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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1, 3, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0302660 (Kahn)(previously cited), in view of U.S. Patent Application Publication No. 2009/0294307 (Liu)(previously cited), and further in view of ES 2326286 T3 (Bainczyk)(previously cited), and further in view of WO 2010/051421 (Curry)(previously cited), and further in view of U.S. Patent No. 6,605,200 (Mao)(previously cited). Citations to Bainczyk will refer to the English translation that accompanied the Office Action mailed on 7/12/2022.
Kahn teaches a pH sensor comprising: a first carbon working electrode (the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is sensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, and 0155 of Kahn), a second carbon working electrode (the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is insensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn), and at least one other electrode (the counter electrode of Kahn; paragraphs 0122-0123 of Kahn); a first active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to a polymer) located upon the first carbon working electrode (the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles to which the polymer is covalently bounded), the first active portion comprising a polymer (the polymer) and a substance having pH-dependent oxidation-reduction chemistry (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the polymer (the polymer)(paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn); and a second active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to a polymer) located upon the second carbon working electrode (the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles to which the polymer is covalently bounded), the second active portion comprising a polymer (the polymer) and a substance having oxidation-reduction chemistry that is substantially invariant with pH (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the polymer (the polymer) (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn).
Kahn further teaches that the device is implantable in tissue (paragraphs 0114-0115 of Kahn). Further, Kahn teaches an arrangement of electrodes in which they lay side-by-side on the face of an insulating probe head (FIG. 3 of Kahn). Liu teaches that a layered arrangement of a substrate, electrodes, and insulating layers (FIGS. 5A-5B of Liu) is an alternative arrangement to a side-by-side arrangement on a base (FIG. 4 of Liu)(paragraphs 0071-0078 of Liu). Further, Liu teaches that any one of the electrodes, including the counter electrode 503 of Liu, may be provided on the opposing side of the substrate relative to the other two electrodes 501 and 502 (paragraph 0077 of Liu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a layered arrangement of the substrate, electrodes, and insulating layers of FIG. 5B of Liu modified such that the counter electrode is on an opposing side of the substrate relative the other two electrodes in place of the side-by-side arrangement of the electrodes of Kahn since it is a simple substitution of one known element for another to obtain predictable results, as explicitly disclosed in Liu.
Kahn further teaches that the device is implantable in tissue (paragraphs 0114-0115 of Kahn). Bainczyk teaches that the use of a membrane made of membrane layers ensures biocompatibility, protects the patient, and/or protects the components of the sensor (abstract, pages 3-4 and 8-9 of the English translation of Bainczyk; Fig. 6 of Bainczyk). Bainczyk teaches that the membrane may envelop the total layer structure of the sensor (pages 4, 8, and 11 of the English translation of Bainczyk). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to envelop the total layer structure of the combination with a membrane so as to ensure biocompatibility, protect the patient, and/or protect the components of the sensor.
Bainczyk teaches that the membrane may be at least partially permeable to the analyte or analytes that are to be detected (pages 4 and 8 of the English translation of Bainczyk). Curry teaches that flux limiting membranes are used to control diffusion of analytes and other analytes to the sensor (paragraph 0076 of Curry) as well as to prevent and/or reduce interfering endogenous or exogenous components (abstract, paragraphs 0004, 0008-0009, 0021, and 0096-0097 of Curry). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the membrane that envelops the total layer structure of the combination be a flux limiting membrane that controls diffusion of the analytes and other analytes to the sensor and/or to prevent and/or reduce interfering endogenous or exogenous components from reaching the electrodes so as to achieve more accurate readings over a longer period of time.
Kahn teaches that the redox-active moiety is covalently bound to a polymer that is immobilized onto the surface of the silicon substrate or that the redox-active moiety is covalently bound to a polymer that is covalently bound to the surface of the silicon substrate (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn). Mao teaches the use of osmium complexes covalently bonded to a polymer to act a redox mediators on an electrode (abstract, col. 1, lines 40-62, col. 2, lines 24-3, col. 2, line 30 to col. 3, line 35, col. 19, lines 1-30, and Example 2 of Mao). The electrooxidation or electroreduction of the enzyme is often facilitated by the presence of a redox mediator on the electrode (abstract, col. 1, lines 40-62, col. 2, lines 24-30 of Mao). The redox mediator assists in the electrical communication between the working electrode and the enzyme (abstract, col. 1, lines 40-62, col. 2, lines 24-30 of Mao). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the osmium complex of Mao covalently bonded to the polymer because it would act as a redox mediator that facilitates electrooxidation or electroreduction and/or assists in the electrical communication between the electrode and the enzyme.
With respect to claim 1, the combination teaches or suggests a pH sensor comprising:
a substrate (the substrate suggested by FIG. 5B of Liu) having a first opposing face and a second opposing face;
a first carbon working electrode (the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is sensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, 0136, and 0155 of Kahn);
a second carbon working electrode (the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is insensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, 0136, and 0155 of Kahn); and
at least one other electrode (the counter electrode of Kahn; paragraphs 0122-0123 of Kahn);
a first active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to the polymer) disposed on a distal end of the first carbon working electrode (the first active portion being on the distal end of the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles to which the polymer is covalently bounded, as suggested by FIG. 5 of Liu), the first active portion comprising a first polymer (the polymer) and a substance having pH-dependent oxidation-reduction chemistry (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the first polymer (the polymer)(paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn);
a second active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to a polymer) disposed on a distal end of the second carbon working electrode (the second active portion being on the distal end of the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles to which the polymer is covalently bounded, as suggested by FIG. 5B of Liu), the second active portion comprising a second polymer (the polymer) and a substance having oxidation-reduction chemistry that is substantially invariant with pH (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the second polymer (the polymer)(paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn), wherein the substance having oxidation-reduction chemistry that is substantially invariant with pH covalently bound to the second polymer has a structure of Formula 2:
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(the use of osmium complex of Mao);
a first dielectric layer (the insulative layer suggested by FIG. 5B of Liu) disposed over the first carbon working electrode other than the distal end of the first carbon working electrode exposing the first active portion (see the arrangement in FIG. 5B of Liu);
a second dielectric layer (the insulative layer suggested by FIG. 5B of Liu) disposed over the second carbon working electrode other than the distal end of the second carbon working electrode exposing the second active portion (see the arrangement in FIG. 5B of Liu); and
a proton-permeable membrane (the membrane suggested by Bainczyk with the flux limiting properties suggested by Curry) disposed over the first and second active portions (the membrane enveloping the layered structure suggested by Bainczyk),
wherein the first and second carbon working electrodes are disposed on the first opposing face and the at least one other electrode is disposed on the second opposing face (the counter electrode is on an opposing side of the substrate relative the other two electrodes as suggested by paragraph 0077 of Liu),
wherein the first carbon working electrode is configured to produce a first signal and the second carbon working electrode is configured to produce a second signal, and a difference between the first signal and the second signal correlates to pH (paragraphs 0024, 0123, 0126, 0161-0163, and 0166 of Kahn); and
wherein the sensor is configured to be partially inserted into a tissue to detect pH in vivo (the implantation of the sensor and the application to tissue; paragraphs 0114-0115, 0185, 0187-0188, 0206, and 0208-0210 of Kahn).
With respect to claim 3, the combination teaches or suggests that the substance having pH- dependent oxidation-reduction chemistry comprises a quinone, a redox indicator compound, or any combination thereof (quinone; paragraphs 0011, 0080, and 0091 and claim 28 of Kahn).
With respect to claim 27, the combination teaches or suggests that the substance having the oxidation-reduction chemistry that is substantially invariant with pH exhibits a response variability that fluctuates by precisely 10 mV or less over a pH range of precisely 5 to precisely 8 (the at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive (as opposed to just being substantially insensitive) to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn; this means there is a fluctuation of 0 mV over any pH range).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kahn, in view of Liu, and further in view of Bainczyk, and further in view of Curry, and further in view of Mao, and further in view of WO 2017/079696 (Ismagilov)(previously cited).
Kahn teaches at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, and 0155 of Kahn). Such species include: quinones, anthroquinones, phenanthroquinones, phenylene diamines, catechols, phenothiazinium dyes1, monoquaternized N-alkyl-4,4’-bipyridinium, Prussian Blue, Ni(OH)2, and RuOx (paragraph 0091 of Kahn). Ismagilov teaches that other pH dependent redox indicators include: sodium 2,6-Dibromophenol-indophenol, sodium o-Cresol indophenol, thionine, methylene blue,2 indigotetrasulfonic acid, indigotrisulfonic acid, indigo carmine, indigomono sulfonic acid, phenosafranin, safranin, neutral red (paragraph 00115 of Ismagilov). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use methylene blue as the redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of pH since it is a simple substitution of one known element for another to obtain predictable results and/or Kahn teaches that phenothiazinium dyes can be used and Ismagilov teaches one such dye.
With respect to claim 4, the combination teaches or suggest that the substance having pH- dependent oxidation-reduction chemistry comprises a redox indicator compound comprising a thiazine (the use of methylene blue of the combination).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kahn, in view of Liu, and further in view of Bainczyk, and further in view of Curry, and further in view of Mao, and further in view of U.S. Patent Application Publication No. 2016/0354542 (Ward)(previously cited).
Kahn teaches that the redox-active moiety is covalently bound to a polymer that is immobilized onto the surface of the silicon substrate or that the redox-active moiety is covalently bound to a polymer that is covalently bound to the surface of the silicon substrate (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn). Ward teaches that polyvinylpyridine or polyvinylimidazole is a suitable polymer for holding electrode components (paragraph 0017 of Ward)3. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyvinylpyridine or polyvinylimidazole as the polymer of the combination since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 25, the combination teaches or suggest the first polymer comprises a polyvinyl pyridine, a polyimidazole, a copolymer of polyvinyl pyridine or polyimidazole, or any combination thereof (the polyvinylpyridine or polyvinylimidazole of the combination).
Claims 1, 3, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0302660 (Kahn)(previously cited), in view of U.S. Patent Application Publication No. 2010/0228110 (Tsoukalis), and further in view of U.S. Patent Application Publication No. 2009/0294307 (Liu)(previously cited), and further in view of ES 2326286 T3 (Bainczyk)(previously cited), and further in view of WO 2010/051421 (Curry)(previously cited), and further in view of U.S. Patent No. 6,605,200 (Mao)(previously cited). Citations to Bainczyk will refer to the English translation that accompanied the Office Action mailed on 7/12/2022.
Kahn teaches a pH sensor comprising: a first working electrode (the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is sensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, and 0155 of Kahn), a second working electrode (the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is insensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn), and at least one other electrode (the counter electrode of Kahn; paragraphs 0122-0123 of Kahn); a first active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to a polymer) located upon the first working electrode (the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles to which the polymer is covalently bounded), the first active portion comprising a polymer (the polymer) and a substance having pH-dependent oxidation-reduction chemistry (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the polymer (the polymer)(paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn); and a second active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to a polymer) located upon the second working electrode (the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles to which the polymer is covalently bounded), the second active portion comprising a polymer (the polymer) and a substance having oxidation-reduction chemistry that is substantially invariant with pH (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the polymer (the polymer) (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn).
Kahn teaches that the silicon electrode may be a thin coating of silicon deposited onto another material (paragraphs 0064 and 0068 of Kahn). Tsoukalis teaches that carbon is one such material (paragraphs 0024-0026, and claim 3 of Tsoukalis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use carbon as the another material for the silicon electrode since Kahn teaches another material may be used and Tsoukalis teaches one such material.
Kahn further teaches that the device is implantable in tissue (paragraphs 0114-0115 of Kahn). Further, Kahn teaches an arrangement of electrodes in which they lay side-by-side on the face of an insulating probe head (FIG. 3 of Kahn). Liu teaches that a layered arrangement of a substrate, electrodes, and insulating layers (FIGS. 5A-5B of Liu) is an alternative arrangement to a side-by-side arrangement on a base (FIG. 4 of Liu)(paragraphs 0071-0078 of Liu). Further, Liu teaches that any one of the electrodes, including the counter electrode 503 of Liu, may be provided on the opposing side of the substrate relative to the other two electrodes 501 and 502 (paragraph 0077 of Liu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a layered arrangement of the substrate, electrodes, and insulating layers of FIG. 5B of Liu modified such that the counter electrode is on an opposing side of the substrate relative the other two electrodes in place of the side-by-side arrangement of the electrodes of Kahn since it is a simple substitution of one known element for another to obtain predictable results, as explicitly disclosed in Liu.
Kahn further teaches that the device is implantable in tissue (paragraphs 0114-0115 of Kahn). Bainczyk teaches that the use of a membrane made of membrane layers ensures biocompatibility, protects the patient, and/or protects the components of the sensor (abstract, pages 3-4 and 8-9 of the English translation of Bainczyk; Fig. 6 of Bainczyk). Bainczyk teaches that the membrane may envelop the total layer structure of the sensor (pages 4, 8, and 11 of the English translation of Bainczyk). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to envelop the total layer structure of the combination with a membrane so as to ensure biocompatibility, protect the patient, and/or protect the components of the sensor.
Bainczyk teaches that the membrane may be at least partially permeable to the analyte or analytes that are to be detected (pages 4 and 8 of the English translation of Bainczyk). Curry teaches that flux limiting membranes are used to control diffusion of analytes and other analytes to the sensor (paragraph 0076 of Curry) as well as to prevent and/or reduce interfering endogenous or exogenous components (abstract, paragraphs 0004, 0008-0009, 0021, and 0096-0097 of Curry). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the membrane that envelops the total layer structure of the combination be a flux limiting membrane that controls diffusion of the analytes and other analytes to the sensor and/or to prevent and/or reduce interfering endogenous or exogenous components from reaching the electrodes so as to achieve more accurate readings over a longer period of time.
Kahn teaches that the redox-active moiety is covalently bound to a polymer that is immobilized onto the surface of the silicon substrate or that the redox-active moiety is covalently bound to a polymer that is covalently bound to the surface of the silicon substrate (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn). Mao teaches the use of osmium complexes covalently bonded to a polymer to act a redox mediators on an electrode (abstract, col. 1, lines 40-62, col. 2, lines 24-3, col. 2, line 30 to col. 3, line 35, col. 19, lines 1-30, and Example 2 of Mao). The electrooxidation or electroreduction of the enzyme is often facilitated by the presence of a redox mediator on the electrode (abstract, col. 1, lines 40-62, col. 2, lines 24-30 of Mao). The redox mediator assists in the electrical communication between the working electrode and the enzyme (abstract, col. 1, lines 40-62, col. 2, lines 24-30 of Mao). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the osmium complex of Mao covalently bonded to the polymer because it would act as a redox mediator that facilitates electrooxidation or electroreduction and/or assists in the electrical communication between the electrode and the enzyme.
With respect to claim 1, the combination teaches or suggests a pH sensor comprising:
a substrate (the substrate suggested by FIG. 5B of Liu) having a first opposing face and a second opposing face;
a first carbon working electrode (the first substrate surface formed from silicon-coated carbon material of the combination which forms the electrode that is sensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, 0136, and 0155 of Kahn);
a second carbon working electrode (the second substrate surface formed from silicon-coated carbon material which forms the electrode that is insensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, 0136, and 0155 of Kahn); and
at least one other electrode (the counter electrode of Kahn; paragraphs 0122-0123 of Kahn);
a first active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to the polymer) disposed on a distal end of the first carbon working electrode (the first active portion being on the distal end of the first substrate surface to which the polymer is covalently bounded, as suggested by FIG. 5 of Liu), the first active portion comprising a first polymer (the polymer) and a substance having pH-dependent oxidation-reduction chemistry (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the first polymer (the polymer)(paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn);
a second active portion (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH covalently bounded to a polymer) disposed on a distal end of the second carbon working electrode (the second active portion being on the distal end of the second substrate surface to which the polymer is covalently bounded, as suggested by FIG. 5B of Liu), the second active portion comprising a second polymer (the polymer) and a substance having oxidation-reduction chemistry that is substantially invariant with pH (at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive to the presence and/or amount of an analyte of interest including pH) covalently bound to the second polymer (the polymer)(paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn), wherein the substance having oxidation-reduction chemistry that is substantially invariant with pH covalently bound to the second polymer has a structure of Formula 2:
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(the use of osmium complex of Mao);
a first dielectric layer (the insulative layer suggested by FIG. 5B of Liu) disposed over the first carbon working electrode other than the distal end of the first carbon working electrode exposing the first active portion (see the arrangement in FIG. 5B of Liu);
a second dielectric layer (the insulative layer suggested by FIG. 5B of Liu) disposed over the second carbon working electrode other than the distal end of the second carbon working electrode exposing the second active portion (see the arrangement in FIG. 5B of Liu); and
a proton-permeable membrane (the membrane suggested by Bainczyk with the flux limiting properties suggested by Curry) disposed over the first and second active portions (the membrane enveloping the layered structure suggested by Bainczyk),
wherein the first and second carbon working electrodes are disposed on the first opposing face and the at least one other electrode is disposed on the second opposing face (the counter electrode is on an opposing side of the substrate relative the other two electrodes as suggested by paragraph 0077 of Liu),
wherein the first carbon working electrode is configured to produce a first signal and the second carbon working electrode is configured to produce a second signal, and a difference between the first signal and the second signal correlates to pH (paragraphs 0024, 0123, 0126, 0161-0163, and 0166 of Kahn); and
wherein the sensor is configured to be partially inserted into a tissue to detect pH in vivo (the implantation of the sensor and the application to tissue; paragraphs 0114-0115, 0185, 0187-0188, 0206, and 0208-0210 of Kahn).
With respect to claim 3, the combination teaches or suggests that the substance having pH- dependent oxidation-reduction chemistry comprises a quinone, a redox indicator compound, or any combination thereof (quinone; paragraphs 0011, 0080, and 0091 and claim 28 of Kahn).
With respect to claim 27, the combination teaches or suggests that the substance having the oxidation-reduction chemistry that is substantially invariant with pH exhibits a response variability that fluctuates by precisely 10 mV or less over a pH range of precisely 5 to precisely 8 (the at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is insensitive (as opposed to just being substantially insensitive) to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn; this means there is a fluctuation of 0 mV over any pH range).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kahn, in view of Tsoukalis, and further in view of Liu, and further in view of Bainczyk, and further in view of Curry, and further in view of Mao, and Ismagilov.
Kahn teaches at least one redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of an analyte of interest including pH (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, and 0155 of Kahn). Such species include: quinones, anthroquinones, phenanthroquinones, phenylene diamines, catechols, phenothiazinium dyes4, monoquaternized N-alkyl-4,4’-bipyridinium, Prussian Blue, Ni(OH)2, and RuOx (paragraph 0091 of Kahn). Ismagilov teaches that other pH dependent redox indicators include: sodium 2,6-Dibromophenol-indophenol, sodium o-Cresol indophenol, thionine, methylene blue,5 indigotetrasulfonic acid, indigotrisulfonic acid, indigo carmine, indigomono sulfonic acid, phenosafranin, safranin, neutral red (paragraph 00115 of Ismagilov). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use methylene blue as the redox-active species having a redox potential (reduction potential or oxidation potential) that is sensitive to the presence and/or amount of pH since it is a simple substitution of one known element for another to obtain predictable results and/or Kahn teaches that phenothiazinium dyes can be used and Ismagilov teaches one such dye.
With respect to claim 4, the combination teaches or suggest that the substance having pH- dependent oxidation-reduction chemistry comprises a redox indicator compound comprising a thiazine (the use of methylene blue of the combination).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kahn, in view of Tsoukalis, in view of Liu, and further in view of Bainczyk, and further in view of Curry, and further in view of Mao, and further in view of Ward.
Kahn teaches that the redox-active moiety is covalently bound to a polymer that is immobilized onto the surface of the silicon substrate or that the redox-active moiety is covalently bound to a polymer that is covalently bound to the surface of the silicon substrate (paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101, 0117-0119, 0123, 0126, and 0155 of Kahn). Ward teaches that polyvinylpyridine or polyvinylimidazole is a suitable polymer for holding electrode components (paragraph 0017 of Ward)6. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use polyvinylpyridine or polyvinylimidazole as the polymer of the combination since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 25, the combination teaches or suggest the first polymer comprises a polyvinyl pyridine, a polyimidazole, a copolymer of polyvinyl pyridine or polyimidazole, or any combination thereof (the polyvinylpyridine or polyvinylimidazole of the combination).
Response to Arguments
The Applicant’s arguments filed 8/10/2026 have been fully considered.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 8/10/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Prior art rejections
There are new grounds of claim rejections that were necessitated by the claim amendments filed on 8/10/2026.
The Applicant asserts:
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These arguments are not persuasive. Kahn teaches a pH sensor comprising:
a first working electrode (the first silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is sensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0031, 0057, 0083, 0101,0117-0119, 0123, 0126, and 0155 of Kahn), and
a second working electrode (the second silicon substrate surface formed from silicon particles dispersed in a binder containing carbon particles (paragraphs 0069-0071, 0083, and 0137 of Kahn) which forms the electrode that is insensitive to the presence and/or amount of an analyte of interest including pH; paragraphs 0006-0007, 0010, 0012, 0019, 0022, 0024, 0026, 0031, 0057, 0083, 0090, 0098, 0101-0102, 0117-0119, 0123, 0126, and 0155 of Kahn).
These electrodes are considered to be carbon working electrodes since they include a binder that is conductive and the conductive components are carbon particles (paragraph 0071 of Kahn).7 The use of carbon in the binder makes the carbon working electrodes. Alternatively, it can be said that the electrodes are silicone/carbon working electrodes, which still makes them carbon working electrodes. The claim language does not require a particular percentage or threshold of carbon for the working electrodes. The claim language does not require that the electroactive surface be carbon-based. 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).
Further, the Applicant’s statement that “Kahn’s silicon electrode cannot be considered a ‘carbon working electrode’ merely because carbon particles may be included in its composite material” is conclusory and not supported by evidence. Also, the fact that the carbon particles are distributed throughout the binder which is distributed throughout the electrode would support the interpretation that it is a carbon electrode due to the pervasiveness of the carbon throughout the electrode.
Further, the Applicant’s statement that the teachings of Kahn “point to a silicon working surface, not a carbon-based working surface” is not persuasive since claim language does not require a carbon-based working surface. 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). As previously mentioned, the fact that the carbon particles are distributed throughout the binder which is distributed throughout the electrode would support the interpretation that it is a carbon electrode due to the pervasiveness of the carbon throughout the electrode.
The argument that Liu, Bainczyk, Curry, and Mao fail to cure the deficiency of Kahn is not persuasive since Kahn does not have the deficiencies alleged by the Applicant.
For the above reasons, the rejection of claim 1 is proper.
The rejections of the dependent claims are proper since the rejection of claim 1 is proper and the prior art teaches or suggests all the features of the dependent claims.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Note that methylene blue is a phenothiazinium dye (see the previously cited article “Exploring the interaction of phenothiazinium dyes methylene blue, new methylene blue, azure A and azure B with tRNAPhe: spectroscopic, thermodynamic, voltammetric and molecular modeling approach”).
2 Note that methylene blue is also considered a thiazine dye (see the previously cited Merriam Webster Dictionary Definition).
3 Claim 21 of U.S. Patent Application Publication No. 2011/0021895 (Heller)(previously cited) teaches this as well.
4 Note that methylene blue is a phenothiazinium dye (see the previously cited article “Exploring the interaction of phenothiazinium dyes methylene blue, new methylene blue, azure A and azure B with tRNAPhe: spectroscopic, thermodynamic, voltammetric and molecular modeling approach”).
5 Note that methylene blue is also considered a thiazine dye (see the previously cited Merriam Webster Dictionary Definition).
6 Claim 21 of U.S. Patent Application Publication No. 2011/0021895 (Heller)(previously cited) teaches this as well.
7 “The binder can be insulating, semiconductive, or conductive. In one embodiment, the binder is a material, such as a polymer, which is an insulating material. Where an insulating binder is used, the current will tend to only flow through the dispersed silicon powder. In some embodiments, the binder includes conductive components. In some embodiments, the binder comprises a conductive polymer such as polyanaline, polyacetylene, poly(alkylthiophene), poly(alkylpyrrole) and the like. In some embodiments, the conductive component can comprise conductive particles such as metal particles, such as nickel particles other conductive particles including carbon particles.”
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