DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. According to the Amendment, filed 21 August 2023, the status of the claims is as follows:
Claims 1-20 are as originally filed.
Claim Objections
3. Claim 5 is objected to because of the following informalities:
In line 6, “less than are 500 µm” is a typographical error, and should be amended to “less than .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1-20 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 the limitation “the electrochemical sensor has flexibility that it is impossible to penetrate the skin alone without the needle”. It is not clear as to the scope of the phrase “impossible to penetrate the skin alone without the needle”, as the realm of impossibility is vague and indefinite without specifying all ways to meet this limitations.
Claims 2-20 are rejected due to their dependencies, either directly or indirectly, to base claim 1.
Claim Rejections - 35 USC § 102
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. 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.
8. Claims 1-14, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brister et al., U.S. Patent Application No. 2006/0020192 A1 (“Brister”).
As to Claim 1, Brister teaches the following:
A continuous analyte meter (see “The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.” in Abstract) comprising:
an electrochemical sensor (“sensor”) 32 including a distal portion (“distal portion”) 42 having a plurality of electrodes (“two or more electrodes”) 44, 46 reacting with an analyte in the body and a proximal portion (“proximal portion”) 40 having a plurality of sensor pads (“contacts”) 28 connected to the electrodes 44, 46 (see “Preferably, the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host`s skin, and a proximal portion 40, also referred to as an ex vivo portion, adapted to remain above the host`s skin after sensor insertion and to operably connect to the electronics unit 16 via contacts 28. Preferably, the sensor 32 includes two or more electrodes: a working electrode 44 and at least one additional electrode, which can function as a counter electrode and/or reference electrode, hereinafter referred to as the reference electrode 46. A membrane system is preferably deposited over the electrodes, such as described in more detail with reference to Figs. 5A to 5C, below.” in para. [0107]); and
a transmitter (“mounting unit”) 14 attached to the skin, the transmitter 14 including a main substrate (“electronics unit”) 16 on which at least one of a power supply unit (“battery”) 144, a communication unit (“RF module”) 148, and a control unit (“processing module”) 138 is formed, and a housing (“electronics”) 132 in which the main substrate 16 is accommodated (see “Figs. 12A to 12C are perspective and side views of a sensor system including the mounting unit 14 and electronics unit 16 attached thereto.” in para. [0211]; see “Fig. 13 is a block diagram that illustrates the electronics 132 associated with the sensor system 10 in one embodiment.” in para. [0226]; see “A processor module 138 includes the central control unit that controls the processing of the sensor electronics 132.” in para. [0228]; see “A battery 144 is operably connected to the sensor electronics 132 and provides the power for the sensor.” in para. [0232]; see “An RF module 148 is operably connected to the processor 138 and transmits the sensor data from the sensor to a receiver within a wireless transmission 150 via antenna 152.” in para. [0235]),
wherein the distal portion 42 of the electrochemical sensor 32 is disposed at an exposed portion of a needle (“needle subassembly”) 68 exposed along a longitudinal direction of the needle 68 (see “A needle subassembly 68 is provided that includes a needle carrier 70 and needle 72. The needle carrier 70 cooperates with the other applicator components and carries the needle 72 between its extended and retracted positions. The needle can be of any appropriate size that can encompass the sensor 32 and aid in its insertion into the host.” in para. [0178]),
the distal portion 42 of the electrochemical sensor 32 is inserted into the body after the skin is incised by the needle (see “Preferably, the sensor 32 includes a distal portion 42, also referred to as the in vivo portion, adapted to extend out of the mounting unit for insertion under the host`s skin, and a proximal portion 40, also referred to as an ex vivo portion, adapted to remain above the host`s skin after sensor insertion and to operably connect to the electronics unit 16 via contacts 28.” in para. [0107]; and see “In addition to the above-described advantages, the coaxial sensor design of the preferred embodiments enables the diameter of the connecting end of the sensor (proximal portion) to be substantially the same as that of the sensing end (distal portion) such that the needle is able to insert the sensor into the host and subsequently slide back over the sensor and release the sensor from the needle, without slots or other complex multi-component designs.” in para. [0124]),
the electrochemical sensor 32 has flexibility that it is impossible to penetrate the skin alone without the needle 68 (see “For example, the distal portion 42 of the sensor can benefit in general from greater flexibility as it encounters greater mechanical stresses caused by movement of the tissue within the patient and relative movement between the in vivo and ex vivo portions of the sensor. On the other hand, the proximal portion 40 of the sensor can benefit in general from a stiffer, more robust design to ensure structural integrity and/or reliable electrical connections. Additionally, in some embodiments wherein a needle is retracted over the proximal portion 40 of the device (see Figs. 6 to 8), a stiffer design can minimize crimping of the sensor and/or ease in retraction of the needle from the sensor. Thus, by designing greater flexibility into the in vivo (distal) portion 42, the flexibility is believed to compensate for patient movement, and noise associated therewith.” in para. [0127]), and
the electrochemical sensor 32 comprises a flexible base layer (“electroactive surface”, not labeled) (see “Fig. 5C is a cross-sectional view through the sensor on line C-C of Fig. 5B showing the exposed electroactive surface of the working electrode surrounded by the membrane system in one embodiment.” in para. [0129]), a conductive layer (“electrode domain”) 47 stacked on the base layer (see “The electrode domain 47 is provided to ensure that an electrochemical reaction occurs between the electroactive surfaces of the working electrode and the reference electrode, and thus the electrode domain 47 is preferably situated more proximal to the electroactive surfaces than the enzyme domain. Preferably, the electrode domain 47 includes a semipermeable coating that maintains a layer of water at the electrochemically reactive surfaces of the sensor, for example, a humectant in a binder material can be employed as an electrode domain; this allows for the full transport of ions in the aqueous environment. The electrode domain can also assist in stabilizing the operation of the sensor by overcoming electrode start-up and drifting problems caused by inadequate electrolyte. The material that forms the electrode domain can also protect against pH-mediated damage that can result from the formation of a large pH gradient due to the electrochemical activity of the electrodes.” in para. [0131], and an insulating layer (“interference domain”) 48 attached on the conductive layer 47 (see “In some embodiments, an optional interference domain 48 is provided, which generally includes a polymer domain that restricts the flow of one or more interferants. In some embodiments, the interference domain 48 functions as a molecular sieve that allows analytes and other substances that are to be measured by the electrodes to pass through, while preventing passage of other substances, including interferants such as ascorbate and urea (see U.S. Patent No 6,001,067 to Shults).” in para. [0136]).
As to Claim 2, Brister teaches the following:
wherein the electrochemical sensor 32 has a thickness equal to or less than 300 um (see “In some embodiments, the working electrode has a diameter of from about 0.001 inches or less to about 0.010 inches or more, preferably from about 0.002 inches to about 0.008 inches, and more preferably from about 0.004 inches to about 0.005 inches. The length of the window can be from about 0.1 mm (about 0.004 inches) or less to about 2 mm (about 0.078 inches) or more, and preferably from about 0.5 mm (about 0.02 inches) to about 0.75 mm (0.03 inches). In such embodiments, the exposed surface area of the working electrode is preferably from about 0.000013 in.sup.2 (0.0000839cm.sup.2) or less to about 0.0025 in.sup.2 (0.016129 cm.sup.2) or more (assuming a diameter of from about 0.001 inches to about 0.010 inches and a length of from about 0.004 inches to about 0.078 inches).” in para. [0119]).
As to Claim 3, Brister teaches the following:
wherein the base layer or the insulating layer 48 has a thickness equal to or less than 100 µm, and the conductive layer has a thickness equal to or less than 10 µm (see “In preferred embodiments, the interference domain 48 is deposited onto the electrode domain (or directly onto the electroactive surfaces when a distinct electrode domain is not included) for a domain thickness of from about 0.05 micron or less to about 20 microns or more, more preferably from about 0.05, 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 1, 1.5, 2, 2.5, 3, or 3.5 to about 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 19.5 microns, and more preferably from about 2, 2.5 or 3 microns to about 3.5, 4, 4.5, or 5 microns.” in para. [0138]).
As to Claim 4, Brister teaches the following:
wherein a plurality of leads (“wire”) respectively connecting the electrodes 44, 46 and the sensor pads to each other are formed by partially cutting the conductive layer 47 in vertical directions, like the electrodes 44, 46 and the sensor pads (see “In preferred embodiments, each electrode is formed from a fine wire with a diameter of from about 0.001 or less to about 0.010 inches or more, for example, and is formed from, e.g., a plated insulator, a plated wire, or bulk electrically conductive material. Although the illustrated electrode configuration and associated text describe one preferred method of forming a transcutaneous sensor, a variety of known transcutaneous sensor configurations can be employed with the transcutaneous analyte sensor system of the preferred embodiments, such as are described in U.S. Patent No. 6,695,860 to Ward et al., U.S. Patent No. 6,565,509 to Say et al., U.S. Patent No. 6,248,067 to Causey III, et al., and U.S. Patent No. 6,514,718 to Heller et al.” in para. [0111]).
As to Claim 5, Brister teaches the following:
wherein a plurality of leads (“surface area of electrodes”, not labeled) respectively connecting the electrodes and the sensor pads to each other are formed on the conductive layer (see para. [0119]),
the electrochemical sensor has a width equal to or less than 600 µm, and a length equal to or less than 3 cm (see para. [0119]),
the electrodes and the sensor pads have a width equal to or less than are 500 µm (see para. [0119]),
the leads have a width equal to or less than 150 µm (see para. [0119]), and
at least two electrodes and at least two leads are formed on one surface of the distal portion of the electrochemical sensor (see para. [0117] and [0119], and figs. 5B and 5C).
As to Claim 6, Brister teaches the following:
wherein the conductive layer 47 is formed by sputtering a metal on the base layer (see para. [0111]).
As to Claim 7, Brister teaches the following:
wherein the conductive layer 47 is formed by sputtering a metal over the entire exposed area of the base layer before edge boundaries of the electrodes 44, 46 and edge boundaries of the sensor pads are formed (see para. [0111]).
As to Claim 8, Brister teaches the following:
wherein the conductive layer 48 is formed by sputtering a metal over the entire exposed area of the base layer before edge boundaries of the electrodes 44, 46 and edge boundaries of the sensor pads are formed (see para. [0111]),
the edge boundaries of the electrodes 44, 46 and the edge boundaries of the sensor pads are formed after the conductive layer 48 is deposited (see para. [0111],
an insulating layer 48 is attached after the edge boundaries of the electrodes 44, 46 and the edge boundaries of the sensor pads are formed (see para. [0111], and
the conductive layer 47, the electrodes 44, 46, and the sensor pads all have the same thickness (see para. [0111]).
As to Claim 9, Brister teaches the following:
wherein the conductive layer 47 is formed by sputtering a metal over the entire exposed area of the base layer (see para. [0131] and [0134]),
the conductive layer 47 is partially cut along an edge of the electrochemical sensor after the conductive layer is deposited (see para. [0131]),
the insulating layer 48 is attached onto the base layer at the edge of the electrochemical sensor (see para. [0138]), and
the insulating layer 48 is attached onto the conductive layer 47 stacked on the base layer at a position inside the edge of the electrochemical sensor (see para. [0138]).
As to Claim 10, Brister teaches the following:
wherein the electrodes 44, 46 and the sensor pads are formed by a laser etching method in which the conductive layer is partially removed by irradiation of a laser beam onto the conductive layer 47 (see “In embodiments wherein an outer insulator is disposed, a portion of the coated assembly structure can be stripped or otherwise removed, for example, by hand, excimer lasing, chemical etching, laser ablation, grit-blasting (e.g., with sodium bicarbonate or other suitable grit), or the like, to expose the electroactive surfaces.” in para. [0116]).
As to Claim 11, Brister teaches the following:
wherein the insulating layer 48 is adhered onto the conductive layer 47 in a state in which portions of the insulating layer 48 corresponding to the electrodes and the sensor pads are removed so that the electrodes 44, 46 and the sensor pads are exposed to the outside (see “Alternatively, a portion of the electrode can be masked prior to depositing the insulator in order to maintain an exposed electroactive surface area.” in para. [0116]).
As to Claim 12, Brister teaches the following:
wherein a via hole (“hole”) 122 is formed by partially cutting a base layer, and the conductive layer is sputtered with the same metal material continuously seamlessly along a top surface of the base layer, a surface of the via hole, and a bottom surface of the base layer (see “Additionally, the sealant can be disposed within the additional void spaces, for example a hole 122 that extends through the sealing member 36.” in para. [0215]).
As to Claim 13, Brister teaches the following:
wherein a plurality of conductive islands (“sections”) 41 separated from each other are provided on the conductive layer 47 by laser etching for partially removing the conductive layer 47 with a laser beam irradiated onto the conductive layer 47, and each of the conductive islands forms a closed surface (see “In the embodiment illustrated in Fig. 5B, a radial window 43 is formed through the insulating material 45 to expose a circumferential electroactive surface of the working electrode. Additionally, sections 41 of electroactive surface of the reference electrode are exposed. For example, the 41 sections of electroactive surface can be masked during deposition of an outer insulating layer or etched after deposition of an outer insulating layer.” in para. [0117]).
As to Claim 14, Brister teaches the following:
wherein a trench is formed in the conductive layer 47 by laser etching for partially removing the conductive layer 47 with a laser beam irradiated onto the conductive layer 47, and the trench is etched into the conductive layer 47 (see para. [0116]-[0117]).
As to Claim 19, Brister teaches the following:
wherein a plurality of openings are formed through the insulating layer, the openings comprise a proximal opening exposing each of the sensor pads to the outside and a distal opening exposing each of the electrodes to the outside (see “In embodiments wherein an outer insulator is disposed, a portion of the coated assembly structure can be stripped or otherwise removed, for example, by hand, excimer lasing, chemical etching, laser ablation, grit-blasting (e.g., with sodium bicarbonate or other suitable grit), or the like, to expose the electroactive surfaces. Alternatively, a portion of the electrode can be masked prior to depositing the insulator in order to maintain an exposed electroactive surface area. In one exemplary embodiment, grit blasting is implemented to expose the electroactive surfaces, preferably utilizing a grit material that is sufficiently hard to ablate the polymer material, while being sufficiently soft so as to minimize or avoid damage to the underlying metal electrode (e.g., a platinum electrode).” in para. [0116]),
a selective transmission layer (“enzyme domain”) 49 is applied to the openings (see “In preferred embodiments, the membrane system further includes an enzyme domain 49 disposed more distally situated from the electroactive surfaces than the interference domain 48 (or electrode domain 47 when a distinct interference is not included). In some embodiments, the enzyme domain is directly deposited onto the electroactive surfaces (when neither an electrode or interference domain is included). In the preferred embodiments, the enzyme domain 49 provides an enzyme to catalyze the reaction of the analyte and its co-reactant, as described in more detail below. Preferably, the enzyme domain includes glucose oxidase, however other oxidases, for example, galactose oxidase or uricase oxidase, can also be used.” in para. [0139]),
a material (“enzyme”, not labeled) of the selective transmission layer 49 is determined according to a type of the analyte to be electrochemically reacted with the electrodes 44, 46 (see “In preferred embodiments, the membrane system further includes an enzyme domain 49 disposed more distally situated from the electroactive surfaces than the interference domain 48 (or electrode domain 47 when a distinct interference is not included). In some embodiments, the enzyme domain is directly deposited onto the electroactive surfaces (when neither an electrode or interference domain is included). In the preferred embodiments, the enzyme domain 49 provides an enzyme to catalyze the reaction of the analyte and its co-reactant, as described in more detail below. Preferably, the enzyme domain includes glucose oxidase, however other oxidases, for example, galactose oxidase or uricase oxidase, can also be used.” in para. [0139]),
when the electrodes are reference electrodes, the selective transmission layer includes Ag/AgCl (see “The reference electrode 46, which can function as a reference electrode alone, or as a dual reference and counter electrode, is formed from silver, silver/silver chloride, or the like. Preferably, the reference electrode 46 is juxtapositioned and/or twisted with or around the working electrode 44; however other configurations are also possible. In the illustrated embodiments, the reference electrode 46 is helically wound around the working electrode 44. The assembly of wires is then optionally coated or adhered together with an insulating material, similar to that described above, so as to provide an insulating attachment.” in para. [0115]), and
when the electrodes are working electrodes 44, the selective transmission layer has a mesoporous structure and the selective transmission layer includes platinum (see “In preferred embodiments, the working electrode comprises a wire formed from a conductive material, such as platinum, platinum-iridium, palladium, graphite, gold, carbon, conductive polymer, alloys, or the like. Although the electrodes can by formed by a variety of manufacturing techniques (bulk metal processing, deposition of metal onto a substrate, or the like), it can be advantageous to form the electrodes from plated wire (e.g., platinum on steel wire) or bulk metal (e.g., platinum wire). It is believed that electrodes formed from bulk metal wire provide superior performance (e.g., in contrast to deposited electrodes), including increased stability of assay, simplified manufacturability, resistance to contamination (e.g., which can be introduced in deposition processes), and improved surface reaction (e.g., due to purity of material) without peeling or delamination.” in para. [0112]).
As to Claim 20, Brister teaches the following:
wherein a plurality of electrochemical sensors are simultaneously manufactured in the form of an array in which the sensors are repeatedly arranged, and then are separated from each other individually (see “Although the electrodes can by formed by a variety of manufacturing techniques (bulk metal processing, deposition of metal onto a substrate, or the like), it can be advantageous to form the electrodes from plated wire (e.g., platinum on steel wire) or bulk metal (e.g., platinum wire). It is believed that electrodes formed from bulk metal wire provide superior performance (e.g., in contrast to deposited electrodes), including increased stability of assay, simplified manufacturability, resistance to contamination (e.g., which can be introduced in deposition processes), and improved surface reaction (e.g., due to purity of material) without peeling or delamination.” in para. [0112]).
Allowable Subject Matter
9. Claims 15-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
10. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 15, neither Brister nor the prior art of record teaches the continuous analyte meter of base claim 1, including the following, in combination with all other limitations of the base claim:
… wherein a trench is formed in the conductive layer by laser etching for partially removing the conductive layer with a laser beam irradiated onto the conductive layer,
the trench has a width ranging from 2 to 200 µm, and
the trench has a height equal to a thickness of the conductive layer.
As to Claim 16, neither Brister nor the prior art of record teaches the continuous analyte meter of base claim 1, including the following, in combination with all other limitations of the base claim:
… wherein a trench is formed in the conductive layer by laser etching for partially removing the conductive layer with a laser beam irradiated onto the conductive layer, and
a width of the trench is increased as a laser head for laser irradiation is moved a plurality of times and performs laser etching a plurality of times.
As to Claim 17, neither Brister nor the prior art of record teaches the continuous analyte meter of base claim 1, including the following, in combination with all other limitations of the base claim:
… wherein a plurality of conductive islands separated from each other are provided on the conductive layer by laser etching for partially removing the conductive layer with a laser beam irradiated onto the conductive layer, and
the conductive islands comprise a conductive island in which portions thereof corresponding to each of the electrodes and each of the sensor pads are exposed to the outside through cut portions of the insulating layer, and a dummy portion entirely covered with the insulating layer so as not to be exposed to the outside.
As to Claim 18, neither Brister nor the prior art of record teaches the continuous analyte meter of base claim 1, including the following, in combination with all other limitations of the base claim:
… wherein the electrochemical sensor further comprises a bending portion that connects the proximal portion and the distal portion to each other, is disposed between the proximal portion and the distal portion, and is flexibly bendable,
a plurality of conductive islands separated from each other are formed on the conductive layer,
a current resulting from an electrochemical reaction of glucose at the distal portion flows to the sensor pads of the proximal portion along a plurality of leads formed on the base layer, and
each of the sensor pads is disposed on each of the conductive islands at a position corresponding to the proximal portion, each of the leads is disposed on each of the conductive islands at a position corresponding to the bending portion, and each of the electrodes is disposed on each of the conductive islands at a position corresponding to the distal portion.
Conclusion
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 07/13/2026
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