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 June 1, 2026 has been entered. Claims 1-24 remain pending in the application. Applicant’s amendments to the claims have overcome each and every double patenting rejection, 101 rejection, 112 rejection, and claim objection previously set forth in the Non-Final Office Action mailed March 3, 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 1-24 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 configured for inserting a sensor 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 having a bottom portion configured to be contactable with the skin of
the user ([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 the sensor unit, which comprises 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, sensors may be provided in sensor cartridges”; [0045]), an adhesive layer comprised in the sensor unit housing ([0006] “The infusion set base may have an adhesive included on a bottom face thereof”), and a protective sheet covering the 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 where the sensor unit is spaced apart from the skin of the user to a second position where the sensor is 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 carriage to which a part of the protective sheet is coupled and which is installed to the applicator body to move in a direction away from the sensor unit housing for releasing 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.”); and
an operation member installed to the applicator body to operate the carriage 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 wherein the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member.
However,
Jensen teaches wherein the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member ([0080] “When the device is actuated the infusion part on the mounting pad is pushed in the direction towards the skin and during this movement the second and third section of the release layer will start to peel off the mounting pad, as the two projecting parts and the tongue are secured to the application device, preferably on different sides of the housing of the device. Accordingly, the first section of the release layer and the mounting pad will move in one direction while the second and third section of the release layer will begin to move in a deviating direction, thus gradually exposing the adhesive surface of the mounting pad”; [0124])
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 applicator taught by Lanigan to include automatic movement of the carriage away from the bottom portion with manipulation of the operation member. One would have been motivated to make this modification because the automatic and rapid application of a device on the user’s body does not require fine finger movements and provided optimum placement of the cannula without significant pain to the user or contamination, as suggested by Jensen ([0056, 0078]).
Regarding claim 2, Lanigan teaches the applicator according to claim 1, wherein the carriage is installed to move in a direction away from the bottom portion ([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 2, wherein the carriage is installed to move in a direction opposite to a movement direction of the sensor unit ([0035]; [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 4, Lanigan teaches the applicator according to claim 1, comprising a carriage driver configured to move the carriage ([0044] “inserter assembly may further comprise at least one spring biased lock member displaceable from a withdrawn position to an extended position”).
Regarding claim 5, Lanigan teaches the applicator according to claim 1, comprising an elastic member configured to apply an elastic force to the carriage in a direction away from the bottom portion ([0044] “inserter assembly may further comprise at least one spring biased lock member displaceable from a withdrawn position to an extended position”).
Regarding claim 6, Lanigan teaches the applicator according to claim 5,
further comprising a moving member installed to the applicator body to constrain movement of the carriage by engaging with the carriage such that the carriage maintains a third position in which the carriage is coupled to the protective sheet in a state in which the 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 operating member is configured to operate to bias the moving member in a direction of being disengaged from the carriage ([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 moving member is installed to move in a direction intersecting a moving direction of the carriage ([0290] “after actuation certain components of the inserter assembly 100 may be locked in place. Alternatively, certain components may be prevented from displacement in particular directions or prevented from displacement beyond a predefined distance in particular directions. This may inhibit reuse of the inserter assembly 100 and may aid in protecting a user from unintended finger sticks. Some embodiments of retainer bases 140 may include one or more lock members 141. As shown, two lock members 141 are included though other embodiments, may include a greater or lesser number (e.g. three or four). The lock members 141 in the example embodiment are disposed opposite one another on the retainer base 140.”).
Regarding claim 8, Lanigan teaches the applicator according to claim 6,
further comprising a return member elastically deformably installed to the applicator body and configured to apply an elastic force in a direction of being retreated with respect to the moving member by being elastically deformed by the moving member advanced by the operating 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”),
wherein the carriage is configured to, as the moving member advances by the operating member, be disengaged from a first detent portion provided at one side of the moving member to move to a fourth position engaged with a second detent portion provided at an other side of the moving member, and, as the moving member retracts by the return member, be disengaged from the second detent to move to a fifth position separating the protective sheet from the adhesive layer 1192. ([0353] “A catch 1198 may be included where the second portion 1194 meets the first portion 1192 of each latch arm 1190. As the retraction spring retainer 1102 is driven into contact with the second portion 1194 of each latch arm 1190, the latch arms 1190 may be spread apart from one another as shown in FIG. 85.”; [0354] “Thus, the catch 1198 may hold the retraction spring retainer 1102 in place with the bias members 1104A, B, 1108 compressed. The inserter assembly 1000 may then be ready to be actuated in order to drive installation of the infusion set 102 to the chosen infusion site on the patient. The exterior housing 116 and retainer cap 406 may be considered in a ready position in FIGS. 86-88”).
Regarding claim 9, Lanigan teaches the applicator according to claim 8, wherein:
the insertion unit comprises:
a plunger installed movably from the first position to the second position together with the sensor unit ([0334] “the insertion driver 1062 may have a plunger 1106 and a spring 1108 housed in a portion of the insertion driver 1062. An assembly resetting body 1110 may be included. As further described later in the specification, the resetting body 1110 may act on various components of the inserter assembly 1000 to place the components in a ready state in preparation for an actuation. When freed to transition from an energy storing state to a relaxed state, the spring 1108, may displace the insertion driver 1062 to cause insertion of a cannula 104 from an attached set cartridge 1002 and complete assembly of the infusion set 102 of the set cartridge 1002. Retraction of the sharp 132 into the set cartridge 1002 may also occur as spring 1104 (or springs 1104A, B of FIGS. 71A-71B) is freed to transition from an energy storing state to a relaxed state.”),
a needle separatably coupled to the sensor unit to be insertable 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.”),
a carrier installed to the plunger and coupled to the needle, and
a plunger driver configured to provide a moving force in a direction of moving from the first position to the second position with respect to the plunger ([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
the plunger is configured to contact the moving member at the first position such that movement of the plunger is restricted ([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 a first moving distance by which the moving member advances to disengage the carriage from the first detent portion is shorter than a second moving distance by which the moving member advances to disengage the plunger from the moving member ([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 10, wherein the carriage is configured to restrain a forward movement of the moving member to prevent the moving member from moving by the second moving distance in a state that the carriage is engaged with the second detent portion ([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 12, Lanigan teaches the applicator according to claim 9, wherein the plunger is configured to be released from the moving member after a separation operation of the protective film by the carrier is completed ([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.”).
Regarding claim 13, Lanigan teaches the applicator according to claim 9, wherein:
the applicator body includes:
a column portion accommodating the plunger ([0349] “This may cause the barrel 1132 to advance along the plunger 1106 such that an increasing amount of the plunger 1106 is disposed within the bore of the barrel 1132.”),
the column portion has a column rail configured to guide the carriage to move linearly ([0349] “This may cause the barrel 1132 to advance along the plunger 1106 such that an increasing amount of the plunger 1106 is disposed within the bore of the barrel 1132. As bias member 1108 is captured between an end of the barrel 1132 and a flange 1136 of the plunger 1106, the advancement of the barrel 1132 over the plunger 1106 may cause the bias member 1108 to be compressed.”), and
the elastic member is installed to connect the column portion and the carriage ([0334] “As will be further described later in the specification, the insertion driver 1062 may have a plunger 1106 and a spring 1108 housed in a portion of the insertion driver 1062.”).
Regarding claim 14, Lanigan teaches the applicator according to claim 9, wherein:
the applicator body comprises:
a frame base portion having the bottom portion ([0349] “This may cause the barrel 1132 to advance along the plunger 1106 such that an increasing amount of the plunger 1106 is disposed within the bore of the barrel 1132.”),
a base frame protruding from the frame base portion and having a column portion accommodating the plunger ([0349] “This may cause the barrel 1132 to advance along the plunger 1106 such that an increasing amount of the plunger 1106 is disposed within the bore of the barrel 1132. As bias member 1108 is captured between an end of the barrel 1132 and a flange 1136 of the plunger 1106, the advancement of the barrel 1132 over the plunger 1106 may cause the bias member 1108 to be compressed.”), and
a middle frame comprising a stage arranged at an upper side of the frame base and supporting the moving member, and a middle frame opening formed at a middle of the stage to allow the column portion to be inserted ([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 15, Lanigan teaches the applicator according to claim 9, further comprising a needle release driver configured to provide a moving force to the carrier such that the carrier moves the needle in a direction away from the skin of the user after the needle is inserted into the skin of the user with the sensor ([0006] “he inserter assembly may further comprise a trigger having a first state in which the bias member is maintained in an energy storing state and a second state in which the bias member is released from the energy storing state. The bias member may be configured to propel the sharp holder to displace the insertion sharp out of the casing when released from the energy storing state.”; [0334] “Retraction of the sharp 132 into the set cartridge 1002 may also occur as spring 1104 (or springs 1104A, B of FIGS. 71A-71B) is freed to transition from an energy storing state to a relaxed state. During this transition, the spring 1104 may in some embodiments, drive the retraction spring retainer 1102 towards a retracted state within the inserter assembly 1000. This may cause the insertion driver 1062 (which may be attached to the sharp holder 130, see e.g. discussion of FIG. 73) to be driven to a retracted state.”).
Regarding claim 16, Lanigan teaches the applicator according to claim 1,
wherein the protective sheet comprises a protection portion covering the adhesive layer ([0031] “The adhesive being covered by a liner or backing. In some embodiments, the interior housing may include an indention providing a recess within which pull tabs of the liner are positioned.”), and
a wing portion extending from an edge of the protection portion to be coupled to the carriage ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed.”; [0315]).
Regarding claim 17, Lanigan teaches the applicator according to claim 1, wherein:
the protective sheet has a protective sheet groove ([0199] “he adhesive may be covered by an adhesive backing 111, liner, or film which is removed to expose the adhesive before use.”; [0209]), and
the carriage comprises a grip portion inserted into the protective sheet groove ([0209] “As a result, the lock member 146 may be attached to the adhesive backing 111 such that a user would have a visual cue in the event that one of the lock member 146 or adhesive backing 111 is removed while the other is still in place.”; [0215] “he 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.”).
Regarding claim 18, Lanigan teaches the applicator according to claim 1, wherein the carriage is configured to complete a separation operation of the protective sheet before the sensor unit moves from the first position ([0260] “The lock member 146 (see, e.g., FIG. 21) and adhesive backing 111 (see, e.g., FIG. 1A) have been removed in FIGS. 24A-B. The adhesive 374 is depicted on the bottom face 162 of the infusion set base 106. As shown, both springs 136, 138 may be in an energy storing state, which in this particular embodiment is a compressed state. In the example, spring 136 serves as an insertion driving bias member while spring 138 serves as an insertion sharp retraction driving bias member.”).
Regarding claim 19, 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 having a bottom portion configured to be contactable with the skin of the user ([0196] “FIG. 1A depicts an exploded view of an embodiment of an example inserter assembly 100.”, Abstract);
an insertion unit ([0006] “an infusion set base in retaining engagement with the body”) installed to the applicator body to move the sensor unit, which comprises 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, sensors may be provided in sensor cartridges”; [0045]), an adhesive layer comprised in the sensor unit housing ([0006] “The infusion set base may have an adhesive included on a bottom face thereof”), and a protective sheet covering the 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 where the sensor unit is spaced apart from the skin of the user to a second position where the sensor is 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 grip portion installed to the applicator body such that a portion of the protective sheet is coupled ([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.”); and
an operation member installed to the applicator body ([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”)
Lanigan does not explicitly teach wherein the applicator is configured such that the protective sheet is automatically separated from the sensor unit housing by changing a distance between the sensor unit housing and the grip portion in interlock with a manipulation of the operation member
However,
Jensen teaches wherein the applicator is configured such that the protective sheet is automatically separated from the sensor unit housing by changing a distance between the sensor unit housing and the grip portion in interlock with a manipulation of the operation member ([0080] “When the device is actuated the infusion part on the mounting pad is pushed in the direction towards the skin and during this movement the second and third section of the release layer will start to peel off the mounting pad, as the two projecting parts and the tongue are secured to the application device, preferably on different sides of the housing of the device. Accordingly, the first section of the release layer and the mounting pad will move in one direction while the second and third section of the release layer will begin to move in a deviating direction, thus gradually exposing the adhesive surface of the mounting pad”; [0124])
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 applicator taught by Lanigan to include automatic separation of the protective sheet with manipulation of the operation member. One would have been motivated to make this modification because the automatic and rapid application of a device on the user’s body does not require fine finger movements and provided optimum placement of the cannula without significant pain to the user or contamination, as suggested by Jensen ([0056, 0078]).
Regarding claim 20, Lanigan teaches the applicator according to claim 19, wherein the grip portion is installed to the applicator body such that the grip portion is movable in a direction away from the sensor unit housing ([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 21, Lanigan teaches the applicator according to claim 19, wherein the grip portion is fixed at a position spaced apart from the bottom portion ([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 22, Lanigan teaches an applicator for inserting 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 to which a base unit comprising 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 on the base unit housing configured to be attached to the skin of the user is separatably 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.”), the applicator body having a bottom portion configured to be contactable with the skin of the user (Fig. 1A, Abstract, [0196]);
an insertion unit installed to the applicator body to move the sensor unit, which comprises the sensor, a sensor unit housing to which the sensor is mounted, an adhesive layer comprised in the sensor unit housing to be adhered to the base unit housing, and a protective sheet covering the adhesive layer, from a first position where the sensor unit is spaced apart from the base unit to a second position where the sensor unit is coupled to the base unit configured such that the sensor is inserted 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 carriage to which a part of the protective sheet is coupled and which is installed to the applicator body to move in a direction away from the bottom portion for releasing 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.”); and
an operation member installed to the applicator body to operate the carriage by a manipulation of a 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 wherein the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member.
However,
Jensen teaches wherein the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member ([0080] “When the device is actuated the infusion part on the mounting pad is pushed in the direction towards the skin and during this movement the second and third section of the release layer will start to peel off the mounting pad, as the two projecting parts and the tongue are secured to the application device, preferably on different sides of the housing of the device. Accordingly, the first section of the release layer and the mounting pad will move in one direction while the second and third section of the release layer will begin to move in a deviating direction, thus gradually exposing the adhesive surface of the mounting pad”; [0124])
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 applicator taught by Lanigan to include automatic movement of the carriage away from the bottom portion with manipulation of the operation member. One would have been motivated to make this modification because the automatic and rapid application of a device on the user’s body does not require fine finger movements and provided optimum placement of the cannula without significant pain to the user or contamination, as suggested by Jensen ([0056, 0078]).
Regarding claim 23, Lanigan teaches an applicator assembly comprising:
a sensor unit comprising a sensor, a sensor unit housing to which the sensor is mounted, an adhesive layer comprised in 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 applicator body having a bottom portion configured to be contactable with skin of an user ([0196] “FIG. 1A depicts an exploded view of an embodiment of an example inserter assembly 100.”; Abstract, Fig. 1A, [0196]);
an insertion unit installed to the applicator body configured to move the sensor unit from a first position where the sensor unit is spaced apart from the skin of the user to a second position where the sensor unit 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 carriage to which a part of the protective sheet is coupled and which is installed to the applicator body to move in a direction away from the bottom portion for releasing 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.”); and
an operation member installed to the applicator body to operate the carriage by a manipulation of a 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 wherein the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member.
However,
Jensen teaches wherein the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member ([0080] “When the device is actuated the infusion part on the mounting pad is pushed in the direction towards the skin and during this movement the second and third section of the release layer will start to peel off the mounting pad, as the two projecting parts and the tongue are secured to the application device, preferably on different sides of the housing of the device. Accordingly, the first section of the release layer and the mounting pad will move in one direction while the second and third section of the release layer will begin to move in a deviating direction, thus gradually exposing the adhesive surface of the mounting pad”; [0124])
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 applicator taught by Lanigan to include automatic movement of the carriage away from the bottom portion with manipulation of the operation member. One would have been motivated to make this modification because the automatic and rapid application of a device on the user’s body does not require fine finger movements and provided optimum placement of the cannula without significant pain to the user or contamination, as suggested by Jensen ([0056, 0078]).
Regarding claim 24, Lanigan teaches the applicator assembly according to claim 23,
further comprising a base unit comprising a base unit housing and an adhesive portion provided on the base unit housing configured to be attached to the skin of the user, wherein the base unit separatably 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 attached 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 June 1, 2026 have been fully considered. With respect to the 102 Rejections in the Non-Final Office Action (See Page 11 of Applicant’s Response “Rejection under 35 U.S.C. § 102(a)(1)”), Applicant argues that Lanigan fails to disclose or suggest the amended limitation “the carriage is configured to automatically move in the direction away from the bottom portion in interlock with a manipulation of the operation member”.
There are new grounds of claim rejections that were necessitated by the claim amendments.
Jensen teaches an automatic movement of the slidable member and sections of the release layer away from the bottom adhesive portion in response to actuation of the device and disengagement of the locking member ([0080], [0124]), which is analogous to the amended limitation reciting the carriage and protective sheet automatically moving in interlock with a manipulation of the operation member. It would be obvious for one to incorporate the automatic movement of Jensen in the device of Lanigan, as described in the 103 rejection above.
Claims 2-18, 20-21, and 24 are rejected because the rejections of claim 1, 19, 22, and 23 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.
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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