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 July 01, 2026 has been entered. Claims 1, 5-6, and 10-15 remain pending in the application. Claims 2-4, 7-9, and 16-18 have been cancelled. Applicant’s amendments to the abstract and claims have overcome the objections and rejections under 35 USC 101 previously set forth in the Non-Final Office Action mailed July 01, 2026.
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, 5-6, 10-11 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oberg et al. (US 20220226568).
Regarding claim 1, Oberg discloses an infusion set (insulin delivery system 100) configured to facilitate delivery of insulin from an infusion pump to a user, comprising:
an infusion hub (hub 105) configured to be placed on a body of the user (“the hub 105 can include a patch 330 or other mechanism configured to adhere to the patient” [0100]);
infusion tubing (tubing 103) configured to transfer insulin from the infusion pump to the infusion hub (“The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106.” [0100]);
a cannula (cannula 106) extending from the infusion hub into the body of the user (Figures 1A-1B); and
a septum (barrel 333 having septum 334 with barrier 337) facilitating transfer of the insulin from the infusion tubing to the cannula (“The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106.” [0100]), wherein the septum comprises septum body (septum 334 with barrier 337 shown in Figure 3; “the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss.” [0103]) formed from a halogenated siloxane material (“The barriers described herein can include…organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides)” [0105]).
Regarding claim 5, Oberg discloses the infusion set of claim 1, further comprising a transfer needle (introducer 332) extending from the infusion tubing configured to pierce the septum (“an introducer 332 extending from the tubing 103…The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106.” [0100]; Figure 1B).
Regarding claim 6, Oberg discloses an ambulatory infusion pump system (insulin delivery system 100), comprising:
a reservoir (reservoir 101) configured to contain insulin (“an insulin reservoir 101 (configured to store an insulin medication therein),” [0100]);
a cannula (cannula 106) configured to extend into a body of a user (“The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106.” [0100]); and
a septum (barrel 333 having septum 334 with barrier 337) facilitating transfer of the insulin from the reservoir to the cannula (“The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106.” [0100]), wherein the septum comprises a septum body (septum 334 with barrier 337 shown in Figure 3; “the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss.” [0103]) formed from a halogenated siloxane material (“The barriers described herein can include…organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides)” [0105]).
Regarding claim 10, Oberg discloses the ambulatory infusion pump system of claim 6, further comprising an infusion hub (hub 105) configured to be placed on the body of the user (“the hub 105 can include a patch 330 or other mechanism configured to adhere to the patient,” [0100]) and infusion tubing (tubing 103), wherein the infusion tubing is configured to transfer the insulin from the reservoir to the septum and the cannula extends from the infusion hub into the body of the user (Figures 1A-1B; “the hub 105 can include a patch 330 or other mechanism configured to adhere to the patient, a barrel 333 connected to the cannula 106, and an introducer 332 extending from the tubing 103…The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106.” [0100]).
Regarding claim 11, Oberg discloses the ambulatory infusion pump system of claim 10, further comprising a transfer needle (introducer 332) extending from the infusion tubing configured to pierce the septum (“an introducer 332 extending from the tubing 103…The fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106.” [0100]; Figure 1B).
Regarding claim 15, Oberg discloses a septum (barrel 333 having septum 334 with barrier 337) for use in facilitating delivery of insulin to a user (“fluid introducer 332 can be configured to pierce the septum 334 and to deliver fluid to the cannula 106. The fluid path for the insulin medication, therefore, can run from the reservoir 101 through the tubing 103 to the barrel 333 and to the patient via the cannula 106.” [0100]), the septum comprising a septum body (septum 334 with barrier 337 as shown in Figure 3; “the septum 334 can be coated with a barrier 337 to minimize preservative loss and/or the interior of the mechanical housing 335 can be lined with a barrier 338 to minimize preservative loss.” [0103]) formed from a halogenated siloxane material (“The barriers described herein can include…organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides)” [0105]).
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 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Oberg et al. (US 20220226568) in view of Michaud et al. (USPN 9993595).
Regarding claims 12-14, Oberg discloses the ambulatory infusion pump system of claim 6.
Oberg fails to explicitly disclose the system further comprising an infusion pump containing the reservoir and a pump holder configured to be worn on the body of the user to releasably hold the infusion pump, as required by claim 12; wherein the pump holder includes a cannula port from which the cannula extends into the body of the user, as required by claim 13; and wherein the septum is disposed in the cannula port; as required by claim 14.
Michaud discloses an ambulator infusion pump system (patch pump 100) comprising a reservoir (cartridge 116), a cannula (cannula 188; Figures 11A-11E), and a septum (“a sealing membrane”: “Retention frame 106 of attachment portion 104 includes an insertion portion 112 through which a disposable needle can be inserted to penetrate a sealing membrane and insert a cannula for medicament delivery.” [Col 4, lines 11-14]); further comprising an infusion pump (pump 102) containing the reservoir (“Reusable drive unit 118 of pump includes a drive mechanism 122 that mates with a recess 124 in disposable cartridge 116 to attach the cartridge 116 to the drive unit 118 and provide for delivery of medicament such as insulin from the cartridge 116 to a user through the cannula.” [Col 4, lines 15-19]) and a pump holder (attachment portion 104) configured to be worn on the body of the user (“an adhesive backing 107 can be removed from the adhesive patch 108 holding the retention frame 106 and the patch applied to the skin at the desired insertion site.” [Col 7, lines 45-47]) to releasably hold the infusion pump (“To mate the pump 102 with the corresponding attachment portion 104, initially hook portion 114 on retention frame 106 is inserted, or hooked, into a recess 138 in the drive unit 118, as shown in FIGS. 1C and 1D.” [Col 4, lines 22-26]); wherein the pump holder includes a cannula port (insertion portion 112) from which the cannula extends into the body of the user (Figures 11A-E); and wherein the septum is disposed in the cannula port (Retention frame 106 of attachment portion 104 includes an insertion portion 112 through which a disposable needle can be inserted to penetrate a sealing membrane and insert a cannula for medicament delivery.” [Col 4, lines 11-14]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the ambulatory infusion pump of Oberg to include an infusion pump containing the reservoir and a pump holder configured to be worn on the body of the user to releasably hold the infusion pump, wherein the pump holder includes a cannula port from which the cannula extends into the body of the user, and wherein the septum is disposed in the cannula port based on the teachings of Michaud to provide a user-wearable ambulatory infusion pump that is able to positioned directly on the infusion site, eliminating the necessity for external tubing (Michaud [Col 1, lines 50-60]).
Response to Arguments
Applicant's arguments filed July 01, 2026 have been fully considered but they are not persuasive.
Regarding the argument that Oberg et al. (US 20220226568) does not explicitly disclose or suggest “the septum comprises a septum body formed from a halogenated siloxane material” as required by the amended independent claims (Remarks, page 7), the examiner respectfully disagrees. As detailed above, Oberg discloses a septum (barrel 333 having septum 334 with barrier 337) comprising septum body (septum 334 with barrier 337 shown in Figure 3; “the septum 334 can be coated with a barrier 337” [0103]) formed from a halogenated siloxane material (“The barriers described herein can include…organic or inorganic plasma-deposited coatings (e.g. PTFE, PVC, halogenated siloxanes, silicon suboxides)” [0105]). The septum body of Oberg is considered to be combination of the septum 334 and the barrier 337, which completely surrounds the septum 334 as shown in Figure 3. This barrier 337, and therefore at least a portion of the septum body is formed from a halogenated siloxane, as disclosed in Oberg [0105]. It is noted that the claims as currently presented do not require that an entirety of the septum body be formed from halogenated siloxane.
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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