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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on April 18, 2024 are accepted.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15 and 22-24, drawn to an analyte sensor, classified in A61B5/14865.
II. Claims 16-19, drawn to a method of inhibiting microorganism growth in an area in and around an insertion site comprising inserting an analyte sensor, classified in A61B5/14865.
III. Claims 20-21, drawn to a method of preparing an analyte sensor overcoated with a membrane, classified in A61B 2562/125.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process can be used to make an entirely different product and the product could be made by an entirely different process.
Inventions I and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the process can be used to make an entirely different product and the product could be made by an entirely different process.
Inventions II and III are directed to related processes . The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are not obvious variants. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The groups differ in claim scope significantly and require different areas of searching and different search strategies.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Attorney Stephanie L. Elmer on February 12, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15 and 22-24. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mccanless et al. (US 2021/0236028 A1) (“Mccanless”) in view of Hatakeyama et al. (US 2017/0323698 A1) (“Hatakeyama”).
Regarding claim 1, Mccanless discloses An analyte sensor comprising (Abstract and entire document):
a sensor tail substrate having a lower portion and configured for insertion into a tissue (FIG. 2A, [0055], “FIG. 2A shows a diagram of an illustrative two-electrode analyte sensor configuration, which is compatible for use in some embodiments of the disclosure herein. As shown, analyte sensor tail 200”);
a first working electrode disposed on the lower portion of the sensor tail substrate (FIG. 2A, [0055], “As shown, analyte sensor tail 200 (showing the tip or lower portion thereof) comprises substrate 212 disposed between working electrode 214 and counter/reference electrode 216. Alternately, working electrode 214 and counter/reference electrode 216 may be located upon the same side of substrate 212 with a dielectric material interposed in between (configuration not shown).”);
a sensing layer disposed upon a surface of the first working electrode (FIG. 2A, [0055], “Sensing element 218 is disposed as at least one layer upon at least a portion of working electrode 214.”); and
a membrane disposed over at least the sensing layer (FIG. 2A, [0056], “Referring still to FIG. 2A, membrane 220 overcoats at least active area 218 and may optionally overcoat some or all of working electrode 214 and/or counter/reference electrode 216, according to some embodiments. One or both faces of analyte sensor tail 200 may be overcoated with membrane 220.”);
wherein the membrane comprises 20% to 50% by weight of a silver salt ([0090 -0093], “As one example, the counter or reference electrode (or combination thereof) may comprise silver/silver iodide (Ag/AgI) the Ag/AgI is reduced to form silver metal (Ag) and iodide ions (I.sup.−). As another example, the counter or reference electrode (or combination thereof) may comprise silver/silver chloride (Ag/AgCl) the Ag/AgCl is reduced to form silver metal (Ag) and chloride ions (Cl.sup.−). The silver metal and iodide ions provide an antimicrobial quality and, accordingly, the mere generation of the analyte sensor provides antimicrobial protection (alone or in combination with any other antimicrobial quality, such as those described herein)” and [0131 – 0133], “These metal-based antimicrobial compounds may be metal ion, a metal oxide, metal salts, metal coordination compounds including chelates, and the like. Specific examples of suitable metal-based antimicrobial compounds may include, but are not limited to, silver, sliver chloride, silver-silver chloride, silver iodide, silver carbonate, silver nitrate, copper, copper sulfate, cupric oxalate, silver oxalate….about 0.1% to about 50% by weight”)
Mccanless fails to explicitly disclose with a particle size of ≤ 60 µm.
However, in the same field of endeavor, Hatakeyama teaches with a particle size of ≤ 60 µm ([0088] – [0089], “The average particle size of the particles, the surface of which being coated with gold, platinum, silver, or alloy of these metals, is preferably 1 μm or more and 1,000 μm or less, more preferably 2 μm or more and 800 μm or less, and further preferably 3 μm or more and 600 μm or less. When the average particle size of the particles is 1 μm or more, it is not difficult to form the resin layer, which have to be formed with the thickness being equal to or thinner than an average particle size of the particles.” And further discussing variation and uniformity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the sensor as taught by Mccanless to include with a particle size of ≤ 60 µm as taught by Hatakeyama for desired properties such as weight ([0088], “When the average particle size of the particles is 1,000 μm or less, there is no risk of difficulty for holding the particles, which is caused by too large particles, or excessive increase of the weight of the bio-electrode.”).
Regarding claim 2, Mccanless as modified discloses The analyte sensor of claim 1, Mccanless as modified further discloses wherein the silver salt is uniformly distributed within the membrane (Hatakeyama [0088] – [0089], “The average particle size of the particles, the surface of which being coated with gold, platinum, silver, or alloy of these metals, is preferably 1 μm or more and 1,000 μm or less, more preferably 2 μm or more and 800 μm or less, and further preferably 3 μm or more and 600 μm or less. When the average particle size of the particles is 1 μm or more, it is not difficult to form the resin layer, which have to be formed with the thickness being equal to or thinner than an average particle size of the particles.” And further discussing variation and uniformity).
Regarding claim 3, Mccanless as modified discloses The analyte sensor of claim 1, wherein the silver salt is selected from the group consisting of silver chloride, silver-silver chloride, silver iodide, and combinations thereof (Mccanless [0130] “silver iodide”).
Regarding claim 4, Mccanless as modified discloses The analyte sensor of claim 1, wherein the silver salt is silver iodide (Mccanless [0130] “silver iodide”).
Regarding claim 5, Mccanless as modified discloses The analyte sensor of claim 4, Mccanless as modified further discloses wherein the silver iodide has a particle size of ≤ 53 µm (Hatakeyama [0088] – [0089], “The average particle size of the particles, the surface of which being coated with gold, platinum, silver, or alloy of these metals, is preferably 1 μm or more and 1,000 μm or less, more preferably 2 μm or more and 800 μm or less, and further preferably 3 μm or more and 600 μm or less. When the average particle size of the particles is 1 μm or more, it is not difficult to form the resin layer, which have to be formed with the thickness being equal to or thinner than an average particle size of the particles.” And further discussing variation and uniformity).
Regarding claim 7, Mccanless as modified discloses The analyte sensor of claim 4, Mccanless as modified further discloses wherein the membrane comprises 30% to 40% by weight of silver iodide (Mccanless [0090 -0093], “As one example, the counter or reference electrode (or combination thereof) may comprise silver/silver iodide (Ag/AgI) the Ag/AgI is reduced to form silver metal (Ag) and iodide ions (I.sup.−). As another example, the counter or reference electrode (or combination thereof) may comprise silver/silver chloride (Ag/AgCl) the Ag/AgCl is reduced to form silver metal (Ag) and chloride ions (Cl.sup.−). The silver metal and iodide ions provide an antimicrobial quality and, accordingly, the mere generation of the analyte sensor provides antimicrobial protection (alone or in combination with any other antimicrobial quality, such as those described herein)” and [0131 – 0133], “These metal-based antimicrobial compounds may be metal ion, a metal oxide, metal salts, metal coordination compounds including chelates, and the like. Specific examples of suitable metal-based antimicrobial compounds may include, but are not limited to, silver, sliver chloride, silver-silver chloride, silver iodide, silver carbonate, silver nitrate, copper, copper sulfate, cupric oxalate, silver oxalate….about 0.1% to about 50% by weight”).
Regarding claim 8, Mccanless as modified discloses The analyte sensor of claim 4, Mccanless as modified further discloses wherein the membrane comprises 35% by weight of silver iodide (Mccanless [0090 -0093], “As one example, the counter or reference electrode (or combination thereof) may comprise silver/silver iodide (Ag/AgI) the Ag/AgI is reduced to form silver metal (Ag) and iodide ions (I.sup.−). As another example, the counter or reference electrode (or combination thereof) may comprise silver/silver chloride (Ag/AgCl) the Ag/AgCl is reduced to form silver metal (Ag) and chloride ions (Cl.sup.−). The silver metal and iodide ions provide an antimicrobial quality and, accordingly, the mere generation of the analyte sensor provides antimicrobial protection (alone or in combination with any other antimicrobial quality, such as those described herein)” and [0131 – 0133], “These metal-based antimicrobial compounds may be metal ion, a metal oxide, metal salts, metal coordination compounds including chelates, and the like. Specific examples of suitable metal-based antimicrobial compounds may include, but are not limited to, silver, sliver chloride, silver-silver chloride, silver iodide, silver carbonate, silver nitrate, copper, copper sulfate, cupric oxalate, silver oxalate….about 0.1% to about 50% by weight”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mccanless in view of Hatakeyama in further view of Thull (US 2011/0272276 A1) (“Thull”).
Regarding claim 6, Mccanless as modified discloses The analyte sensor of claim 4, Mccanless as modified fails to disclose wherein the silver iodide has a purity of at least 99%.
However, in the same field of endeavor, Thull teaches wherein the silver iodide has a purity of at least 99% (See at least claim 3, silver purity above 99%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the sensor as taught by Mccanless to include wherein the silver iodide has a purity of at least 99% as taught by Thull to increase the effect of the coating ([0011]).
Claims 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Mccanless in view of Hatakeyama in further view of Bommakanti et al. (US 2022/0002498 A1) (“Bommakanti”).
Regarding claims 9-15, Mccanless as modified discloses The analyte sensor of claim 1, Mccanless as modified fails to explicitly disclose the ISO protocols for cytotoxicity, etc. including: wherein the analyte sensor does not sensor does not induce cytotoxicity as measured according to ISO 10993-5. wherein the analyte sensor does not cause skin irritation or skin sensitization according to ISO 10993-10. wherein the analyte sensor does not cause intradermal irritation according to ISO 10993-10. wherein the analyte sensor does not cause systemic toxicity according to ISO 10993-11. wherein the analyte sensor is non-hemolytic according to ISO 10993-4 and ASTM F 756. wherein the analyte sensor does not cause intramuscular irritation according to ISO 10993-6. wherein the analyte sensor is not a potential mutagen according to ISO 10993-3 and OECD 471.
However, in the same field of endeavor, Bommakanti teaches the ISO 10993 protocols, the ASTM and OECD as well ([0022], [0060], [0081], [0100 – 0102], biocompatibility, cytotoxicity, iso 10993 protocols including the requirement for 10993-5, -4, -10, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the sensor as taught by Mccanless to include the ISO 10993 protocols, the ASTM and OECD as taught by Bommakanti for biocompatibility ([0022], [0060], [0081], [0100 – 0102], biocompatibility, cytotoxicity, iso 10993 protocols).
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mccanless in view of Bommakanti.
Regarding claim 22, Mccanless discloses An analyte sensor comprising (Abstract and entire document):
a sensor tail substrate having a lower portion and configured for insertion into a tissue (FIG. 2A, [0055], “FIG. 2A shows a diagram of an illustrative two-electrode analyte sensor configuration, which is compatible for use in some embodiments of the disclosure herein. As shown, analyte sensor tail 200”);
a first working electrode disposed on the lower portion of the sensor tail substrate (FIG. 2A, [0055], “As shown, analyte sensor tail 200 (showing the tip or lower portion thereof) comprises substrate 212 disposed between working electrode 214 and counter/reference electrode 216. Alternately, working electrode 214 and counter/reference electrode 216 may be located upon the same side of substrate 212 with a dielectric material interposed in between (configuration not shown).”);
a sensing layer disposed upon a surface of the first working electrode (FIG. 2A, [0055], “Sensing element 218 is disposed as at least one layer upon at least a portion of working electrode 214.”);
a membrane disposed over at least the sensing layer (FIG. 2A, [0056], “Referring still to FIG. 2A, membrane 220 overcoats at least active area 218 and may optionally overcoat some or all of working electrode 214 and/or counter/reference electrode 216, according to some embodiments. One or both faces of analyte sensor tail 200 may be overcoated with membrane 220.”); and
a non-electrochemical functional layer comprising a silver salt ([0090 -0093], “As one example, the counter or reference electrode (or combination thereof) may comprise silver/silver iodide (Ag/AgI) the Ag/AgI is reduced to form silver metal (Ag) and iodide ions (I.sup.−). As another example, the counter or reference electrode (or combination thereof) may comprise silver/silver chloride (Ag/AgCl) the Ag/AgCl is reduced to form silver metal (Ag) and chloride ions (Cl.sup.−). The silver metal and iodide ions provide an antimicrobial quality and, accordingly, the mere generation of the analyte sensor provides antimicrobial protection (alone or in combination with any other antimicrobial quality, such as those described herein)” and [0131 – 0133], “These metal-based antimicrobial compounds may be metal ion, a metal oxide, metal salts, metal coordination compounds including chelates, and the like. Specific examples of suitable metal-based antimicrobial compounds may include, but are not limited to, silver, sliver chloride, silver-silver chloride, silver iodide, silver carbonate, silver nitrate, copper, copper sulfate, cupric oxalate, silver oxalate….about 0.1% to about 50% by weight”);
Mccanless fails to explicitly disclose wherein the analyte sensor does not induce cytotoxicity as measured according to ISO 10993-5.
However, in the same field of endeavor, Bommakanti teaches wherein the analyte sensor does not induce cytotoxicity as measured according to ISO 10993-5 ([0022], [0060], [0081], [0100 – 0102], biocompatibility, cytotoxicity, iso 10993 protocols including the requirement for 10993-5, -4, -10, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the sensor as taught by Mccanless to include as taught by Bommakanti for biocompatibility ([0022], [0060], [0081], [0100 – 0102], biocompatibility, cytotoxicity, iso 10993 protocols).
Regarding claim 24, Mccanless as modified discloses The analyte sensor of claim 22, Mccanless as modified further discloses wherein the silver salt is silver-silver chloride (Mccanless [0130], “silver-silver chloride”).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Mccanless in view of Bommakanti in further view of Hatakeyama in further view of Thull.
Regarding claim 23, Mccanless as modified discloses The analyte sensor of claim 22, Mccanless as modified further discloses wherein the silver salt is silver iodide (Mccanless [0130] “silver iodide”)
Mccanless fails to explicitly disclose with a particle size of ≤ 60 µm.
However, in the same field of endeavor, Hatakeyama teaches with a particle size of ≤ 60 µm ([0088] – [0089], “The average particle size of the particles, the surface of which being coated with gold, platinum, silver, or alloy of these metals, is preferably 1 μm or more and 1,000 μm or less, more preferably 2 μm or more and 800 μm or less, and further preferably 3 μm or more and 600 μm or less. When the average particle size of the particles is 1 μm or more, it is not difficult to form the resin layer, which have to be formed with the thickness being equal to or thinner than an average particle size of the particles.” And further discussing variation and uniformity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the sensor as taught by Mccanless to include with a particle size of ≤ 60 µm as taught by Hatakeyama for desired properties such as weight ([0088], “When the average particle size of the particles is 1,000 μm or less, there is no risk of difficulty for holding the particles, which is caused by too large particles, or excessive increase of the weight of the bio-electrode.”).
Mccanless as modified fails to disclose wherein the silver iodide has a purity of at least 99%.
However, in the same field of endeavor, Thull teaches wherein the silver iodide has a purity of at least 99% (See at least claim 3, silver purity above 99%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the sensor as taught by Mccanless to include wherein the silver iodide has a purity of at least 99% as taught by Thull to increase the effect of the coating ([0011]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791