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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/12/2026 has been entered.
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 § 112
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 the first carbon working electrode, the second carbon 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” in lines 19-21, but it is not clear what “relative to the at least one other electrode” is meant to convey since the claim language does not describe that the first carbon working electrode, the second carbon working electrode, the first opposing face of the substrate, or the second opposing face of the substrate has a relative spatial frame of reference with the at least one other electrode. That is, the first and second carbon working electrodes and the first and second opposing faces are not described as having any spatial placement with respect to the at least one other electrode. This ambiguity renders claim 1 indefinite.
Claim 1 recites “wherein the sensor provides continuous pH monitoring in vivo” in line 26, 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 18 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 26, 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, lines 10-11. This contradiction renders claim 26 indefinite.
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), 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 second polymer has a structure of Formula 2:
PNG
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(the use of osmium complex of Mao);
a first dielectric layer (the insulative layer suggested by FIG. 5B of Liu) covering 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) covering 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 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 carbon working electrode, the second carbon 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 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 at least partially inserted into a tissue (the 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 (the continuous operation suggested by Kahn; paragraphs 0237, 0242 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).
Claims 25-26 are 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 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).
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).
Response to Arguments
The Applicant’s arguments filed 3/12/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 3/12/2026, the previous claim objections are withdrawn.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
In view of the claim amendments filed on 3/12/2026, the previous claim rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn.
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.
The Applicant did not address, by amendment or argument, the indefiniteness issues with respect to the recitation “wherein the sensor provides continuous pH monitoring in vivo” in claim 1, line 26. The Examiner cannot find a reason to withdraw the rejection.
The Applicant did not address, by amendment or argument, the indefiniteness issues with respect to the recitation “wherein the second polymer comprises a polyvinyl pyridine, a polyimidazole, a copolymer of polyvinyl pyridine or polyimidazole, or any combination thereof” in claim 26, lines 1-3. The Examiner cannot find a reason to withdraw the rejection.
Prior art rejections
There are new prior art rejections art rejections.
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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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.
Prosecution Insights