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 .
Response to Amendment
The Amendment filed 7/10/2026 has been entered. Claims 1-4, 6, 7 and 9-14 remain pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 3/10/2026.
The drawings were received on 7/10/2026. These drawings are acceptable.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/11/2026 was filed after the mailing date of the Non-Final Office Action on 3/10/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stull (US 3,117,701).
Regarding claim 9, Stull teaches a disposable container 19 (figure 1), comprising:
a reservoir (hollow portion inside element 19 that contains contents and is configured to hold foodstuff or a drug) configured for storing a foodstuff or a drug;
a dispensing opening 34 and a venting opening 52 that provides access to the reservoir and a single, combined closure 11 including a tamper evident closure (presence of element 62 makes element 11 a tamper evident closure) and a rip-open venting closure 37 that seals the dispensing opening 34 and the venting opening 52, wherein the tamper evident closure 11 and the rip-open venting closure 37 are both formed as a single element (see figure 2);
a body-wearable medical device fastener 46 (element 46 could be used for attaching to a body-wearable medical device that contains complementary connection to connect to element 46, the claim does not positively recite a body-wearable medical device as a part of the claimed invention and the claimed features of the body-wearable medical device does not affect the structure of the disposable container) configured for detachably fastening the disposable container to a body-wearable medical device, wherein the body-wearable medical device is an insulin pump, a continuous glucose monitor or a handheld diabetes management device.
Regarding claim 10, Stull teaches wherein the body-wearable medical device fastener 46 comprises a non-adhesive medical device fastener (element 46 is non-adhesive).
Claims 13 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seeley et al. (US 2015/0119804 A1).
Regarding claim 13, Seeley teaches a body-wearable medical device 100 (figure 8) comprising a disposable container fastener 145 configured for detachably fastening a disposable container 200 to the body-wearable medical device 100, wherein the body-wearable medical device is an insulin pump, a continuous glucose monitor or a handheld diabetes management device (paragraph 0002, lines 1-6), wherein the disposable container includes a dispensing opening and a venting opening being sealed by a single, combined closure including a tamper evident closure and a rip-open venting closure, and wherein the tamper evident closure and the rip-open venting closure are both formed as a single element (the disposable container is not positively claimed as a part of the claimed invention and body-wearable medical device is capable to be connected to disposable container with the claimed invention since the claimed invention does not affect the connection of the container as long as container connection is not modified).
Regarding claim 14, Seeley teaches wherein the disposable container fastener 145 comprises a mechanical, non-adhesive disposable container fastener 145.
Response to Arguments
Applicant's arguments filed 7/10/2026 have been fully considered but they are not persuasive.
Applicant argues that amended claims 13 and 14 overcomes the rejection over Seeley. Examiner respectfully disagrees. Claims 13 and 14 are drawn to a body-wearable medical device configured to connect to a disposable container and further including the structural limitations of the disposable container. However, the claimed structural limitations of the disposable container do not place any structural limitations on the claimed body-wearable medical device. Therefore, Seeley still teaches the claimed limitations of claims 13 and 14.
Allowable Subject Matter
Claims 1-4, 6 and 7 are allowed.
Claims 11 and 12 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Seeley et al. (US 2015/0119804 A1) in view of Sutcliffe et al. (US 2010/0054847 A1) is silent regarding a single combined closure including a tamper evident closure and a rip-open venting closure that seals the dispensing opening and the venting opening, wherein the tamper evident closure and the rip-open venting closure are both formed as a single element in combination with other claimed limitations of claim 1.
Claims 2-4, 6 and 7 being dependent on claim 1 are also indicated allowable.
The closest prior art of record, Stull (US 3,117,701), is silent regarding wherein the body-wearable medical device fastener comprises a medical device bracket configured for at least partially embracing the body-wearable medical device in combination with other claimed limitations of claim 11.
The closest prior art of record, Stull (US 3,117,701), is silent regarding wherein the disposable container comprises a circumferential edge, which, when the disposable container is fastened to the body-wearable medical device, circumferentially contacts the body-wearable medical device in combination with other claimed limitations of claim 12.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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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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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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