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 26, 2026 has been entered. Claims 1-16, and 18 remain pending in the application, and claims 17 and 19 were cancelled. Applicant’s amendments to the claims have overcome each and every claim objection, 112 rejection, double patenting rejection, 101 rejection, and 102 rejection previously set forth in the Non-Final Office Action mailed April 1, 2026. Applicant’s amendments to the claims necessitate new grounds of rejection, as described in the Response to Arguments and 103 Rejections below.
Claim Objections
Claim 18 is objected to because of the following informalities: “the base unit separatably coupled to the applicator body” should read “the base unit is separatably coupled to the applicator body” (lines 11-12). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is 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 8 recites “the protective sheet is coupled to the protective sheet” in lines 2-3. It is unclear what is meant by this limitation, as the protective sheet is recited as being coupled to itself. Further clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-16 and 19 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.”) to which a base unit comprising a base unit housing and an adhesive portion provided on the base unit to be attached to the skin of the user is separatably coupled ([0046-0047] “an infusion set base for an infusion set may comprise a platform portion having a first face and a second face on an opposing side thereof”; [0199] “The first portion may include a base 106 which may be applied to the skin of a patient”; [0220] “adhesive may be applied to the bottom face 162 of a platform portion 160”);
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, 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 is spaced apart from the base unit to a second position where the sensor is coupled to the base unit such that 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]; [0196] “For example, 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”; [0326]);
separate the protective sheet from the adhesive layer before the sensor unit reaches the second position ([0033] “the housing may include an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed”; [0199] “The base 106 may be provided with an adhesive (e.g. adhesive pad) which retains the infusion set 102 in place on the patient. The adhesive may be covered by an adhesive backing 111, liner, or film which is removed to expose the adhesive before use.”; [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 operating member installed to the applicator body such that the removing unit is configured to be operated by manipulation of 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 unit installed to the applicator body to separate the protective sheet from the adhesive layer before the sensor unit reaches the second position.
However,
Jensen teaches a removing unit installed to the applicator body to separate the protective sheet from the adhesive layer before the sensor unit reaches the second position ([0124] “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).”).
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 device taught by Lanigan to include a removing unit to separate the protective sheet from the adhesive layer. One would have been motivated to make this modification because automating the removal of the release layer relieves the user of fine finger movements that may be problematic for people with poor dexterity and minimizes contamination, as suggested by Jensen [0007, 0056, 0078, 0124].
Regarding claim 2, Lanigan teaches the applicator according to claim 1
Lanigan does not explicitly teach wherein the removing unit comprises a moving member installed movably to the applicator body to pull the protective sheet in a direction of separating the protective sheet from the adhesive layer, wherein a portion of the protective sheet is coupled to the moving member.
However,
Jensen teaches wherein the removing unit comprises a moving member installed movably to the applicator body to pull the protective sheet in a direction of separating the protective sheet from the adhesive layer, wherein a portion of the protective sheet is coupled to the moving member ([0123] “The pivoting member (36) has means for securing an enlarged surface area (15) of a centrally projecting part (7) of a release layer protecting an adhesive surface of the mounting pad until use”; [0136] “As the central projecting part (10) is attached to the pivoting member and the other two projecting parts (8, 8') of the second and third sections are secured to the other side of the housing, when the injector device is actuated, the central projecting part (10) pulls a part of the release layer in one direction while the other two projecting parts (8, 8') pull in the opposite direction, thereby peeling the release layer off the mounting pad and exposing the adhesive surface underneath.”).
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 device taught by Lanigan to include a moving member to separate the protective sheet from the adhesive layer. One would have been motivated to make this modification because automating the removal of the release layer relieves the user of fine finger movements that may be problematic for people with poor dexterity and minimizes contamination, as well as protects patients from being stung, as suggested by Jensen [0007, 0056, 0078, 0142].
Regarding claim 3, Lanigan teaches the applicator according to claim 2, wherein the removing unit includes
a moving member driver configured to move the moving member ([0044] “inserter assembly may further comprise at least one spring biased lock member displaceable from a withdrawn position to an extended position”).
Jensen also teaches a driver (spring actuator) of a moving member to release the adhesive layer to mount the device [0055].
Regarding claim 4, Lanigan teaches the applicator according to claim 3,
wherein the moving member driver includes an elastic member configured to apply an elastic force to the moving member in the direction of separating off the protective sheet from the adhesive layer ([0044] “inserter assembly may further comprise at least one spring biased lock member displaceable from a withdrawn position to an extended position”).
Jensen also teaches an elastic member (spring) of a moving member to release the adhesive layer to mount the device [0055].
Regarding claim 5, Lanigan teaches the applicator according to claim 4,
comprising a stopper configured to restrain movement of the moving member in a state that 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 release the stopper such that the moving member is movable by the elastic member ([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]).
Regarding claim 6, Lanigan teaches the applicator according to claim 2,
Lanigan does not explicitly teach wherein the moving member is installed to move in a direction of intersecting a direction in which the sensor unit moves from the first position to the second position.
However,
Jensen teaches wherein the moving member is installed to move in a direction of intersecting a direction in which the sensor unit moves from the first position to the second position ([0080] “By pulling the pivoting member of the application device and placing it in a position perpendicular to the housing said device is ready for use. Now a front end of the application device is held in contact with the skin, preferably approximately perpendicularly to the skin, and the device is thereafter activated by pressing the release means. 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.”; [0097]).
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 device taught by Lanigan to include a moving member moving in an intersecting direction. One would have been motivated to make this modification because the movement of the moving member causes the removal of the release layer so that the device is adhered to the skin correctly [0097].
Regarding claim 7, Lanigan teaches the applicator according to claim 6,
comprising a support installed to the applicator body to support the protective sheet separated from the adhesive layer by the moving member ([0033] “the housing may include an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed”).
Regarding claim 8, Lanigan teaches the applicator according to claim 7, wherein:
the moving member is installed to be movable from a third position where the protective sheet is coupled to the protective sheet in a state that the protective sheet covers the adhesive layer to a fourth position where the protective sheet is separated from the adhesive layer ([0035]; [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. This gripping region 224 may be grasped by a user and used to peel the adhesive backing 111 off of the infusion set 106. Once the backing 111 has been removed, the inserter assembly 100 may be placed against the desired infusion site using the raised rib 118 to aid in alignment. The lock member 146 may then be pulled out of the inserter assembly 100 to allow for the inserter assembly 100 to be actuated. 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
the support is configured to be elastically deformable by being pressed by the moving member when the moving member is in the third position, and return to an original state to support the protective sheet by being released from the moving member when the moving member moves to the fourth position ([0218] “However, in various embodiments, fenestrations similar to fenestrations 148, 150 in FIGS. 1A-1C may be included in the exterior housing 116 and interior housing 120 to accommodate a lock member 146. In these various embodiments, the adhesive backing 111 may be bonded onto the lock member 146. In the example embodiment, however, the adhesive backing 111 includes two pull tabs 410. These pull tabs 410 may be grasped by a user to facilitate removal of the adhesive backing 111. The additional spring 158 depicted in FIG. 1C is also included in FIG. 3”).
Regarding claim 9, Lanigan teaches the applicator according to claim 2, wherein
the insertion unit includes:
a plunger installed to be movable from the first position to the second position 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 detachably coupled to the sensor unit configured to be inserted into the skin of the user 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 with the needle ([0283] “sharp holder 130”), and
a plunger driver configured to provide a moving force to the plunger in a direction of moving from 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 the plunger is configured such that movement of the plunger at the first position is restricted by being contacted with the moving member, and is configured to move away from the moving member toward the second position when the moving member moves in the direction of separating the protective sheet from the adhesive layer ([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 plunger is configured to deviate from the moving member after a separation operation of the protective sheet by the moving member is completed ([0334]; [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”).
Lanigan does not explicitly teach wherein the moving member is installed to move in a direction of intersecting a direction in which the sensor unit moves from the first position to the second position.
However,
Jensen teaches wherein the moving member is installed to move in a direction of intersecting a direction in which the sensor unit moves from the first position to the second position ([0080] “By pulling the pivoting member of the application device and placing it in a position perpendicular to the housing said device is ready for use. Now a front end of the application device is held in contact with the skin, preferably approximately perpendicularly to the skin, and the device is thereafter activated by pressing the release means. 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.”; [0097]).
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 device taught by Lanigan to include a moving member moving in an intersecting direction. One would have been motivated to make this modification because the movement of the moving member causes the removal of the release layer so that the device is adhered to the skin correctly [0097].
Regarding claim 11, Lanigan teaches the applicator according to claim 9, wherein:
the applicator body includes:
a frame base portion configured to be contactable with the skin of the user, a base frame having a column portion protruding from the frame base portion and 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.”),
a stage disposed at an upper side of the frame base and supporting the moving member, and a middle frame having a middle frame opening formed in 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.”; [0349]).
Regarding claim 12, Lanigan teaches the applicator according to claim 11, wherein:
the removing unit comprises:
an elastic member configured to apply an elastic force to the moving member in the direction of separating the protective sheet from the adhesive layer ([0044] “inserter assembly may further comprise at least one spring biased lock member displaceable from a withdrawn position to an extended position”; [0045]),
a stopper configured to restrain movement of the moving member in a state in which the elastic member is elastically deformed and is comprised in one of the middle frame and the moving member ([0044] “The at least one set of stop surfaces configured to flank the at least one lock member when the lock member is in the extended position inhibiting rotation of the disposable cartridge.”; [0256] “Actuation may be triggered when removal of the lock member 146 allows components of the inserter assembly 100 to displace relative to one another such that, for example, a latch may be released.”), and
the operating member is configured to release the stopper such that the moving member is movable by the elastic member ([0045] “the at least one lock member may be a resiliently cantilevered member”; [0256] “In embodiments including a lock member 146 (see, e.g., FIG. 19), the lock member 146 may be kept in place until the user has begun withdrawing the inserter assembly 100 from the skin. Actuation may be triggered when removal of the lock member 146 allows components of the inserter assembly 100 to displace relative to one another such that, for example, a latch may be released.”).
Jensen also teaches an elastic member (spring) of a removal unit to release the adhesive layer to mount the device [0055].
Regarding claim 13, Lanigan teaches the applicator according to claim 9.
Lanigan does not explicitly teach wherein: the moving member comprises: a moving member body, a moving member opening formed in a middle of the moving member body to allow the plunger to pass through the moving member opening, and a grip portion comprised in the moving member body to be coupled with the protective sheet.
However,
Jensen teaches wherein: the moving member comprises:
a moving member body ([0135] “pivoting member (36)”),
a moving member opening formed in a middle of the moving member body to allow the plunger to pass through the moving member opening ([0080] “the tongue is inserted through a hole in the pivoting member”), and
a grip portion comprised in the moving member body to be coupled with the protective sheet ([0136] “As the central projecting part (10) is attached to the pivoting member and the other two projecting parts (8, 8') of the second and third sections are secured to the other side of the housing, when the injector device is actuated, the central projecting part (10) pulls a part of the release layer in one direction while the other two projecting parts (8, 8') pull in the opposite direction, thereby peeling the release layer off the mounting pad and exposing the adhesive surface underneath.”).
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 device taught by Lanigan to include a moving member to separate the protective sheet from the adhesive layer. One would have been motivated to make this modification because automating the removal of the release layer relieves the user of fine finger movements that may be problematic for people with poor dexterity and minimizes contamination, as well as protects patients from being stung, as suggested by Jensen [0007, 0056, 0078, 0142].
Regarding claim 14, 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] “the 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 15, Lanigan teaches the applicator according to claim 2, wherein the protective sheet comprises:
a protective 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 protective portion to be coupled to the moving member ([0035] “The housing may include an indention in which pull tabs of the adhesive backing are disposed.”; [0315]).
Regarding claim 16, Lanigan teaches the applicator according to claim 2, wherein:
the protective sheet has a protective sheet groove ([0199] “the adhesive may be covered by an adhesive backing 111, liner, or film which is removed to expose the adhesive before use.”; [0209]), and
the moving member includes 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 an applicator assembly comprising:
a sensor unit comprising a sensor, a sensor unit housing to which the sensor is mounted, an adhesive layer comprises 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.”);
an insertion unit installed to the applicator body to move the sensor unit from a first position where the sensor is spaced apart from the skin of the user to a second position where the sensor is 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 base unit comprising a base unit housing and an adhesive portion provided on the base unit housing to be attached to the skin of the user, wherein the base unit separatably coupled to the applicator body ([0046-0047] “an infusion set base for an infusion set may comprise a platform portion having a first face and a second face on an opposing side thereof”; [0199] “The first portion may include a base 106 which may be applied to the skin of a patient”; [0220] “adhesive may be applied to the bottom face 162 of a platform portion 160”);
separate the protective sheet from the adhesive layer before the sensor unit reaches the second position ([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 operating member installed to the applicator body such that the removing unit is operated by manipulation of 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”);
wherein the sensor unit housing is attached to the base unit housing by the adhesive layer at the second position ([0033] “the housing may include an indention within which pull tabs of an adhesive backing covering adhesive on the infusion set base are disposed”; [0199] “The base 106 may be provided with an adhesive (e.g. adhesive pad) which retains the infusion set 102 in place on the patient. The adhesive may be covered by an adhesive backing 111, liner, or film which is removed to expose the adhesive before use.”; [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.”).
Lanigan does not explicitly teach a removing unit installed to the applicator body to separate the protective sheet from the adhesive layer before the sensor unit reaches the second position.
However,
Jensen teaches a removing unit installed to the applicator body to separate the protective sheet from the adhesive layer before the sensor unit reaches the second position ([0124] “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).”).
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 device taught by Lanigan to include a removing unit to separate the protective sheet from the adhesive layer. One would have been motivated to make this modification because automating the removal of the release layer relieves the user of fine finger movements that may be problematic for people with poor dexterity and minimizes contamination, as suggested by Jensen [0007, 0056, 0078, 0124].
Response to Arguments
Applicant's arguments filed June 26, 2026 have been fully considered. With respect to the 102 Rejections in the Non-Final Office Action (See Pages 8-9 of Applicant’s Response “Rejection under U.S.C. § 102”), Applicant argues that Lanigan fails to disclose any technical features corresponding to the protective sheet or the moving member of the claimed invention. Applicant states that Lanigan is silent with respect to a protective sheet for protecting the adhesive layer disposed on the sensor unit, or a structure configured to remove the protective sheet while the sensor unit is moving within the applicator to the second position, as required by the amended independent claims.
There are new grounds of claim rejections that were necessitated by the claim amendments.
MPEP § 2111 discusses proper claim interpretation, including giving claims their broadest reasonable interpretation in light of the specification during examination. Under broadest reasonable interpretation (BRI), the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. The requirements for anticipation are discussed in MPEP § 2131.
Under BRI, claim 1 recites a protective sheet covering the adhesive layer, which is taught by the adhesive backing taught by Lanigan [0119]. Additionally, Jensen teaches an analogous device, which discloses a release layer that is removed from an adhesive surface to mount a sensor device on a user [0053] using a slidable member and a pivoting member [0124, 0136]. Under BRI, the removing unit is taught by the slidable member of Jensen and the moving member in claim 2 is taught by the pivoting member of Jensen. It would be obvious to incorporate these components of Jensen to remove the adhesive backing sheet of Lanigan automatically, as described in the 103 rejections above.
Claims 2-16 are rejected because the rejection of claims 1 and 18 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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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
Prosecution Insights