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 .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pace (US 2013/0150691-Cited by the Applicant) in view of Halac (US 2017/0188912, cited by the Applicant) and further in view of Chae (US 2020/0178899, cited previously).
Pace teaches an implantation device for prompt subcutaneous implantation of a sensor (applicator 212, Fig. 3) to measure a physiological signal of an analyte in a biofluid of a living body having a skin surface ("an analyte sensor (e.g., a glucose sensor) and an applicator assembly to position a portion of the sensor beneath a skin surface," par. 8), comprising: a housing (314) having a bottom opening (Fig. 3); an implantation module including an implanting device (carrier 1022 and sharp 1030 act as an equivalent implanting device) and a needle extracting device (sharp retraction assembly 1024 comprising sharp carrier 1120 and coil return spring 1118); a detachable module including: the sensor (sensor 1102) detachably engaged with the implantation module ("sensor 1102 is supported within sharp 1030," par. 107; Figs. 11C- 11E); and a base (electronics assembly 310) configured to mount the sensor thereon and having an adhesive pad disposed thereon (adhesive patch 312);
a protective ring sleeved on a bottom portion of the housing and having a lateral opening (sheath or guide sleeve 318; lateral openings can be seen in Figs. 3, 10C, 10N), wherein the base and the adhesive pad are disposed on an inner side of a bottom edge of the protective ring such that when the bottom edge of the protective ring abuts against the skin surface, the adhesive pad does not contact the skin surface (Fig. 11A; "adhesive of the on-body device does not contact the user until the application operation (108) is performed," par. 78) and is visible through the lateral opening before implantation of the sensor (Fig. 10N shows the adhesive patch can be seen through the opening on the sides of sheath 318); a bottom cover (applicator end cap 214) detachably coupled to the bottom opening so that the housing and the bottom cover together form an accommodating space (Fig. 2C), wherein: the implantation module and the detachable module are accommodated in the accommodating space (Fig. 11A shows that all components are held within applicator 212); and a transmitter coupled with the base for transmitting the physiological signal that is measured by the sensor ("analyte levels detected by the sensor of the on-body device 222 can be retrieved over a wireless communication link 224 via a communications facility (e.g., a transmitter, a transponder, etc.) within the on-body device 222," par. 81).
While Pace doesn't show the components held within applicator 212 with end cap 214 attached and forming an accommodating space, the internal components of Pace are still accommodated within applicator 212. Pace's end cap 214 can also be reattached. So, the internal components of Pace can be interpreted as being within the accommodating space as they are entirely within the internal space of applicator 212 regardless of whether end cap 214 is attached or not. Thus, Pace teaches all limitations of claim 1 above except for the detachable module and accommodating space excluding a transmitter prior to the subcutaneous implantation of the portion of the sensor and the transmitter being attached to the base after sensor implantation.
Halac teaches an analogous an implantation device (applicator system 104, Figs. 2-3) for subcutaneous implantation of a sensor ("transcutaneous insertion of analyte sensors a system for applying an on-skin sensor assembly to skin of a host, para. 7), comprising: a housing having a bottom opening (shell 120); the sensor (glucose sensor 138) detachably engaged with the implantation module (Figs. 10-11); and a base configured to mount the sensor thereon (base 128, Fig. 4); and the detachable
module and the accommodating space exclude a transmitter prior to subcutaneous implantation of the portion of the sensor and the transmitter is attached to the base after implantation ("the user can also couple the electronics unit 500 to the base 128 (as shown in Fig. 6) after the applicator system 104 places at least a portion of a sensor in a subcutaneous position," para. 261).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Pace to attach the sensor assembly to a base with an adhesive within the implantation device and attach the transmitter after the sensor is inserted, as taught by Halac Fig. 4 and paragraph 261. One would be motivated to do so because not packaging the sensor transmitter with the applicator allows for applicator reuse ("enable the telescoping assembly to be thrown away, recycled, or reused," par. 347; "the user can...reuse the applicator," par. 386). Since Halac also teaches that the electronics and sensor can be separately sterilized in this arrangement (par. 542) and that this arrangement still works to assemble a continuous analyte sensor (Figs. 4-6), then Pace as modified by Halac should also still function as an implantation device for a sensor.
Pace teaches a release layer releasably attached to the adhesive pad (backing 1606, pars. 171-118), a tearing element ("boss," par. 117) connected to the release layer and attached to a chassis portion (container 206 of base 1704, Figs. 16-17), wherein the tearing element is configured to tear away the release layer from the adhesive pad ("backing 1606 is spiral-cut and attached to a boss so that when the on-body device 1604 is transferred from the container 1500, the peel-away backing 1606 is left behind," par. 117). But Pace and Halac do not teach or suggest the tearing element is within the bottom cover and operates when the bottom cover is separated from the bottom opening by the user.
Chae teaches an analogous analyte sensor applicator (Abstract). Chae teaches a sensor base (pod base 510, Fig. 2) and an adhesive pad fixed to a bottom of the base (adhesive tape 560); a release layer releasably attached to the adhesive pad (release paper 561, Fig. 9B), and a tearing element connected to the release layer and attached to a chassis portion of the bottom cover ("adhesive member 562 is bonded to the top surface of the inner support 203" para. 76; Fig. 9B), wherein the tearing element is configured to tear away the release layer from the adhesive pad when the bottom cover is separated from the bottom opening by the user ("the release paper 561 of the adhesive tape 560 may be detached and removed from the adhesive tape 560 while the protective cap 200 is being detached from the applicator 10," para 65).the inner container body 62...a coloring state of the dry discoloration elements 5 in the moisture-indicating portion 63 can be observed," para. 29).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Pace in view of Halac to incorporate a desiccation indicator that can be seen through a transparent portion of the housing, as taught by Lai. One would be motivated to do so because this allows for easy notification if the moisture has entered the medical device ("provide the dry discoloration elements to the desiccant container for maintaining internal dryness and for indicating the internal dryness by absorbing moisture to discolor," Lai para. 6), and Pace in view of Halac can be improved in the same way to prevent use of compromised applicators.
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 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 16945203 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader than those of the Patent. As, such, any invention meeting the limitations of the claims of the Patent would necessarily meet those of the instant application as well.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MARJAN FARDANESH/ Primary Examiner, Art Unit 3791
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