Prosecution Insights
Last updated: October 02, 2026
Application No. 18/681,448

APPLICATOR FOR TRANSCUTANEOUS SENSOR, AND APPLICATOR ASSEMBLY

Non-Final OA §102§103
Filed
Feb 05, 2024
Priority
Aug 05, 2021 — RE 10-2021-0103240 +1 more
Examiner
PARK, EVELYN GRACE
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
i-SENS Inc.
OA Round
2 (Non-Final)
52%
Grant Probability
Moderate
2-3
OA Rounds
12m
Est. Remaining
92%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
47 granted / 91 resolved
-18.4% vs TC avg
Strong +40% interview lift
Without
With
+40.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
35 currently pending
Career history
118
Total Applications
across all art units

Statute-Specific Performance

§101
13.6%
-26.4% vs TC avg
§103
34.6%
-5.4% vs TC avg
§102
31.8%
-8.2% vs TC avg
§112
18.2%
-21.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 91 resolved cases

Office Action

§102 §103
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 The amendment filed May 18, 2026 has been entered. Claims 1-3 and 5-14 remain pending in the application, and claim 4 was cancelled. Applicant’s amendments to the claims have overcome each and every 101, 102, and 112 rejection previously set forth in the Non-Final Office Action mailed February 18, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 103 Rejections below. 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 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200289748 A1 (Lanigan et al.) in view of US 20090198190 A1 (Jensen et al.) Regarding claim 1, Lanigan teaches an applicator for inserting a sensor configured for measuring biometric information into skin of a user ([0196] “certain inserter assemblies 100 may be operated to place physiological monitors into working relationship with a patient's body. In certain examples, an analyte sensor may be placed onto a patient with an inserter assembly 100.”), the applicator comprising: an applicator body ([0196] “FIG. 1A depicts an exploded view of an embodiment of an example inserter assembly 100.”); an insertion unit ([0006] “an infusion set base in retaining engagement with the body”) installed to the applicator body to move a sensor unit, which includes the sensor, a sensor unit housing to which the sensor is mounted ([0312] “install a next infusion set 102 (or analyte sensor in certain examples) … infusion sets 102 may be provided in separate set cartridges 1002. Similarly, where the inserter assembly 100 is configured to apply a sensor to the patient, s+ensors may be provided in sensor cartridges”); [0045]), an adhesive layer provided at the sensor unit housing ([0006] “The infusion set base may have an adhesive included on a bottom face thereof”), and a protective sheet covering an adhesive layer ([0024] “removing an adhesive backing from the infusion set base”; [0031] “The adhesive being covered by a liner or backing.”), from a first position spaced apart from the skin of the user to a second position where the sensor is configured to be inserted into the skin of the user ([0036] “The insertion bias member may propel the insertion driver from the first position to the extended position when released from the stressed state.”; [0360] “free the spring 1108 to transition to its unstressed state and displace the insertion driver 1062 toward the skin 356.”; [0041]); a removing member to which a portion of the protective sheet is coupled and is rotatably installed to the applicator body to remove the protective sheet from the adhesive layer ([0033] “the housing may include an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed”; [0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and` housing are coupled. In some embodiments, the container may be configured to displace the lock members when pressed against the inserter assembly to unlock rotational displacement of the housing. In some embodiments, the spring loaded tab may be configured to displace to the deflected state upon coupling of the cartridge to the inserter assembly”; [0209]; [0247] “As the example adhesive backing 111 is attached to the lock member 146, extraction of the lock member 146 may complete disassociation of the adhesive backing 111 from the inserter assembly 100.”); an operation member installed to the applicator body to operate the removing member configured to be manipulated by the user ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled”; [0247] “The adhesive backing 111 may include a gripping region 224 which may be in the form of a flange, tab, or other projection of backing material which extends beyond the footprint of the inserter assembly 100”). Lanigan does not explicitly teach a removing member driver configured to provide rotary force to the removing member, wherein the operation member is configured to operate the removing member driver such that the removing member is rotated by the removing member driver However, Jensen teaches a removing member driver configured to provide rotary force to the removing member ([0015] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle, wherein a projecting part of the release layer is secured to the housing of the injector device.”; [0124] “the spring (34) drives the slidable member (32) and the infusion part (0B) to its forward position, thus introducing the cannula (5) of the infusion part into the patient by means of the needle. The release layer is provided with projections (8, 8') being secured to the housing (30), so when the slidable member (32) moves to its forward position, the release layer is automatically removed. After the introduction of the cannula the injector device can be withdrawn leaving the needle in a free position, and the infusion part is secured to the skin using the mounting pad (2). The pivoting member (36) can then be swung into a position in which it embraces the needle and protects patients or assisting persons from being stung.”; [0140] “A pivoting member on the injector device is pulled back in order to unlock the device and to prepare the application of the infusion set. When the pivoting member is pulled back the second section of the release layer is accessible and subsequently removed by pulling one of the projecting parts (43, 44) thereby exposing the adhesive surface underneath.”) wherein the operation member is configured to operate the removing member driver such that the removing member is rotated by the removing member driver ([0124], [0140], [0097], [0071] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the invention to include a removing member driver. One would have been motivated to make this modification because the release of the locking means of the spring is used to swing the pivot member in order to pull back the adhesive release layer to secure the injector device and protect the patient of assisting persons from being stung by the device, as suggested by Jensen ([0015]; [0097]; [0124]). Regarding claim 2, Lanigan teaches the applicator according to claim 1, wherein the removing member is configured to be rotatable around a central rotation axis perpendicular to a movable direction of the sensor unit ([0035] “the container may be configured to displace the lock members when pressed against the inserter assembly to unlock rotational displacement of the housing”). Regarding claim 3, Lanigan teaches the applicator according to claim 1, wherein the removing member is coupled to the protective sheet by an adhesive member ([0247] “As the example adhesive backing 111 is attached to the lock member 146, extraction of the lock member 146 may complete disassociation of the adhesive backing 111 from the inserter assembly 100.”. Regarding claim 5, Lanigan teaches the applicator according to claim 1. Lanigan does not explicitly teach wherein the removing member driver is coupled with the removing member and configured to apply elastic force to the removing member. However, Jensen teaches wherein the removing member driver is coupled with the removing member and configured to apply elastic force to the removing member ([0015] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle, wherein a projecting part of the release layer is secured to the housing of the injector device.”; [0124] “the spring (34) drives the slidable member (32) and the infusion part (0B) to its forward position, thus introducing the cannula (5) of the infusion part into the patient by means of the needle. The release layer is provided with projections (8, 8') being secured to the housing (30), so when the slidable member (32) moves to its forward position, the release layer is automatically removed. After the introduction of the cannula the injector device can be withdrawn leaving the needle in a free position, and the infusion part is secured to the skin using the mounting pad (2). The pivoting member (36) can then be swung into a position in which it embraces the needle and protects patients or assisting persons from being stung.”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the invention to include a removing member driver using an elastic force. One would have been motivated to make this modification because the release of the locking means of the elastic spring is used to swing the pivot member in order to pull back the adhesive release layer to secure the injector device and protect the patient of assisting persons from being stung by the device, as suggested by Jensen ([0015]; [0097]; [0124]). Regarding claim 6, Lanigan teaches the applicator according to claim 5, comprising a stopper member installed to the applicator body to restrain movement of the removing member by being contacted with the removing member to maintain a position in which the removing member is coupled with the protective sheet in a state that a removing elastic member is elastically deformed ([0340] “This may inhibit rotation of the interior housing 1008 of the cartridge 1002 relative to the inserter assembly 1000 as the edge walls 1084 may act as stop surfaces which present a mechanical interference blocking displacement of the lock members 1112A, B”), wherein the operation member is operated to release restraining force of the removing member caused by the stopper member ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled.”). Regarding claim 7, Lanigan teaches the applicator according to claim 6, wherein the stopper member is installed to be movable in a direction of intersecting with a movable direction of the sensor unit ([0331] “As shown in FIGS. 70A-70B, the exterior housing 116 may also include stop protrusions 1094 on the interior face of the exterior housing 116. The stop protrusions 1094 may be nubs, pins, rails or any suitable feature”). Regarding claim 8, Lanigan teaches the applicator according to claim 7, comprising an elastic member configured to apply elastic force to the stopper member such that the stopper member is movable in a direction of releasing the restraining force of the removing member ([0012] “The inserter assembly may further comprise a sharp retractor having a cavity at least partially containing the sharp holder and having a stop therein configured to engage the ledge. The sharp retractor may additionally have a catch configured to engage the ledge and hold an insertion spring in a biased state”); and a stopper member fixing portion provided at the stopper member or the applicator body to interlock the stopper member and the applicator body to maintain a position in which the stopper member restrains movement of the removing member in a state that the elastic member is elastically deformed ([0012] “The inserter assembly may further comprise an infusion set base releasably coupled to the sharp retractor and holding a retraction spring in a biased state while releasably coupled to the sharp retractor.”), wherein the operation member is operated to release fixing force of the stopper member caused by the stopper member fixing portion ([0260] “Spring 138 is held in compression between the interior housing 120 and the sharp retractor 134. Upon release, spring 138 drives the sharp retractor 134 and sharp holder 130 from a post insertion state to a retracted state”). Regarding claim 9, Lanigan teaches the applicator according to claim 6, wherein the insertion unit comprises a shuttle installed to be movable from the first position to the second position together with the sensor unit ([0009] “the infusion set base may be arranged to be decoupled from the body as the sharp holder is propelled toward the skin”), a needle coupled with the shuttle to be movable from the first position to the second position together with the shuttle, and separably coupled to the sensor unit configured to be inserted into the skin of the user together with the sensor ([0206] “The sharp holder 130 may retain an insertion sharp 132 thereon”; [0316] “When the set cartridge 1002 is assembled, the insertion sharp 132 may extend through the cannula sub assembly 114 and the cannula sub assembly 114 may be disposed against the sharp holder 130. In sensor cartridge embodiments, the cannula sub assembly 114 and infusion set base 106 may be replaced by a sensor assembly.”), and a shuttle driver configured to provide moving force to the shuttle in a direction of moving the first position to the second position ([0283] “As shown, the restoring action of the spring 136 may drive the sharp holder 130, insertion sharp 132, and cannula subassembly 114 toward the skin 356 along an insertion path”), and wherein movement of the shuttle is restrained by the stopper member at the first position, and the shuttle is movable to the second position by the shuttle driver by releasing restraining force of the stopper member according to movement of the stopper member ([0334] “As shown in FIGS. 70A-70B, the exterior housing 116 may also include stop protrusions 1094 on the interior face of the exterior housing 116. The stop protrusions 1094 may be nubs, pins, rails or any suitable feature”). Regarding claim 10, Lanigan teaches the applicator according to claim 9, wherein the stopper member is configured to release restraining force applied to the removing member first, and after completing a separation operation of the protective film by the removing member, release restraining force applied to the shuttle ([0011-0012] “the sharp holder may include at least one ledge and the sharp retractor includes a least one stop. There may be a dwell distance between the at least one ledge and the stop when the retractor bias member is released from the retraction energy storing state.”). Regarding claim 11, Lanigan teaches the applicator according to claim 1, wherein the removing member is configured to complete a separation operation of the protective sheet before the sensor unit is moved from the first position ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled. In some embodiments, the container may be configured to displace the lock members when pressed against the inserter assembly to unlock rotational displacement of the housing. In some embodiments, the spring loaded tab may be configured to displace to the deflected state upon coupling of the cartridge to the inserter assembly”; [0036] “a sensor cartridge”; [0209]; [0247] “As the example adhesive backing 111 is attached to the lock member 146, extraction of the lock member 146 may complete disassociation of the adhesive backing 111 from the inserter assembly 100.”). Regarding claim 12, Lanigan teaches an applicator configured for inserting a sensor into skin of a user ([0196] “certain inserter assemblies 100 may be operated to place physiological monitors into working relationship with a patient's body. In certain examples, an analyte sensor may be placed onto a patient with an inserter assembly 100.”), the applicator comprising: an applicator body to which a base unit including a base unit housing ([0196] “FIG. 1A depicts an exploded view of an embodiment of an example inserter assembly 100.”; [0206] “A retainer base 140 may a serve to couple to a bottom portion of the inserter assembly 100 to hold the various components in place within the inserter assembly 100. In the example, the retainer base 140 includes retaining interfaces 142 which may snap into cantilevered retainer arms 144 included on the exterior housing 116.”), and an adhesive portion provided at the base unit housing configured to be attached to the skin of the user is separably coupled ([0215] “In various embodiments, however, fenestrations similar to fenestrations 148, 150 in FIGS. 1A-1C in the exterior housing 116 and interior housing 120 may be included to accommodate a lock member 146. In these embodiments, the adhesive backing 111 could be bonded onto the lock member 146. In the example embodiment, however, the adhesive backing 111 includes two pull tabs 410 (though any suitable number may be included). These pull tabs 410 may be grasped by a user to facilitate removal of the adhesive backing 111.”); an insertion unit installed to the applicator body to move the sensor unit, which includes the sensor and a sensor unit housing to which the sensor is mounted, an adhesive layer provided at the sensor unit housing to be attachable to the base unit housing, and a protective sheet covering the adhesive layer from a first position which is spaced apart from the base unit to a second position where the sensor unit is coupled with the base unit configured to insert the sensor into the skin of the user ([0030] “The cartridge may further comprise an infusion set base retainer having an infusion set base retained thereon.”; [0031] “In some embodiments, the infusion set base may include adhesive on a face thereof. The adhesive being covered by a liner or backing”); a removing member to which a portion of the protective sheet is coupled and is rotatably installed to the applicator body to remove the protective sheet from the adhesive layer ([0033] “the housing may include an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed”; [0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled. In some embodiments, the container may be configured to displace the lock members when pressed against the inserter assembly to unlock rotational displacement of the housing. In some embodiments, the spring loaded tab may be configured to displace to the deflected state upon coupling of the cartridge to the inserter assembly”; [0209]; [0247] “As the example adhesive backing 111 is attached to the lock member 146, extraction of the lock member 146 may complete disassociation of the adhesive backing 111 from the inserter assembly 100.”); an operation member installed to the applicator body to operate the removing member configured to be manipulated by the user ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled”; [0247] “The adhesive backing 111 may include a gripping region 224 which may be in the form of a flange, tab, or other projection of backing material which extends beyond the footprint of the inserter assembly 100”); and Lanigan does not explicitly teach a removing member driver configured to provide rotary force to the removing member, wherein the operation member is configured to operate the removing member driver such that the removing member is rotated by the removing member driver However, Jensen teaches a removing member driver configured to provide rotary force to the removing member ([0015] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle, wherein a projecting part of the release layer is secured to the housing of the injector device.”; [0124] “the spring (34) drives the slidable member (32) and the infusion part (0B) to its forward position, thus introducing the cannula (5) of the infusion part into the patient by means of the needle. The release layer is provided with projections (8, 8') being secured to the housing (30), so when the slidable member (32) moves to its forward position, the release layer is automatically removed. After the introduction of the cannula the injector device can be withdrawn leaving the needle in a free position, and the infusion part is secured to the skin using the mounting pad (2). The pivoting member (36) can then be swung into a position in which it embraces the needle and protects patients or assisting persons from being stung.”; [0140] “A pivoting member on the injector device is pulled back in order to unlock the device and to prepare the application of the infusion set. When the pivoting member is pulled back the second section of the release layer is accessible and subsequently removed by pulling one of the projecting parts (43, 44) thereby exposing the adhesive surface underneath.”) wherein the operation member is configured to operate the removing member driver such that the removing member is rotated by the removing member driver ([0124], [0140], [0097], [0071] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the invention to include a removing member driver. One would have been motivated to make this modification because the release of the locking means of the spring is used to swing the pivot member in order to pull back the adhesive release layer to secure the injector device and protect the patient of assisting persons from being stung by the device, as suggested by Jensen ([0015]; [0097]; [0124]). Regarding claim 13, Lanigan teaches an applicator assembly comprising: an applicator body ([0196] “FIG. 1A depicts an exploded view of an embodiment of an example inserter assembly 100.”); a sensor unit including a sensor, a sensor unit housing to which the sensor is mounted, an adhesive layer provided at the sensor unit housing, and a protective sheet covering the adhesive layer ([0312] “install a next infusion set 102 (or analyte sensor in certain examples) … infusion sets 102 may be provided in separate set cartridges 1002. Similarly, where the inserter assembly 100 is configured to apply a sensor to the patient, sensors may be provided in sensor cartridges”; [0024] “removing an adhesive backing from the infusion set base”; [0031] “The adhesive being covered by a liner or backing.”); an insertion unit installed to the applicator body configured to move the sensor unit from a first position spaced away from a skin of a user to a second position where the sensor is configured to be inserted into the skin of the user ([0006] “an infusion set base in retaining engagement with the body”; [0036] “The insertion bias member may propel the insertion driver from the first position to the extended position when released from the stressed state.”; [0360] “free the spring 1108 to transition to its unstressed state and displace the insertion driver 1062 toward the skin 356.”; [0041]); a removing member to which a portion of the protective sheet is coupled and is rotatably installed to the applicator body to remove the protective sheet from the adhesive layer ([0033] “the housing may include an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed”; [0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled. In some embodiments, the container may be configured to displace the lock members when pressed against the inserter assembly to unlock rotational displacement of the housing. In some embodiments, the spring loaded tab may be configured to displace to the deflected state upon coupling of the cartridge to the inserter assembly”; [0209]; [0247] “As the example adhesive backing 111 is attached to the lock member 146, extraction of the lock member 146 may complete disassociation of the adhesive backing 111 from the inserter assembly 100.”); an operation member installed to the applicator body to operate the removing member configured to be manipulated by the user ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed. In some embodiments, the housing may include a set of stop surfaces configured to interact with lock members of the inserter assembly to lock the housing from rotational displacement once the inserter assembly and housing are coupled”; [0247] “The adhesive backing 111 may include a gripping region 224 which may be in the form of a flange, tab, or other projection of backing material which extends beyond the footprint of the inserter assembly 100”); and Lanigan does not explicitly teach a removing member driver configured to provide rotary force to the removing member, wherein the operation member is configured to operate the removing member driver such that the removing member is rotated by the removing member driver However, Jensen teaches a removing member driver configured to provide rotary force to the removing member ([0015] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle, wherein a projecting part of the release layer is secured to the housing of the injector device.”; [0124] “the spring (34) drives the slidable member (32) and the infusion part (0B) to its forward position, thus introducing the cannula (5) of the infusion part into the patient by means of the needle. The release layer is provided with projections (8, 8') being secured to the housing (30), so when the slidable member (32) moves to its forward position, the release layer is automatically removed. After the introduction of the cannula the injector device can be withdrawn leaving the needle in a free position, and the infusion part is secured to the skin using the mounting pad (2). The pivoting member (36) can then be swung into a position in which it embraces the needle and protects patients or assisting persons from being stung.”; [0140] “A pivoting member on the injector device is pulled back in order to unlock the device and to prepare the application of the infusion set. When the pivoting member is pulled back the second section of the release layer is accessible and subsequently removed by pulling one of the projecting parts (43, 44) thereby exposing the adhesive surface underneath.”) wherein the operation member is configured to operate the removing member driver such that the removing member is rotated by the removing member driver ([0124], [0140], [0097], [0071] “locking means for maintaining the spring in a compressed state and release means for disengaging the locking means, said device further comprising a pivoting member which can be swung into a position in which it embraces the needle”). It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the invention to include a removing member driver. One would have been motivated to make this modification because the release of the locking means of the spring is used to swing the pivot member in order to pull back the adhesive release layer to secure the injector device and protect the patient of assisting persons from being stung by the device, as suggested by Jensen ([0015]; [0097]; [0124]). Regarding claim 14, Lanigan teaches the applicator assembly according to claim 13, comprising a base unit including a base unit housing to which the sensor unit housing is coupled and an adhesive portion provided at the base unit housing configured to be attachable to the skin of the user, and spaced apart from the sensor unit and separably coupled to the applicator body ([0196] “FIG. 1A depicts an exploded view of an embodiment of an example inserter assembly 100.”; [0206] “A retainer base 140 may a serve to couple to a bottom portion of the inserter assembly 100 to hold the various components in place within the inserter assembly 100. In the example, the retainer base 140 includes retaining interfaces 142 which may snap into cantilevered retainer arms 144 included on the exterior housing 116.”; [0215] “In various embodiments, however, fenestrations similar to fenestrations 148, 150 in FIGS. 1A-1C in the exterior housing 116 and interior housing 120 may be included to accommodate a lock member 146. In these embodiments, the adhesive backing 111 could be bonded onto the lock member 146. In the example embodiment, however, the adhesive backing 111 includes two pull tabs 410 (though any suitable number may be included). These pull tabs 410 may be grasped by a user to facilitate removal of the adhesive backing 111.”), wherein the sensor unit housing is configured to be attachable to the base unit housing by the adhesive layer at the second position ([0030] “The cartridge may further comprise an infusion set base retainer having an infusion set base retained thereon.”; [0031] “In some embodiments, the infusion set base may include adhesive on a face thereof. The adhesive being covered by a liner or backing”). Response to Arguments Applicant's arguments filed May 18, 2026 have been fully considered but they are not persuasive. With respect to the Double Patenting Rejections in the Non-Final Office Action (See Page 7 of Applicant’s Response “Double Patenting Rejections”), Applicant argues that the incorporation of limitations from claim 4 into independent claims 1, 12, and 13 makes the claims patentably distinct from 18/575,260 and 18/575,315. With respect to the 102 Rejections in the Non-Final Office Action (See Pages 8-9 of Applicant’s Response “Rejection under 35 U.S.C. § 102(a)(1)”), Applicant argues that Lanigan fails to disclose or suggest at least a removing member driver configure to provide rotary force to the removing member required by the amended independent claims. Applicant states that Lanigan teaches locking rotational displacement and preventing movement, and therefore does not anticipate the limitations of the independent claims. There are new grounds of claim rejections that were necessitated by the claim amendments. Jensen teaches an elastic removing member driver to rotatably move a removing member, as described in [0015], which would be obvious to incorporate into the device taught by Lanigan as explained in the 103 rejections above. Claims 2-3, 5-11, and 14 are rejected because the rejections of claims 1, 12, and 13 are proper and the prior art teaches or suggests all the features of these claims for the reasons described in the 103 rejections. 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 EVELYN GRACE PARK whose telephone number is (571)272-0651. The examiner can normally be reached Monday - Friday, 9AM - 5:00PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Feb 05, 2024
Application Filed
Feb 18, 2026
Non-Final Rejection mailed — §102, §103
May 18, 2026
Response Filed
Aug 06, 2026
Final Rejection mailed — §102, §103
Sep 17, 2026
Response after Non-Final Action

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5y 4m to grant Granted May 26, 2026
Patent 12622622
BLOOD GLUCOSE STATES BASED ON SENSED BRAIN ACTIVITY
2y 2m to grant Granted May 12, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

2-3
Expected OA Rounds
52%
Grant Probability
92%
With Interview (+40.5%)
3y 7m (~12m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 91 resolved cases by this examiner. Grant probability derived from career allowance rate.

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