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 .
Status of Claims
This office action is responsive to the amendment filed 20 August 2025.
Claims 1, 5, and 13 are amended.
Claims 1-23 are presently pending in this application.
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 1, 2, 4, 6, 8-11, 13, 14, 16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Carter et al. (US Patent Publication No. US 20150065959 A1), hereinafter Carter, in view of Hasted et al. (US Patent Publication No. US 20110098652 A1), hereinafter Hasted, in further view of Navarro et al. (US Patent Publication No. US 20150246176 A1), hereinafter Navarro.
Regarding claim 1, Carter discloses a fill closure tab (Carter: Fig. 3, cannula cover 130) for an infusion device (Fig. 1, system 100) comprising: an attachment portion (Fig. 27, feet 125) shaped to attach the fill closure tab (Fig. 27, cannula cover 130 attaches to the body of the device via feet 125; para. 0076) to an infusion device (Fig. 1, system 100), the infusion device (Fig. 1, system 100) comprising a skin attachment surface (Fig. 1, adhesive layer 140 attaches to a patient’s skin; para. 0050); wherein the fill closure tab (Fig. 3, cannula cover 130) is removable from the infusion device (cannula cover 130 is removable; para. 0056).
Carter does not expressly disclose a gripping portion.
Hasted teaches a removable tab (Hasted: Fig. 2A, inserter 10 can be removed; para. 0036) with a gripping portion (Fig. 2A, actuator handle 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fill closure tab of Carter to have a gripping portion as taught by Hasted in order to allow for improved handling of the tab by the user (Hasted: para. 0036).
Carter does not expressly disclose a hydrophobic member arranged to seal a distal end of an insertion needle of the infusion device.
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Navarro teaches a hydrophobic member (Navarro: Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A) arranged to seal a distal end of an insertion needle (Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A seals distal end of fixed needle 53, preventing drug passage and allowing air passage; para. 0139-0141). Examiner interprets that the hydrophobic membrane 51 of Navarro, if combined with the fill closure tab of Carter in view of Hasted, would seal the priming channel 138 of Carter, as the hydrophobic membrane 51 of Navarro seals the extremity of inserted needle 53 in a slotted fashion as shown in Fig. 17c above. Additionally, as shown in Fig. 6 of Carter, if the hydrophobic member 51 of Navarro seals the priming channel 138 of Carter, the seal would be present on the adhesive layer 140, thus, seals the distal end of the insertion needle on the skin attachment surface of the infusion device.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the hydrophobic member of Navarro in the fill closure tab of Carter such that the hydrophobic member is arranged to seal a distal end of the insertion needle on the skin attachment surface of the infusion device in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
Regarding claim 2, Carter in view of Hasted and Navarro discloses the fill closure tab above, further comprising a fill assist mechanism (Carter: Fig. 27, filling channel 131) arranged adjacent to a fill port of the infusion device (Fig. 4, filling channel 131 is arranged adjacent to fill port 114).
Regarding claim 4, Carter in view of Hasted and Navarro discloses the fill closure tab above, wherein the fill assist mechanism (Carter: Fig. 27, filling channel 131) is shaped to receive a syringe (para. 0051).
Regarding claim 6, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted does not expressly disclose a hydrophobic member that permits air to pass, but prevents medicament from passing through the hydrophobic member.
Navarro teaches a hydrophobic member (Navarro: Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A) that permits air to pass, but prevents medicament from passing through the hydrophobic member (hydrophobic membrane 51 and fill tubing A prevents drug passage and allowing air passage; para. 0141).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted such that the hydrophobic member permits air to pass, but prevents medicament from passing through the hydrophobic member as taught by Navarro in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
Regarding claim 8, Carter in view of Hasted and Navarro discloses the fill closure tab above, further comprising a slot (Carter: Fig. 28, priming channel 138) configured to receive a fill tube (Priming channel 138 receives cannula 180; para. 0079 and 0081), the slot (Carter: Fig. 28, priming channel 138) forming a volume in which the fill tube (Fig. 12, cannula 180) is received (Priming channel 138 receives cannula 180; para. 0079 and 0081) and at least one barb (Fig. 28, fins 139) to retain the fill tube (Fig. 12, cannula 180) in the slot (para. 0081).
Regarding claim 9, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted does not expressly disclose a hydrophobic member sealed around the slot.
Navarro teaches a hydrophobic member (Navarro: Fig. 17c, hydrophobic membrane 51) sealed around the slot (Carter: Fig. 28, priming channel 138). Examiner interprets that the hydrophobic membrane 51 of Navarro, if combined with the fill closure tab of Carter in view of Hasted, would seal the priming channel 138 of Carter, as the hydrophobic membrane 51 of Navarro seals the extremity of inserted needle 53 in a slotted fashion as shown in Fig. 17c above.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the hydrophobic member of Navarro such that it sealed around the slot of Carter in view of Hasted in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
Regarding claim 10, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted does not expressly disclose a hydrophobic member that is attached to a distal end of fill tubing that seals the distal end of the insertion needle.
Navarro teaches a hydrophobic member (Navarro: Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A) is attached to a distal end of fill tubing (Fig. 17c shown above, hydrophobic membrane 51 is attached to distal end of fill tubing A) that seals the distal end of the insertion needle (Fig. 17c shown above, fill tubing A located at lower extremity of insertion needle, wherein hydrophobic membrane 51 and fill tubing A seals distal end of fixed needle 53, preventing drug passage and allowing air passage; para. 0139-0141; para. 0139).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted and Navarro such that the hydrophobic member is attached to a distal end of fill tubing that seals the distal end of the insertion needle as taught by Navarro in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
Regarding claim 11, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted does not expressly disclose a hydrophobic member is a fill tubing sealed to a distal end of the insertion needle.
Navarro teaches a hydrophobic member (Navarro: Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A) is a fill tubing sealed to a distal end of the insertion needle (Fig. 17c shown above, fill tubing A located at lower extremity of insertion needle, wherein hydrophobic membrane 51 and fill tubing A seals distal end of fixed needle 53, preventing drug passage and allowing air passage; para. 0139-0141; para. 0139).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted and Navarro such that the hydrophobic member is a fill tubing sealed to a distal end of the insertion needle in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
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Regarding claim 13, Carter discloses an infusion device (Carter: Fig. 1, system 100) comprising: a housing (Fig. 14 shown above, housing A) containing a reservoir (Fig. 10, reservoir 115), a fill port (Fig. 4, port 114) fluidly connected to the reservoir (Port 114 is fluidly connected to reservoir 115; para. 0060) and an insertion mechanism (Fig. 12 and 14, needle 170, cannula 180 and cannula port 185) comprising a cannula (Fig. 12, needle 170) fluidly connected to the reservoir (medicament is transported from the reservoir 115 to the cannula port 185; para. 0060) with an insertion mechanism opening (Fig. 14, cannula port 185), and a removable fill closure tab (Fig. 3, cannula cover 130 is removable; para. 0056) comprising: an attachment portion (Fig. 27, feet 125) shaped to attach the fill closure tab (Fig. 27, cannula cover 130 attaches to the body of the device via feet 125; para. 0076) to the infusion device (Fig. 1, system 100), the infusion device (Fig. 1, system 100) comprising a skin attachment surface (Fig. 1, adhesive layer 140 attaches to a patient’s skin; para. 0050); wherein the fill closure tab (Fig. 3, cannula cover 130 is removable; para. 0056) is removable from the infusion device (Fig. 1, system 100).
Carter does not expressly disclose a gripping portion.
Hasted teaches a removable tab (Hasted: Fig. 2A, inserter 10 can be removed; para. 0036) with a gripping portion (Fig. 2A, actuator handle 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fill closure tab of Carter to have a gripping portion as taught by Hasted in order to allow for improved handling of the tab by the user (Hasted: para. 0036)
Carter does not expressly disclose a hydrophobic member arranged to seal a distal end of an insertion needle of the infusion device.
Navarro teaches a hydrophobic member (Navarro: Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A) arranged to seal a distal end of an insertion needle (Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A seals distal end of fixed needle 53, preventing drug passage and allowing air passage; para. 0139-0141). Examiner interprets that the hydrophobic membrane 51 of Navarro if combined with the fill closure tab of Carter in view of Hasted, it would seal the priming channel 138 of Carter, as the hydrophobic membrane 51 of Navarro seals the extremity of inserted needle 53 in a slotted fashion as shown in Fig. 17c above. Additionally, as shown in Fig. 6 of Carter, if the hydrophobic member 51 of Navarro seals the priming channel 138 of Carter, the seal would be present on the adhesive layer 140, thus, covers a needle opening on the skin attachment surface of the infusion device.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the hydrophobic member of Navarro in the fill closure tab of Carter such that the hydrophobic member covers a needle opening on the skin attachment surface of the infusion device in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
Regarding claim 14, Carter in view of Hasted and Navarro discloses the infusion device above, further comprising a fill assist mechanism (Carter: Fig. 27, filling channel 131) arranged adjacent to a fill port of the infusion device (Fig. 4, filling channel 131 is arranged adjacent to fill port 114).
Regarding claim 16, Carter in view of Hasted and Navarro discloses the infusion device above, wherein the fill assist mechanism (Carter: Fig. 27, filling channel 131) is shaped to receive a syringe (para. 0051).
Regarding claim 18, Carter in view of Hasted and Navarro discloses the infusion device above.
Carter in view of Hasted does not expressly disclose a hydrophobic membrane that permits air to pass, but prevents medicament from passing through the hydrophobic membrane.
Navarro teaches a hydrophobic member (Navarro: Fig. 17c shown above, hydrophobic membrane 51 and fill tubing A) permits air to pass, but prevents medicament from passing through the hydrophobic member (hydrophobic membrane 51 and fill tubing A prevents drug passage and allowing air passage; para. 0141).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted and Navarro such that the hydrophobic member permits air to pass, but prevents medicament from passing through the hydrophobic member as taught by Navarro in order to avoid ambient air from being sucked with medicament during filling and prevent drug leakage (Navarro: para. 0141).
Regarding claim 19, Carter in view of Hasted and Navarro discloses the infusion device above, wherein the infusion device is a patch pump (Navarro: Fig. 28 shows a disposable patch pump; para. 0190).
Regarding claim 20, Carter in view of Hasted and Navarro discloses the infusion device above, wherein the infusion device is an insulin pump (Carter: system 100 is an infusion system for medicament such as insulin; para. 0048).
Regarding claim 21, Carter in view of Hasted and Navarro discloses the infusion device above, wherein the medicament is insulin (Carter: para. 0048).
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Carter, in view of Hasted and Navarro, in further view of Brister et al. (US Patent Publication No. US 20080306444 A1), hereinafter Brister.
Regarding claim 3, Carter in view of Hasted and Navarro disclose the fill closure tab above, wherein the fill assist mechanism (Carter: Fig. 27, filling channel 131) is shaped to receive a syringe (para. 0051).
Carter in view of Hasted and Navarro does not expressly disclose the fill assist mechanism is shaped to receive a pen needle.
Brister teaches a receptacle shaped to receive a pen needle (Brister: para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fill assist mechanism of Carter in view of Hasted and Navarro such that it is shaped to receive a pen needle as taught by Brister in order for the fill assist mechanism to be able to receive and hold a medicament injection pen (Brister: para. 0227).
Regarding claim 15, Carter in view of Hasted and Navarro disclose the injection device above, wherein the fill assist mechanism (Carter: Fig. 27, filling channel 131) is shaped to receive a syringe (para. 0051).
Carter in view of Hasted and Navarro does not expressly disclose the fill assist mechanism is shaped to receive a pen needle.
Brister teaches a receptacle shaped to receive a pen needle (Brister: para. 0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fill assist mechanism of Carter in view of Hasted and Navarro such that it is shaped to receive a pen needle as taught by Brister in order for the fill assist mechanism to be able to receive and hold a medicament injection pen (Brister: para. 0227).
Claims 5, 17, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Carter, in view of Hasted and Navarro, in further view of Petisce (US Patent Publication No. US 20080306444 A1).
Regarding claim 5, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted and Navarro does not expressly disclose that the hydrophobic member is formed of a material that changes color in a presence of medicament.
Petisce teaches a member (Petisce: Fig. 1, membrane layer 34; para. 0042-0043) is formed of a material that changes color in a presence of medicament (membrane layer 34 changes color based on the presence of insulin; para. 0042-0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted and Navarro such that the hydrophobic member is formed of a material that changes color in a presence of medicament as taught by Petisce in order for the presence of insulin to be visualized (Petisce: para. 0042-0043).
Regarding claim 17, Carter in view of Hasted and Navarro discloses the infusion device above.
Carter in view of Hasted and Navarro does not expressly disclose that the hydrophobic member is formed of a material that changes color in the presence of medicament.
Petisce teaches a member (Petisce: Fig. 1, membrane layer 34; para. 0042-0043) is formed of a material that changes color in the presence of medicament (membrane layer 34 changes color based on the presence of insulin; para. 0042-0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted and Navarro such that the hydrophobic member is formed of a material that changes color in the presence of medicament as taught by Petisce in order for the presence of insulin to be visualized (Petisce: para. 0042-0043).
Regarding claim 22, Carter in view of Hasted and Navarro discloses the infusion device above, wherein the medicament is insulin (Carter: para. 0048).
Claims 7 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Carter, in view of Hasted and Navarro, in further view of Murphy et al. (US Patent Publication No. US 20240197984 A1), hereinafter Murphy.
Regarding claim 7, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted and Navarro does not expressly disclose the fill closure tab further comprising a magnet adapted to be sensed when the fill closure tab is attached to a patch pump.
Murphy teaches an assembly comprising a magnet (Murphy: Fig. 36, magnet 844) adapted to be sensed (para. 0398, magnet 844 interacts with Hall Effect sensor to determine if a removable assembly is attached properly to intended component; para. 0398-0399) when a removable assembly is attached to an intended component (para. 0398-0399).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fill closure tab of Carter in view of Hasted and Navarro such that it comprises a magnet adapted to be sensed when the fill closure tab is attached to a patch pump as taught by Murphy in order to determine if the assembly is properly attached to an intended component (Murphy: para. 0399).
Regarding claim 23, Carter in view of Hasted and Navarro disclose the infusion device above.
Carter in view of Hasted and Navarro does not expressly disclose that the housing encloses a printed circuit board comprising a sensor configured to detect a magnet, and the removable fill closure tab comprises a magnet that aligns with the sensor when the removable fill closure tab is attached to the housing.
Murphy teaches a housing (Murphy: Fig. 36, body 820) encloses a printed circuit board (Murphy: Fig. 36, printed circuit board 830) comprising a sensor (Hall Effect sensor; para. 0398) configured to detect a magnet (Fig. 36, magnet 844 is sensed by the Hall Effect sensor; para. 0398), and a removable assembly (para. 0398) comprises a magnet (Fig. 36, magnet 844) that aligns with the sensor (para: 0398) when the removable assembly is attached to the housing (para. 0398, magnet 844 interacts with Hall Effect sensor to determine if a removable assembly is attached properly to intended component; para. 0398-0399).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Carter in view of Hasted and Navarro such that the housing encloses a printed circuit board comprising a sensor configured to detect a magnet, and the removable fill closure tab comprises a magnet that aligns with the sensor when the removable fill closure tab is attached to the housing as taught by Murphy in order to determine if an assembly is properly attached to an intended component (Murphy: para. 0399).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Carter, in view of Hasted and Navarro, in further view of Andrews et al. (US Patent Publication No. US 5989407 A), hereinafter Andrews.
Regarding claim 12, Carter in view of Hasted and Navarro discloses the fill closure tab above.
Carter in view of Hasted and Navarro does not expressly disclose that the hydrophobic member permits medicament to pass if a pressure of the medicament exceeds a predetermined threshold.
Andrews teaches a hydrophobic member (Andrews: hydrophobic membranes; col 15, ln 13-16) that permits medicament to pass if a pressure of the medicament exceeds a predetermined threshold (hydrophobic membranes allow fluid to pass once the breakthrough pressure is exceeded; col 15, ln 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the hydrophobic member of Carter in view of Hasted and Navarro such that the hydrophobic member permits medicament to pass if a pressure of the medicament exceeds a predetermined threshold as taught by Andrews in order to prevent catastrophic failures due to overpressure within the system (Andrews: col 15, ln 13-16).
Response to Arguments
Applicant’s arguments, see page 7, filed 20 August 2025, with respect to the objection to the drawings has been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 7, filed 20 August 2025, with respect to the objection to the specification has been fully considered and are persuasive. The objection of the specifications has been withdrawn.
Applicant’s arguments, see page 7, filed 20 August 2025, with respect to the rejection of claim 5 under 35 USC 112(b) has been fully considered and are persuasive. The rejection of claim 5 has been withdrawn.
Applicant's arguments, see pages 8-9, filed 20 August 2025, with respect to the rejections of claims 1-23 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that Carter, Hasted, nor Navarro disclose a hydrophobic member that is disclosed at the distal end of an insertion needle at a skin attachment surface of the infusion device.
Examiner interprets that the hydrophobic membrane 51 of Navarro, if combined with the fill closure tab of Carter in view of Hasted, would seal the priming channel 138 of Carter, as the hydrophobic membrane 51 of Navarro seals the extremity of inserted needle 53 in a slotted fashion as shown in Fig. 17c above. Additionally, as shown in Fig. 6 of Carter, if the hydrophobic member 51 of Navarro seals the priming channel 138 of Carter, the seal would be present on the adhesive layer 140, thus, seals the distal end of the insertion needle on the skin attachment surface of the infusion device. Therefore the rejection is maintained.
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 LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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