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 (IDS) submitted on July 21, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on August 21, 2024 are accepted.
Claim Objections
Claim 49 is objected to because of the following informalities: “A analyte senor” should read “An analyte sensor”. Appropriate correction is required.
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 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 1-9, 11-17, 35 and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gyrn et al. (US 2010/0286714 A1) (“Gyrn”) (submitted in IDS dated July 21, 2025).
Regarding claim 1, Gyrn discloses An analyte sensor applicator for inserting a sensor of a wearable analyte monitoring device, the analyte sensor applicator comprising (Abstract and entire document):
an applicator housing (FIG. 2, housing 201, 221, 251, 501, 502, 503);
a skin-piercing device and an insertable portion of the sensor (FIG. 2, penetrating member 105, 243 and see [0012]);
a cam assembly within the applicator housing, the cam assembly comprising: a cylindrical cam comprising a rotational axis and an external cam surface (FIG. 2, rotating member 204 see at least [0063]); and
a thrust barrel interfacing with the external cam surface, the thrust barrel comprising a bottom portion having a port therethrough for being coupled to the skin-piercing device (FIG. 2, middle section 221 see [0063 – 0064]); and
a piston in contact with the bottom portion of the thrust barrel (FIG. 2, piston 242),
wherein the thrust barrel moves linearly between a proximal position and a distal position for inserting the sensor with the skin-piercing device (As shown in FIG. 9).
Regarding claim 2, Gyrn discloses The analyte sensor applicator of Claim 1, wherein the thrust barrel interfaces with the external cam surface through one or more grooves (FIG. 2, grooves 216).
Regarding claim 3, Gyrn discloses The analyte sensor applicator of Claim 2, wherein upon activation of the cylindrical cam, the piston is pushed to the distal position by the thrust barrel and locked in the distal position and the thrust barrel returns to the proximal position without the piston (As shown in FIG. 9).
Regarding claim 4, Gyrn discloses The analyte sensor applicator of Claim 1, wherein skin piercing device is configured to retract to the proximal position independent of the movement of the cylindrical cam (As shown in FIG. 9).
Regarding claim 5, Gyrn discloses The analyte sensor applicator of Claim 2, wherein the cylindrical cam comprises one or more grooves on the external cam surface and the thrust barrel comprises one or more pins that ride in the grooves (As shown in FIG. 6-7).
Regarding claim 6, Gyrn discloses The analyte sensor applicator of Claim 2, wherein the thrust barrel comprises one or more grooves on the external cam surface and the cylindrical cam comprises one or more pins that ride in the grooves (As shown in FIG. 6-7).
Regarding claim 7, Gyrn discloses The analyte sensor applicator of Claim 2, wherein a speed of inserting the sensor is at least partially determined by a pattern of the one or more grooves (transformation from rotational movement to longitudinal movement is based on the pattern of the groove, see at least [0065]).
Regarding claim 8, Gyrn discloses The analyte sensor applicator of Claim 1, wherein the analyte sensor applicator further comprises a spring positioned in contact with the cylindrical cam, the spring having a spring force that at least partially determines a speed of inserting the sensor (FIG. 2, spring 203, see [0061 – 0062]).
Regarding claim 9, Gyrn discloses The analyte sensor applicator of Claim 1, wherein the piston comprises a piston base that engages with the wearable analyte monitoring device (FIG. 2, 242/252/253 see [0066]).
Regarding claim 11, Gyrn discloses The analyte sensor applicator of Claim 1, wherein the applicator housing comprises a housing bottom and wherein the analyte sensor applicator further comprises a sterile cap key configured to insert into an opening at a distal end of the housing bottom ([0154] sealing foil).
Regarding claim 12, Gyrn discloses The analyte sensor applicator of Claim 11, wherein the sterile cap key is configured to provide support to the wearable analyte monitoring device to keep the wearable analyte monitoring device in place ([0154] sealing foil).
Regarding claim 13, Gyrn discloses The analyte sensor applicator of Claim 11, wherein the analyte sensor applicator further comprises a sterile cap having a bottom portion and at least one tab, wherein the sterile cap key is configured to loosely engage with the sterile cap ([0154] sealing foil).
Regarding claim 14, Gyrn discloses The analyte sensor applicator of Claim 1, wherein the applicator further comprises an applicator frame having one or more slides on an internal surface of the applicator, the slide is aligned parallel to an axis of the applicator (FIG. 2, guiding means 244).
Regarding claim 15, Gyrn discloses The analyte sensor applicator of Claim 1, wherein the piston and/or the applicator housing comprises one or more vent holes (FIG. 2, [0063] openings).
Regarding claim 16, Gyrn discloses The analyte sensor applicator of Claim 14, wherein the piston comprises one or more anti-rotation features, each anti-rotation feature configured to move along one slide (FIG. 2, guiding means 244).
Regarding claim 17, Gyrn discloses An implantation system comprising: the analyte sensor applicator of Claim 1; and the wearable analyte monitoring device comprising (Abstract and entire document and see claim 1 above):
an electronics assembly and sensor components coupled on a proximal side of the wearable analyte monitoring device (FIG. 1 - FIG. 2 and [0012]); and
an adhesive component on a distal side of the wearable analyte monitoring device to adhere the wearable analyte monitoring device to a user (FIG. 1 - FIG. 2 and mounting pad, see [0051])),
wherein insertable portions of the skin-piercing device and the sensor project from the distal side (As shown in FIG. 1-2).
Regarding claim 35, Gyrn discloses An applicator system, comprising (Abstract and entire document and see claim 1 above):
a housing comprising an opening at a bottom of the housing (FIG. 1-2 and [0154]);
a wearable device configured to be housed in the housing (FIG. 1-2, device 100); and
a key configured to be inserted into the housing through the opening ([0154] sealing foil),
wherein the key is in direct contact with the wearable device and provides support to the wearable device against a component of the applicator system ([0154] sealing foil).
Regarding claim 49, Gyrn discloses An analyte senor for being implanted into a user, the analyte sensor comprising a sensing area, the sensing area configured to be placed inside a skin piercing device (FIG. 1 - FIG. 2 and [0012]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gyrn in view of Cole et al. (US 2022/0080678 A1) (“Cole”).
Regarding claim 10, Gyrn discloses The analyte sensor applicator of Claim 1, Gyrn fails to disclose wherein the thrust barrel further comprises a magnetic component, the magnetic component magnetically engages with the wearable analyte monitoring device.
However, in the same field of endeavor, Cole teaches wherein the thrust barrel further comprises a magnetic component, the magnetic component magnetically engages with the wearable analyte monitoring device ([0239] magnetic).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the applicator as taught by Gyrn to include wherein the thrust barrel further comprises a magnetic component, the magnetic component magnetically engages with the wearable analyte monitoring device as taught by Cole to break connection with a small force ([0226]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791
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