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 .
Response to Amendment
Applicant’s amendments filed 25th February 2026 have been entered. Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 25th February 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with regard to the prior art rejections are as follows:
Applicant argues ‘Rao describes something entirely different than the amended claimed subject matter.’, Applicant provides amended claim language with item callouts. Applicant continues for clarification: ‘the sensor assembly is detachably coupled to the insertion device while the electronics assembly is located on the base. This is entirely different than what is described in Rao. For example, in Figs. 3A – 3G of Rao the sensor tray 810 contains the sensor assembly which is completely separate from the applicator 150. As shown in Figs. 3C-3E of Rao, the sensor becomes loaded with the applicator only after the applicator moved between it’s first and second positions. Applicants submit this is completely different than the amended claimed subject matter that includes an insertion device in a first position containing a slider to which a sensor assembly is detachably coupled.‘.
Examiner respectfully disagrees with Applicant. With the amended subject matter changing the scope with clarifying structure. Examiner has included updated mapping to the citations provided in response to the clarifying structure within the amended subject matter regarding the arguments pertaining to claim 1: Rao discloses an insertion device (item 4150) containing a slider in a first position (Rao: item 4606 & item 4604 combined; Para. [0160] & Fig. 19A) and
a sensor assembly detached from the electronics assembly (Rao: Para. [0147], [0219]; Para. [0158]; Note: by default, the sensor control device 102 is detached from the electronics assembly, but is capable of being removably coupled with it via Para. [0147] ‘At Step 1105, a sensor control device 102 is loaded into the applicator 150.’ & Para. [0098].)
wherein the sensor assembly includes a sensor and at least one mating feature (Rao: Para. [0147]),
the sensor assembly detachably couple to the slider in a first position (Rao: Para. [0147], [0219]; Para. [0158]; Note: by default, the sensor control device 102 is detached from the electronics assembly, but is capable of being removably coupled with it via Para. [0147] ‘At Step 1105, a sensor control device 102 is loaded into the applicator 150.’ & Para. [0098].) (updated citations added).
The citations map to the structural requirements of the claims and thus meet the claim limitations, there are currently no amendments that result in a structural difference or inventive concept over the prior art of record.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites ‘an insertion device containing a slider in a first position and a sensor assembly detached from the electronics assembly wherein the sensor assembly includes a sensor and at least one mating feature’, Examiner suggesting amending this limitation to read ‘an insertion device containing a slider in a first position and a sensor assembly detached from the electronics assembly, wherein the sensor assembly includes a sensor and at least one mating feature’.
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.
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 ‘detachably coupled to the slider in a first position’, it is unclear if this is referring to ‘a first position’, as previously recited or not, rendering claim 1 indefinite. Examiner interprets this limitation to intend ‘the first position’.
Claim 18, ‘wherein the vent is formed in a receiver portion’, it is unclear if this is referring to ‘a receiver portion’ as previously recited in claim 1, rendering claim 18 indefinite. Examiner interprets this limitation to intend ‘the receiver portion’.
Claims 2-20 are rejected by virtue of their dependence on a rejected parent claim.
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.
Claim(s) 1-17, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200196919 A1 to Rao et al. (hereinafter, Rao)
Regarding Claim 1, Rao discloses an insertion assembly (Rao: Abstract), comprising:
an electronics assembly being supported by a stand (Rao: item 4704 sheath), the electronics assembly including a base and a housing (Rao: Para. [0093] ‘the sensor applicator 150 contains an electronics housing (not shown) that retains the electrical components’ item 4702; Para. [0157] ‘sensor electronics carrier 4710’; Fig. 18A item 4710),
the housing having an enclosed portion and a receiver portion (Rao: Para. [0169] bottom portion of applicator 4150 where the applicator deploys the sensor control device to the skin is interpreted to be the receiver portion. The enclosed portion is the portion of the housing that appears to enclose);
an insertion device (item 4150) containing a slider in a first position (Rao: item 4606 & item 4604 combined; Para. [0160] & Fig. 19A) and
a sensor assembly detached from the electronics assembly (Rao: Para. [0147], [0219]; Para. [0158]; Note: by default, the sensor control device 102 is detached from the electronics assembly, but is capable of being removably coupled with it via Para. [0147] ‘At Step 1105, a sensor control device 102 is loaded into the applicator 150.’ & Para. [0098].)
wherein the sensor assembly includes a sensor and at least one mating feature (Rao: Para. [0147] ),
the sensor assembly detachably coupled to the slider in a first position (Rao: Para. [0147], [0219]; Para. [0158]; Note: by default, the sensor control device 102 is detached from the housing, but is capable of being removably coupled with it via Para. [0147] ‘At Step 1105, a sensor control device 102 is loaded into the applicator 150.’ & Para. [0098]; Note: the sensor control device is loaded into the applicator with the slider in an initial position, where the slider is coupled with the carrier for the control device and thus coupled to the sensor assembly when loaded, then upon activation the slider is transitioned to an unloaded position driving the sensor control device to the base of the sheath/applicator to the target location of skin for in vivo analyte sensing.),
wherein the slider is coupled to an energy storage system (Rao: Para. [0111], [0114], [0160] ‘drive spring… retraction spring… each in a preloaded state… a first end coupled to firing pin… and a second end coupled to sensor electronics carrier’);
wherein the slider is further configured to transition to a second position that couples the sensor assembly to the receiver portion to define an on-body assembly (Rao: Para. [0084]; Rao: Para. [0147], [0219]; Para. [0158]; Note: by default, the sensor control device 102 is detached from the housing, but is capable of being removably coupled with it via Para. [0147] ‘At Step 1105, a sensor control device 102 is loaded into the applicator 150.’ & Para. [0098]; Note: the sensor control device is loaded into the applicator with the slider in an initial position, where the slider is coupled with the carrier for the control device and thus coupled to the sensor assembly when loaded, then upon activation the slider is transitioned to an unloaded position driving the sensor control device to the base of the sheath/applicator to the target location of skin for in vivo analyte sensing),
the transition to the second position loads the energy storage system and upon actuation, the energy storage system is unloaded to transition the slider to the first position (Rao: Rao: Para. [0147], [0219]; Para. [0158]; Note: by default, the sensor control device 102 is detached from the housing, but is capable of being removably coupled with it via Para. [0147] ‘At Step 1105, a sensor control device 102 is loaded into the applicator 150.’ & Para. [0098]; Para. [0168]; Para. [0170] ‘As retraction spring 4604 expands in a proximal direction, sharp carrier 4602 is displaced to the third position within applicator 4150 (e.g., top of sheath 4704), which causes the sharp to withdraw from the skin surface.’; Para. [0244]; Note: the sensor control device is loaded into the applicator with the slider in an initial position, where the slider is coupled with the carrier for the control device and thus coupled to the sensor assembly when loaded, then upon activation the slider is transitioned to an unloaded position driving the sensor control device to the base of the sheath/applicator to the target location of skin for in vivo analyte sensing, then the slider retraction processes) and
the on-body assembly is positioned to decouple from the slider (Rao: Para. [0098]).
Regarding Claim 2, Rao discloses the insertion assembly as described in claim 1, Rao further discloses comprising: a slider engagement coupled with the slider (Rao: Para. [0244]);
a sharp configured to be coupled with the slider (Rao: Para. [0125] ‘sensor electronics carrier 710 that can retain sensor electronics within applicator 150. It can also retain sharp carrier 1102 with sharp module 2500’; Para. [0160] ‘Drive spring 4606 includes a first end coupled to firing pin 4705 and a second end coupled to sensor electronics carrier 4710.’); and
a patch coupled to the base, the patch having a skin-side adhesive configured to couple the on-body assembly to a subject (Rao: Para. [0098] ‘The adhesive patch 105 (FIG. 1) applied to the bottom of sensor control device 102 adheres to the skin to secure the sensor control device 102 in place.’).
Regarding Claim 3, Rao discloses the insertion assembly as described in claim 2, Rao further discloses wherein a first coupling force between the skin-side adhesive and the subject is greater than a second coupling force between the on-body assembly and the slider (Rao: Para. [0126] ‘The adhesive force retains sensor control device 102 on the skin and overcomes the lateral force applied by spring arms 1518. As a result, spring arms 1518 deflect radially outwardly and disengage detents 1519 from sensor control device 102 thereby releasing sensor control device 102 from applicator 150.’; Para. [0158]).
Regarding Claim 4, Rao discloses the insertion assembly as described in claim 1, Rao further discloses wherein the electronics assembly further includes electrical circuitry along with a power supply being contained within the enclosed portion (Rao: Para. [0088] ‘sensor control devices 102 having analyte sensors 104 and sensor electronics 160 (including analyte monitoring circuitry) that can have the majority of the processing capability for rendering end-result data suitable for display to the user. In FIG. 2B, a single semiconductor chip 161 is depicted that can be a custom application specific integrated circuit (ASIC).’; Para. [0089] ‘ASIC 161 is coupled with power source 170, which can be a coin cell battery, or the like.’) and
a conductor that extends from within the housing into the receiver portion (Rao: Para. [0147] ‘Sensor control device 102 can include various components, including… an analyte sensor extending from a bottom of the electronics housing…’; Para. [0131] ‘Tail 2408 can be the portion of sensor 104 that resides under a user’s skin after insertion.’; Para. [0158]).
Regarding Claim 5, Rao discloses the insertion assembly as described in claim 4, Rao further discloses wherein the sensor assembly further includes a cap that includes a cap feature, the cap feature having an interior face and an exterior face (Rao: Fig. 12A and 12B item 504 sensor module structure defines a ‘cap’ having an interior and exterior face).
Regarding Claim 6, Rao discloses the insertion assembly as described in claim 5, Rao further discloses wherein the sensor has a distal end and a proximal end, the proximal end being parallel with the interior face (Rao: Para. [0134] ‘Sensor 3104 includes a proximal sensor portion, coupled to sensor module 3504, as described above, and a distal sensor portion that is positioned beneath a skin surface in contact with a bodily fluid.’; Fig. 15A & 15B show the distal portion (item 2420) of sensor 104 parallel to the interior face of the sensor module when assembled).
Regarding Claim 7, Rao discloses the insertion assembly as described in claim 6, Rao further discloses wherein the cap further includes a sharp support that extends away from the interior face, the sharp support further having a channel (Rao: Fig. 12A and 12B, the structures of the sensor module that make up the openings of item 2208 & item 2204 are interpreted to be the sharp support; Para. [0129] ‘A sharp slot 2208 can provide a location for sharp tip 2502 to pass through and sharp shaft 2504 to temporarily reside.’).
Regarding Claim 8, Rao discloses the insertion assembly as described in claim 7, Rao further discloses wherein the sharp support further includes a sensor support being formed within the channel (Rao: Para. [0129] ‘A sensor ledge 2212 can define a sensor position in a horizontal plane, prevent a sensor from lifting connector 2300 off of posts and maintain sensor 104 parallel to a plane of connector seals. It can also define sensor bend geometry and minimum bend radius. It can limit sensor travel in a vertical direction and prevent a tower from protruding above an electronics housing surface and define a sensor tail length below a patch surface. A sensor wall 2216 can constrain a sensor and define a sensor bend geometry and minimum bend radius.’).
Regarding Claim 9, Rao discloses the insertion assembly as described in claim 8, Rao further discloses wherein the sensor further includes a first jog, the first jog interacting with the sensor support to position the sensor within the channel (Rao: Fig. 14, 2412; Para. [0131] ‘A biasing tower 2412 can be a tab that biases the tail 2408 into sharp slot 2208.’; Para. [0129] ‘A sensor ledge 2212 can define a sensor position in a horizontal plane, prevent a sensor from lifting connector 2300 off of posts and maintain sensor 104 parallel to a plane of connector seals. It can also define sensor bend geometry and minimum bend radius. It can limit sensor travel in a vertical direction and prevent a tower from protruding above an electronics housing surface and define a sensor tail length below a patch surface. A sensor wall 2216 can constrain a sensor and define a sensor bend geometry and minimum bend radius.’).
Regarding Claim 10, Rao discloses the insertion assembly as described in claim 9, Rao further discloses wherein the cap includes at least one sensor retainer being formed on the interior face of the cap (Rao: Fig. 12B; Para. [0129] ‘A sensor ledge 2212 can define a sensor position in a horizontal plane, prevent a sensor from lifting connector 2300 off of posts and maintain sensor 104 parallel to a plane of connector seals. It can also define sensor bend geometry and minimum bend radius. It can limit sensor travel in a vertical direction and prevent a tower from protruding above an electronics housing surface and define a sensor tail length below a patch surface. A sensor wall 2216 can constrain a sensor and define a sensor bend geometry and minimum bend radius.’).
Regarding Claim 11, Rao discloses the insertion assembly as described in claim 10, Rao further discloses wherein the sensor further includes a second jog, the second jog interacting with the sensor retainer to position the sensor relative to the cap (Rao: Para. [0131] ‘A neck 2406 can be a zone which allows folding of the sensor, for example ninety degrees.’).
Regarding Claim 12, Rao discloses the insertion assembly as described in claim 6, Rao further discloses further including a first gasket being coupled to the interior face of the cap (Rao: Para. [0130] ‘The connector can also serve as a moisture barrier for sensor 104 when assembled in a compressed state after transfer from a container to an applicator and after application to a user's skin. A plurality of seal surfaces 2304 can provide a watertight seal for electrical contacts and sensor contacts.’; Para. [0132] ‘FIGS. 15A and 15B are bottom and top perspective views, respectively, depicting an example embodiment of a sensor module assembly comprising sensor module 504, connector 2300, and sensor 104.’).
Regarding Claim 13, Rao discloses the insertion assembly as described in claim 12, Rao further discloses wherein the proximal end of the sensor is coupled to the first gasket (Rao: Para. [0132] ‘FIGS. 15A and 15B are bottom and top perspective views, respectively, depicting an example embodiment of a sensor module assembly comprising sensor module 504, connector 2300, and sensor 104.’).
Regarding Claim 14, Rao discloses the insertion assembly as described in claim 7, Rao further discloses wherein the distal end extends away from the channel (Figs. 15A and 15B show the distal end of sensor 104 extending away from the channel).
Regarding Claim 15, Rao discloses the insertion assembly as described in claim 5, Rao further discloses wherein the sensor receives power from the power supply upon coupling of the electronics assembly and the sensor assembly (Rao: Para. [0084] ‘The sensor can be part of the sensor control device that resides on the body of the user and contains the electronics and power supply that enable and control the analyte sensing.’; Para. [0008] ‘The user can couple the sensor module to the electronics housing, and can couple the sharp to the applicator with an assembly process that involves the insertion of the applicator into the container in a specified manner.’).
Regarding Claim 16, Rao discloses the insertion assembly as described in claim 13, Rao further discloses further including a second gasket being coupled to both the sensor and the first gasket (Rao: Para. [0130] ‘The connector can also serve as a moisture barrier for sensor 104 when assembled in a compressed state after transfer from a container to an applicator and after application to a user's skin. A plurality of seal surfaces 2304 can provide a watertight seal for electrical contacts and sensor contacts.’).
Regarding Claim 17, Rao discloses the insertion assembly as described in claim 16, Rao further discloses wherein the second gasket includes a contact opening, the contact opening exposing electrical contact of the sensor (Rao: Para. [0130]; Para. [0131] ‘Contacts 2418 can electrically couple the active portion of the sensor to connector 2300.’).
Regarding Claim 19, Rao discloses the insertion assembly as described in claim 14, Rao further discloses wherein the electronics assembly includes a sharp support aperture to ensure that the sharp and the sensor have an unobstructed path through the electronics assembly (Rao: Para. [0108], [0127], [0129] ‘A sharp slot 2208 can provide a location for sharp tip 2502 to pass through and sharp shaft 2504 to temporarily reside.’).
Regarding Claim 20, Rao discloses the insertion assembly as described in claim 19, Rao further discloses wherein the sharp support is configured to fit within the sharp support aperture to place the sharp and sensor to pass through the electronics assembly (Rao: Para. [0129] ‘A sharp slot 2208 can provide a location for sharp tip 2502 to pass through and sharp shaft 2504 to temporarily reside.’; Note the sharp support aperture are the openings of item 2204 and 2208 in Figs. 12A and 12B, the structures that make-up those openings are interpreted as the sharp support, see rejection for Claim 9).
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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200196919 A1 to Rao et al. (hereinafter, Rao) in view of US 20180353117 A1 to Bullington et al. (hereinafter, Bullington).
Regarding Claim 18, Rao discloses The insertion assembly as described in claim 17, Rao does not explicitly disclose wherein the electronics assembly includes a vent being formed in a receiver portion.
However, Bullington teaches wherein the electronics assembly includes a vent, wherein the vent is formed in a receiver portion (Bullington: Para. [0091]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the electronics assembly of Rao to include a vent as taught by Bullington to allow gas to vent from the assembly (Para. [0091] ‘the vent material 242 can be a self-sealing material configured to selectively allow a flow of gas (e.g., air) to vent from the sequestration portion 234 through the opening 235.’).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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