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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March has been entered.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are necessitated by the amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 41-42, 44-45, 48, 52, 54, and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devadoss (US 2019/0233869) in view of Tan (Y. Tan, Polymeric Bionanocomposite Cast Thin Films with In Situ Laccase-Catalyzed Polymerization of Dopamine for Biosensing and Biofuel Cell Applications, J. Phys. Chem. B 2010 (114), pp. 5016-24), and further in view of Etsu (JP 2019/071880), supported by Zhang (CN 107064261) as an evidence.
Regarding claim 41, Devadoss teaches an oxygen-passive biosensor device (¶1: enzyme-based electrochemical biosensors; ¶47: an example of the redox enzyme is glucose dehydrogenase; Fig. 3: GDH 26) comprising at least one electrode having a surface region (Fig. 3; ¶39: electrode with a surface 14) composed of at least one carbon allotrope (Fig. 3; ¶42: carbon nanomaterials 18), the surface region being associated with a matrix material (Fig. 3; ¶42: the reagent layer 12/gel network 16) entrapping at least one enzyme (Fig. 3: GDH 26; ¶47: an example of the redox enzyme is glucose dehydrogenase) and at least one redox charge mediator (Fig. 3; ¶44: a redox polymer; ¶57: the donor can be any redox mediator, e.g., ferrocene),
Wherein the carbon allotrope comprises multi-walled carbon nanotubes (MWCNTs) (¶41: one or more carbon nanomaterials 18, e.g., carbon nanotubes (multiwalled)), and wherein:
(a) for glucose sensing,
the enzyme comprises glucose dehydrogenase (GDH) (Fig. 3; ¶47).
Devadoss fails to teach wherein the matrix material comprises polydopamine.
However, Tan teaches electrochemical biosensor using lac-catalyzed polymerization of dopamine (DA) on a glassy carbon electrode (GCE), which yields a robust polydopamine (PDA)-Lac-MWCNTs/GCE and the best biosensing performance ([Abstract]); for example, exhibiting glucose-detection sensitivity of 68.6 µA mM-1 cm-2 ([Abstract]). Scheme 2 indicates that the MWCNTs are on the top surface of the electrode.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss by substituting the matrix material with polydopamine (PDA) as taught by Tan. The suggestion for doing so would have been that polydopamine is a suitable matrix material in glucose sensor and the selection of the known materials, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Further, the lac-catalyzed polymerization of dopamine (DA) yields the best biosensing performance on glucose detection ([Abstract]).
Devadoss fails to teach the enzyme GDH is flavin adenine dinucleotide-dependent GDH or the redox charge mediator comprises dichlorophenol indophenol (DCPIP) and/or dichloronaphthoquinone (DCNQ).
However, Etsu teaches a glucose sensor using FAD-dependent glucose dehydrogenase ([Abstract]). As a mediator and a coloring reagent, 2,6-dichlorophenol indophenol (DCPIP) can be added as an electron acceptor for sensing glucose (p. 15, para. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss by substituting oxidoreductase GDH with FAD-GDH and the redox mediator with DCPIP as taught by Etsu. The suggestion for doing so would have been that FAD-GDH is a suitable material for enzyme and DCPIP is a suitable material for redox mediator in glucose sensor and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
As evidenced by Zhang, glucose dehydrogenase does not react with oxygen and therefore does not interfere with the oxygen content of the sample, suitable for detecting samples of different oxygen content (p. 2, para. 2). Thus, the biosensor device of Devadoss using glucose dehydrogenase as the redox enzyme would be an oxygen-passive biosensor device.
Regarding claim 42, Devadoss teaches wherein the at least one enzyme and at least one redox mediator are confined to a molecular film of the matrix material (¶36: a film of the reagent layer).
Regarding claim 44, Devadoss teaches wherein the carbon allotrope is carbon nanotubes (¶42: an example of the carbon nanomaterials 18 is carbon nanotubes).
Regarding claim 45, Devadoss teaches wherein the electrode is a glassy carbon electrode (GCE) (¶95) and the carbon allotrope is carbon nanotube (¶42).
Regarding claim 48, Devadoss in view of Tan and Etsu disclose all limitations of claim 41, and the device being an oxygen-passive biosensor device (Devadoss, ¶1: enzyme-based electrochemical biosensors; ¶47: an example of the redox enzyme is glucose dehydrogenase; Fig. 3: GDH 26; as evidenced by Zhang, p. 2, para. 2) comprising the surface region (Fig. 3; ¶39: electrode with a surface 14) of a carbon allotrope (Fig. 3; ¶42: carbon nanomaterials 18) and polydopamine (Tan, [Abstract]: (PDA)-Lac-MWCNTs/GCE) as a matrix material layer (Scheme 2), associated with said surface region (Devadoss, Fig. 3; ¶42: the reagent layer 12/gel network 16), the polydopamine matrix material layer entrapping the at least one enzyme (Tan, Scheme 2; Devadoss, Fig. 3: GDH 26; ¶47: an example of the redox enzyme is glucose dehydrogenase) and the at least one redox charge mediator (Devadoss, Fig. 3; ¶44: a redox polymer; ¶57: the donor can be any redox mediator, e.g., ferrocene).
The limitation “or wherein the device is an oxygen-passive biosensor comprising the surface region of a carbon allotrope and agarose as a matrix material layer, associated with said surface region, the agarose matrix material layer entrapping the at least one enzyme and the at least one redox charge mediator” is optional and not required in the prior art.
Regarding claim 52, Devadoss teaches the biosensor being a glucose sensor (p. 11: Example 1; ¶95: glucose sensor).
Regarding claim 54, Devadoss teaches the biosensor being a lactate sensor (p. 11: Example 2; ¶96: lactate sensor).
Regarding claim 62, Devadoss in view of Tan and Etsu discloses all limitations of claim 41, including wherein the matrix material is polydopamine (Tan, [Abstract]).
The designation “wherein the polydopamine is not formed in situ” is product-by-process limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I). Here, there is no apparent difference between the claimed biosensor and the one of the prior art as taught by Devadoss in view of Tan and Etsu.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devadoss in view of Tan and Etsu, and further in view of Auger (US 2016/0181648).
Regarding claim 43, Devadoss, Tan, and Etsu disclose all limitations of claim 41, but fail to teach wherein the carbon allotrope has a specific surface area per unit mass between 120 and 1315 m2/gr.
However, Auger teaches a fuel biocell (Title) using electron transfer between the active center of an enzyme and a surface of the electrode that is also encountered in the field of biosensors (¶8). To improve the active and specific surface area, multiwall carbon nanotubes (MWCNT) is used (¶226), rendering the specific surface area is a result-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss and Tan by adjusting the surface area of the carbon allotrope within the claimed range because the surface area of the carbon allotrope is a result-effective variable and can be optimized through routine experimentation to improve the electrode activity (¶226). MPEP 2144.05 (II)(B).
Claim(s) 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devadoss in view of Tan and Etsu, and further in view of Schuhmann (W. Schuhmann, Conducting Polymer Based Amperometric Enzyme Electrodes, Mikrochim. Acta, 1995(121), pp. 1-29).
Regarding claim 60, Devadoss, Tan, and Etsu disclose all limitations of claim 41, including the device being an oxygen-passive biosensor device (as evidenced by Zhang, p. 2, para. 2) comprising the surface region (Devadoss, Fig. 3; ¶39: electrode with a surface 14) of the carbon allotrope (Devadoss, Fig. 3; ¶42: carbon nanomaterials 18) and polydopamine (Tan, [Abstract]) as the matrix material layer, the polydopamine matrix material layer entrapping glucose dehydrogenase (GDH) (Devadoss, Fig. 3: GDH 26; ¶47).
Devadoss, Tan, and Etsu fail to teach the matrix material layer entrapping dichloronaphtoquinone (DCNQ).
However, Schuhmann teaches preparation of electrochemically polymerizable redox polymers for dehydrogenase-based biosensors (p. 20, para. 3). Pyrrole has been modified by reaction with chloranil or 2,3-dichloro-l,4-naphthoquinone (DCNQ), and these quinone-modified pyrrole monomers could be copolymerized with pyrrole to form a polymer film which in cyclic voltammetry showed the redox wave of polymer-integrated quinone centres (p. 20, para. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss, Tan, and Etsu by incorporating DCNQ in the matrix material layer as taught by Schuhmann because DCNQ would provide the sensing layer, i.e., the matrix material layer, the redox wave of polymer-integrated quinone centres in cyclic voltammetry (p. 20, para. 3). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devadoss in view of Tan and Etsu, and further in view of Kaneda (US 2013/0075277), and further in view of Oja (US 2019/0004005), and further in view of Schuhmann.
Regarding claim 61, Devadoss, Tan, and Etsu disclose all limitations of claim 41, including the device being an oxygen-passive biosensor device (as evidenced by Zhang, p. 2, para. 2) comprising the surface region (Devadoss, Fig. 3; ¶39: electrode with a surface 14) of the carbon allotrope (Fig. 3; ¶42: carbon nanomaterials 18) and the matrix material as the matrix material layer.
Devadoss, Tan, and Etsu fails to teach the matrix material comprises agarose.
However, Kaneda teaches a lactate sensor (¶2), using a reagent layer containing a polysaccharide to further enhance measurement sensitivity, e.g., agarose (¶33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss, Tan, and Etsu by substituting the matrix material of the reagent layer with agarose as taught by Kaneda because it would further enhance measurement sensitivity of lactate sensor (¶33). Further, the suggestion for doing so would have been that agarose is a suitable material for the reagent layer of lactate sensors and the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Devadoss, Tan, and Etsu fail to teach the matrix material layer entrapping lactate dehydrogenase (LDH).
However, Oja teaches electrochemical enzymatic biosensor (¶3), using analyte-specific enzyme, for example, glucose dehydrogenase, lactate dehydrogenase (¶16). Lactate dehydrogenase is used for oxidizing lactate (¶128), and thus would be able to use as the enzyme for detecting lactate.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss, Tan, and Etsu by substituting the at least one enzyme, e.g., glucose dehydrogenase (GDH) for glucose biosensing, with lactate dehydrogenase (LDH) for lactate biosensing because analyte-specific enzyme is selected for specific biosensor and the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Devadoss, Tan, and Etsu fail to teach the matrix material layer entrapping dichloronaphtoquinone (DCNQ).
However, Schuhmann teaches preparation of electrochemically polymerizable redox polymers for dehydrogenase-based biosensors (p. 20, para. 3). Pyrrole has been modified by reaction with chloranil or 2,3-dichloro-l,4-naphthoquinone (DCNQ), and these quinone-modified pyrrole monomers could be copolymerized with pyrrole to form a polymer film which in cyclic voltammetry showed the redox wave of polymer-integrated quinone centres (p. 20, para. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss, Tan, and Etsu by incorporating DCNQ in the matrix material layer as taught by Schuhmann because DCNQ would provide the sensing layer, i.e., the matrix material layer, the redox wave of polymer-integrated quinone centres in cyclic voltammetry (p. 20, para. 3). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). As a result, the combined Devadoss, Tan, Etsu, Kaneda, Oja, and Schuhmann would necessarily result in a lactate sensor comprising an agarose matrix material layer entrapping both LDH and DCNQ.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devadoss in view of Tan and Etsu, and further in view of Goff (A. L. Goff, Facile and tunable functionalization of carbon nanotube electrodes with ferrocene by covalent coupling and p-stacking interactions and their relevance to glucose bio-sensing, Journal of Electroanalytical Chemistry, 2010(641), pp. 57-63).
Regarding claim 63, Devadoss, Tan, and Etsu disclose all limitations of claim 41, but fails to teach wherein said at least one redox charge mediator is chemically associated to the at least one carbon allotrope.
However, Goff teaches glucose sensors based on CNTs modified with ferrocene derivatives, wherein ferrocene plays the role of an electron mediator in the oxidation of glucose (p. 57, col. 2, para. 3). There are two methods used to functionalize MWCNTs with ferrocene, via π-stacking and down or via covalent grating (Fig. 1; p. 58). Thus, Goff teaches said at least one redox charge mediator (ferrocene derivatives) chemically associated (Fig. 1: covalent grafting, p. 59, col. 1, para. 1) to the at least one carbon allotrope (NWCNTs).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Devadoss, Tan, and Etsu by incorporating chemical association, i.e., covalent grafting, between the mediator and the carbon allotrope as taught by Goff because the covalent functionalization would obtain a better electronic communication (p. 61, bridging para. of col. 1-2).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues Devadoss does not disclose the use of oxygen-insensitive flavin-dependent enzymes (such as FAD-GDH) (Response, p. 9, para. 1). However, Etsu teaches a glucose sensor using FAD-dependent glucose dehydrogenase ([Abstract]). Thus, the combined Devadoss and Etsu would arrive the claimed subject matter by substituting the enzyme GDH with FAD-GDH. Regarding the arguments that the instant invention would provide a device capable of the oxygen-independent, high-current, and stable performance (p. 9, para. 1, citing Affidavit, item 9) or enable high anodic bioelectrocatalytic currents at low applied potentials (p. 9, para. 2, citing Affidavit, item 10) are not structural elements of the recited biosensor. Applicant is reminded that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Applicant argues the glucose biosensor demonstrate advantageous performance, e.g., stable operation with reproducible responses, effective operation in the presence of interferents, and exhibits a wide effective measurement range (p. 14, citing Affidavit, item 17 supported by items 13-16). These features are not structural limitations of the claimed biosensor and thus do not add patentable weight to the claims.
Applicant argues the lactate oxidase system of Devadoss different from the instant invention (pp. 14-15, citing Affidavit, item 18). Examiner notes the rejection of claim 61 (i.e., a lactate biosensor using LDH as the enzyme and DCNQ as the mediator) is based on Devadoss, Tan, Etsu, Kaneda, Oja, and Schuhmann, not Devadoss alone. Applicant is reminded that it cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795
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