DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6-11, 15-16, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suri et al. (US Publication No. 2017/0273610 A1).
Regarding claim 1, Suri et al. discloses an analyte monitoring assembly for monitoring one or more analytes in a bodily fluid of a user, the analyte monitoring assembly comprising:
a housing (350) configured to be mounted on a body of a user (see [0085] – “Referring now to FIGS. 3A and 3B, an electrochemical sensing system 300 includes a penetration member 302, an electrical circuit 340 a communications module 342, and a housing 350. The electrochemical sensing system 300 can be configured to be associated with a target, for example, the skin of the user, such that the electrochemical sensing system 300 is wearable”);
sensor electronics (340, 342) arranged within the housing (see [0085] – “Referring now to FIGS. 3A and 3B, an electrochemical sensing system 300 includes a penetration member 302, an electrical circuit 340 a communications module 342, and a housing 350. The electrochemical sensing system 300 can be configured to be associated with a target, for example, the skin of the user, such that the electrochemical sensing system 300 is wearable”); and
an analyte sensor, comprising:
a body portion coupled to the sensor electronics and arranged within the housing (see Figures 3A-B, 7A-B, and 9A-10B),
one or more tail portions (210, 230, 302, 302a, 302b, 602, 702) configured to be positioned in the body of the user (see Figures 2A-3B and 7A-10B and [0086] – “A distal end of the penetration member 302 can forms a sharp tip 303, such that the penetration member 302 can resemble a needle (e.g., a 30 gage needle). This can enable the penetration member 302 to easily pierce into the skin of a user”),
a first electrode comprising a first active area for detecting a first analyte (see [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte” and [0095] – “In some embodiments, the first working electrode 610a and the second working electrode 610 can include different sensing chemistries, for example, to sense different target analytes or to reduce noise, as described herein”), and
a second electrode comprising a second active area for detecting a second analyte (see [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte” and [0095] – “In some embodiments, the first working electrode 610a and the second working electrode 610 can include different sensing chemistries, for example, to sense different target analytes or to reduce noise, as described herein”).
Regarding claim 6, Suri et al. discloses the first active area comprises one or more spots of a reagent composition (see [0046] – “In some embodiments, a biosensing molecule (not shown) can optionally be disposed on the working electrode 110. In such embodiments, the target analyte can be a biomolecule which is non-electroactive. Such target analytes can include, for example, glucose, sucrose, glutamate, lactate, cholesterol, alcohol, aspartate transaminase, alkaline transaminase, alkaline phosphatase, urea, ascorbate, pyruvate, L-arginine, creatine, choline, or any other biomolecule. The biosensing molecule can be configured to catalytically decompose the non-electroactive target analyte and yield an electroactive by-product. The electroactive by-product can thereby, be oxidized or reduced at the working electrode 110 to yield a current which corresponds to the concentration of the target analyte. In some embodiments, the biosensing molecule can be an enzyme such as, for example, glucose oxidase, glutamate oxidase, lactate oxidase, lactate dehydrogenase, cholesterol oxidase, ascorbate oxidase, pyruvate oxidase, myokinase, arginase, choline oxidase, creatine phosphokinase, phosphatase, any other suitable enzyme or combination thereof”).
Regarding claim 7, Suri et al. discloses the one or more tail portions comprises a first tail portion (302a) comprising the first electrode and the first active area and a second tail portion (302b) comprising the second electrode and the second active area (see Figures 7A-B and [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”).
Regarding claim 8, Suri et al. discloses the first tail portion comprises a single electrode (see Figures 7A-B and [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”).
Regarding claim 9, Suri et al. discloses a tail portion of the one or more tail portions of the analyte sensor comprises a tubular configuration (see [0086] – “As shown in FIGS. 4A and 4B, the penetration member 302 includes a cylindrical member 302 that defines a lumen 305” and [0094] – “The penetration member 602 can be a substantially cylindrical member that defines a lumen 605”).
Regarding claim 10, Suri et al. discloses the tail portion having the tubular configuration comprises the first electrode, the first active area, the second electrode, and the second active area (see [0094] – “A first working electrode 610a can be disposed on an outer surface of the penetration member 602 and a second working electrode 610b can be disposed on an inner surface of the penetration member 602”).
Regarding claim 11, Suri et al. discloses an analyte monitoring assembly for monitoring one or more analytes in a bodily fluid of a user, the analyte monitoring assembly comprising:
a housing (350) configured to be mounted on a body of the user (see [0085] – “Referring now to FIGS. 3A and 3B, an electrochemical sensing system 300 includes a penetration member 302, an electrical circuit 340 a communications module 342, and a housing 350. The electrochemical sensing system 300 can be configured to be associated with a target, for example, the skin of the user, such that the electrochemical sensing system 300 is wearable”);
sensor electronics (340, 342) arranged within the housing (see [0085] – “Referring now to FIGS. 3A and 3B, an electrochemical sensing system 300 includes a penetration member 302, an electrical circuit 340 a communications module 342, and a housing 350. The electrochemical sensing system 300 can be configured to be associated with a target, for example, the skin of the user, such that the electrochemical sensing system 300 is wearable”); and
an analyte sensor comprising a body portion coupled to the sensor electronics and arranged within the housing (see Figures 3A-B, 7A-B, and 9A-10B), and a plurality of tail portions (302a, 302b) extending from the body portion, wherein each of the plurality of tail portions is configured to extend out of the housing and into the body of the user to detect the one or more analytes in the bodily fluid of the user (see Figures 7A-B and [0092] – “Referring now to FIGS. 7A and 7B, in some embodiments, the electrochemical sensing system 300 can include a first penetration member 302a and a second penetration member 302b which can be substantially similar to each other. Each of the first penetration member 302a and the second penetration member 302b can be substantially similar to any of the penetration member 302, 402 or 502 described herein, and are therefore not described in further detail herein”),
wherein a first tail portion (302a) of the plurality of tail portions comprises a first active area for detecting signals indicative of a first analyte in the bodily fluid (see [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”), and
wherein a second tail portion (302b) of the plurality of tail portions comprises a second active area for detecting signals indicative of a second analyte in the bodily fluid (see [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”).
Regarding claim 15, Suri et al. discloses the first active area comprises one or more spots of a reagent composition (see [0046] – “In some embodiments, a biosensing molecule (not shown) can optionally be disposed on the working electrode 110. In such embodiments, the target analyte can be a biomolecule which is non-electroactive. Such target analytes can include, for example, glucose, sucrose, glutamate, lactate, cholesterol, alcohol, aspartate transaminase, alkaline transaminase, alkaline phosphatase, urea, ascorbate, pyruvate, L-arginine, creatine, choline, or any other biomolecule. The biosensing molecule can be configured to catalytically decompose the non-electroactive target analyte and yield an electroactive by-product. The electroactive by-product can thereby, be oxidized or reduced at the working electrode 110 to yield a current which corresponds to the concentration of the target analyte. In some embodiments, the biosensing molecule can be an enzyme such as, for example, glucose oxidase, glutamate oxidase, lactate oxidase, lactate dehydrogenase, cholesterol oxidase, ascorbate oxidase, pyruvate oxidase, myokinase, arginase, choline oxidase, creatine phosphokinase, phosphatase, any other suitable enzyme or combination thereof”).
Regarding claim 16, Suri et al. discloses an analyte monitoring assembly for monitoring multiple analytes in a bodily fluid of a user, the analyte monitoring assembly comprising:
a housing (350) configured to be worn on a body of a user (see [0085] – “Referring now to FIGS. 3A and 3B, an electrochemical sensing system 300 includes a penetration member 302, an electrical circuit 340 a communications module 342, and a housing 350. The electrochemical sensing system 300 can be configured to be associated with a target, for example, the skin of the user, such that the electrochemical sensing system 300 is wearable”);
sensor electronics (340, 342) arranged within the housing (see [0085] – “Referring now to FIGS. 3A and 3B, an electrochemical sensing system 300 includes a penetration member 302, an electrical circuit 340 a communications module 342, and a housing 350. The electrochemical sensing system 300 can be configured to be associated with a target, for example, the skin of the user, such that the electrochemical sensing system 300 is wearable”);
an analyte sensor, comprising:
a substrate layer comprising a body portion configured to be arranged above a skin surface of the user (see Figures 3A-B, 7A-B, and 9A-10B), and a tail portion (302a, 302b) configured to be arranged below the skin surface and in contact with the bodily fluid of the user for sensing analytes in the bodily fluid (see Figures 7A-B and [0092] – “Referring now to FIGS. 7A and 7B, in some embodiments, the electrochemical sensing system 300 can include a first penetration member 302a and a second penetration member 302b which can be substantially similar to each other. Each of the first penetration member 302a and the second penetration member 302b can be substantially similar to any of the penetration member 302, 402 or 502 described herein, and are therefore not described in further detail herein”), wherein the tail portion comprises a tubular configuration (see [0086] – “As shown in FIGS. 4A and 4B, the penetration member 302 includes a cylindrical member 302 that defines a lumen 305”);
a first electrode (302a) disposed on an exterior surface of the tail portion of the substrate layer (see [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”);
a first active area disposed on the first electrode for detecting a first analyte (see [0046] – “In some embodiments, a biosensing molecule (not shown) can optionally be disposed on the working electrode 110. In such embodiments, the target analyte can be a biomolecule which is non-electroactive. Such target analytes can include, for example, glucose, sucrose, glutamate, lactate, cholesterol, alcohol, aspartate transaminase, alkaline transaminase, alkaline phosphatase, urea, ascorbate, pyruvate, L-arginine, creatine, choline, or any other biomolecule. The biosensing molecule can be configured to catalytically decompose the non-electroactive target analyte and yield an electroactive by-product. The electroactive by-product can thereby, be oxidized or reduced at the working electrode 110 to yield a current which corresponds to the concentration of the target analyte. In some embodiments, the biosensing molecule can be an enzyme such as, for example, glucose oxidase, glutamate oxidase, lactate oxidase, lactate dehydrogenase, cholesterol oxidase, ascorbate oxidase, pyruvate oxidase, myokinase, arginase, choline oxidase, creatine phosphokinase, phosphatase, any other suitable enzyme or combination thereof” and [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”);
a second electrode (302b) disposed on the exterior surface of the tail portion of the substrate layer (see [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”); and
a second active area disposed on the second electrode for detecting a second analyte, wherein the second analyte is different from the first analyte (see [0046] – “In some embodiments, a biosensing molecule (not shown) can optionally be disposed on the working electrode 110. In such embodiments, the target analyte can be a biomolecule which is non-electroactive. Such target analytes can include, for example, glucose, sucrose, glutamate, lactate, cholesterol, alcohol, aspartate transaminase, alkaline transaminase, alkaline phosphatase, urea, ascorbate, pyruvate, L-arginine, creatine, choline, or any other biomolecule. The biosensing molecule can be configured to catalytically decompose the non-electroactive target analyte and yield an electroactive by-product. The electroactive by-product can thereby, be oxidized or reduced at the working electrode 110 to yield a current which corresponds to the concentration of the target analyte. In some embodiments, the biosensing molecule can be an enzyme such as, for example, glucose oxidase, glutamate oxidase, lactate oxidase, lactate dehydrogenase, cholesterol oxidase, ascorbate oxidase, pyruvate oxidase, myokinase, arginase, choline oxidase, creatine phosphokinase, phosphatase, any other suitable enzyme or combination thereof” and [0092] – “In some embodiments, the working electrode included in the first penetration member 302a can be configured to sense a first target analyte, and the working electrode included in the second penetration member 302b can be configured to sense a second target analyte different from the first target analyte”).
Regarding claim 20, Suri et al. discloses the first active area comprises one or more spots of a reagent composition (see [0046] – “In some embodiments, a biosensing molecule (not shown) can optionally be disposed on the working electrode 110. In such embodiments, the target analyte can be a biomolecule which is non-electroactive. Such target analytes can include, for example, glucose, sucrose, glutamate, lactate, cholesterol, alcohol, aspartate transaminase, alkaline transaminase, alkaline phosphatase, urea, ascorbate, pyruvate, L-arginine, creatine, choline, or any other biomolecule. The biosensing molecule can be configured to catalytically decompose the non-electroactive target analyte and yield an electroactive by-product. The electroactive by-product can thereby, be oxidized or reduced at the working electrode 110 to yield a current which corresponds to the concentration of the target analyte. In some embodiments, the biosensing molecule can be an enzyme such as, for example, glucose oxidase, glutamate oxidase, lactate oxidase, lactate dehydrogenase, cholesterol oxidase, ascorbate oxidase, pyruvate oxidase, myokinase, arginase, choline oxidase, creatine phosphokinase, phosphatase, any other suitable enzyme or combination thereof”).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-5, 12-14, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suri et al., further in view of Hoss et al. (US Publication No. 2010/0230285 A1).
Regarding claim 2, it is noted Suri et al. does not specifically teach the first electrode is connected to a first electrical contact on the body portion and the second electrode is connected to a second electrical contact on the body portion. However, Hoss et al. teaches the first electrode (121a) is connected to a first electrical contact (123a) on the body portion (110) and the second electrode (121b) is connected to a second electrical contact (123b) on the body portion (see Figure 1 and [0069] – “The conductive material may include one or more electrodes 121a, 121b, 121c, conductive traces 122a, 122b, 122c and contacts 123a, 123b, 123c. In one embodiment, one or more electrodes 121a, 121b, 121c are disposed near the distal end 126 of distal section 120 of the sensor 100. In this manner, the one or more electrodes 121a, 121b, 121c are implanted in the tissue of a user in fluid contact with an interstitial fluid, for example, to detect and measure the analyte of interest in the bodily fluid. The signals generated by the analyte sensor are communicated via the conductive traces 122a, 122b, 122c and eventually to transmitting circuitry, described below”). 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 analyte monitoring assembly of Suri et al. to include the first electrode is connected to a first electrical contact on the body portion and the second electrode is connected to a second electrical contact on the body portion, as disclosed in Hoss et al. so as to communicate signals generated by the analyte sensor to transmitting circuitry (see Hoss et al.: [0069]).
Regarding claim 3, it is noted Suri et al. does not specifically teach each of the one or more tail portions comprises a longitudinal axis extending from a proximal end of the tail portion to a distal end opposite the proximal end, wherein the first electrode comprises a first side opposite a second side in a direction traverse to the longitudinal axis, wherein a width of the first electrode measured from the first side to the second side is in a range of 150 microns to 250 microns. However, Hoss et al. teaches each of the one or more tail portions comprises a longitudinal axis extending from a proximal end of the tail portion to a distal end opposite the proximal end, wherein the first electrode comprises a first side opposite a second side in a direction traverse to the longitudinal axis, wherein a width of the first electrode measured from the first side to the second side is in a range of 150 microns to 250 microns (see Figure 7A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”). 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 analyte monitoring assembly of Suri et al. to include each of the one or more tail portions comprises a longitudinal axis extending from a proximal end of the tail portion to a distal end opposite the proximal end, wherein the first electrode comprises a first side opposite a second side in a direction traverse to the longitudinal axis, wherein a width of the first electrode measured from the first side to the second side is in a range of 150 microns to 250 microns, as disclosed in Hoss et al. so as to provide an electrode having a width appropriate or suitable for transcutaneous positioning through a skin surface of a user (see Hoss et al.: [0068]).
Regarding claim 4, Hoss et al. teaches a ratio of the width of the first electrode to a width of the first active area is in a range of 1:1 to 1.7:1 (see Figures 5A, 6A, 7A, 8A, 9A, and 10A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”).
Regarding claim 5, Hoss et al. teaches the width of the first electrode is substantially the same as a width of the first active area (see Figures 7A, 9A, and 10A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”).
Regarding claim 12, it is noted Suri et al. does not specifically teach the first tail portion comprises a longitudinal axis, a first side opposite a second side, and a first surface opposite a second surface, wherein a width of the first tail portion is measured from the first side to the opposing second side in a direction transverse to the longitudinal axis, and wherein the width is in a range of 150 µm to 250 µm. However, Hoss et al. teaches the first tail portion comprises a longitudinal axis, a first side opposite a second side, and a first surface opposite a second surface, wherein a width of the first tail portion is measured from the first side to the opposing second side in a direction transverse to the longitudinal axis, and wherein the width is in a range of 150 µm to 250 µm (see Figure 7A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”). 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 analyte monitoring assembly of Suri et al. to include the first tail portion comprises a longitudinal axis, a first side opposite a second side, and a first surface opposite a second surface, wherein a width of the first tail portion is measured from the first side to the opposing second side in a direction transverse to the longitudinal axis, and wherein the width is in a range of 150 µm to 250 µm, as disclosed in Hoss et al. so as to provide an electrode having a width appropriate or suitable for transcutaneous positioning through a skin surface of a user (see Hoss et al.: [0068]).
Regarding claim 13, Hoss et al. teaches a ratio of the width of the first tail portion to a width of the first active area is in a range of 1:1 to 1.7:1 (see Figures 5A, 6A, 7A, 8A, 9A, and 10A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”).
Regarding claim 14, Hoss et al. teaches the width of the first tail portion is the same as a width of the first active area (see Figures 7A, 9A, and 10A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”).
Regarding claim 17, it is noted Suri et al. does not specifically teach the tail portion comprises a longitudinal axis, wherein the first electrode comprises a first side opposite a second side, wherein a width of the first electrode is measured from the first side to the opposing second side in a direction transverse to the longitudinal axis, and wherein the width is in a range of 150 µm to 250 µm. However, Hoss et al. teaches the tail portion comprises a longitudinal axis, wherein the first electrode comprises a first side opposite a second side, wherein a width of the first electrode is measured from the first side to the opposing second side in a direction transverse to the longitudinal axis, and wherein the width is in a range of 150 µm to 250 µm (see Figure 7A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”). 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 analyte monitoring assembly of Suri et al. to include the tail portion comprises a longitudinal axis, wherein the first electrode comprises a first side opposite a second side, wherein a width of the first electrode is measured from the first side to the opposing second side in a direction transverse to the longitudinal axis, and wherein the width is in a range of 150 µm to 250 µm, and wherein the width is in a range of 150 µm to 250 µm, as disclosed in Hoss et al. so as to provide an electrode having a width appropriate or suitable for transcutaneous positioning through a skin surface of a user (see Hoss et al.: [0068]).
Regarding claim 18, Hoss et al. teaches a ratio of the width of the first electrode to a width of the first active area is in a range of 1:1 to 1.7:1 (see Figures 5A, 6A, 7A, 8A, 9A, and 10A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”).
Regarding claim 19, Hoss et al. teaches the width of the first electrode is substantially the same as a width of the first active area (see Figures 7A, 9A, and 10A and [0097] – “In one aspect, sensing layer 706 may have a defined width WS which is narrower than the width WC of working electrode 704 (as well as the width of the substrate 702), but may be substantially the same or wider than the working electrode and/or substrate. In certain embodiments, the width of the sensing layer WS may be in the range from about 0.05 mm to about 5 mm, e.g., from about 0.1 mm to about 3 mm, and the width of the conducting layer WC, i.e., the width of the substrate, is in the range from about 0.1 mm to about 1 mm, e.g., from about 0.2 mm to about 0.5 mm, with the resulting active area in the range from about 0.005 mm2 to about 5 mm2, e.g., from about 0.02 mm2 to about 1.5 mm2”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
Prosecution Insights