DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on February 3, 2026 were received and fully considered. Upon further consideration, in view of applicant’s persuasive arguments, Examiner has withdrawn the previous restriction requirement. Claims 7-20 are considered on the merits. See below for more detail.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies (KR10-2017-0068964 filed on 6/2/17; and KR10-2018-0063374 filed on 6/1/18) have been received.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior filed applications (16/618785 filed on 12/2/19; and PCT/KR18/06320 filed on 6/1/18) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1 February 2023, 19 September 2024, 18 February 2025, 7 May 2025, and 2 October 2025 have been considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 needs to end in a period. Appropriate correction is required.
Claim Rejections - 35 USC § 112B
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.
Claims 7-13, and 17-20 are 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 7, and all dependent claims thereof, recites “a distance between a top end portion and a bottom end portion of the main container is substantially constant” in lines 34-35, which is indefinite for reciting relative terminology. What is substantially constant?
Similar indefiniteness (substantially constant) is also exhibited in claims 8-10, and 17-20.
Claim Rejections - 35 USC § 102(A)(1)
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 7-20 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Stafford (US PG Pub. No. 2008/0114280 A1).
Stafford was cited in applicant’s IDS filed on September 19, 2024.
With respect to claim 7, Stafford teaches a sensor applicator assembly for a glucose monitoring system (abstract; par.0001 “monitoring glucose”), comprising: a sensor module including a pod and a sensor probe which is disposed inside the pod and having a one end portion protruding from a bottom surface of the pod (sensor 314 and mount 312; see Fig. 4); and an applicator in which the sensor module is accommodated (inserter kit 300 and housing 344; see Fig. 4; par.0042+) and which includes the following: a main container including an internal container (Fig. 4 shows an exploded perspective view of the inserter kit depicting multiple internal compartments, containers, etc.); a plunger body which is disposed inside the internal container and having a first accommodating space in which the sensor module is accommodated and a second accommodating space (par.0050 “push actuator button 324”; see Fig. 4); an elastic plunger spring disposed between the internal container and the plunger body (drive spring 336 in Fig. 4), a needle withdrawing body disposed inside the second accommodating space of the plunger body (shuttle 338 in Fig. 4); a needle withdrawing elastic spring disposed between the plunger body and the needle withdrawing body in the second accommodating space of the plunger body (retraction spring 342 is disposed between plunger body 324 and needle withdrawing body 338; Fig. 4); and a needle which is coupled to the needle withdrawing body and configured to pass through the pod so as to surround at least a portion of the one end portion of the sensor probe (“introducer sharp 340”; Fig. 4; par.0042+), wherein the internal container and the plunger body are detachably coupled to each other at a first position, when the plunger body and the internal container are decoupled, the plunger body is moved from the first position to a second position below the first position due to extending of the elastic plunger spring (par.0041 “components may then be removed”; see also par.0045-46, 0051), when the plunger body is moved from the first position to the second position, each of the needle withdrawing body, the needle withdrawing elastic spring, the sensor module, and the needle is moved together with the plunger body (par.0042+, 0044, 0046, 0049, 0051-52; Fig. 4), the plunger body is coupled to the needle withdrawing body (Fig. 4), and is decoupled to the needle withdrawing body at the second position (Fig. 4), when the needle withdrawing body and the plunger body are decoupled, the needle withdrawing body is moved toward the first position due to extending of the needle withdrawing elastic spring, and a distance between a top end portion and a bottom end portion of the main container is substantially constant (Fig. 4).
With respect to claim 8, Stafford teaches wherein a top end portion of the elastic plunger spring is maintained at a substantially constant height (Fig. 4).
With respect to claim 9, Stafford teaches wherein a distance between the top end portion of the elastic plunger spring and the top end portion of the main container is substantially constant (Fig. 4).
With respect to claim 10, Stafford teaches wherein the needle withdrawing elastic spring has a top end portion and a bottom end portion, and a distance between the top end portion and the bottom end portion of the needle withdrawing elastic spring is substantially constant when the plunger body is moved from the first position to the second position (Fig. 4).
With respect to claim 11, Stafford teaches wherein the main container further includes an external container that covers at least a portion of the internal container, and a press button for releasing the coupling of the plunger body and the internal container at the first position by being pressed in a lateral direction is formed on the external container (Fig. 4).
With respect to claim 12, Stafford teaches wherein a fixing stepped portion is formed in the internal container, and an elastic hook engaged with the fixing stepped portion of the internal container at the first position is formed on the plunger body (Fig. 4; par.0052).
With respect to claim 13, Stafford teaches wherein the elastic hook is deformed due to the lateral pressure so that the engagement with the fixing stepped portion is released (Fig. 4; par.0052).
With respect to claim 14, Stafford teaches a sensor applicator assembly for a glucose monitoring system (abstract; par.0001 “monitoring glucose”), comprising: a sensor module including a pod and a sensor probe which is disposed inside the pod and having a one end portion protruding from a bottom surface of the pod (sensor 314 and mount 312; see Fig. 4); and an applicator in which the sensor module is accommodated (inserter kit 300 and housing 344; see Fig. 4; par.0042+) and which includes the following: a main container including an internal container and an external container that covers at least a portion of the internal container (Fig. 4 shows an exploded perspective view of the inserter kit depicting multiple internal compartments, containers, etc.); a plunger body which is disposed inside the internal container and having a first accommodating space in which the sensor module is accommodated and a second accommodating space (par.0050 “push actuator button 324”; see Fig. 4); an elastic plunger spring disposed between the internal container and the plunger body (drive spring 336 in Fig. 4), a needle withdrawing body disposed inside the second accommodating space of the plunger body (shuttle 338 in Fig. 4); a needle withdrawing elastic spring disposed between the plunger body and the needle withdrawing body in the second accommodating space of the plunger body (retraction spring 342 is disposed between plunger body 324 and needle withdrawing body 338; Fig. 4); and a needle which is coupled to the needle withdrawing body and configured to pass through the pod so as to surround at least a portion of the one end portion of the sensor probe (“introducer sharp 340”; Fig. 4; par.0042+), wherein the internal container and the plunger body are detachably coupled to each other at a first position, when the plunger body and the internal container are decoupled, the plunger body is moved from the first position to a second position below the first position due to extending of the elastic plunger spring (par.0041 “components may then be removed”; see also par.0045-46, 0051), when the plunger body is moved from the first position to the second position, each of the needle withdrawing body, the needle withdrawing elastic spring, the sensor module, and the needle is moved together with the plunger body (par.0042+, 0044, 0046, 0049, 0051-52; Fig. 4), the plunger body is coupled to the needle withdrawing body (Fig. 4), and is decoupled to the needle withdrawing body at the second position (Fig. 4), when the needle withdrawing body and the plunger body are decoupled, the needle withdrawing body is moved toward the first position due to extending of the needle withdrawing elastic spring (Fig. 4), and a press button for releasing the coupling of the plunger body and the internal container at the first position by being pressed in a lateral direction is formed on the external container (Fig. 4; par.0040, 0042, 0057).
With respect to claim 15, Stafford teaches wherein a fixing stepped portion is formed in the internal container, and an elastic hook engaged with the fixing stepped portion of the internal container at the first position is formed on the plunger body (Fig. 4; 0052).
With respect to claim 16, Ohkoshi teaches wherein the elastic hook is elastically deformed in the lateral direction so that the engagement with the fixing stepped portion is released (Fig. 4; 0052).
With respect to claim 17, Ohkoshi teaches wherein a distance between a top end portion and a bottom end portion of the main container is substantially constant (Fig. 4).
With respect to claim 18, Ohkoshi teaches wherein a top end portion of the elastic plunger spring is maintained at a substantially constant height (Fig. 4).
With respect to claim 19, Ohkoshi teaches wherein a distance between the top end portion of the elastic plunger spring and a top end portion of the main container is substantially constant (Fig. 4).
With respect to claim 20, Ohkoshi teaches wherein the needle withdrawing elastic spring has a top end portion and a bottom end portion, and a distance between the top end portion and the bottom end portion of the needle withdrawing elastic spring is substantially constant when the plunger body is moved from the first position to the second position (Fig. 4).
Claims 7-20 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Ohkoshi et al. (US PG Pub. No. 2015/0190076 A1) (hereinafter “Ohkoshi”).
With respect to claim 7, Ohkoshi teaches a sensor applicator assembly for a glucose monitoring system (abstract; par.0078 “information about the concentration of glucose”), comprising: a sensor module including a pod and a sensor probe which is disposed inside the pod and having a one end portion protruding from a bottom surface of the pod (sensor base 52 and sensor 50 in Fig. 2; see also par.0068); and an applicator in which the sensor module is accommodated (movement mechanism 16 of sensor insertion device 10, see Figs. 1-2) and which includes the following: a main container including an internal container (Fig. 2 shows an exploded perspective view of the sensor insertion device 10 depicting multiple internal compartments, containers, etc.); a plunger body which is disposed inside the internal container and having a first accommodating space in which the sensor module is accommodated and a second accommodating space (pusher 88 disposed internally having spaces for accommodating the sensor module 50/52, as depicted in Figs. 1-2); an elastic plunger spring disposed between the internal container and the plunger body (coil spring 90 in Fig. 2), a needle withdrawing body disposed inside the second accommodating space of the plunger body (needle holder 84 in Fig. 2); a needle withdrawing elastic spring disposed between the plunger body and the needle withdrawing body in the second accommodating space of the plunger body (par.0095 “needle holder is inserted into the coil spring”); and a needle which is coupled to the needle withdrawing body and configured to pass through the pod so as to surround at least a portion of the one end portion of the sensor probe (par.0082+ “insertion needle 46”), wherein the internal container and the plunger body are detachably coupled to each other at a first position, when the plunger body and the internal container are decoupled, the plunger body is moved from the first position to a second position below the first position due to extending of the elastic plunger spring (par.0029 “detach the movement mechanism from the device body”; see also par.0116, 0121, 0153, 0158), when the plunger body is moved from the first position to the second position, each of the needle withdrawing body, the needle withdrawing elastic spring, the sensor module, and the needle is moved together with the plunger body (par.0085 “a pusher 88 (pushing member) which pushes the needle holder 84, and a coil spring 90 (resilient member) which elastically biases the needle holder 84”), the plunger body is coupled to the needle withdrawing body (Fig. 2), and is decoupled to the needle withdrawing body at the second position (Fig. 2), when the needle withdrawing body and the plunger body are decoupled, the needle withdrawing body is moved toward the first position due to extending of the needle withdrawing elastic spring, and a distance between a top end portion and a bottom end portion of the main container is substantially constant (Fig. 2).
With respect to claim 8, Ohkoshi teaches wherein a top end portion of the elastic plunger spring is maintained at a substantially constant height (Fig. 2).
With respect to claim 9, Ohkoshi teaches wherein a distance between the top end portion of the elastic plunger spring and the top end portion of the main container is substantially constant (Fig. 2).
With respect to claim 10, Ohkoshi teaches wherein the needle withdrawing elastic spring has a top end portion and a bottom end portion, and a distance between the top end portion and the bottom end portion of the needle withdrawing elastic spring is substantially constant when the plunger body is moved from the first position to the second position (Fig. 2).
With respect to claim 11, Ohkoshi teaches wherein the main container further includes an external container that covers at least a portion of the internal container, and a press button for releasing the coupling of the plunger body and the internal container at the first position by being pressed in a lateral direction is formed on the external container (Fig. 2).
With respect to claim 12, Ohkoshi teaches wherein a fixing stepped portion is formed in the internal container, and an elastic hook engaged with the fixing stepped portion of the internal container at the first position is formed on the plunger body (Fig. 2; par.0073, 0125, 0131-132, 0160).
With respect to claim 13, Ohkoshi teaches wherein the elastic hook is deformed due to the lateral pressure so that the engagement with the fixing stepped portion is released (Fig. 2; par.0073, 0125, 0131-132, 0160).
With respect to claim 14, Ohkoshi teaches a sensor applicator assembly for a glucose monitoring system (abstract; par.0078 “information about the concentration of glucose”), comprising: a sensor module including a pod and a sensor probe which is disposed inside the pod and having a one end portion protruding from a bottom surface of the pod (sensor base 52 and sensor 50 in Fig. 2; see also par.0068); and an applicator in which the sensor module is accommodated (movement mechanism 16 of sensor insertion device 10, see Figs. 1-2) and which includes the following: a main container including an internal container and an external container that covers at least a portion of the internal container (Fig. 2 shows an exploded perspective view of the sensor insertion device 10 depicting multiple internal compartments, containers, etc.); a plunger body which is disposed inside the internal container and having a first accommodating space in which the sensor module is accommodated and a second accommodating space (pusher 88 disposed internally having spaces for accommodating the sensor module 50/52, as depicted in Figs. 1-2); an elastic plunger spring disposed between the internal container and the plunger body (coil spring 90 in Fig. 2), a needle withdrawing body disposed inside the second accommodating space of the plunger body (needle holder 84 in Fig. 2); a needle withdrawing elastic spring disposed between the plunger body and the needle withdrawing body in the second accommodating space of the plunger body (par.0095 “needle holder is inserted into the coil spring”); and a needle which is coupled to the needle withdrawing body and configured to pass through the pod so as to surround at least a portion of the one end portion of the sensor probe (par.0082+ “insertion needle 46”), wherein the internal container and the plunger body are detachably coupled to each other at a first position, when the plunger body and the internal container are decoupled, the plunger body is moved from the first position to a second position below the first position due to extending of the elastic plunger spring (par.0029 “detach the movement mechanism from the device body”; see also par.0116, 0121, 0153, 0158), when the plunger body is moved from the first position to the second position, each of the needle withdrawing body, the needle withdrawing elastic spring, the sensor module, and the needle is moved together with the plunger body (par.0085 “a pusher 88 (pushing member) which pushes the needle holder 84, and a coil spring 90 (resilient member) which elastically biases the needle holder 84”), the plunger body is coupled to the needle withdrawing body (Fig. 2), and is decoupled to the needle withdrawing body at the second position (Fig. 2), when the needle withdrawing body and the plunger body are decoupled, the needle withdrawing body is moved toward the first position due to extending of the needle withdrawing elastic spring (Fig. 2), and a press button for releasing the coupling of the plunger body and the internal container at the first position by being pressed in a lateral direction is formed on the external container (par.0111).
With respect to claim 15, Ohkoshi teaches wherein a fixing stepped portion is formed in the internal container, and an elastic hook engaged with the fixing stepped portion of the internal container at the first position is formed on the plunger body (Fig. 2; par.0073, 0125, 0131-132, 0160).
With respect to claim 16, Ohkoshi teaches wherein the elastic hook is elastically deformed in the lateral direction so that the engagement with the fixing stepped portion is released (Fig. 2; par.0073, 0125, 0131-132, 0160).
With respect to claim 17, Ohkoshi teaches wherein a distance between a top end portion and a bottom end portion of the main container is substantially constant (Fig. 2).
With respect to claim 18, Ohkoshi teaches wherein a top end portion of the elastic plunger spring is maintained at a substantially constant height (Fig. 2).
With respect to claim 19, Ohkoshi teaches wherein a distance between the top end portion of the elastic plunger spring and a top end portion of the main container is substantially constant (Fig. 2).
With respect to claim 20, Ohkoshi teaches wherein the needle withdrawing elastic spring has a top end portion and a bottom end portion, and a distance between the top end portion and the bottom end portion of the needle withdrawing elastic spring is substantially constant when the plunger body is moved from the first position to the second position (Fig. 2).
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 7-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,596,356 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791