DETAILED ACTION
This is a final rejection in response to amendment filed 7/7/26. Claims 1-20 are currently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 9 is objected to because of the following informalities: the preamble for claim 9 should read “The user-wearable infusion pump system of claim 8”. Appropriate correction is required.
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 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(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 2019/0351134) in view of Zhang (CN 202620364).
Regarding independent claim 1, Cook teaches a user-wearable infusion pump system, comprising:
a user-wearable infusion pump 102,202,302,402,802 configured to contain a medicament [0023];and
a pump holder 106,206,406 configured to releasably hold the user-wearable infusion pump [0021,0025-0028], the pump holder including a base (surface 207 sized to accommodate the pump and generally flat frame 406 [0025,0028],
wherein the switch automatically releasably locks the user-wearable infusion pump onto the pump holder when the user-wearable infusion pump is inserted onto the pump holder [0024] by sliding the user-wearable infusion pump parallel along the base of the pump holder [0026,0028,0030].
Cook teaches locking tabs on the holder engaging recesses on the pump but is silent to the user wearable infusion pump including a switch disposed on a perimeter of the user-wearable infusion pump.
Zhang teaches the user wearable infusion pump including a switch 2-2 disposed on a perimeter of the user-wearable infusion pump 2.
It would have been obvious to one of ordinary skill in the art at the time of filing to provide the pump of Cook with the switch of Zhang, as Zhang teaches improved safety [0004].
Regarding dependent claim 2, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the pump holder 106,206 comprises a tray having a perimeter shape generally matching a perimeter shape of the user-wearable infusion pump (fig. 1F) and an adhesive patch 108 configured to releasably retain the pump holder on a body of a user [0021,0025].
Regarding dependent claim 3, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the tray includes one or more retaining walls extending upwardly around a perimeter of the tray (retention walls of retention frame 106, 206).
Regarding dependent claim 4, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the tray includes an open end having no retaining wall to enable the user-wearable infusion pump to be slid onto the tray from the open end parallel to the base (see fig. 2A-2D, [0026], also see claims 23 and 25 of Cook).
Regarding dependent claim 5, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the tray includes a guide rail 407 extending upwardly from a base of the tray between two opposing retaining walls.
Regarding dependent claim 6, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the user-wearable infusion pump includes a lower guide rail on a bottom surface of the user-wearable infusion pump, wherein the lower guide rail of the user-wearable infusion pump is configured to slide along the guide rail of the tray to guide the user-wearable infusion pump onto the tray [0028].
Regarding dependent claim 7, Cook in view of Zhang teaches the invention as disclosed above. Zhang further teaches wherein the switch is biased in a locked position [0011,0040].
Regarding dependent claim 8, Cook in view of Zhang teaches the invention as disclosed above. Zhang further teaches where a guide feature on the pump holder causes the switch to slide to an unlocked position while the user-wearable infusion pump is being slid onto the pump holder [0037-0039].
Regarding dependent claim 9, Cook in view of Zhang teaches the invention as disclosed above. Zhang further teaches wherein the guide feature is an angled ramp (A1 and A2) that interfaces with an angled surface connected to the switch to cause the switch to slide laterally from the locked position to the unlocked position [0037-0039].
Regarding dependent claim 10, Cook in view of Zhang teaches the invention as disclosed above. Zhang further teaches wherein the switch automatically returns to the locked position when the user-wearable infusion pump is fully inserted onto the pump holder [0037-0039].
Regarding dependent claim 11, Cook in view of Zhang teaches the invention as disclosed above. Zhang further teaches wherein the switch includes a traylock that nests into a locking aperture on the pump holder when the switch returns to the locked position [0035].
Regarding dependent claim 12, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the user-wearable infusion pump includes a drive unit 118,218 and a cartridge 116,216 selectively attachable to the drive unit, and wherein the switch is disposed on the cartridge. Zhang teaches the locking mechanism on the insulin pump body, it would have been obvious to configure the locking switch to be disposed on the cartridge as claimed, to allow for locking engagement upon cartridge installation or pump installation.
Regarding dependent claim 13, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the switch is configured to remain in the unlocked position if the switch is manually moved from the locked position to the unlocked position when the user-wearable infusion pump is fully inserted onto the pump holder [0035-0040].
Regarding dependent claim 14, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the switch remains in the unlocked position due to a tray lock on the switch being held against a flange on the pump holder preventing the switch from sliding back into the locked position while the user-wearable infusion pump is fully inserted onto the pump holder [0037-0039].
Regarding independent claim 15, Cook teaches a user-wearable infusion pump 102,802 configured to contain a medicament, [0023], wherein is configured to automatically releasably lock the user-wearable infusion pump onto a pump holder when the user-wearable infusion pump is inserted onto the pump holder [0024,0032] by sliding the user-wearable infusion pump along and parallel to a base of the pump holder [0026,0028,0030].
Cook teaches locking tabs on the holder engaging recesses on the pump but is silent to the user wearable infusion pump including a switch disposed on a perimeter of the user-wearable infusion pump.
Zhang teaches the user wearable infusion pump including a switch 2-2 disposed on a perimeter of the user-wearable infusion pump 2.
It would have been obvious to one of ordinary skill in the art at the time of filing to provide the pump of Cook with the switch of Zhang, as Zhang teaches improved safety [0004].
Regarding dependent claim 16, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the switch 2-2 is biased in a locked position [0040].
Regarding dependent claim 17, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches wherein the user-wearable infusion pump includes a drive unit 118,218 and a cartridge 116,216 selectively attachable to the drive unit, and wherein the switch is disposed on the cartridge. Zhang teaches the locking mechanism on the insulin pump body, it would have been obvious to configure the locking switch to be disposed on the cartridge as claimed, to allow for locking engagement upon cartridge installation or pump installation.
Regarding independent claim 18, Cook teaches a pump holder 106,206,406,806 configured to releasably hold a user-wearable infusion pump [0021-0022,0026,0032], wherein the pump holder comprises a base and is configured to cause a switch on the user-wearable infusion pump to automatically releasably lock the user-wearable infusion pump onto the pump holder when the user-wearable infusion pump is inserted onto the pump holder [0035,0038-40] by sliding the user-wearable infusion pump along and parallel to the base.
Cook is silent to wherein the pump holder is configured to cause a switch on a user-wearable infusion pump to automatically releasably lock the user-wearable infusion pump onto the pump holder when the user-wearable infusion pump is inserted onto the pump holder.
Zhang teaches the user wearable infusion pump including a switch 2-2 on a user-wearable infusion pump 2.
It would have been obvious to one of ordinary skill in the art at the time of filing to provide the pump of Cook with the switch of Zhang, as Zhang teaches improved safety [0004].
Regarding dependent claim 19, Cook in view of Zhang teaches the invention as disclosed above. Zhang further teaches further configured to cause the switch to remain in an unlocked position if the switch is manually moved from the locked position to the unlocked position when the user-wearable infusion pump is fully inserted onto the pump holder [0035-0040].
Regarding dependent claim 20, Cook in view of Zhang teaches the invention as disclosed above. Cook further teaches comprising a tray (retention walls of retention frame 106, 206) having a perimeter shape generally matching a perimeter shape of the user-wearable infusion pump (fig. 1F) and an adhesive patch 108 configured to releasably retain the pump holder on a body of a user [0021,0025], wherein the tray includes one or more retaining walls extending upwardly around a perimeter of the tray (retention walls of retention frame 106, 206) and an open end having no retaining wall to enable the user-wearable infusion pump to be slid onto the tray from the open end parallel to the base (see fig. 2A-2D, [0026], also see claims 23 and 25 of Cook).
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 CRAIG SANG KIM whose telephone number is (571)270-1418. The examiner can normally be reached 7:00 AM - 3:00 PM.
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
