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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 10 is objected to because of the following informalities: the limitation "at least one of the conductive areas comprises conductive areas" recited in lines 2-3 is redundant. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 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.
Regarding Claim 1, the limitation "the pin" recited in line 6 of the claim is unclear. It is unclear if "the pin" is the same or different from "pins" recited earlier in the claim. Furthermore, it is unclear if each pin is being referenced or just at least one pin is being referenced. It is being interpreted that the limitation "the pin" means "at least one of the pins are".
Regarding Claim 1, the limitation "the wire" recited in line 6 lacks proper antecedent basis. It is being interpreted that the limitation "the wire" should be recited as "a wire".
Regarding Claim 1, the limitation "the pin" recited in line 7 of the claim is unclear. It is unclear if "the pin" is the same or different from "pins" recited earlier in the claim. Furthermore, it is unclear if each pin is being referenced or just at least one pin is being referenced. It is being interpreted that the limitation "the pin" means "at least one of the pins, the wire…".
Regarding Claim 1, the limitation "the pin" recited in line 8 of the claim is unclear. It is unclear if "the pin" is the same or different from "pins" recited earlier in the claim. Furthermore, it is unclear if each pin is being referenced or just at least one pin is being referenced. It is being interpreted that the limitation "the pin" means "at least one of the pins faces…".
Regarding Claim 1, the limitation "distributed at intervals" recited in line 11 of the claim is unclear. It is unclear what constitutes as "intervals". Are the intervals dependent on a number, space, time, etc.?
Regarding Claim 1, the limitation "the conductive area" recited in line 11 of the claim is unclear. It is unclear if "the conductive area" is the same or different from "at least one conductive area" recited earlier in the claim. It is being interpreted that the limitation "the conductive area" should be recited as "at least one conductive areas".
Regarding Claim 1, the limitation "the pin" recited in line 11 of the claim is unclear. It is unclear if "the pin" is the same or different from "pins" recited earlier in the claim. Furthermore, it is unclear if each pin is being referenced or just at least one pin is being referenced. It is being interpreted that the limitation "the pin" means "at least one of the pins faces…".
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
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.
Claims 1-2, 8-9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rao et. al.'535 (U.S. Publication Number 20170290535).
Regarding Claim 1, Rao et. al.’535 discloses an analyte detection device (Paragraph [0119] - allowing continuous monitoring of the sensed analyte) comprising:
a transmitter provided with an electrical connection area (Paragraph [0028] - The sensing device may further include a transmitter electrically coupled to the printed circuit board assembly and inside the case, wherein the transmitter is adapted to transmit analyte readings sensed by the sensor);
a bottom case provided with a sensor base (Paragraph [0084] - A printed circuit board assembly (PCBA) 320 fits inside the lower housing 130);
a sensor comprising a signal output end (Paragraph [0083] - The sensor electrodes 15 generate electrical signals representative of patient condition, wherein these signals are transmitted via the contact pads 18 and connector);
a detection end (Paragraph [0083] - An opposite or distal segment of the sensor 12 includes the corresponding plurality of exposed sensor electrodes 15 for contacting patient body fluid when the sensor distal segment is placed into the body of the patient) wherein
the signal output end is provided with pins (Paragraph [0083] - The sensor electrodes 15 generate electrical signals representative of patient condition, wherein these signals are transmitted via the contact pads 18 and connector);
the detection end is provided with an electrode (Paragraph [0083] - An opposite or distal segment of the sensor 12 includes the corresponding plurality of exposed sensor electrodes 15 for contacting patient body fluid when the sensor distal segment is placed into the body of the patient);
at least one of the pins are connected with the electrode through the wire, the pin, the wire and the electrode are arranged on an insulated substrate and located on a same side of the substrate (Paragraph [0083] - include elongated conductive elements 24 embedded or encased between layers of a selected insulative sheet material…The proximal end or head 16 of the sensor 12 is relatively enlarged and defines electrical contacts, the conductive contact pads 18, which are exposed through the insulative sheet material for electrical connection; Figure 3);
at least one of the pins faces towards the sensor base (Paragraph [0083] - the conductive contact pads 18, which are exposed through the insulative sheet material for electrical connection to the printed circuit board assembly); and
an elastic conductor comprising at least one conductive area and an insulating area distributed at intervals (Paragraph [0086] - The sensors 12A, 12B may be held in place by sensor elastomeric connector/elastomeric pad 350; Paragraph [0098] - The sensor elastomeric connector/pad 1350, also shown in FIG. 31 as reference number 350, includes alternating conductive layers 357 and non-conductive layers 358 (see FIG. 31) along its length, such that the elastomeric connector is conductive along its width and height but not along its length); wherein
at one of the conductive areas are electrically connected with the electrical connection area (Paragraph [0025] - the elastomeric pad contains conductive strips positioned to connect electrically the contact pads of the printed circuit board assembly to respective electrical contacts of the sensor to maintain the electrical connection); and
at least one of the pins and the elastic conductor are electrically connected through an external circuit (Paragraph [0088] - The sensor elastomeric connector 350 electrically connects the upper sensor contact pads to the PCBA sensor pads).
Regarding Claim 2, Rao et. al.’535 discloses the elastic conductor is a cuboid structure (see element 350 from Figure 5).
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Figure 5
Regarding Claim 8, Rao et. al.’535 discloses the conductive area and the insulating area pass through the elastic conductor in a longitudinal direction (Paragraph [0098] - The sensor elastomeric connector/pad 1350, also shown in FIG. 31 as reference number 350, includes alternating conductive layers 357 and non-conductive layers 358 (see FIG. 31) along its length, such that the elastomeric connector is conductive along its width and height but not along its length).
Regarding Claim 9, Rao et. al.’535 discloses the conductive area and the insulating area surround a surface of the elastic conductor (Paragraph [0098] - The sensor elastomeric connector/pad 1350, also shown in FIG. 31 as reference number 350, includes alternating conductive layers 357 and non-conductive layers 358 (see FIG. 31) along its length, such that the elastomeric connector is conductive along its width and height but not along its length).
Regarding Claim 12, Rao et. al.’535 discloses the signal output end is bent relative to the detection end, and the signal output end is laid flat on the sensor base (Paragraph [0096] - Locating posts 1326 are connected to the lower housing 1130 or the PCBA 1320 and are placed to locate the sensors in the correct position with respect to the sensor pads; see element 1012B in Figure 13).
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Figure 13
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.
Claims 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rao et. al.'535 (U.S. Publication Number 20170290535) as applied to Claim 2 above, and in view of Antonio et. al.'532 (U.S. Publication Number 20170290532).
Regarding Claim 3, Rao et. al.’535 discloses the system outlined in Claim 2 above, as well as a first surface of the elastic conductor is in contact with the signal output end (Paragraph [0086] - The sensors 12A, 12B may be held in place by sensor elastomeric connector/elastomeric pad 350 and sealed using sensor gaskets 340);
a second surface of the elastic conductor is in contact with the external circuit (Paragraph [0088] - The sensor elastomeric connector 350 electrically connects the upper sensor contact pads to the PCBA sensor pads; Paragraph [0092] - Battery tabs 1706 lead from the batteries 1300 to the PCBA 1320; Figure 12).
Rao et. al.’535 fails to disclose a third surface of the elastic conductor is in contact with the electrical connection area. Antonio et. al.’532 teaches a transmitter – electrical connection area – in contact with an elastomeric connection – elastic conductor (Paragraph [0331] -elastomeric connector 1332 and contact 1328 of transmitter assembly 1306 line up with elastomeric connector 1302 of sensor assembly 1312, thus competing the connection; Paragraph [0332] - When a transmitter assembly is connected to the sensor assembly, at least one contact of the transmitter assembly makes a connection with the elastomeric connection 1432. In this embodiment, six contacts 1428 of a transmitter assembly connect with elastomeric connector 1432). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 to connect the transmitter and elastic conductor in order to create a cohesive device that completes electrical connections/paths between the sensors and the housing as seen in Antonio et. al.’532.
Regarding Claim 4, Rao et. al.’535 discloses the system outlined in Claim 2 above, as well as a first surface of the elastic conductor is in contact with the signal output end and the external circuit (Paragraph [0088] - The sensor elastomeric connector 350 electrically connects the upper sensor contact pads to the PCBA sensor pads).
Rao et. al.’535 fails to disclose a third surface of the elastic conductor is in contact with the electrical connection area. Antonio et. al.’532 teaches a transmitter – electrical connection area – in contact with an elastomeric connection – elastic conductor (Paragraph [0331] -elastomeric connector 1332 and contact 1328 of transmitter assembly 1306 line up with elastomeric connector 1302 of sensor assembly 1312, thus competing the connection; Paragraph [0332] - When a transmitter assembly is connected to the sensor assembly, at least one contact of the transmitter assembly makes a connection with the elastomeric connection 1432. In this embodiment, six contacts 1428 of a transmitter assembly connect with elastomeric connector 1432; Paragraph [0344] - a signal path to transmitter contacts 2017 is created through active contact pads WE-D and WE-B of first sensor 2040a). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 to connect the transmitter and elastic conductor in order to create a cohesive device that completes electrical connections/paths between the sensors and the housing as seen in Antonio et. al.’532.
Regarding Claim 5, Rao et. al.’535 in view of Antonio et. al.’532 discloses the system outlined in Claim 3 above, as well as the external circuit is a stereoscopic circuit laid on the sensor base (Paragraph [0084] - A printed circuit board assembly (PCBA) 320 fits inside the lower housing 130).
Regarding Claim 7, Rao et. al.’535 discloses the system outlined in Claim 3 above, as well as the first surface of the elastic conductor is opposite to the third surface (refer to element 350 in Figure 5 that shows multiple surfaces).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rao et. al.'535 (U.S. Publication Number 20170290535) in view of Antonio et. al.'532 (U.S. Publication Number 20170290532) as applied to Claim 4 above, and further in view of Rodthongkum et. al.'577 (U.S. Publication Number 20230157577).
Regarding Claim 6, Rao et. al.’535 in view of Antonio et. al.’532 discloses the system outlined in Claim 4 above, but fails to disclose the external circuit is one of conductive gel, conductive adhesive, conductive coating, conductive tape or conductive glue applied to the sensor base. Rodthongkum et. al.’577 teaches a conductive coating on base material (Paragraph [0017] - modifying the base material using the liquid absorber before coating it with a conductive material and optionally a mediator on the electrochemical sensor can enhance the electrochemical conductivity of the sensor). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 in view of Antonio et. al.’532 to use a conductive coating on a base sensor in order to enhance the electrochemical conductivity of the sensor as seen in Rodthongkum et. al.’577.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rao et. al.'535 (U.S. Publication Number 20170290535) as applied to Claim 1 above, and in view of Ackermann et. al.'814 (CN Patent Application 110430814).
Regarding Claim 10, Rao et. al.’535 discloses the system outlined in Claim 1 above, as well as the at least one conductive area (Paragraph [0098] - The sensor elastomeric connector/pad 1350, also shown in FIG. 31 as reference number 350, includes alternating conductive layers 357 and non-conductive layers 358 (see FIG. 31) along its length, such that the elastomeric connector is conductive along its width and height but not along its length).
Rao et. al.’535 fails to disclose the insulating area is an air area between the conductive areas. Ackermann et. al.’814 teaches a space – air – in between insulating and conductive layers (Page 10 Paragraph 5 - Specifically, the insulating layer may be configured to be used as a spacer between the first conductive layer and the second conductive layer. Therefore, the first conductive layer and the second conductive layer can be arranged at a distance to each other). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 to include a spacer such as air between insulating and conductive layers in order to control the distance and arrangements of layers as seen in Ackermann et. al.’814.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rao et. al.'535 (U.S. Publication Number 20170290535) as applied to Claim 8 above, and in view of Barry et. al.'036 (U.S. Publication Number 20200330036).
Regarding Claim 11, Rao et. al.’535 discloses the system outlined in Claim 8 above, but fails to disclose the elastic conductor is one of conductive adhesive strips, conductive foam or conductive bubble. Barry et. al.’036 teaches an elastic conductor as conductive foam (Paragraph [0226] - a compliant component 740 (e.g., a soft, foam or rubber material, see FIG. 7B)…Accordingly, compliant component 740 datums sensor 138 to the surface of lower housing 622 within cavity 750 in a compliant manner and seals first portion 752 of cavity 750 from second portion 754 of cavity 750). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 to use a material such as conductive foam as an elastic conductor in order to datum the elastic conductor to the surface of the lower housing when the housing is sealed as seen in Barry et. al.’036.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rao et. al.'535 (U.S. Publication Number 20170290535) as applied to Claim 1 above, and in view of Choy et. al.'205 (U.S. Publication Number 20220031205).
Regarding Claim 13, Rao et. al.’535 discloses the system outlined in Claim 1 above, as well as the electrical connection area comprising conductive contact (Paragraph [0028] - The sensing device may further include a transmitter electrically coupled to the printed circuit board assembly and inside the case, wherein the transmitter is adapted to transmit analyte readings sensed by the sensor).
Rao et. al.’535 fails to disclose the electrical connection area comprises at least one metal conductive contact. Choy et. al.’205 teaches metal conductive contacts within an electrical connection area (Paragraph [0060] - contacts 105 (e.g., conductive surfaces, metal layers or regions, metallization, or contact pads comprising metal) electrically connected to the one or more electrodes via conductive tracks through the sensor portion 102. In this way, the contacts 105 (CE, WE1, WE2, RE) comprise the electrical connections 110 between the sensor portion 102 and a printed circuit board assembly (PCBA), electrically connecting the one or more electrodes 103 (CE, WE1, WE2, RE) to the PCBA). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 to connect the transmitter to electrical sensors via metal contacts in order to provide electrical paths from the sensors to the PCBA as seen in Choy et. al.’205.
Regarding Claim 14, Rao et. al.’535 in view of Choy et. al.’205 discloses the system outlined in Claim 13 above, but fails to disclose a number of at the at least one metal conductive contact is consistent with a number of the pins. Choy et. al.’205 teaches a number of metal contacts consistent with a number of electrical sensors (Paragraph [0060] - In this way, the contacts 105 (CE, WE1, WE2, RE) comprise the electrical connections 110 between the sensor portion 102 and a printed circuit board assembly (PCBA), electrically connecting the one or more electrodes 103 (CE, WE1, WE2, RE) to the PCBA). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rao et. al.’535 to include the same number of metal contacts as the number of electrical sensors in order to electrically connect each of the sensors to the PCBA as seen in Choy et. al.’205.
Conclusion
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791