castro in view of Haustein.
Regarding claim 7, Castro does not teach “wherein the polymer brush has anti-fouling properties”.
Haustein, as previously discussed, teaches wherein the polymer brush has anti-fouling properties. (Figs. 4A-B PEG, page 876, last paragraph NB 'the PEG in the mixed SAM forms a brush-like layer'.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the polymer brush has anti-fouling properties” as taught by Haustein. Doing so creates a highly hydrated, repulsive layer to prevent the adsorption of foreign material.
Regarding claim 24, Castro does not teach “wherein the liquid sample is whole blood”.
Haustein teaches wherein the liquid sample is whole blood. (p. 874, first paragraph.)
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the liquid sample is whole blood”, as taught by Haustein. Doing so provides a biological sample derived from a subject that contains the analytes to be measured.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Castro in view of Greene, W. et al., 'Lubricin Antiadhesive Coatings Exhibit Size-Selective Transport Properties that Inhibit Biofouling of Electrode Surfaces with Minimal Loss in Electrochemical Activity', Advanced Materials Interfaces, 2018, vol. 5, no. 7, pages 1 – 10 (cited by Applicant).
Regarding claim 10, Castro teaches wherein the polymer brush is polyethylene glycol (PEG), but does not teach “wherein the polymer brush is a telechelic polymer tethered to the electrode surface”.
Greene, in a related field of endeavor, teaches wherein the polymer brush is a telechelic polymer tethered to the electrode surface (Page 2, third full paragraph, teaches use of lubricin (LUB) as an alternative anti-adhesive polymer brush with properties comparable, and in certain cases, better than grafted layers of PEG).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the polymer brush is a telechelic polymer tethered to the electrode surface” as taught by Greene. Doing so provides a highly hydrated layer with anti-fouling benefits.
Regarding claim 13, Castro does not teach “wherein the polymer brush comprises lubricin”.
Greene, in a related field of endeavor, teaches wherein the polymer brush comprises lubricin (Page 2, third full paragraph, teaches use of lubricin (LUB) as an alternative anti-adhesive polymer brush with properties comparable, and in certain cases, better than grafted layers of PEG).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the polymer brush comprises lubricin” as taught by Greene. Doing so provides a highly hydrated layer with anti-fouling benefits.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Castro in view of Liu, N. et al., Antifouling biosensors for reliable protein quantification in serum based on designed all-in-one branched peptides. Chem. Commun. 2021; 57 (6): pages 777–780 (cited by Applicant).
Regarding claim 14, Castro does not teach “wherein the reporter is a redox reporter or an electro-chemiluminescent species.”
Liu, in a related field of endeavor, teaches wherein the reporter is a redox reporter (Page 778, Col. 2, redox probes).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the reporter is a redox reporter”, as taught by Liu. Doing so links the reporter, which undergoes a predictable oxidation-reduction reaction, to the transduction element to produce a measurable electrical current when the target is present.
Claim 23 is are rejected under 35 U.S.C. 103 as being unpatentable over Castro in view of Takahashi (US 20040086856) (cited by Applicant)
Regarding claim 23, Castro does not teach “wherein the complex liquid sample requires minimal or no processing prior to use”.
Takahashi teaches wherein the complex liquid sample requires minimal or no processing prior to use. (Paragraph [0073] resultant nucleic acid sample is subjected, if necessary).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the complex liquid sample requires minimal or no processing prior to use” as taught by Takahashi. Doing so maintains sample integrity, lowers sample consumption, and enhances efficiency.
Claim 26 rejected under 35 U.S.C. 103 as being unpatentable over Castro in view of Feldman (US 20140026646) (cited by Applicant).
Regarding claim 26, Castro does not teach “wherein the first and second electrode active surfaces are opposing and separated by a non-conductive spacer that forms a channel into which the liquid sample can be introduced”.
Feldman discloses suitable analyte sensor electrode configurations can include configurations having a working electrode position in opposition to a reference/counter electrode or configurations having the working electrode position coplanar with the reference/counter electrode. (Paragraph [0091]).
As a result, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Castro to teach “wherein the first and second electrode active surfaces are opposing and separated by a non-conductive spacer that forms a channel into which the liquid sample can be introduced” as taught by Feldman. Doing so merely represents an alternative electrode arrangement which is common in the art.
Conclusion
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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