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 inserter including a cartridge receptacle, the cartridge having an engaged state in which the cartridge is retained in the cartridge receptacle and a disengaged state in which the cartridge is uncoupled from the receptacle” (claim 13) must be shown or the feature canceled from the claim. 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.
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 1-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sonderegger et al (U.S. Pub. 2017/0014570 A1, hereinafter “Sonderegger”).
Regarding claim 1, Sonderegger discloses a cartridge comprising:
a housing assembly (combination of outer barrel 12, base 14, button 16 and barrel cap 50; see Figs. 2 and 8), the housing assembly having a wall (exterior of the outer barrel 12) defining an aperture (opening of base 14; see Fig. 2) leading to a cavity within the housing assembly (i.e., inside of the housing assembly containing the sharp 40, catheter 28, drive spring 24, and sharp holder 38; see Fig. 2), the wall including at least one cantilevered arm 18 (see Figs. 1, 2, 9 and 15); and
a sharp holder 38 (see Fig. 2) displaceably received within the cavity and having a displacement range between a first position (shown in Fig. 2) and a second position (shown in Fig. 3); and
a sharp 40 (see Fig. 2) extending from the sharp holder, the sharp is completely disposed within the cavity when the sharp holder is in the first position (as shown in Fig. 2) and at least partially projected through the aperture when the sharp holder is in the second position (as shown in Fig. 3).
Regarding claim 2, Sonderegger discloses the cartridge of claim 1, wherein the cartridge further comprises a medical device disposed at least partially within the cavity (such as an infusion set with a base 14, catheter 28 and septum 30; the catheter 28 and septum 30 are within the cavity).
Regarding claim 3, Sonderegger discloses the cartridge of claim 1, wherein the cartridge further comprises a device selected from the group consisting of, an infusion set and an analyte sensor (the base 14, catheter 28 and septum 30 form the infusion set).
Regarding claim 4, Sonderegger discloses the cartridge of claim 1, wherein the at least one cantilevered arm 18 further comprises a ledge at an unsupported end thereof (the barrel retention tab 18 is shown to curve into an “L” shape to form a ledge on the retention tab 18).
Regarding claim 5, Sonderegger discloses the cartridge of claim 1, wherein the housing assembly comprises a top portion (combination of barrel cap 50 and button 16; see Figs. 2 and 8) opposite the aperture, the top portion closing an end of the cavity (as shown in Fig. 2).
Regarding claim 6, Sonderegger discloses a cartridge comprising:
a housing assembly (combination of outer barrel 12, base 14, button 16 and barrel cap 50; see Figs. 2 and 8) including a wall (exterior of the outer barrel 12) having at least one cantilevered arm 18 (see Figs. 1, 2, 9 and 15), a cavity (i.e., inside of the housing assembly containing the sharp 40, catheter 28, drive spring 24, and sharp holder 38; see Fig. 2), a bottom end (at base 14; see Fig. 2) having an aperture (opening in the base for the sharp 40), and at least one guide channel 36 (see Fig. 2);
a sharp holder 38 (see Fig. 2) displaceably received within the cavity and having at least one projection 26 (see Fig. 2), each of the at least one projection 26 disposed within a respective guide channel 36 (see Fig. 2) of the at least one guide channel;
a sharp 40 (see Fig. 2) extending from the sharp holder (see Fig. 2); and
wherein the sharp holder has a displacement range between a first position (as shown in Fig. 2) in which the sharp is completely disposed within the housing assembly and a second position (see Fig. 3) in which the sharp is at least partially projected through the aperture.
Regarding claim 7, Sonderegger discloses the cartridge of claim 6, wherein the cartridge further comprises a medical device disposed at least partially within the cavity (such as an infusion set with a base 14, catheter 28 and septum 30; the catheter 28 and septum 30 are within the cavity).
Regarding claim 8, Sonderegger discloses the cartridge of claim 6, wherein the cartridge further comprises a medical device selected from the group consisting of, an infusion set and an analyte sensor (the base 14, catheter 28 and septum 30 form the infusion set).
Regarding claim 9, Sonderegger discloses the cartridge of claim 6, wherein the housing assembly further comprises a detachable exterior housing (combination of 12, 16 and 50), the exterior housing having a donned state in which the exterior housing is coupled to the remainder of the housing assembly (see Figs. 2-4, showing the combination of 12, 16 and 50 connected to the base 14), and a doffed state in which the exterior housing is separated from the remainder of the housing assembly (see Fig. 5 and para [0044], disclosing the combination of 12, 16 and 50 separated from the base 14, leaving the base 14 in condition for attachment of the tube set),
the exterior housing having a closed end (at the top of the barrel cap 50 and the button 16) disposed adjacent to and spanning over the aperture when the exterior housing is in the donned state (see Fig. 2, showing the barrel cap 50 and the button 16 spanning over the aperture in the base 14).
Regarding claim 10, Sonderegger discloses the cartridge of claim 6, wherein the at least one cantilevered arm further comprises a nub at an unsupported end thereof (the nub is characterized by the flat end of the “L”-shaped tab at the end of the cantilevered portion).
Regarding claim 11, Sonderegger discloses the cartridge of claim 6, wherein each of the at least one projection of the sharp holder extend outwardly from the sharp holder and runs parallel to an axis of the sharp (see Fig. 2).
Regarding claim 12, Sonderegger discloses the cartridge of claim 6, wherein the housing assembly comprises a top portion (combination of barrel cap 50 and button 16; see Figs. 2 and 8) opposite the bottom end, the top portion closing an end of the cavity (as shown in Fig. 2).
Regarding claim 13, Sonderegger discloses a system for creating a puncture comprising:
a cartridge including:
a sharp holder 38 (see Fig. 2) having a sharp 40 (see Fig. 2) extending therefrom;
a housing assembly (combination of outer barrel 12, button 16 and barrel cap 50; see Figs. 2 and 8) including a wall (exterior of the outer barrel 12) defining at least one cantilevered arm 18 (see Figs. 1, 2, 9 and 15), and a cavity (i.e., inside of the housing assembly containing the sharp 40, catheter 28, drive spring 24, and sharp holder 38; see Fig. 2), and an aperture (opening of outer barrel just above base 14 for the sharp 40; see Fig. 2) leading to the cavity,
the sharp holder displaceably received within the cavity and having a displacement range between a first position (as shown in Fig. 2) and a second position (as shown in Fig. 3),
the sharp completely disposed within the cavity in the first position (see Fig. 2) and at least partially projected beyond the aperture in the second position (see Fig. 3); and
an inserter 14 (see Fig. 2) including a cartridge receptacle 20 (see Fig. 5), the cartridge having an engaged state in which the cartridge is retained in the cartridge receptacle (see Fig. 4) and a disengaged state in which the cartridge is uncoupled from the receptacle (see Fig. 5).
Regarding claim 14, Sonderegger discloses the system of claim 13, wherein the cartridge further comprises a medical device disposed at least partially disposed within the cavity (such as an infusion set with a base 14, catheter 28 and septum 30; the catheter 28 and septum 30 are within the cavity).
Regarding claim 15, Sonderegger discloses the system of claim 13, wherein the cartridge further comprises a medical device selected from the group consisting of, an infusion set and an analyte sensor (the base 14, catheter 28 and septum 30 form the infusion set).
Regarding claim 16, Sonderegger discloses the system of claim 13, wherein in the second position the sharp at least partially projects through a medical device (see Fig. 3; although it is not immediately clear whether the sharp projects through the end of the cannula 28, it projects at least partially through the top portion of the cannula 28 and the septum 30).
Regarding claim 17, Sonderegger discloses the system of claim 13, wherein the housing assembly further comprises an exterior housing (combination of 12, 16 and 50), the exterior housing having a donned state in which the exterior housing is coupled to the remainder of the housing assembly (see Figs. 2-4, showing the combination of 12, 16 and 50 connected to the base 14), and a doffed state in which the exterior housing is separated from the remainder of the housing assembly (see Fig. 5 and para [0044], disclosing the combination of 12, 16 and 50 separated from the base 14, leaving the base 14 in condition for attachment of the tube set),
the exterior housing having a closed end (at the top of the barrel cap 50 and the button 16) disposed adjacent to and spanning over the aperture when the exterior housing is in the donned state (see Fig. 2, showing the barrel cap 50 and the button 16 spanning over the aperture in the base 14).
Regarding claim 18, Sonderegger discloses the system of claim 13, wherein the at least one cantilevered arm further comprises at least one of a nub (the nub is characterized by the flat end of the “L”-shaped tab at the end of the cantilevered portion) and a ledge (the barrel retention tab 18 is shown to curve into an “L” shape to form a ledge on the retention tab 18) at an unsupported end thereof.
Regarding claim 19, Sonderegger discloses the system of claim 13, wherein the housing assembly comprises a top portion (combination of barrel cap 50 and button 16; see Figs. 2 and 8) closing an end of the cavity opposite the aperture (as shown in Fig. 2).
Regarding claim 20, Sonderegger discloses a method for loading and using an inserter assembly 10 (see Figs. 1 and 2), the method comprising:
placing a cartridge including a sharp (the cartridge is the combination of sharp 40 and the outer barrel 12, button 16 and barrel cap 50; see Fig. 2) into a receptacle 20 (see Fig. 5) of an inserter 14 (see Fig. 2) to form a loaded inserter assembly (see para [0041], disclosing placing the cartridge into the opening 20 of the base 14 and then rotating the cartridge so that the shoulders 22 of the base capture the retention tabs 18 of the cartridge);
coupling the loaded inserter assembly to an infusion site (see para [0042], disclosing using a skin contacting adhesive layer 15 to position the loaded inserter assembly onto the skin);
pressing the inserter toward the infusion site (see para [0043], disclosing pressing button 16, causing the button 16 to move downward; see also Figs. 1-2 showing the downward pressing of the button 16);
actuating the inserter to drive the sharp to a position in which the sharp to projects outside of the loaded inserter assembly (see Fig. 3) from a position in which the sharp is entirely within the loaded inserter assembly (see Fig. 2 and para [0043]); and
retracting the sharp entirely back into the cartridge (see para [0046] and Fig. 14).
Regarding claim 21, Sonderegger discloses the method of claim 20, wherein the method further comprises removing an exterior housing 500 (see Fig. 62) from the cartridge prior to placing the cartridge and inserter against the infusion site (see para [0098]).
Regarding claim 22, Sonderegger discloses the method of claim 20, further comprising decoupling the cartridge from the inserter (see para [0047] and Figs. 15-16).
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 10/14/2026
