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 .
Election/Restrictions
Applicant’s election without traverse of claims 22-31 in the reply filed on September 2, 2026 is acknowledged. Claims 12-21 are withdrawn from consideration.
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 (18/631782 filed on 4/10/2024; 16/943677 filed on 7/30/2020; 15/478110 filed on 4/3/2017; 62/460710 filed on 2/17/2017; 15/357982 filed on 11/21/2016; 15/357885 filed on 11/21/2016; 62/402676 filed on 9/30/2016; 62/344847 filed on 6/20/2016; 62/344852 filed on 6/20/2016; 62/320290 filed on 4/8/2016) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 November 2024 and 2 September 2026 have been considered by the examiner.
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 22-31 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Curry et al. (US PG Pub. No. 2012/0190951 A1) (hereinafter “Curry”).
With respect to claim 22, Curry teaches an apparatus comprising: a medical device including a surface adapted to be held against a skin of a user and a filament extending therefrom (on body housing 122 with adhesive pad 218 and analyte sensor 14; see par.0091); and an insertion tool, comprising: a frame having a mouth for positioning against the skin during placement of the medical device on the skin, and an internal cavity for retention of the medical device prior to placement (interior housing 2402 with a distal opening covered by adhesive patch 218 and cap 2412. Housing 122 is retained inside by detent features 2440; par.0171), a retractable needle extending through the medical device and carrying the filament (sharp 2404 passes through housing 122 and the patch aperture, carrying the sensor into the skin and is retracted by the inserter’s return spring; par.0178); a striker holding the medical device and being axially movable within the frame from a first retracted position within the frame to a second position in which the surface of the medical device is presented at the mouth of the frame (plunger 2405 holds housing 122 and sharp holder 2408 (tabs 2422). It travels distally until housing 122 contacts adhesive pad 218, then stops against wall 2426; par.0170+); a driver configured to urge the striker towards the second position (drive spring 4010 drives plunger 4012 into plunger 2405; par.0195); a releasable striker lock holding the striker in the first retracted position (appendages 4018 on ledge 4017 hold plunger 4012 (and so the plunger train) retraced); par.0193+); and a plunger axially movable with respect to the frame in a direction towards the mouth, from a rest position to a firing position (outer button 4002 allows outer button 3904 to be moved between a proximal and distal position; par.0188), the apparatus having a mechanism configured to release the releasable striker lock when the plunger reaches the firing position, allowing the striker to move from the first retracted position to the second position (button travel displaces appendages 4018 from edge 4017. The displacement of appendages 4018 from ledge 4017 allows drive spring 4010 to drive plunger 4012 towards plunger 2405 of inserter 2400; par.195).
With respect to claim 23, Curry teaches wherein the driver is a spring longitudinally extending between the striker and the plunger (drive spring 4010 sits between inner button 4008 and plunger 4012; see Fig. 71).
With respect to claim 24, Curry teaches further including a retractor exerting a force on the retractable needle to pull the retractable needle out of the medical device (return spring 2406 in inserter 2400. The return spring located in inserter 2400 retracts sharp 2404 from the subject’s skin; par.0178).
With respect to claim 25, Curry teaches further including a releasable retractor lock preventing the retractor from pulling the retractable needle out of the medical device (par.0156 “locking mechanism 3718”; par.0160 “locking element”; par.0161 Pawl 3818 locks shaft 3816 into place”; par.0192 “lock inner button 4008”).
With respect to claim 26, Curry teaches further including a retractor lock release mechanism configured to release when the striker is in the second position (par.0156, 0160, 0192).
With respect to claim 27, Curry teaches wherein the retractor is a spring acting on a needle hub coupled to a proximal end of the retractable needle (par.0013 “needle seat”).
With respect to claim 28, Curry teaches wherein the plunger is disposed over the frame (outer button 4002 sits over housing 4004; see Figs. 73-79).
With respect to claim 29, Curry teaches wherein the releasable striker lock locks the striker to the frame to prevent axial movement of the striker (appendages 4018 on ledge 4017 of housing 4004; par.0189 “housing may be designed for snap-fit”; par.0193).
With respect to claim 30, Curry teaches further comprising a cover, wherein the cover is detachably positioned over the mouth and configured to be removed from the mouth prior to positioning the mouth against the user's skin (removable distal cap 2412; par.0166).
With respect to claim 31, Curry teaches wherein the medical device is a continuous glucose monitor (par.0022).
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 22-31 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12115002. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
