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 .
Response to Amendment
The Amendment filed May 20, 2026 has been entered. Claims 1-17 and 20-24 remain pending in the application. It is noted that applicant appears to type that claims 25-26 are pending, by mistake. There are no claims 25 and 26 submitted in the May 20, 2026 claim set.
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 1-15 and 22-24 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.
The term “about” in claim 1 is a relative term which renders the claim indefinite. The term “about” 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 unclear of the range defined by “about 10 µm to about 60 µm”. Claims 5 and 22 recite the same issues.
Dependent claims are rejected as depending on a rejected base claim.
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 Brewster et al. (US 2021/0085819 A1) (“Brewster”).
Regarding claim 1, Mccanless discloses An analyte sensor comprising (Abstract and entire document):
a 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 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 silver salt particles ([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 the silver salt particles have particle size of about 10 µm to about 60 µm, and (Mccanless discloses, [0093], “The membrane which may have an antimicrobial quality may for use in the embodiments of the present disclosure may similarly be a single layer or multiple areas or “spots,” without being bound by shape or size or composition.” However, fails to disclose the exact range claimed)
wherein the membrane permits outward diffusion of the silver salt particles.
However, in the same field of endeavor, Brewster teaches the silver salt particles have particle size of about 10 µm to about 60 µm ([0144], [0226], [0345], particle size of about 10 micron to about 25 micron and other ranges listed within the range), and
wherein the membrane permits outward diffusion of the silver salt particles ([0144] discussing release or outward diffusion).
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 silver salt particles have particle size of about 10 µm to about 60 µm, and wherein the membrane permits outward diffusion of the silver salt particles as taught by Brewster to improve safety profile and have more effective material ([0028]).
Further, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal particle size, including a particle size of about 10 µm to about 60 µm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the particle size of about 10 µm to about 60 µm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 2, Mccanless as modified discloses The analyte sensor of claim 1, Mccanless as modified further discloses wherein the silver salt particles are uniformly distributed within the membrane (Brewster, as shown in FIG. 1-5).
Regarding claim 3, Mccanless as modified discloses The analyte sensor of claim 1, Mccanless as modified further discloses wherein the silver salt particles comprise a silver salt 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, Mccanless as modified further discloses 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 about 10 µm to about 53 µm (Brewster [0144], [0226], [0345], particle size of about 10 micron to about 25 micron and other ranges listed within the range).
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 Brewster 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 as modified 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, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mccanless in view of Brewster 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 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 as modified 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).
Regarding claim 22, Mccanless discloses An analyte sensor comprising (Abstract and entire document):
a 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 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 silver salt particles ([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 the silver salt particles have particle size of about 10 µm to about 60 µm, and (Mccanless discloses, [0093], “The membrane which may have an antimicrobial quality may for use in the embodiments of the present disclosure may similarly be a single layer or multiple areas or “spots,” without being bound by shape or size or composition.” However, fails to disclose the exact range claimed)
wherein the membrane permits outward diffusion of the silver salt particles.
However, in the same field of endeavor, Brewster teaches the silver salt particles have particle size of about 10 µm to about 60 µm ([0144], [0226], [0345], particle size of about 10 micron to about 25 micron and other ranges listed within the range), and
the non-electrochemical functional layer permits outward diffusion of the silver salt particles ([0144] discussing release or outward diffusion).
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 silver salt particles have particle size of about 10 µm to about 60 µm, and the non-electrochemical functional layer permits outward diffusion of the silver salt particles as taught by Brewster to improve safety profile and have more effective material ([0028]).
Further, it would have been obvious to one of ordinary skill in the art, through routine optimization, to determine the optimal particle size, including a particle size of about 10 µm to about 60 µm. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Absent a teaching as to criticality that the particle size of about 10 µm to about 60 µm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Mccanless as modified 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 as modified 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 particles comprise 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 Brewster in further view of Bommakanti 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 particles comprise silver iodide (Mccanless [0130] “silver iodide”)
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 as modified 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]).
Response to Arguments
Applicant’s arguments with respect to claims 1-17 and 20-24 have been considered but are moot because the new ground of rejection does not solely rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 extension fee 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 date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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