DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, an exterior housing “including a closed end” must be shown or the features canceled from claim 1. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Claims 15-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/31/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the new matter is “an exterior housing including a closed end”.
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 1, 12 and all claims depending therefrom 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.
Regarding claim 1, the limitation “an infusion set base retainer having an infusion set base releasably coupled thereto” does not clearly set forth whether the infusion set base is part of the infusion set base retainer (“the infusion set base retainer ‘has’” could mean “the infusion set base member ‘comprises’”) or if the infusion set base and infusion set retainer are two different parts; if the latter interpretation is taken, it is not clear whether the infusion set base is intended to be part of the claimed invention since it is not positively recited using the same “comprising” language as other limitations (e.g., “an exterior housing”; “an interior housing”; “a sharp holder”, etc.).
For the purpose of examination, the limitation will be interpreted to mean “an infusion set base retainer and an infusion set base releasably coupled to the infusion set base retainer”.
Regarding claim 12, the limitation “the interior housing includes an indention providing a recess within which pull tabs of the liner are positioned” is indefinite because “pull tabs of the liner” were not previously recited as being part of the cartridge, and so it is not clear if they are intended to be part of the claimed invention or recited in terms of the function of the indentation (i.e., the indention provides a recess within which pull tabs of the liner are able to be positioned).
For the purpose of examination, the latter interpretation will be applied.
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 1-5, 8, 9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gyrn et al (U.S. Pat. 11,786,653, hereinafter “Gyrn”).
Regarding claim 1, Gyrn discloses a cartridge for a reusable inserter assembly comprising:
an exterior housing 12 (see Figs. 9 and 12) including a closed end (shown, but not labeled at the top of the housing 1);
an interior housing 1 (see Figs. 9 and 12) releasably coupled to the exterior housing;
an infusion set base retainer (combination of 45 and 52; see Fig. 12) having an infusion set base 44 (see Fig. 1B) releasably coupled thereto;
a sharp holder 46 (see Fig. 12) having an insertion sharp 47 (see Fig. 12) coupled thereto; and
a cannula subassembly 43 (see Fig. 12) mounted on the insertion sharp such that an insertion end of the insertion sharp extends out of an outlet end of a cannula of the cannula subassembly (as shown in Fig. 9), the insertion end of the insertion sharp being within the interior housing (also shown in Fig. 9).
Regarding claim 2, Gyrn discloses the cartridge of claim 1, wherein the cartridge further comprises a removable barrier member 67 (see Fig. 12) spanning an open end of the exterior housing.
Regarding claim 3, Gyrn discloses the cartridge of claim 2, wherein the barrier member is permeable to a sterilization agent (see col. 13, lines 42-43 disclosing that the barrier member can be made of woven material, which would be understood to be permeable to a sterilization agent that can penetrate between the weaves).
Regarding claim 4, Gyrn discloses the cartridge of claim 1, wherein the exterior housing is shaped as a cup (see Figs. 9 and 12).
Regarding claim 5, Gyrn discloses the cartridge of claim 1, wherein the exterior housing includes at least one receptacle (see Figs. 9 and 12) and the interior housing includes at least one displaceable projection (see Fig. 7 showing projections around the exterior housing), the interior housing being releasably coupled to the exterior housing via engagement of each of the at least one projection with a respective one of the at least one receptacle (the projections engage arms located on the housing 12, most clearly shown in Fig. 10D and in the annotated Figs. 10C and 10D, below).
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Gyrn, Annotated Figs. 10C and 10D
Regarding claim 8, Gyrn discloses the cartridge of claim 1, wherein the cartridge further comprises a set of mating pins 56 (see Fig. 1); the limitation “for mating with a mating interface of the reusable inserter assembly” covers the function of the cartridge, and does not positively require a reusable inserter assembly; this recitation places no structural limitation on the cartridge itself.
Regarding claim 9, the limitation “wherein the mating pins are configured to be received in retention shoes of the reusable inserter assembly when the cartridge is coupled to the reusable inserter assembly” covers the function of the cartridge, and does not positively require a reusable inserter assembly; this recitation places no structural limitation on the cartridge itself.
Regarding claim 11, Gyrn discloses the cartridge of claim 1, wherein the infusion set base includes adhesive on a face thereof, the adhesive being covered by a liner (see col. 7, lines 49-55).
Regarding claim 12, Gyrn discloses the cartridge of claim 11, wherein the interior housing includes an indention providing a recess (areas in between projections on the outside of the interior housing; see Fig. 7) within which pull tabs of the liner are able to be positioned.
Regarding claim 13, Gyrn discloses the cartridge of claim 1, wherein the infusion set base retainer includes a cavity within which a majority of the insertion sharp holder is disposed (see Fig. 9).
Regarding claim 14, Gyrn discloses the cartridge of claim 13, wherein the cavity includes guides (see Fig. 12 shown as interior portions of the lid 45) and the insertion sharp holder includes rails 54 (see Fig. 12) which cooperate with the guides to constrain displacement of the insertion sharp holder within the cavity to a prescribed path (see Fig. 12; the insertion sharp holder is only able to slide up and down along the lid 45).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wojcik et al (U.S. Pub. 2009/0088722, hereinafter “Wojcik”).
Regarding claim 1, Wojcik discloses a cartridge for a reusable inserter assembly comprising:
an exterior housing including a closed end (the "sterilized package" described in para [0017]);
an interior housing 68 (see Fig. 6) releasably coupled to the exterior housing (the sterilized package is opened up and the interior housing can be released from the packaging);
an infusion set base retainer 15 (see Fig. 6) having an infusion set base 111 (see Fig. 15) releasably coupled thereto;
a sharp holder 39 (see Fig. 6) having an insertion sharp 49 (see Fig. 6) coupled thereto;
and a cannula subassembly 16 (see Fig. 6) mounted on the insertion sharp such that an insertion end of the insertion sharp extends out of an outlet end of a cannula of the cannula subassembly, the insertion end of the insertion sharp being within the interior housing (see para [0042] and Fig. 3).
Allowable Subject Matter
Claims 6, 7, 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and pending overcoming the rejection(s) under 35 U.S.C. 112.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 01/16/2026