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 .
Claims Accounting
Applicant's arguments, filed 06/12/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/12/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claim 1 has been amended.
Claim 13 has been cancelled.
Claims 1-12, 14-16, and 18 are the current claims hereby under examination.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “wherein a projection of whole of the probe” in line 27. This should read “wherein a projection of the whole of the probe”.
Appropriate correction is required.
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 1-2, 6-7, 9-12, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2014/0121989 by Kamath et al. – previously cited, hereinafter “Kamath” in view of US Patent Publication 2019/0120785 by Halac et al. – previously cited, hereinafter “Halac”.
Regarding claim 1, Kamath teaches: a body fluid analyte detection device (Fig. 1, sensor system 10), comprising: a transmitter which is provided with at least one first clamp part (Fig. 12C, transmitter 16 has lower front edge (under base 24)); a bottom shell (Fig. 12C, [0181]; base 24 of mounting unit 14) which is provided with at least one second clamp part corresponding to the first clamp part (Fig. 12C, protruding edge of base 24), wherein the transmitter is assembled on the bottom shell by the first clamp part and the second clamp part clamped together (Fig. 12C, the first and second parts are pressed (i.e., clamped) together when assembled), the bottom shell comprises a fixed part (Fig. 12B, the portion of base 24 disposed at the end of the mounting unit opposite the tabs) and a forced part (Fig 12A-C, [0362]; tab 120 that is a part of the base 24 can be considered the forced part.), during separating the bottom shell and the transmitter, the fixed part is fixed, and only one force is applied to the forced part in one direction ([0361-0362], Fig. 12C, Tabs 120 provide additional rigid support for force and counter force by the user (e.g., fingers) during connection. The connection is detachable, therefore to detach, the opposite must be performed (applying force and counterforce). Where force is applied on the bottom tab (a part of base 24) can be considered the forced part. The counterforce is applied to the other tab, which is not on the bottom shell. On the opposite side of the base, no force is applied and this is considered the fixed part. It is noted that in the detachment of the transmitter, it is possible to only apply force to the bottom tab. For example, a user could hit the bottom tab with an object with enough force to overcome the friction fit and separate the two pieces.), the bottom shell is in a failure mode (Fig. 12C, For the tabs to disengage a frictional force must be overcome, and the tabs will deform (i.e., fail)), and the at least one first clamp part and the at least one second clamp part that are clamped together are separated from each other, thereby separating the bottom shell from the transmitter (Fig. 12C, the edge of transmitter 16 mating with the bottom edge of 24 (opposite tabs 120) will pull away from the edge of 24 of the bottom shell); wherein the bottom shell comprises a through hole (See annotated Fig. 12C. The space corresponds to exit port 126, which is a hole that allows the sensor and needle to pass through. It is noted that par. [0369] teaches that the exit port may not include a sealing material and may comprise a clearance hole or space) and first engaging member disposed at an edge of the through hole ([0352]; The hinge 38 of the contact subassembly rests at the edge of the through hole. The hinge may be a ball and detent type hinge. Therefore the contact subassembly and the mating structure on the bottom shell at an edge of the through hole must contain either the balls or the detents. The hinge structure (ball or detent) connected to the base 24 can be considered the first engaging member).
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Annotated Fig. 12C (Kamath)
a sensor (Fig. 4A, contact subassembly 26) comprising a probe (Figs. 4A and 12, sensor 32 and a sensor base (Figs. 4A and 12, contact holder 34), wherein the sensor base comprises a second engaging member corresponding to the first engaging member (the sensor base comprises the other of the ball and detent mating with the corresponding structure of the first engaging member), the sensor base is fixed to the bottom shell by engagement of the first engaging member and the second engaging member (The hinge is assembled by the ball and detent being engaged together), the probe is disposed on the sensor base, so as to be installed on the bottom shell (See fig Figs. 3 and 12, the components of contact subassembly 26 are installed in the bottom shell below electronics unit 16, and the probe is a part of contact subassembly 26), the probe is used to detect a parameter information of body fluid analyte ([0005]; sensors are configured to detect analytes);
a battery electrically connected with the transmitter to provide electrical energy for the transmitter ([0183]; electronics unit can comprise a power source for providing power to a sensor and transmitter); and a waterproof structure (Figs. 3 and 4A, [0194]; contact subassembly 26 comprises a waterproof feature), comprising a groove ([0194]; groove of contact holder 34 where sealing member 36 is seated) and a sealing ring (Figs. 3-4, sealing member 36) arranged on the bottom shell (Shown in Fig. 1), wherein a lower end of the sealing ring is placed in the groove (Fig. 4A, sealing member 36 sits in the groove of contact holder 34 when assembled), and an upper end contacts a shell of the transmitter to provide waterproof protection for an electrical connection area of the body fluid analyte detection device (Fig. 4A, [0202]; the upper end of the sealing member 36 contacts the electronics unit 16), wherein the electrical connection area is formed between the sensor and the transmitter (Fig. 4A, the sensor is located below the sealing member 36. Fig. 12C, the transmitter is located above the sealing member 36, therefore the waterproof structure and the electrical contact area is between the sensor and transmitter)
wherein a projection of whole of the probe projected onto the bottom shell is totally located within the through hole and does not overlap with a physical part of the bottom shell (See Fig. 10B of Kamath, immediately following insertion and release of the applicator from the mounting unit, the sensor 32 (i.e., probe) is projected onto the bottom shell at the angle α. The sensor is straight at this time, and the projection at the angle α goes directly through the through hole. Because the straight configuration of the sensor is directed through the through hole, its projection does not overlap any physical part of the bottom shell at an angle α).
Kamath does not teach the sensor comprising a conductive tape, and the probe being electrically connected with the transmitter through the conductive tape to transmit a parameter signal.
Fig. 22 of Halac teaches a body-worn analyte sensor with a conductive tape that uses conductive tape to connect targeted regions of the sensor wire to the to the electrical contacts ([0263]). Using conductive tape can provide mechanical attachment of electrical contacts while allowing for electrical communication ([0264]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the sensor of Kamath to include a conductive tape, and the probe being electrically connected with the transmitter through the conductive tape to transmit a parameter signal, in order to provide mechanical attachment of electrical contacts while allowing for electrical communication, as taught by Halac ([0264]).
Regarding claim 2, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, wherein the battery is sealed in the transmitter (Kamath, [0183, 0383]; electronics unit 16 houses sensor electronics including the battery 144).
Regarding claim 6, Kamath in view of Halac teaches the body fluid analyte detection device of claim 2, wherein the waterproof structure is located in the electrical connection area in the sensor and the transmitter (Kamath, Fig. 4A, [0194]; contact subassembly 26 is located in between the sensor 32 and the electrical contacts that touch the transmitter (electronics unit)).
Regarding claim 7, Kamath in view of Halac teaches the body fluid analyte detection device of claim 6, wherein when the force is applied to the forced part, the sealing ring provides elastic force to promote separation of the transmitter and the bottom shell (Kamath, [0208-0209]; Sealing member 36 may have an elasticity to deform or compress to create the seal. Elastic deformation results in a storage of potential energy. When removing the transmitter, the potential energy stored by sealing member would be released and would bias the transmitter away from the sealing member, promoting separation of the transmitter and the bottom shell.).
Regarding claim 9, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, wherein the sealing ring is an insulating rubber ring (Kamath, [0195-0197]; The material of the sealing member may be selecting using the Shore A scale for rubbers. Rubbers are generally insulating, therefore the sealing ring being rubber comprises insulating rubber ring.).
Regarding claim 10, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, but does not teach wherein a diameter of the sealing ring is larger than an inner diameter of the groove.
Kamath teaches that the contacts are larger than the groove of the electronics unit, forming an interference fit to form a stable mechanical and electrical connection ([0218]). An interference fit is defined by a part being larger than the hole or recess it is mating with, creating a tight connection.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the sealing ring of Kamath in view of Halac to have a diameter of the sealing ring is larger than an inner diameter of the groove to create an interference fit and for a stable mechanical and electrical connection, as taught by Kamath ([0218]).
Regarding claim 11, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, wherein the upper end of the sealing ring is higher than an upper end of the groove (Kamath, Fig. 3; the top of protrusions 37 are above that of the groove).
Regarding claim 12, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, further comprising another sealing ring, the sealing ring and the another sealing ring are respectively located on an upper side and a lower side of the probe (Kamath, Fig. 4A; The first sealing ring is on the upper side of the probe. [0369-0370]; There may be another sealing member on the lower side of the probe between the housing unit and the skin).
Regarding claim 14, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, wherein a side of the bottom shell is provided with a convex part which is outward, and the convex part is the forced part (Kamath, Figs. 12A-12B; tab 120 of the base 24 (i.e., bottom shell) is considered the forced part (See the rejection of claim 1 above). The tab 120 of the base features a convex curve facing outward that matches the convex shape of the upper tab 120.).
Regarding claim 18, Kamath in view of Halac teaches a continuous glucose monitoring device, comprising: a body fluid analyte detection device of claim 1 (see the rejection of claim 1 above); and a receiver for receiving the parameter signal transmitted by the transmitter (Kamath, Figs. 15 and 17A; [0180, 0422-0423]; receiver 158 can be a part of the system and can receive a data stream from the sensor system 10).
Claims 3-5, 8, and 15-16 is rejected under 35 U.S.C. 103 as being unpatentable over Kamath in view of Halac, as applied to claim 1, in view of US Patent Publication 2019/0336055 by Shah et al. – previously cited, hereinafter “Shah”.
Regarding claim 3, Kamath in view of Halac teaches the body fluid analyte detection device of claim 1, but does not teach wherein the battery is sealed in the bottom shell to form a battery sealing chamber, and at least two electrodes are led out from the battery sealing chamber, and the electrodes at least comprise one anode and one cathode.
Fig. 10 of Shah teaches an analyte sensor base similar to that of Kamath, wherein the battery disposed in the base of the sensor. The base may include one or more electrical contacts 1028 and 1029, wherein one can be positive and one can be negative, (i.e., anode and cathode) that can contact the electrical contacts in the sensor electronics module to supply power via electrical connector 1032. A component may be provided to extend over the batteries and seal with the base ([0250-0254]). In this arrangement, sensor electronics are disposed in a mechanically separable enclosure or module from the analyte sensor and/or battery, and can advantageously allow for replacement of inexpensive components of the analyte sensor system and reuse of relatively more expensive components ([0299]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Kamath in view of Halac to include the battery sealed in the bottom shell to form a battery sealing chamber, and at least two electrodes are led out from the battery sealing chamber, and the electrodes at least comprise one anode and one cathode, to enable the replacement of inexpensive components of the analyte sensor system and reuse of relatively more expensive components, as taught by Shah ([0299]).
Regarding claim 4, the combination of Kamath, Halac, and Shah teaches the body fluid analyte detection device of claim 3, wherein the transmitter is electrically connected with the anode and the cathode respectively to obtain electric energy of the battery. (Shah; [0253]; The electrical contacts are configured to deliver battery power to a sensor electronics module. The sensor electronics module includes the transmitter.).
Regarding claim 5, the combination of Kamath, Halac, and Shah teaches the body fluid analyte detection device of claim 4, wherein another electrical connection area is formed between the transmitter and the anode and cathode (Shah; The electrical contacts 1028 and 1029 define another area where electrical connection occurs) but does not teach wherein another waterproof structure is located in the electrical connection areas in the transmitter and the anode and cathode.
Kamath teaches that providing seals around electrical connection areas protects the electrodes and the operable connections formed therein. Kamath also teaches that sealing members may form interference fits to increase the strength of a seal. ([0194, 0201-0202]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the bottom shell taught by the combination of Kamath, Halac, and Shah to include a groove and sealing member to create an interference fit between the protrusion and the bottom shell to improve the strength of the seal and to provide protection for the operable electrical connections formed, as taught by Kamath ([0194, 0201-0202]). This combination would result in a waterproof structure as claimed in claim 1, located in the electrical connection areas in the transmitter and the anode and cathode.
Regarding claim 8, Kamath, Halac, and Shah teaches the body fluid analyte detection device of claim 3, wherein the electrodes are an elastic conductive material. (Shah, [0253]; the contacts may be conductive elastomeric contacts).
Regarding claim 15, Kamath, Halac, and Shah teaches the body fluid analyte detection device of claim 3, wherein the battery is arranged in the bottom shell, and at least one connection hole is arranged in the bottom shell (Shah, Fig. 10B; each protrusion comprises a hole), the transmitter is electrically connected with the two electrodes of the battery through the connection hole (Shah; the connection of the electrical contacts occurs through the holes of the sealing members), and a battery part is the forced part (Shah, Fig 10A; the battery is located at an area that corresponds to the forced part (the lower tab 120 of Kamath is considered the forced part. See the rejection of claim 1)).
Regarding claim 16, Kamath, Halac, and Shah teaches the body fluid analyte detection device of claim 15, wherein another sealing ring is arranged around one of the at least one connection hole to seal (Shah, [0250]; each protrusion is a sealing member, which comprises a sealing ring), when the force is applied to the forced part, the another sealing ring provides elastic force to promote separation of the bottom shell and the transmitter (Shah, [0252]; The sealing member is elastomeric, therefore it stores potential energy when it is compressed. When the compression is released, the elastomeric member will release this energy, biasing the transmitter away from the bottom shell).
Response to Arguments
Applicant’s arguments, filed 06/12/2026 have been fully considered.
The amendment to claim 1 overcomes the rejection under 35 U.S.C. 112(b).
Applicant’s assertion regarding the rejection of claim 1 under 35 U.S.C. 103 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Applicant’s assertions regarding Fig. 12C of Kamath relies upon only one configuration of the device of Kamath (with an inclined and horizontal part of the sensor 32), wherein Fig. 10B provides another configuration of the device relied upon in the rejection of claim 1 (with only an inclined part of sensor 32).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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