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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 29, 2023, February 18, 2025, August 15, 2025, and November 12, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informality: “a plunger installed to be movably” should read “a plunger installed to be movable” (line 3).
Claim 12 is objected to because of the following informalities:
“a stropper configured to restrains” should read “a stopper configured to restrain” (line 4); and
“the elastic member is elastically deformed is comprised in one of…” should read “the elastic member is elastically deformed and is comprised in one of…” (lines 4-5).
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 4 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 4 recites “a direction of peeling off the protective sheet from the adhesive layer” in lines 3-4. It is unclear if this direction is the same as “a direction of separating the protective sheet from the adhesive layer” of claim 2, or if these are different directions. Claim 5 is rejected based on its dependence on claim 4.
Claim 9 recites “a direction of separating the protective sheet from the adhesive layer” in lines 12-13. It is unclear if this direction is the same as “a direction of separating the protective sheet from the adhesive layer” of claim 2, or if these are different directions. Claims 10-14 are rejected based on its dependence on claim 9.
Claim 12 recites “a direction of peeling off the protective sheet from the adhesive layer” in line 3. It is unclear if this direction is the same as “a direction of separating the protective sheet from the adhesive layer” of claim 9, or if these are different directions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 12, and 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 22, and 23-24 of copending Application No. 18/575,260 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the differing claim language “removing member” in the present application and “carriage” in the reference application are merely using different terminology for the same component described in the claims.
Claims 1, 12, and 13-14 are additionally provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, and 18-19 of copending Application No. 18/575,315. Although the claims at issue are not identical, they are not patentably distinct from each other because the differing claim language “removing member” in the present application and “removing unit” in the reference application are merely using different terminology for the same component described in the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Present Application
18/575,315
Reference Application 18/575,260
Reference Application 18/681,448
Claim 1 - An applicator for inserting a sensor for measuring biometric information into skin of a user, the applicator comprising:
an applicator body configured to be contactable with the skin of the user;
an insertion unit installed to the applicator body to move a 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, and a protective sheet covering the adhesive layer, 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;
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; and
an operating member installed to the applicator body such that the removing unit is operated by manipulation of the user.
Claim 1 - An applicator for inserting a sensor for measuring biometric information into skin of a user, the applicator comprising:
an applicator body having a bottom portion configured to be contactable with the skin of the user;
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, and a protective sheet covering the adhesive layer, 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;
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; and
an operation member installed to the applicator body to operate the carriage by a
manipulation of a user.
Claim 1 - An applicator for inserting a sensor for measuring biometric information into skin of a user, the applicator comprising:
an applicator body;
an insertion unit installed to the applicator body to move a sensor unit, which includes the sensor, a sensor unit housing to which the sensor is mounted, an adhesive layer provided at the sensor unit housing, from a first position spaced apart from the skin of the user to a second position where the sensor is inserted into the skin of the user;
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; and
an operation member installed to the applicator body to operate the removing member by being manipulated by the user.
Claim 17 - An applicator for inserting a sensor into skin of a user, the applicator comprising:
an applicator body to which 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 is separatably coupled;
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 such that the sensor is inserted into the skin of the user;
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; and
an operating member installed to the applicator body such that the removing unit is operated by manipulation of the user.
Claim 22 - An applicator for inserting a sensor into skin of a user, the applicator comprising:
an applicator body to which 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 is separatably coupled, the applicator body having a bottom portion configured to be contactable with the skin of the user;
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 such that the sensor is inserted into the skin of the user;
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; and
an operation member installed to the applicator body to operate the carriage by a manipulation of a user.
Claim 12 - An applicator for inserting a sensor into skin of a user, the applicator comprising:
an applicator body to which a base unit including a base unit housing, and an adhesive portion provided at the base unit housing to be attached to the skin of the user is separably coupled;
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 to insert the sensor into the skin of the user;
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; and
an operation member installed to the applicator body to operate the removing member by being manipulated by the user.
Claim 18 - 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;
an applicator body having a bottom portion configured to be contactable with skin of an user;
an insertion unit installed to the applicator body 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 inserted into the skin of the user;
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; and
an operating member installed to the applicator body such that the removing unit is operated by manipulation of the user.
Claim 23 - 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;
an applicator body having a bottom portion configured to be contactable with skin of an user;
an insertion unit installed to the applicator body 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 inserted into the skin of the user;
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; and
an operation member installed to the applicator body to operate the carriage by a manipulation of a user.
Claim 13 - An applicator assembly comprising:
an applicator body;
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;
an insertion unit installed to the applicator body to move the sensor unit from a first position spaced away from the skin of the user to a second position where the sensor is inserted into the skin of the user;
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; and
an operation member installed to the applicator body to operate the removing member by being manipulated by the user.
Claim 19 - The applicator assembly according to claim 18,
further comprising 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,
wherein the sensor unit housing is attached to the base unit housing by the adhesive layer at the second position.
Claim 24 - 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 to be attached to the skin of the user, wherein the base unit separatably coupled to the applicator body,
wherein the sensor unit housing is attached to the base unit housing by the adhesive layer at the second position.
Claim 23 - 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 to be attachable to the skin of the user, and spaced apart from the sensor unit and separably coupled to the applicator body,
wherein the sensor unit housing is configured to be attachable to the base unit housing by the adhesive layer at the second position.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “inserting a sensor for measuring biometric information into the skin of a user” in lines 1-2, which encompasses a portion of a human body as part of the invention. In order to overcome this rejection, the claim language may be amended to recite “inserting a sensor configured for measuring biometric information into the skin of a user”. Additionally, claim 1, lines 11-12 recite “an operation member installed to the applicator body such that the removing member is operated by manipulation of the user”, which encompasses a human user. In order to overcome this rejection, the claim language may be amended to recite “an operation member installed to the applicator body such that the removing member is configured to be operated by manipulation of the user”. Claims 2-16 are rejected based on their dependence on claim 1.
Claim 9 recites “a needle detachably coupled to the sensor unit to be inserted into the skin of the user” in line 5, which encompasses a portion of a human body as part of the invention. In order to overcome this rejection, the claim language may be amended to recite “a needle detachably coupled to the sensor unit configured to be inserted into the skin of the user”.
Claim 17 recites “An applicator for inserting a sensor into the skin of a user” in line 1, which encompasses a portion of the human body as part of the invention. In order to overcome this rejection, the claim language may be amended to recite “An applicator configured for inserting a sensor into the skin of a user”. Additionally, claim 17, line 3 recites “the base unit housing to be attached to the skin of the user”, which encompasses a human user. In order to overcome this rejection, the claim language may be amended to recite “the base housing configured to be attached to the skin of the user”. Additionally, claim 17, lines 9-10 recites “the base unit such that the sensor is inserted into the skin of the user”, which encompasses a portion of a human body as part of the invention. In order to overcome this rejection, the claim language may be amended to recite “the base unit such that the sensor is configured to be inserted into the skin of the user”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200289748 A1 (Lanigan et al.).
Regarding claim 1, Lanigan teaches an applicator 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 ([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, 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 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 removing unit installed to the applicator body to 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”).
Regarding claim 2, Lanigan teaches the applicator according to claim 1, 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 ([0024] “removing a lock member from the inserter assembly and removing an adhesive backing from the infusion set base”).
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”).
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 a direction of peeling 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”).
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,
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 ([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”; [0044] “one spring biased lock member displaceable from a withdrawn position to an extended position”).
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 movably 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 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 a 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 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 ([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”; [0044] “one spring biased lock member displaceable from a withdrawn position to an extended position”), and
the plunger is configured to deviate from the moving member after a separation operation of the protective film 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”).
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 a direction of removing 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 restrains movement of the moving member in a state in which the elastic member is elastically deformed 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.”).
Regarding claim 13, Lanigan teaches the applicator according to claim 9, wherein:
the moving member comprises
a moving member body ([0030] “a cartridge for a reusable inserter assembly may comprise an exterior housing”),
a moving member opening formed in a middle of the moving member body to allow the plunger to pass through the moving member opening ([0034] “the insertion driver 1062 may have a plunger 1106 and a spring 1108 housed in a portion of the insertion driver 106”; [0349] “displacement of the exterior housing 116 may cause the standoffs 1130 to push against the flange 1134 such that the reset body 1110 moves together with the exterior housing 116. 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”), and
a grip portion comprised in the moving member body to be coupled with the protective sheet ([0215] “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.”).
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 17, Lanigan teaches an applicator 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 on the base unit housing 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 comprises the sensor, a sensor unit housing to which the sensor is mounted, an adhesive layer comprises 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 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 removing unit installed to the applicator body to separate the protective sheet from the adhesive layer before the sensor 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”).
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 removing unit installed to the applicator body to 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”).
Regarding claim 19, Lanigan teaches the applicator assembly according to claim 18,
further comprising 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 ([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”).
Conclusion
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.
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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