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 on July 17, 2026 was considered by the examiner. Claims 1-8 and 10-19 are pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: an insertion unit assembly in claims 1, 15-17, and 19; an operating member in claims 1, 15-17, and 19; a stopper part in claims 1, 15-17, and 19; an adhesive part in claim 7; a locking assembly/body in claim 10; and an elastic part in claim 13.
Prong 1: “unit”, “assembly”, “part”, “member”, and “body” are generic placeholders. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition words “to” and “by” are used, followed by functional language:
“an insertion unit assembly… to move a sensor unit”;
“an operating member… to be operated by the user”;
“a stopper part… to operate the insertion unit assembly in association with the operation member”;
“coupled… by an adhesive part”;
“a locking assembly including a locking body installed to the applicator body to be engaged with the stopper member or disengaged from the stopper member”; and
“an elastic part configured to apply elastic force to the locking body in a direction away from the stopper part”.
Prong 3: there is not sufficient structure to modify the generic placeholders.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The examiner interprets the structure including the column member 410, the shuttle 441, the carrier 462, and the needle 485 (see specification ¶[00123]-[00125]; Fig. 15) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the insertion unit assembly.
The examiner interprets the structure including the button portion 366 and the pressing protrusion 367 (see specification ¶[00121]; Figs. 10 and 12) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the operating member.
The examiner interprets the structure including the stopper member body 510, the rail portion 515, the stopper member opening 512, the supporting pad 516, and the bracket portion 514 (see specification ¶[00170]-[00174]; Fig. 12) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the stopper part.
The examiner interprets the double sided tape (see specification ¶[0095]) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the adhesive part.
The examiner interprets the structure including the body portion 340, the hook portion 341, and the leg portion 342 (see specification ¶[00113]-[00114]; Fig. 14) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the locking assembly/body.
The examiner interprets the coil spring 491 (see specification ¶[00148]; Fig. 15) to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof for the elastic part.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 6 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 6 recites “one side of the moving tab body” in line 2, but it is not clear if this recitation is the same as, related to, or different from the recitation “one side of the moving tab body” in claim 5, line 5. The similar phraseology suggest that they are the same, but the lack of definite article “the” suggests that they are different. If the recitations are the same, the present recitation should be “the one side of the moving tab body”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
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 1-8, 10-13, and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16-17 of copending Application No. 18/727,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1-8, 10-13, and 15-19, copending claims 1-13 and 16-17 correspond to and include all of the elements of the present claims 1-8, 10-13, and 15-19.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16-17 of copending Application No. 18/727,686 in view of Lanigan et al. (US Patent Application Publication 2020/0289748 – cited by Applicant), hereinafter Lanigan.
Regarding Claim 14, copending claims 1-13 and 16-17 correspond to and include all of the elements of the present claim 14, except that the insertion unit assembly includes a needle which is movable from the first position to the second position to be inserted into the skin of the user together with the sensor, and
wherein the moving tab includes a cover portion arranged between the protective sheet and the needle to prevent the needle from contacting the protective sheet.
Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator for inserting a sensor for measuring biometric information into skin of a user (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B), the applicator comprising:
an applicator body (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B);
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) installed to the applicator body to move a sensor unit 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 (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B); and
the sensor unit including the sensor, a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
an adhesive layer provided at the sensor unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place; Figs. 1A-3), and
a protective sheet covering the adhesive layer (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3),
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be moved by the user to move the protective sheet in a removal direction away from the sensor unit housing to separate the protective sheet from the adhesive layer (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C);
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive layer to cover the adhesive layer, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive layer (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21);
wherein the insertion unit assembly includes a needle which is movable from the first position to the second position to be inserted into the skin of the user together with the sensor (¶[0206] the insertion sharp 132, such as a needle; see generally Figs. 1A-3 and 40A-44B), and
wherein the moving tab includes a cover portion arranged between the protective sheet and the needle to prevent the needle from contacting the protective sheet (¶[0273] the portion of the set base 106 that acts as a protective barrier for the sharp 32, see Figs. 24A-24B, the adhesive 374 remains in both figures, but the protective portion of the set base 106 is removed from therebetween in Fig. 24B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the needle of Lanigan as the insertion portion of the copending claims 1-13 and 16-17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the copending claims 1-13 and 16-17 require an insertion portion and Lanigan teaches one such insertion portion.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the protective barrier of Lanigan for the insertion portion of the modified copending claims 1-13 and 16-17 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the protective barrier would help to protect the insertion portion and other elements from the sharp end of the insertion portion (see for example Lanigan ¶[0273]).
These are provisional nonstatutory double patenting rejections.
Claims 1-6, 10-13, and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10, and 13 of copending Application No. 18/681,479 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claims 1-6, 10-13, and 15-19, copending claims 1-6, 10, and 13 correspond to and include all of the elements of the present claims 1-6, 10-13, and 15-19.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10, and 13 of copending Application No. 18/681,479 in view of Chae et al. (US Patent Application Publication 2020/0178899 – cited in prior action), hereinafter Chae.
Regarding Claim 7, copending claims 1-6, 10, and 13 correspond to and include all of the elements of the present claim 7, except that the moving tab is coupled to the protective sheet by an adhesive part.
Chae teaches a sensor applicator assembly for a continuous glucose monitoring system (see abstract and Fig. 1), in which adhesive tape 560 is attached to a body contact surface of the sensor module 20 so that the sensor module 20 may be attached to the human body (see ¶[0065]) and Figs. 2a-2b), in which a release paper 561 may be attached to the adhesive tape 560 to protect the adhesive tape 560 (see ¶[0065]), in which the release paper 561 may be attached to a removable protective cap 200 via separate adhesive member 562 (see ¶[0065]-[0066] and ¶[0076]; Figs. 9A-9B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive member 562 of Chae as the engagement of the moving tab to the protective sheet of the copending claims 1-6, 10, and 13 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the copending claims 1-6, 10, and 13 require an bond engagement of the moving tab to the protective sheet and Chae teaches one such engagement; and/or (3) the adhesive would enable the user to remove the protective sheet when removing the moving tab, thus simplifying the operating procedure (see Chae ¶[0065]-[0066] and ¶[0076]; Figs. 9A-9B).
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims1-6, 10, and 13 of copending Application No. 18/681,479 in view of Larson et al. (US Patent Application Publication 2012/0227358 – cited in prior action), hereinafter Larson.
Regarding Claim 8, copending claims 1-6, 10, and 13 correspond to and include all of the elements of the present claim 8, except that the protective sheet comprises a wing portion extended from an edge of the protective portion, and a protective sheet hole formed at one side of the wing portion, and wherein the moving tab has a grip portion corresponding to the protective sheet hole, and the moving tab is coupled with the protective sheet in a way that the grip portion is inserted into the protective sheet hole.
Larson teaches of a sealed glucose sensor so as to maintain the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented (see abstract and Figs. 1-2), in which the glucose sensor may have an assembly 104 comprising a glucose sensor 200, a sensor base 202 coupled to the glucose sensor 200, a sensor introducer 204 that cooperates with the sensor base 202, a mounting base 206 for the sensor base 202, a liner 207, a sensor mounting pedestal 208, and an adhesive disk 209 (see ¶[0025] and Figs. 3-4), in which the liner 207 is a temporary structure used during the shipping and handling of the assembly 100 (see ¶[0029]), in which the liner 207 is held and separated from sensor portion before usage via liner holder 211, such as the hook, that engages an edge, a hole, tabs, or any cooperating feature of the liner 207 (see ¶[0031]; Figs. 3 and 6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the liner holder 211 (i.e., the grip portion) for engaging the hole of the liner 207 of Larson as the engagement of the moving tab to the protective sheet of the copending claims 1-6, 10, and 13 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the copending claims 1-6, 10, and 13 require an engagement of the moving tab to the protective sheet and Larson teaches one such bond; and/or (3) the liner holder would enable the user to remove the protective sheet when removing the moving tab, thus simplifying the operating procedure (see Larson ¶[0031]).
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 10, and 13 of copending Application No. 18/681,479 in view of Lanigan et al. (US Patent Application Publication 2020/0289748 – cited by Applicant), hereinafter Lanigan.
Regarding Claim 14, copending claims 1-6, 10, and 13 correspond to and include all of the elements of the present claim 14, except that the insertion unit assembly includes a needle which is movable from the first position to the second position to be inserted into the skin of the user together with the sensor, and
wherein the moving tab includes a cover portion arranged between the protective sheet and the needle to prevent the needle from contacting the protective sheet.
Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator for inserting a sensor for measuring biometric information into skin of a user (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B), the applicator comprising:
an applicator body (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B);
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) installed to the applicator body to move a sensor unit 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 (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B); and
the sensor unit including the sensor, a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
an adhesive layer provided at the sensor unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place; Figs. 1A-3), and
a protective sheet covering the adhesive layer (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3),
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be moved by the user to move the protective sheet in a removal direction away from the sensor unit housing to separate the protective sheet from the adhesive layer (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C);
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive layer to cover the adhesive layer, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive layer (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21);
wherein the insertion unit assembly includes a needle which is movable from the first position to the second position to be inserted into the skin of the user together with the sensor (¶[0206] the insertion sharp 132, such as a needle; see generally Figs. 1A-3 and 40A-44B), and
wherein the moving tab includes a cover portion arranged between the protective sheet and the needle to prevent the needle from contacting the protective sheet (¶[0273] the portion of the set base 106 that acts as a protective barrier for the sharp 32, see Figs. 24A-24B, the adhesive 374 remains in both figures, but the protective portion of the set base 106 is removed from therebetween in Fig. 24B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the needle of Lanigan as the sensor inserter of the copending claims 1-6, 10, and 13 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the copending claims 1-6, 10, and 13 require an insertion portion and Lanigan teaches one such insertion portion.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the protective barrier of Lanigan for the sensor inserter of the modified copending claims 1-6, 10, and 13 because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the protective barrier would help to protect the insertion portion and other elements from the sharp end of the insertion portion (see for example Lanigan ¶[0273]).
These are provisional nonstatutory double patenting rejections.
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 1-6, 10-14, and 17 are rejected under 35 U.S.C. 102 (a) (2) as being anticipated by Lanigan et al. (US Patent Application Publication 2020/0289748 – cited by Applicant), hereinafter Lanigan.
Regarding Claim 1, Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator for inserting a sensor for measuring biometric information into skin of a user (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B), the applicator comprising:
an applicator body (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B);
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) installed to the applicator body to move a sensor unit 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 (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B); and
the sensor unit including the sensor, a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
an adhesive layer provided at the sensor unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place; Figs. 1A-3), and
a protective sheet covering the adhesive layer (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3),
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be moved by the user to move the protective sheet in a removal direction away from the sensor unit housing to separate the protective sheet from the adhesive layer (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C);
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive layer to cover the adhesive layer, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive layer (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21).
Regarding Claim 2, Lanigan teaches the device of claim 1 as stated above. Lanigan further teaches the removal direction intersects a movement direction of the sensor unit (see Figs. 1A-3 and 17A-18C, the pull tabs 410 and/or the gripping region 224 and/or the lock member 146 are perpendicular/intersecting from the direction of the sensor unit, shown for example by the insertion sharp 132).
Regarding Claim 3, Lanigan teaches the device of claim 1 as stated above. Lanigan further teaches the removal direction is perpendicular to a movement direction of the sensor unit (see Figs. 1A-3 and 17A-17B, the pull tabs 410 and/or the gripping region 224 and/or the lock member 146 are perpendicular/intersecting from the direction of the sensor unit, shown for example by the insertion sharp 132).
Regarding Claim 4, Lanigan teaches the device of claim 1 as stated above. Lanigan further teaches an opening is provided at one side of the applicator body (see Figs. 1A-3, the opening on the bottom side of the retainer base 140 and/or the opening on the bottom side of the exterior housing 116 and/or the opening on the side of the exterior housing 116 for the lock member 146),
the moving tab is configured to move in the removal direction such that at least a portion of the moving tab is drawn out from an inside of the applicator body to an outside of the applicator body through the opening (see Figs. 1A-3 and 17A-17B, the pull tabs 410 and/or the gripping region 224 and/or the lock member 146 are perpendicular/intersecting from the direction of the sensor unit, shown for example by the insertion sharp 132, which is removed from the opening);
the removal direction intersects a movement direction of the sensor unit (see Figs. 1A-3 and 17A-18C, the pull tabs 410 and/or the gripping region 224 and/or the lock member 146 are perpendicular/intersecting from the direction of the sensor unit, shown for example by the insertion sharp 132).
Regarding Claim 5, Lanigan teaches the device of claim 4 as stated above. Lanigan further teaches wherein the moving tab comprises: a moving tab body located inside the applicator body and coupled with the protective sheet (see Figs. 1A-3 and 17A-17B, the portion inside the device connected to the adhesive backing 111), and
a handle portion extending from one side of the moving tab body and exposed to the outside of the applicator body for the user to be able to hold the handle portion with a hand (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer; Figs. 1A-3 and 17A-17B).
Regarding Claim 6, Lanigan teaches the device of claim 5 as stated above. Lanigan further teaches a moving tab arm is provided at one side of the moving tab body to be elastically deformable, the moving tab arm being configured to be engageable with an applicator body detent provided at the applicator body is provided to be elastically deformable at one side of the moving tab body (¶[0249] the arms 228/230 that interface with the exterior housing 116 and the interior housing 120; Figs. 18A-18C), and
when a force greater than a preset amount is applied to the moving tab, the moving tab arm is configured to be disengaged from the applicator body detent such that the moving tab is withdrawn from the opening (¶[0249] the arms 228/230 are configured such that some force may be required to remove the lock member 146 from the inserter assembly and may inhibit the lock member 146 from being inadvertently dislodged; Figs. 18A-18C).
Regarding Claim 10, Lanigan teaches the device of claim 1 as stated above. Lanigan further teaches a locking assembly (¶[0261] the sharp holder 130; Figs. 24A-29) including a locking body (¶[0261]-[0262] the cantilevered arms 296; Figs. 24A-29) installed to the applicator body to be engaged with the stopper part or disengaged from the stopper part (¶[0261]-[0264] the cantilevered arms 296 comprise the ledge 302 that engages with the catch 306; Figs. 24A-29), and
wherein the moving tab is configured to bias the locking body to be engaged with the stopper part by contacting the locking body in the initial position (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21), and
wherein the locking body is configured to, when the moving tab moves to the removal position, be disengaged from the stopper part (¶[0264] the finger 308 may disengage the ledge 302 from the catch 306, allowing release of energy stored in the spring 136, only possible after the lock member 146 has been disengaged; Figs. 24A-24B).
Regarding Claim 11, Lanigan teaches the device of claim 10 as stated above. Lanigan further teaches the locking body comprises: a body portion connected to the applicator body (¶[0261] the sharp holder 130 movably connected within the exterior housing 116; Figs. 24A-24B), wherein an angle of the body portion relative to the applicator body is changeable (¶[0262] the cantilevered arms 296 would have a changeable angle; Figs. 24A-24B),
a hook portion connected to one side of the body portion to be engaged with the stopper part (¶[0261]-[0264] the cantilevered arms 296 comprise the ledge 302 that engages with the catch 306; Figs. 24A-29), and
a leg portion connected to another side of the body portion to contact the moving tab (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, the connection of the backside of the cantilevered arm 296 and/or the ledge 302 to the locking member 146, see generally Figs. 17A-21), and
wherein the locking body is configured to, when the moving tab is located in the initial position, be biased in a direction in which the hook portion is engaged with the stopper part by contact of the leg portion with the moving tab (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, the engagement of the ledge 302 to the catch 306, see generally Figs. 17A-21 and 24A-24B), and
the leg portion is configured to, when the moving tab moves to the removal position, move away from the moving tab and be biased in a direction in which the hook portion is disengaged from the stopper part (¶[0264] the finger 308 may disengage the ledge 302 from the catch 306, allowing release of energy stored in the spring 136, only possible after the lock member 146 has been disengaged and thus disengaged from the backside of the cantilevered arm 296 and/or the ledge 302 to the locking member 146; see generally Figs. 17A-21 and 24A-24B).
Regarding Claim 12, Lanigan teaches the device of claim 11 as stated above. Lanigan further teaches the applicator body includes a stage which movably supports the stopper part, and the body portion is arranged in a through hole formed at one side of the stage to penetrate the stage (see generally ¶[0206] and Figs. 1A-3 and 24A-24B, the portion of the sharp retractor 134 that the cantilevered arm 296 extends through and supporting the catch 306).
Regarding Claim 13, Lanigan teaches the device of claim 10 as stated above. Lanigan further teaches the locking assembly comprises an elastic part configured to apply elastic force to the locking body in a direction away from the stopper part (¶[0264] the spring 136; Figs. 24A-24B), and
wherein the locking body is configured to, when the moving tab is located in the initial position, be pressed by the moving tab toward engagement with the stopper part (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, the engagement of the ledge 302 to the catch 306, see generally Figs. 17A-21 and 24A-24B), and,
when the moving tab moves to the removal position, deviate from the moving tab to be biased toward disengagement from the stopper part by the elastic force of the elastic part (¶[0264] the finger 308 may disengage the ledge 302 from the catch 306, allowing release of energy stored in the spring 136, only possible after the lock member 146 has been disengaged and thus disengaged from the backside of the cantilevered arm 296 and/or the ledge 302 to the locking member 146; see generally Figs. 17A-21 and 24A-24B).
Regarding Claim 14, Lanigan teaches the device of claim 1 as stated above. Lanigan further teaches wherein the insertion unit assembly includes a needle which is movable from the first position to the second position to be inserted into the skin of the user together with the sensor (¶[0206] the insertion sharp 132, such as a needle; see generally Figs. 1A-3 and 40A-44B), and
wherein the moving tab includes a cover portion arranged between the protective sheet and the needle to prevent the needle from contacting the protective sheet (¶[0273] the portion of the set base 106 that acts as a protective barrier for the sharp 32, see Figs. 24A-24B, the adhesive 374 remains in both figures, but the protective portion of the set base 106 is removed from therebetween in Fig. 24B).
Regarding Claim 17, Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator assembly (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B) comprising:
an applicator body (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B);
a sensor unit, including a sensor, a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
an adhesive layer provided at the sensor unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place; Figs. 1A-3), and
a protective sheet covering an adhesive layer (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3),
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) installed to the applicator body to move the sensor unit (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
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 (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B);
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be movable by the user to move the protective sheet in a removal direction of being away from the sensor unit housing to separate the protective sheet from the adhesive layer (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C),
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive layer to cover the adhesive layer, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive layer (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lanigan.
Regarding Claim 15, Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator for inserting a sensor into skin of a user (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B), the applicator comprising:
an applicator body (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B) to which a base unit is separably coupled, and the base unit including a base unit housing (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided, ¶[0206] the retainer base 140, which may use couplings such as adhesive; Figs. 1A-3), and an adhesive portion provided at the base unit housing to be attached to the skin of the user (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided; Figs. 1A-3),
a protective sheet covering the adhesive portion (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3);
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) installed to the applicator body to move a sensor unit (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
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 (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B and 80-81); and
the sensor unit including the sensor and a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
an adhesive layer provided at the sensor unit housing to be attachable to the base unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81), and
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be moved by the user to move the protective sheet in a removal direction of being away from the sensor unit housing to separate the protective sheet from the adhesive portion (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C);
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive portion to cover the adhesive portion, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive portion (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21).
Lanigan teaches that a protective sheet covering the adhesive portion for removal before use (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3), and that lock members 141 may be utilized (see ¶[0290]-[0291]; Figs. 45-47), but not specifically that such a sheet covers the adhesive layer for removal.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive backing 111 of the adhesive portion with the adhesive of the retainer before the device is readied (i.e., in the relax state before the lock members are removed) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the adhesive backing would help to protect the adhesive, such as to ensure that the adhesive does not dry out.
Regarding Claim 16, Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator for inserting a sensor into skin of a user (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B), the applicator comprising:
an applicator body (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B) to which a base unit is separably coupled, the base unit including a base unit housing (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided, ¶[0206] the retainer base 140, which may use couplings such as adhesive; Figs. 1A-3),
an adhesive layer provided at one side of the base unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81), and
an adhesive portion provided at another side of the base unit housing to be attached to the skin of the user is separably coupled (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided; Figs. 1A-3),
a protective sheet covering the adhesive portion (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3);
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) installed to the applicator body to move a sensor unit (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002; Figs. 1A-3 and 70A-71B),
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 (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B and 80-81); and
the sensor unit including the sensor and a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002, Figs. 1A and 70A-71B),
the sensor unit housing being configured to be attachable to the base unit housing by the adhesive layer (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81),
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be moved by the user to move the protective sheet in a removal direction away from the base unit housing to separate the protective sheet from the adhesive portion (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C);
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive portion to cover the adhesive portion, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive portion (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21).
Lanigan teaches that a protective sheet covering the adhesive portion for removal before use (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3), and that lock members 141 may be utilized (see ¶[0290]-[0291]; Figs. 45-47), but not specifically that such a sheet covers the adhesive layer for removal.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive backing 111 of the adhesive portion with the adhesive of the retainer before the device is readied (i.e., in the relax state before the lock members are removed) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the adhesive backing would help to protect the adhesive, such as to ensure that the adhesive does not dry out.
Regarding Claim 18, Lanigan teaches the device of claim 17 as stated above. Lanigan further teaches a base unit including a base unit housing (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided, ¶[0206] the retainer base 140, which may use couplings such as adhesive; Figs. 1A-3), to which the sensor unit housing is coupled (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81), and
an adhesive portion provided at the base unit housing to be attached to the skin of the user (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided; Figs. 1A-3),), and the base unit being spaced apart from the sensor unit and separably coupled to the applicator body (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided, ¶[0206] the retainer base 140, which may use couplings such as adhesive; Figs. 1A-3),
the protective sheet covering the adhesive portion (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3),
wherein the sensor unit housing is configured to be attachable to the base unit housing by the adhesive layer in the second position (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81).
Lanigan teaches that a protective sheet covering the adhesive portion (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3), and that lock members 141 may be utilized (see ¶[0290]-[0291]; Figs. 45-47), but not specifically that such a sheet covers the adhesive layer.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive backing 111 of the adhesive portion with the adhesive of the retainer before the device is readied (i.e., in the relax state before the lock members are removed) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the adhesive backing would help to protect the adhesive, such as to ensure that the adhesive does not dry out.
Regarding Claim 19, Lanigan teaches an inserter assembly with a first unit with a skin contact face, and a second unit with an infusion set base (see abstract and Figs. 1A-3 and 17A-17B). Lanigan teaches an applicator assembly (see abstract and Figs. 1A-3 and 17A-17B; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B) comprising:
a sensor unit including a sensor and a sensor unit housing to which the sensor is mounted (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002; Figs. 1A-3 and 70A-71B),
a base unit including a base unit housing (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided, ¶[0206] the retainer base 140, which may use couplings such as adhesive; Figs. 1A-3),
an adhesive layer provided at one side of the base unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81)
to attach the sensor unit housing to the base unit housing (¶[0199] the base 106 may be provided with an adhesive (i.e., adhesive pad) which retains the infusion set/sensor cartridge 102 in place, and/or ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81), and
an adhesive portion provided at another side of the base unit housing to be attached to the skin of the user (¶[0199] the base 106 to which the adhesive (i.e., the adhesive pad) is provided; Figs. 1A-3),
a protective sheet covering the adhesive portion (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3);
an applicator body to which the base unit is separably coupled (¶[0201] the exterior housing 116, ¶[0329] the exterior housing 116 and the retainer cap 406 together form the first unit; Fig. 1A and 70A-71B);
an insertion unit assembly (¶[0203] the interior housing 120 and/or ¶[0206] the sharp holder 130 for holding the sharp 132; Fig. 1A) mounted to the applicator body to insert the sensor into the skin of the user by moving the sensor unit (¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge 102/1002; Figs. 1A-3 and 70A-71B)
from a first position spaced apart from the base unit to a second position where the sensor unit coupled with the base unit (see generally abstract, ¶[0008]-[0009], ¶[0014]-[0018], ¶[0036]-[0037], and ¶[0329]-[0330], the first unit and second unit, movable relative to one another, to insert the infusion set/sensor cartridge 102; see also ¶[0196], ¶[0312], ¶[0316], and ¶[0326] the inserter may also be usable for inserting an analyte sensor as a sensor cartridge as the set cartridge, Figs. 70A-71B; see additionally ¶[0206], ¶[0348]-[0354], and ¶[0370]-[0371] the retainer base 140, which may use couplings such as adhesive to keep the internal components connected to one another, and that holds the members in a stressed state after the first unit has been pressed in and is in the ready state; Figs. 1A-3 and 80-81, see generally also ¶[0276], ¶[0281], ¶[0283], Figs. 39A-44B and 80-81);
a moving tab coupled to a portion of the protective sheet, the moving tab being movably installed to the applicator body to be moved by the user to move the protective sheet in a removal direction away from the base unit housing to separate the protective sheet from the adhesive portion (¶[0199], ¶[0215], ¶[0218], and ¶[0247] the pull tabs 410 and/or the gripping region 224, such as a tab, so as to facilitate removal of the adhesive backing 111 from the adhesive layer, alternatively and/or additionally, ¶[0208], ¶[0215], and ¶[0218] the lock member 146 including the arms 228/230 inserted through the side hole of the exterior housing 116, facilitated removal via the flange 152, in which the lock member 146 may be bonded to the adhesive backing 111; Figs. 1A-3 and 17A-18C);
an operating member installed to the applicator body to be operated by the user (¶[0304] the button 550 which may trigger actuation when displaced; Fig. 54); and
a stopper part movably installed to the applicator body to operate the insertion unit assembly in association with the operation member (¶[0264] the catch 306 that the ledge 302 rests on; Figs. 24A-24B), and
wherein the moving tab is configured to restrain movement of the stopper part in an initial position where the protective sheet is coupled with the adhesive portion to cover the adhesive portion, and the moving tab is configured to release restraint on the stopper part in a removal position where the protective sheet is separated from the adhesive portion (¶[0208] the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, see generally Figs. 17A-21).
Lanigan teaches that a protective sheet covering the adhesive portion for removal before use (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use; Figs. 1A-3), and that lock members 141 may be utilized (see ¶[0290]-[0291]; Figs. 45-47), but not specifically that such a sheet covers the adhesive layer for removal.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive backing 111 of the adhesive portion with the adhesive of the retainer before the device is readied (i.e., in the relax state before the lock members are removed) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the adhesive backing would help to protect the adhesive, such as to ensure that the adhesive does not dry out.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lanigan as applied to claim 1 above, and in view of Chae et al. (US Patent Application Publication 2020/0178899 – cited in prior action), hereinafter Chae.
Regarding Claim 7, Lanigan teaches the device of claim 1 as stated above. Lanigan teaches that the lock member 146 may be bonded to the adhesive backing 111 (see ¶[0215]), but does not teach any specific bonding including that the moving tab is coupled to the protective sheet by an adhesive part.
Chae teaches a sensor applicator assembly for a continuous glucose monitoring system (see abstract and Fig. 1), in which adhesive tape 560 is attached to a body contact surface of the sensor module 20 so that the sensor module 20 may be attached to the human body (see ¶[0065]) and Figs. 2a-2b), in which a release paper 561 may be attached to the adhesive tape 560 to protect the adhesive tape 560 (see ¶[0065]), in which the release paper 561 may be attached to a removable protective cap 200 via separate adhesive member 562 (see ¶[0065]-[0066] and ¶[0076]; Figs. 9A-9B).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the adhesive member 562 of Chae as the bond of the lock member 146 to the adhesive backing 111 of Lanigan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Lanigan requires a bond between the lock member 146 and the adhesive backing 111 and Chae teaches one such bond; and/or (3) the adhesive would enable the user to remove the adhesive backing 111 when removing the lock member 146, thus simplifying the operating procedure (see Chae ¶[0065]-[0066] and ¶[0076]; Figs. 9A-9B).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lanigan as applied to claim 1 above, and in view of Larson et al. (US Patent Application Publication 2012/0227358 – cited in prior action), hereinafter Larson.
Regarding Claim 8, Lanigan teaches the device of claim 1 as stated above. Lanigan further teaches that the protective sheet comprises a protective portion covering the adhesive layer (¶[0199] the adhesive may be covered by an adhesive backing 111 which is removed to expose the adhesive before use, the protective portion is the portion that specifically covers the adhesive backing 111; Figs. 1A-3).
Lanigan teaches that the lock member 146 may be bonded to the adhesive backing 111 (see ¶[0215]), but does not teach any specific bonding including that the protective sheet comprises a wing portion extended from an edge of the protective portion, and a protective sheet hole formed at one side of the wing portion, and wherein the moving tab has a grip portion corresponding to the protective sheet hole, and the moving tab is coupled with the protective sheet in a way that the grip portion is inserted into the protective sheet hole.
Larson teaches of a sealed glucose sensor so as to maintain the sterility of the glucose sensor while allowing gaseous manufacturing by-products to be vented (see abstract and Figs. 1-2), in which the glucose sensor may have an assembly 104 comprising a glucose sensor 200, a sensor base 202 coupled to the glucose sensor 200, a sensor introducer 204 that cooperates with the sensor base 202, a mounting base 206 for the sensor base 202, a liner 207, a sensor mounting pedestal 208, and an adhesive disk 209 (see ¶[0025] and Figs. 3-4), in which the liner 207 is a temporary structure used during the shipping and handling of the assembly 100 (see ¶[0029]), in which the liner 207 is held and separated from sensor portion before usage via liner holder 211, such as the hook, that engages an edge, a hole, tabs, or any cooperating feature of the liner 207 (see ¶[0031]; Figs. 3 and 6).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the liner holder 211 (i.e., the grip portion) for engaging the hole of the liner 207 of Larson as the bond of the lock member 146 to the adhesive backing 111 of Lanigan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Lanigan requires a bond between the lock member 146 and the adhesive backing 111 and Larson teaches one such bond; and/or (3) the liner holder would enable the user to remove the adhesive backing 111 when removing the lock member 146, thus simplifying the operating procedure (see Larson ¶[0031]).
Response to Arguments
Applicant’s arguments, objections to the drawings
Applicant’s arguments, see pg. 10, filed July 17, 2026, with respect to the objection of the drawings under 37 CFR 1.83(a) have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, objections to the abstract
Applicant’s arguments, see pg. 10, filed July 17, 2026, with respect to the objection of the abstract have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(f)
Applicant’s arguments, see pg. 10, filed July 17, 2026, with respect to the interpretation of the claimed terms under 35 U.S.C. § 112(f) have been fully considered and are NOT persuasive. As explained in the above three-pronged test, the claimed terms recite generic placeholders, modified by functional language, without sufficient structure, material, or acts so as to achieve the specified function. Therefore, Applicant’s arguments are not persuasive and interpretation of the claimed terms under 35 U.S.C. § 112(f) are maintained.
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 11, filed July 17, 2026, with respect to the objections of claims 9, 11, and 19 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 11, filed July 17, 2026, with respect to the rejections of claims 1-19 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made that was necessitated by Applicant’s amendment filed on July 17, 2026.
Applicant’s arguments, prior art
Applicant’s arguments, see pg. 12-14, filed July 17, 2026, with respect to the rejections of claims 1-19 under 35 U.S.C. § 102 (a)(1) and § 103 have been fully considered and are NOT persuasive. Applicant argues that the amended recitation from claim 9 is not taught by Lanigan. Specifically, “the catch 306 of Lanigan is neither a movable member nor a member operating in association with an operating member…The lock member 146 is a simple wedge structure that merely blocks relative movement between the housings and has no restraining relationship with the catch 306. The examiner respectfully disagrees. The catch 306 is movable with the sharp retractor 134 (see specification ¶[0217] and Figs. 1A-3), and would thus fall under the BRI of “movably installed”. The recitation “operate the insertion unit assembly in association with the operating member” is mere intended use and not required in the claimed device. Furthermore, even if the language was required in the claim, “operate the insertion unit assembly in association with the operating member” merely requires that the component operate together when the device is actuated under the BRI. There need not be any narrower association (i.e., physically connected to, or direct actuation caused from the operating member, etc.) to meet the claimed recitation. The claim requires for the moving tab “to restrain movement of the stopper part in an initial position”; and as the lock member 146 mechanically prevents displacement of one or more components of the inserter assembly 100, which would include the catch 306, the components are not yet moving until the lock member 146 is removed, which meets the BRI of the claimed recitation. There need not be any further “functional linkage” between the terms. Any specific/narrower relationships between the operating member, the stopper part, and the moving tab as Applicant has argued should be amended in the claim to carry patentable weight. Therefore, the Applicant’s arguments are not persuasive and the rejections to the claims in view of Lanigan are maintained.
The rejections to the other independent claims, claims 15-17 and 19, are maintained for the aforementioned reasons. The rejections to the dependent claims are maintained by virtue of the rejections to the independent claim.
Similarly, the provisional rejections to the claims of nonstatutory double patenting are maintained for the reasons as stated above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER M. ROBERTSON can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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