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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant's submission filed on 6/3/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/3/2025 was filed on the same date as the filing date of the Request for Continued Examination. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner. However, Kahn reference was struck-through since this particular was already considered by the Examiner and its inclusion was redundant.
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 Objections
Claim 27 is objected to because of the following informalities:
in claim 27, line 1: “the” should be inserted before “oxidation-reduction”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-4, and 25-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “wherein a surface coverage of the second active portion is at least 8.3 x 10.8 mol/cm2” in line 13, but there is no written description support for such a surface coverage. There are no disclosures about surface coverage as a concept. Also, there are no disclosures regarding specific values of surface coverage for the second active portion . Further, there are no disclosures providing a range for surface coverage for the second active portion.1
Claims 3-4 and 25-27 are rejected by virtue of their dependence from claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-4, and 23-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein a surface coverage of the second active portion is at least 8.3 x 10.8 mol/cm2” in line 13, which renders the claim indefinite. Though the number “8.3 x 10.8 mol/cm2” is not preceded by any modifiers, such as “about” or “approximately”, the specification provides:
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The above-cited passage from the specification explicitly states that all numbers, including those in the claims, are approximations that may vary depending upon the desired properties sought. The limitation “8.3 x 10.8 mol/cm2”, therefore, implicitly uses the relative term “about” by operation of the above-cited passage from the specification. Thus, the term “8.3 x 10.8 mol/cm2” is defined as or interpreted to mean “about 8.3 x 10.8 mol/cm2”. Such an expression/interpretation is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what the metes and bounds of “8.3 x 10.8 mol/cm2” (which is implicitly defined/interpreted as “about 8.3 x 10.8 mol/cm2”) are supposed to be given the vagueness of the meaning of “about”. Indeed, the teaching of “the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the embodiments of the present invention” directly injects a vagueness into each number since the value of each number is depended upon “desired properties sought to be obtained by the embodiments of the present invention”, but how that translates into numerical values that one of ordinary skill in the art would understand to be within the scope of such numbers is not clear.
Claim 1 recites “wherein the sensor provides continuous pH monitoring in vivo” in line 30, but it is not clear if this pH monitoring, which is simply monitoring the concentration of hydrogen ions in an aqueous solution, means that “an analyte” of claim 1, line 19 is referring to hydrogen ions or some other chemical. This ambiguity renders claim 1 indefinite.
Claim 1 recites “wherein the sensor provides continuous pH monitoring in vivo” in line 30, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claims 3-4 and 23-27 are rejected by virtue of their dependence from claim 1.
Claim 26 recites “wherein the second polymer comprises a polyvinyl pyridine, a polyimidazole, a copolymer of polyvinyl pyridine or polyimidazole, or any combination thereof” in lines 1-3, but this recitation appears to contradict the recitation “wherein the second polymer has a structure of Formula 2” in claim 1, line 11. This contradiction renders claim 26 indefinite.
Allowable Subject Matter
Claims 1, 3-4,and 25-27 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112 set forth in this Office action.
The following is an examiner’s statement of reasons for allowance.
U.S. Patent Application Publication No. 2008/0302660 (Kahn)(previously cited) 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, 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, 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 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). U.S. Patent Application Publication No. 2009/0294307 (Liu)(previously cited) 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). ES 2326286 T3 (Bainczyk)(previously cited)2 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). WO 2010/051421 (Curry)(previously cited) 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). U.S. Patent No. 6,605,200 (Mao)(previously cited) 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 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 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 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 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 second polymer has a structure of Formula 2:
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(the use of osmium complex of Mao) and
a first dielectric layer (the insulative layer suggested by FIG. 5B of Liu) covering the first working electrode other than the distal end of the first 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) covering the second working electrode other than the distal end of the second working electrode exposing the second active portion (see the arrangement in FIG. 5B of Liu); and
a membrane (the membrane suggested by Bainczyk with the flux limiting properties suggested by Curry) overcoating the first opposing face and the second opposing face of the substrate (the membrane enveloping the layered structure suggested by Bainczyk),
wherein the membrane is capable of limiting flux of an analyte (the flux limiting properties suggested by Curry),
wherein the first working electrode, the second working electrode, or both, reside on the first opposing face or the second opposing face of the substrate relative to the at least one other electrode (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 working electrode is configured to produce a first signal and the second 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 at least partially inserted into a tissue (implantation of the sensor and the application to tissue; paragraphs 0114-0115, 0185, 0187-0188, 0206, and 0208-0210 of Kahn), and
wherein the sensor provides continuous pH monitoring in vivo (continuous operation; paragraphs 0237, 0242 of Kahn).
However, the combination does not teach or suggest that a surface coverage of the second active portion is at least 8.3 x 10.8 mol/cm2 along with the other features of claim 1.
Also, it is noted that, 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 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 if fluctuates by 0 mV over any pH range).
With respect to claim 4, 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 dyes3, monoquaternized N-alkyl-4,4’-bipyridinium, Prussian Blue, Ni(OH)2, and RuOx (paragraph 0091 of Kahn). WO 2017/079696 (Ismagilov)(previously cited) teaches that other pH dependent redox indicators include: sodium 2,6-Dibromophenol-indophenol, sodium o-Cresol indophenol, thionine, methylene blue,4 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. Thus, 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).
With respect to claims 25-26, 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). U.S. Patent Application Publication No. 2016/0354542 (Ward)(previously cited) teaches that polyvinylpyridine or polyvinylimidazole is a suitable polymer for holding electrode components (paragraph 0017 of Ward)5. 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. Thus, with respect to claim 25, the combination teaches or suggest that 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). Also, with respect to claim 26, the combination teaches or suggest that the second 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).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
The Applicant’s arguments filed 6/3/2025 have been fully considered.
Claim objections
There are new grounds of claim objections.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
There are new grounds of claim rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
The Applicant asserts that there is support for the limitation “wherein a surface coverage of the second active portion is at least 8.3 x 10.8 mol/cm2”.
First, the Applicant asserts that FIGS. 4-5 and paragraphs 0002, 0022, 0085, and 0086 support this limitation. This argument is not persuasive. None of these figures and passages refer to surface coverage as a concept. Also, none of these figures and passages disclose specific values of surface coverage for the second active portion . Further, none of these figures and passages disclose a range for surface coverage for the second active portion.
Second, the Applicant relies upon a formula disclosed in an article by Mancini that was published in 2024,6 which is years after the filing date of the current application in 2019. Citations to an article that did not exist at the time of filing does not show that the inventors had possession of the invention at the time of filing.7
Third, the formula from Mancini for determining surface coverage relies on (1) the charge passed during the oxidation wave, (2) the number of electrons transferred in the redox reaction, and (3) the area of the electrochemically active surface area.
As to (1) the charge passed during the oxidation wave, the Applicant relies upon page 5 of a second article by Eckermann8 and the statement that “the integration described in Eckermann can be performed for FIG. 5 using methods known to a person skilled in the art”. The Examiner cannot find where the charge passed during the oxidation wave is achieved by integration on page 5 of Eckermann. Also, FIG. 5 of the present application does not provide enough details regarding the data so that one could integrate this data to any meaningful extent. Further, reliance by the vague statement “using methods known to a person skilled in the art” regarding the integration of FIG. 5 does not lend credence that the Applicant has some particular method in mind for such an integration so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
As to (2) the number of electrons transferred in the redox reaction, the Applicant concludes that the number of electrons transferred in the redox reaction is 1. However, there is no support for how that number was obtained in the present specification. Neither Mancini nor Eckermann disclose this number for the arrangement disclosed in the present application or for the claimed arrangement.
As to (3) the area of the electrochemically active surface area, the Applicant relies upon the teaching of “3 sensing (active) layer spots, each having an approximate area of 0.1 mm2” in paragraph 0085 of the present application. However, given that the areas are each described as being “approximate”, it leads to a problem that the actual area could be very different from 0.3 mm2, depending upon how much variation there was during the making of each of the layer spots. This variation then permeates through the calculation (which itself is not described in the specification), which leads to the potential that the actual result of the calculation is not what the theoretical result would be when assuming exactly 0.3 mm2. This ambiguity of the result of the actual calculation then creates doubt in the mind of one skilled in the art that the inventor had possession of the claimed invention.
Fourth, the formulas from Manicini rely upon the materials used in Mancini and assumptions used in Mancini. For example, Manicini relies upon the use of the electrochemically active surface area (ECSA) “because the electrodes consist of high surface area AU NPs…depending on the electrodeposition conditions” and upon “[a]ssuming the Fc is close-packed with a diameter of 0.66 nm…”. It is not shown that these same conditions apply to the claimed invention and how one of ordinary skill in the art at the time of filing would have known that the same conditions, assumptions, and materials of Manicini apply to the claimed/disclosed invention.
Fifth, even with the formulas from Mancini and Eckermann, there is no support for the open-ended range from 8.3 x 10.8 mol/cm2 to infinity. Indeed, there is no disclosure that there is a range for surface coverage.
For these reasons, there is no support for the recitation “wherein a surface coverage of the second active portion is at least 8.3 x 10.8 mol/cm2” of claim 1.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art rejections
In view of the claim amendments filed on 6/3/2025, the prior art rejections art rejections are withdrawn.
Conclusion
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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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 The Applicant’s arguments in favor of written description support for this recitation are addressed in the Response to Arguments Section of this Office Action.
2 Citations to Bainczyk will refer to the English translation that accompanied the Office Action mailed on 7/12/2022
3 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”).
4 Note that methylene blue is also considered a thiazine dye (see the previously cited Merriam Webster Dictionary Definition).
5 Claim 21 of U.S. Patent Application Publication No. 2011/0021895 (Heller)(previously cited) teaches this as well.
6 Mancini, K.M. et al. “Photoelectrochemistry of Redox-Active Self-Assembled Monolayers Formed on n-Si/Au Nanoparticle Photoelectrodes,” Langmuir 40:17536-17546, American Chemical Society, U.S.A. (2924).
7 “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.” (MPEP 2163).
8 Eckermann, A.L. et al., “Electrochemistry of redox-active self-assembled monolayers,” Coord. Chem. Rev. 254(15-16): 1769-1802, Elsevier B.V., Netherlands (2910).
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