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 Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 7, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kube (CN 110621227 A).
Regarding claim 1, Kube teaches an analyte detection device (Fig 1; 110) ([abstract] at least one analyte sensor (112)) with multilayer adhesive tape ([Pg 8; Para2] the first adhesive layer or the second adhesive layer or an additional adhesive layer or bonding element or adhesive (which may be as described below, such as the third adhesive layer and the fourth adhesive layer), the adhesion can be affected by size or control of the adhesive layer), comprising an analyte detection module ([Pg 6; Para 3] at least one electronic component may comprise at least one voltage measuring device, current measuring device, a current source or a voltage source, a light sensor for use to perform an analyte measurement), configured to detect analyte parameter information ([Pg 6; Para 3] in particular at least one application specific integrated circuit, may include a by using an analyte sensor to perform a function of at least one analyte measurements, such as by providing a suitable electric potential, constant potential or ampere measuring device in one or more of the sensor with the analyte of at least one working electrode and at least one additional electrode (e.g., an analyte sensor counter electrode and/or reference electrode) binding can be performing at least one electrochemical analyte measurement); the adhesive module configured to paste the analyte detection module on a surface (Fig 1; adhesive tape 114) ([Pg 7; Para 4] at least one first adhesive layer can be directly or indirectly applied to the lower side of the flexible electronic patch. For example, at least one first adhesive layer can be directly applied to the base plate facing the skin on the lower side as a binder), wherein the adhesive module comprises N layers of an adhesive tape ([Pg 8; Para 2] the first adhesive layer or the second adhesive layer or an additional adhesive layer or bonding element or adhesive (which may be as described below, such as the third adhesive layer and the fourth adhesive layer), the adhesion can be affected by size or control of the adhesive layer), a first side of a first layer of the N layers of the adhesive tape (Fig 1; first side of layer 138 connected to detection module) is fixedly connected with the analyte detection module ([Pg 7; Para 4] at least one first adhesive layer can be directly or indirectly applied to the lower side of the flexible electronic patch. For example, at least one first adhesive layer can be directly applied to the base plate facing the skin on the lower side as a binder) ([Pg 5; Para 7] at least one first adhesive layer on the lower side of the flexible electronic patch), a second side opposite to the first side of the first layer of the N layers of the adhesive tape (Fig 1; second side of layer 138 coated with adhesive 128) is coated with adhesive material ([Pg 11; Para 11] providing at least one first adhesive layer on the lower side of the flexible electronic patch, the first adhesive layer is configured for the flexible electronic patch is adhered to the skin of the user), a second layer to a Nth layer of the N layers of the adhesive tape (Fig 1; second layer 124) is successively laminated and pasted on the first side of the first layer of the N layers of the adhesive tape ([Pg 12; Para 5] at least one second adhesive layer also is a portion of flexible electronic patch under the condition, then the method may further include the at least one second adhesive layer applied to the upper side of the flexible electronic patch), and N>2 ([Pg 8; Para 2] the first adhesive layer or the second adhesive layer or an additional adhesive layer or bonding element or adhesive (which may be as described below, such as the third adhesive layer and the fourth adhesive layer), the adhesion can be affected by size or control of the adhesive layer).
Regarding claim 2, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 1, wherein each of the second layer to the Nth layer of the N layers of the adhesive tape is an annular structure (Fig 4b; structure of adhesive layers).
Regarding claim 4, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 1, wherein each of the second layer (Fig 1; 124) to Nth layer of the N layers of the adhesive tape covers at least part of an adjacent inner layer of the N layers of the adhesive tape ([Pg 7; Para 6] at least one second adhesive layer, which is used for the flexible electronic patch prior to application to the skin of the user, the flexible electronic patch adhered to the applicator unit. at least one second adhesive layer may be a part of at least one flexible electronic patch can be a portion or both of the applicator unit, or may be provided as a separate adhesive layer. under state for example, the second adhesive layer can still be attached to the applicator unit in flexible electronic patch, namely, the flexible electronic patch is applied to the skin before implemented between the flexible electronic patch and applicator unit and state of the period. the second adhesive layer can be applied to the lower side of the upper side of the flexible electronic patch and/or applicator unit of the adhesive layer) ([Pg 21; Para 4] additionally or alternatively, analyte sensor 112 also can be added before insertion into the body tissue through the at least one third adhesive layer 186 (not shown) attached to the applicator unit 134. Thus, the third adhesive layer 186 can be located on the applicator unit 134, analyte sensor 112 and the protection foil 144 on one or more of. As for the first adhesive layer 128 and second adhesive layer 136, a third adhesive layer 186 may be implemented as one or more points 174. analyte sensor 112 may further include at least one fourth adhesive layer 188 for the analyte sensor 112 attached to the flexible circuit board 116 during insertion. the fourth adhesive layer 188 may specifically includes one or more points 174. the fourth adhesive layer 188 can be located on one or two of analyte sensor 112 and flexible circuit board 116).
Regarding claim 7, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 1, wherein the adhesive module also comprises at least one protective film ([Pg 19; Para 2] flexible electronic patch 114 further comprises at least one flexible protective layer 124. protective layer 124 at least partially covers the upper side 126 of the flexible circuit board 116).
Regarding claim 8, Kube teaches according to the analyte detection device with multilayer adhesive tape of claim 7, wherein the protective film is located between two adjacent layers of the N layers of the adhesive tape (Fig 1; [Pg 19; Para 2] flexible electronic patch 114 further comprises at least one flexible protective layer 124. protective layer 124 at least partially covers the upper side 126 of the flexible circuit board 116) ([Pg 22; Para 2] the flexible protection layer 124 comprises at least one adhesive portion 192).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 3, 6, 11, 12, 15, 16, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kube (CN 110621227 A) in view of Lee (US 20160058380 A1).
Regarding claim 3, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 2, but fails to teach wherein at least a layer of the second layer to the Nth layer of the N layers of the adhesive tape is provided with at least one tearing part.
However, Lee teaches wherein at least a layer of the second layer to the Nth layer of the N layers of the adhesive tape is provided with at least one tearing part ([0218] It should be understood that perforations can also be used for the adhesive pad. For example, a first portion of the adhesive pad may be located radially outward from a second portion of the adhesive pad, with a series of perforations forming a border between the first and second portions. When the edges of the first portion of the adhesive pad begin to peel, the first portion may be easily removed by peeling it off the host's skin) ([0290] The overlay 4160 comprises a central opening 4180 in its interior. With reference to FIG. 41C1, the user bends back the peel tab 4143 formed on the upper liner 4140. With reference to FIG. 41C2, the user next grasps the protruding tab 4136 on the bottom liner 4150 and removes the bottom liner 4150 from the remaining portions of the overlay assembly). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include wherein at least a layer of the second layer to the Nth layer of the N layers of the adhesive tape is provided with at least one tearing part. Doing so allows for the lining to protect the adhesive tape until it is time to be removed and the device is applied to the surface.
Regarding claim 6, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 1, but fails to teach wherein a thickness of the N layers of the adhesive tape is 1~500um.
However, Lee teaches wherein a thickness of the N layers of the adhesive tape is 1~500um ([0159] The adhesive pad 204 preferably has a slight thickness to enhance the wearability of the pad as well as to render it difficult to peel off the host's skin. For example, the adhesive pad 204 may have a thickness in the range of from about 0.05 mm to about 1 mm, preferably from about 0.1 mm to about 0.7 mm, and more preferably from about 0.2 mm to about 0.5 mm).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a thickness of the N layers of the adhesive tape is 1~500um, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 11, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 7, but fails to teach wherein a thickness of the protective film is 10~500um.
However, Lee teaches wherein a thickness of the protective film is 10~500um ([0181] The overlay 232 preferably has a slight thickness to enhance the wearability of the adhesive sensor system 230 as well as to render it difficult to peel the overlay 232 off the host's skin. For example, the overlay 232 may have a thickness in the range of about 0.01 mm to about 0.1 mm, preferably from about 0.3 mm to about 0.8 mm, and more preferably from about 0.4 mm to about 0.6 mm. As the thickness of the overlay 206 decreases, it becomes more and more difficult to peel off the host's skin. Thus, the overlay 206 is preferably as thin as possible without compromising its ability to reinforce the adherence of the adhesive pad 204 to the host's skin). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a thickness of the protective film is 10~500um, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 7, but fails to teach wherein an outer edge contour of the protective film is fit with an outer edge contour of an inner layer of the two adjacent layers.
However, Lee teaches According to the analyte detection device with multilayer adhesive tape mentioned in claim 7, wherein an outer edge contour of the protective film is fit with an outer edge contour of an inner layer of the two adjacent layers ([0162] The overlay 206 has a larger perimeter dimension than the adhesive pad 204, such that the overlay 206 extends outwardly on all sides from a periphery of the adhesive pad 204 when the overlay 206 is positioned over the adhesive pad 204, as shown in FIG. 3) ([0179] the overlay 232 at least partially covers the flange 248 of the frame 238. The overlay 232 is shaped substantially as a thin, flat, sheet and includes a central opening 258. The opening 258 is sized and shaped to accommodate the sensor electronics unit 234, the housing 236, and the frame 238 so that the overlay 232 can be placed over the flange 248, as shown in FIG. 5). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include wherein an outer edge contour of the protective film is fit with an outer edge contour of an inner layer of the two adjacent layers. Doing so allows the protective film to surround the inner layer for maximum protection around the device.
Regarding claim 15, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 1, wherein the analyte detection module comprises a transmitter unit ([Pg 17; Para 4] data transmitter, for the measurement data transmitted to the at least one data reader), a sensor unit (Fig 1; analyte sensor (112)), a battery ([Pg 11; Para 1] flexible electronic patch may further include at least one energy storage device, especially at least one of battery or storage battery) and the sensor unit comprises an internal part ([Pg 21; Para 4] FIG. 7. applicator unit 134 further may include a sensor for the analyte 112 into the insertion needle into the body tissue 178) ([Pg 19; Para 3] flexible analyte sensor in the shaft 146, as shown in FIG. 1, which is provided with at least one working electrode 147 and at least one additional electrode 149 (not shown in FIG. 1), flexible analyte sensor shaft 146 can be inserted into body tissue) and an external part (Fig 1; analyte sensor 112 may also include at least one contact portion 148, the contact portion 148 has at least one electric contact set on it 140).
Kube fails to teach a bottom case. However, Lee teaches a bottom case (Fig 4; [0176] With reference to FIG. 4, the housing 236 comprises a planar bottom wall 240). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include a bottom case. Doing so protects the electrical components from interacting with the surface.
Regarding claim 16, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 15, wherein the first layer of the N layers of the adhesive tape is provided with a first through-hole (Fig 1; opening 150), and the internal part passes through the first through-hole (Fig 1).
Regarding claim 17, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 16, wherein at least one layer of a release paper is provided on the second side of the first layer of the N layers of the adhesive tape before the adhesive module is pasted on the surface ([Pg 21; Para 1] In order to expose the first adhesive layer 128 and the flexible electronic patch 114 adhered to the skin of the user 132, shown in FIG. 5A, it may be necessary to remove the protective sheet 170).
Regarding claim 18, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 17, but fails to teach wherein a second through hole is arranged on the at least one layer of the release paper, and a position of the second through-hole corresponds to the first through-hole, so that the internal part of the sensor unit passes through the second through-hole.
However, Lee teaches wherein a second through hole is arranged on the at least one layer of the release paper, and a position of the second through-hole corresponds to the first through-hole, so that the internal part of the sensor unit passes through the second through-hole ([0290] The overlay 4160 comprises a central opening 4180 in its interior. With reference to FIG. 41C1, the user bends back the peel tab 4143 formed on the upper liner 4140. With reference to FIG. 41C2, the user next grasps the protruding tab 4136 on the bottom liner 4150 and removes the bottom liner 4150 from the remaining portions of the overlay assembly. With reference to FIG. 41C3, the user next places the remaining portions of the overlay assembly, which now includes the upper liner 4140 and the overlay 4160, around the sensor electronics unit housing 4152, such that the central opening 4180 of the overlay 4160 surrounds the sensor electronics unit housing 4152. The user preferably presses down firmly on the upper liner 4140 to securely adhere the overlay 4160 to the skin). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include wherein a second through hole is arranged on the at least one layer of the release paper, and a position of the second through-hole corresponds to the first through-hole, so that the internal part of the sensor unit passes through the second through-hole. Doing so allows for the release paper to surround the sensor portion for ease of application.
Claim(s) 5, 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kube (CN 110621227 A) in view of Larson (US 20190060511 A1).
Regarding claim 5, Kube teaches according to the analyte detection device of multilayer adhesive tape mentioned in claim 1, but fails to teach wherein a material of the N layers of the adhesive tape is polyethylene, polypropylene, non-woven fabric or pure cotton.
However, Larson teaches wherein a material of the N layers of the adhesive tape is polyethylene, polypropylene, non-woven fabric or pure cotton ([0030] The flexible adhesive patch 200 is preferably formed from a flexible and breathable material with adhesive properties, such as cloth, a bandage-like material, or the like. For example, suitable materials could include polyurethane, polyethylene, polyester, polypropylene, polytetrafluoroethylene (PTFE), or other polymers). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a material of the N layers of the adhesive tape is polyethylene, polypropylene, non-woven fabric or pure cotton, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 9, Kube teaches According to the analyte detection device with multilayer adhesive tape mentioned in claim 7, but fails to teach wherein a Rockwell hardness of the protective film is greater than a Rockwell hardness of the N layers of the adhesive tape.
However, Larson teaches wherein a Rockwell hardness of the protective film is greater than a Rockwell hardness of the N layers of the adhesive tape ([0038] The reinforcement liner 206 is formed from a suitable material that reinforces the structural rigidity of the flexible adhesive patch 200 when the reinforcement liner is adhered to the adhesive device-receiving surface 248. In this regard, the reinforcement liner 206 has a stiffness measurement that exceeds the stiffness measurement of the flexible adhesive patch 200. As explained in more detail below, the stiffness of the reinforcement liner 206 is desirable to reduce or eliminate unwanted drooping, bending, creasing, wrinkling, or folding of the flexible adhesive patch 200 during deployment of the glucose sensor 148). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include wherein a Rockwell hardness of the protective film is greater than a Rockwell hardness of the N layers of the adhesive tape. Doing so allows the protective film to be more durable and is able to protect the adhesive layer underneath.
Regarding claim 13, Kube teaches according to the analyte detection device with multilayer adhesive tape of claim 7, but fails to teach wherein the protective film is provided with at least one tearing part.
However, Larson teaches wherein the protective film is provided with at least one tearing part ([0037] In accordance with certain embodiments, the removable reinforcement liner 206 includes at least one fold 272 formed therein to facilitate peeling removal of the reinforcement liner 206 from the adhesive device-receiving surface 248 of the device-affixing feature 204. The illustrated embodiment of the reinforcement liner 206 also includes a pull tab 274 to initiate removal of the reinforcement liner 206 from the device-affixing feature 204) ([0039] The cutout area 270 is particularly shaped to avoid tearing the reinforcement liner 206 during removal. As depicted in the figures, the cutout area 270 resembles the shape of an egg, or oval in shape. The cutout area 270 is intentionally designed to avoid sharp transitions and corners, which could promote tearing when the user peels the reinforcement liner 206 off). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include wherein the protective film is provided with at least one tearing part. Doing so allows for the removal of the protective film for removing the device or replacing the film.
Claim(s) 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kube (CN 110621227 A) in view of Larson (US 20190060511 A1), further in view of Cabiri (CN 104780956 A).
Regarding claim 10, Kube teaches according to the analyte detection device with multilayer adhesive tape described in claim 9, but fails to teach wherein the Rockwell hardness of the protective film is 80 to 100HRM.
However, Cabiri teaches wherein the Rockwell hardness of the protective film is 80 to 100HRM ([Pg 7; Para 2] a reinforcing element may include ribs and/or a bending part. One aspect of embodiments, reinforcement can be optionally made of plastic, for example, polyethylene terephthalate (PET), and its thickness can be, for example in the range of 0.8 mm to 0.1. it also can use other materials, include, for example, polycarbonate and/or ABS). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a material of the protective film is one of polycarbonate, polyamide, polyformaldehyde, poly-phenyl ether, polyester, poly-phenyl sulfide and poly-aryl ester, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Kube to include wherein the Rockwell hardness of the protective film is 80 to 100HRM if the material used for the film is polyethylene terephthalate (PET) or polycarbonate. Doing so is obvious because of the inherent nature of polyethylene terephthalate (PET) or polycarbonate.
Regarding claim 14, Kube teaches according to the analyte detection device with multilayer adhesive tape mentioned in claim 7, but fails to teach wherein a material of the protective film is one of polycarbonate, polyamide, polyformaldehyde, poly-phenyl ether, polyester, poly-phenyl sulfide and poly-aryl ester.
However, Cabiri teaches wherein a material of the protective film is one of polycarbonate, polyamide, polyformaldehyde, poly-phenyl ether, polyester, poly-phenyl sulfide and poly-aryl ester ([Pg 7; Para 2] a reinforcing element may include ribs and/or a bending part. One aspect of embodiments, reinforcement can be optionally made of plastic, for example, polyethylene terephthalate (PET), and its thickness can be, for example in the range of 0.8 mm to 0.1. it also can use other materials, include, for example, polycarbonate and/or ABS). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein a material of the protective film is one of polycarbonate, polyamide, polyformaldehyde, poly-phenyl ether, polyester, poly-phenyl sulfide and poly-aryl ester, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794