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 April 2026.
Claims 14-18 and 20 are withdrawn.
Claim 1 is amended.
Claims 1-13 and 19 are presently pending in this application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 April 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1-13 and 19, the new matter is the limitation “a plurality of horizontal spaces”. This limitation does not appear in the original disclosure.
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, 6, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schieve (US Patent Publication No. 20170165414 A1), in view of Couillaud et al (US Patent Publication No. US 20230166024 A1), hereinafter Couillaud, in further view of Bazargan (US Patent No. 10552580 B2).
Regarding claim 1, Schieve teaches an ambulatory modular infusion pump system (Schieve: Fig. 1, system 100), comprising:
a housing (Fig. 1, pump 12) comprising a housing front (Fig. 4A, side of housing comprising display 52) and a housing back (Fig. 4A, rear of the unit; para. 0030);
a controller (Fig. 1, control module 16) coupled to the housing front (Fig. 1, module 16 is coupled to the pump 12 as a singular unit);
one or more pump modules (Fig. 1 and 3A, pump module 20) disposed within the housing (Fig. 3A, pump module 20 disposed within pump 12), each pump module (Fig. 3A, pump module 20) comprising:
a door assembly (Fig. 3A, comprising door 30 and latch mechanism 37) comprising a door (Fig. 3A, door 30) having a door securement (Fig. 3A, latch mechanism 37);
a channel housing (Fig. 3B, peristaltic assembly 26; para. 0031);
a cartridge gasket (Fig. 3A-3B, thin flexible membrane cover; para. 0032);
at least one sensor (Fig. 3A-3B, pressure sensors; para. 0029);
a plurality of pump fingers (Fig. 3A-3B, plurality of fingers; para. 0029);
a frame assembly (Fig. 3A-3B, cam mechanisms; para. 0029); and
a motor (Fig. 3A-3B, electric motor; para. 0029); and
one or more button assemblies (Fig. 4A, handle portion 37b) disposed on the housing front (Fig. 4A, handle portion 37b is disposed on the front of pump 12), each button assembly (Fig. 4A, handle portion 37b) comprising a button (Fig. 4A, handle portion 37b) disposed adjacent a corresponding pump module (Fig. 4A, pump module 20) and configured to release the door (Fig. 3A, door 30) of the corresponding pump module (Fig. 4A, pump module 20) when the button is moved to a release position (Fig. 5-9; para. 0027).
Schieve does not expressly disclose the housing comprising a housing front comprising a plurality of horizontal spaces, wherein each pump module is removably disposed within one of the plurality of horizontal spaces.
Couillaud teaches the housing (Couillaud: Fig. 2a and 3, rack 20) comprising a housing front (Fig. 2a, side of rack 20 comprising slots 100) comprising a plurality of horizontal spaces (Fig. 2a, slots 100 can be considered horizontal when viewed from an alternative frame of reference), wherein each pump module (Fig. 3, infusion devices 2) is removably disposed within one of the plurality of spaces (Fig. 3, infusion devices can be removably attached to slots 100; para. 0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the housing of Schieve such that the housing comprises a housing front comprising a plurality of horizontal spaces, wherein each pump module is removably disposed within one of the plurality of spaces as taught by Couillaud in order to allow for easy holding and handling of multiple pump modules (Couillaud: para. 0003 and 0009).
Schieve in view of Couillaud appears to disclose a pre-calibrated pump module due to the construction of the module, as any part of the pump module can be calibrated and ready to use without requiring further calibration after installation into the ambulatory modular infusion pump system. Even so, Bazargan discloses a pre-calibrated consumable in a pump assembly.
Bazargan teaches a pump module (Fig. 1, infusion system 100) that is calibrated and ready to use without requiring further calibration after installation (each consumable within the system is pre-calibrated to identify the volume of fluid delivered per rotation; col 5, ln 55 – col 6, ln 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the pump module of Schieve in view of Couillaud such that the pump module is calibrated and ready to use without requiring further calibration after installation into the ambulatory modular infusion pump system as taught by Bazargan in order to deliver different amounts of fluid based on the consumable (col 5, ln 33-54).
Regarding claim 2, Schieve in view of Couillaud and Bazargan discloses the system above, wherein the button assembly (Fig. 4A, handle portion 37b) comprises an engagement latch (Fig. 6, latching door handle assembly 650) coupled to a button assembly shaft (Fig. 6, comprising pin 300 and spring 514), wherein the button assembly shaft (Fig. 6, comprising pin 300 and spring 514) exerts a downward biasing force on the engagement latch (Fig. 6, pin 300 and spring 514 bias the assembly 650 to a closed position, which is downward. Specifically, spring 514 is placed in such a way that would exert force onto the assembly towards the closed position).
Regarding claim 6, Schieve in view of Couillaud and Bazargan discloses the system above, wherein the door assembly (Fig. 3A, comprising door 30 and latch mechanism 37) comprises: an inner face of the door (Fig. 5, inner portion 520), the inner face (Fig. 5, inner portion 520) comprising one or more securement mount points (Fig. 5, blind hole 510); and the door securement (Fig. 4B, latch mechanism 37) comprising one or more door mount points (Fig. 5, opening 540) corresponding to the one or more securement mount points (Fig. 5, opening 540 is coupled to blind hole 510 via pin 300), wherein the door securement (Fig. 4B, latch mechanism 37) is coupled to the inner face (Fig. 5, inner portion 520) via the one or more door mount points (Fig. 5, opening 540) mated with the one or more securement mount points (Fig. 5, opening 540 is coupled to blind hole 510 via pin 300).
Regarding claim 19, Schieve in view of Couillaud and Bazargan discloses a method of single handed operation of the ambulatory modular infusion pump system (Fig. 1, system 100) comprising: lifting one of the button assemblies (Fig. 4A, handle portion 37b can be lifted); releasing the door (Fig. 3A, door 30) of the corresponding pump module (Fig. 1 and 3A, pump module 20); if an existing tube set is disposed in the pump module, removing the existing tube set (Fig. 3A, comprising tube sections 32, 34, and 36); grasping a replacement tube set (Fig. 3A, peristaltic assembly 26. Examiner interprets that the assembly 26 can be mounted into the pump module 20, it could be removed or replaced); inserting the replacement tube set (Fig. 3A, peristaltic assembly 26. Examiner interprets that the assembly 26 can be mounted into the pump module 20, it could be removed or replaced) into the pump module (Fig. 1 and 3A, pump module 20); and closing the door (Fig. 3A, door 30) of the pump module (Fig. 1 and 3A, pump module 20). When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Schieve in view of Couillaud and Bazargan, in further view of Baier et al. (US Patent Publication No. 20200054823 A1), hereinafter Baier.
Regarding claim 3, Schieve in view of Couillaud and Bazargan discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the engagement latch comprises a curved surface configured to receive a finger.
Baier teaches an engagement latch (Baier: Fig. 2, comprising pin catch 166 and door catch 114) comprising a curved surface (Fig. 2, pin catch 166 is cylindrical and, therefore, curved) configured to receive a finger (Fig. 2, hold 164).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the engagement latch of Schieve in view of Couillaud and Bazargan such that the engagement latch comprises a curved surface configured to receive a finger as taught by Baier in order to allow for locking of the door (Baier: para. 0167).
Regarding claim 4, Schieve in view of Couillaud and Bazargan discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the button assembly comprises an engagement portion configured to be received by a channel disposed on the door securement.
Baier teaches an engagement portion (Baier: Fig. 2, comprising pin catch 166 and door catch 114) configured to be received by a channel (Fig. 2, door catch 114).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the button assembly of Schieve in view of Couillaud and Bazargan such that the button assembly comprises an engagement portion configured to be received by a channel disposed on the door securement as taught by Baier in order to allow for locking of the door (Baier: para. 0167).
Regarding claim 5, Schieve in view of Couillaud, Bazargan, and Baier discloses the system above, wherein the door securement (Schieve: Fig. 3A, latch mechanism 37) comprises a door shaft (Fig. 6, comprising pin 300 and spring 514) that exerts a downward biasing force on the engagement portion (Fig. 6, pin 300 and spring 514 bias the assembly 650 to a closed position, which is downward. Specifically, spring 514 is placed in such a way that would exert force onto the assembly towards the closed position).
Claims 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Schieve in view of Couillaud and Bazargan, in further view of Briggs et al. (US Patent No. 6261262 B1), hereinafter Briggs.
Regarding claim 7, Schieve in view of Couillaud and Bazargan discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose that the door comprises a latch deformation configured to receive a portion of a latch extending from the pump module.
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Briggs teaches a door (Briggs: Fig. 7, front door 90) comprising a latch deformation (Fig. 7 above, latch deformation A) configured to receive a portion (Fig. 7, cam follower surface 282) of a latch (Fig. 7, comprising boss 262, roller 268, and surface 282) extending from the pump module (Fig. 7, pump 50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the door of Schieve in view of Couillaud and Bazargan such that the door comprises a latch deformation configured to receive a portion of a latch extending from the pump module as taught by Briggs in order to hold the door in a latched closed position (Briggs: col 13, ln 6-20).
Regarding claim 8, Schieve in view of Couillaud, Bazargan, and Briggs discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the door securement comprises a latch portal disposed in a door securement housing and aligned with the latch deformation, the latch portal configured to receive a portion of the latch extending from the pump module.
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Briggs teaches a door securement (Briggs: Fig. 7, door handle 94) comprising a latch portal (Fig. 8A above, latch portal B of camming surface 254) disposed in a door securement housing (Fig. 7, body of handle 94) and aligned with a latch deformation (Fig. 7 and 8A above, latch portable B is aligned within latch deformation A), the latch portal (Fig. 8A above, latch portal B) configured to receive a portion (Fig. 7, surface 282) of a latch (Fig. 7, comprising boss 262, roller 268, and surface 282) extending from a pump module (Fig. 8A above, latch portal B receives surface 282).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Schieve in view of Couillaud and Bazargan such that the door securement comprises a latch portal disposed in a door securement housing and aligned with the latch deformation, the latch portal configured to receive a portion of the latch extending from the pump module as taught by Briggs in order to hold the door in a latched closed position (Briggs: col 13, ln 6-20).
Regarding claim 9, Schieve in view of Couillaud, Bazargan, and Briggs discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the door securement further comprises a slidable carriage disposed within the door securement housing adjacent to the latch portal.
Briggs teaches a door securement (Briggs: Fig. 7, door handle 94) comprising a slidable carriage (Fig. 8A, arcuate slot 250) disposed within the door securement housing (Fig. 8A, body of handle 94) adjacent to the latch portal (Fig. 7 and 8A above, arcuate slot 250 is adjacent to latch portal B).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the door securement of Schieve in view of Couillaud and Bazargan such that the door securement further comprises a slidable carriage disposed within the door securement housing adjacent to the latch portal as taught by Briggs in order to hold the door in a latched closed position (Briggs: col 13, ln 6-20).
Regarding claim 10, Schieve in view of Couillaud, Bazargan, and Briggs discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the slidable carriage comprises an eye configured to engage with the latch when the door is in a secured position.
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Briggs teaches a slidable carriage (Fig. 8A, arcuate slot 250) comprises an eye (Fig. 8A and B above, eye C of slot 250) configured to engage with a latch (Fig. 7, comprising boss 262, roller 268, and surface 282) when a door is in a secured position (Fig. 8B above, in a secure position, roller 268 is engaged with eye C of slot 250).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the door securement of Schieve in view of Couillaud and Bazargan such that the slidable carriage comprises an eye configured to engage with the latch when the door is in a secured position as taught by Briggs in order to hold the door in a latched closed position (Briggs: col 13, ln 6-20).
Regarding claim 11, Schieve in view of Briggs discloses the system above, wherein the door securement (Schieve: Fig. 4B, latch mechanism 37) further comprises a guide groove (Fig. 5, recess 540) disposed on the door securement housing (Fig. 5, body of latch mechanism 37), the guide groove (Fig. 5, recess 540) configured to receive a portion of a guide pin (Fig. 6, tapered pin 300 and e-clip retainer 506) of the door assembly (Fig. 3A, comprising door 30 and latch mechanism 37) to limit the range of motion of the door securement (pin 300 retains and establishes rotation datum of latch mechanism 37; para. 0046. Latch mechanism 37 is, therefore, limited in rotation along pin 300).
Claim 12 are rejected under 35 U.S.C. 103 as being unpatentable over Schieve in view of Couillaud and Bazargan, in further view of Amon et al. (US Patent Publication No. 20180028745 A1), hereinafter Amon.
Regarding claim 12, Schieve in view of Couillaud and Bazargan disclose the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the housing comprises a battery configured to power the ambulatory modular infusion pump system.
Amon teaches a housing (Amon: Fig. 5, housing 10) comprising a battery (Fig. 5, battery device 182) configured to power an ambulatory modular infusion pump system (battery device 182 powers device 1; para. 0060).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the housing of Schieve in view of Couillaud and Bazargan such that the housing comprises a battery configured to power the ambulatory modular infusion pump system as taught by Amon in order to power the system without connection to an external power supply line (Amon: para. 0020).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schieve in view of Couillaud and Bazargan, in further view of Davis et al. (US Patent Publication No. 20090171289 A1), hereinafter Davis.
Regarding claim 13, Schieve in view of Couillaud and Bazargan discloses the system above.
Schieve in view of Couillaud and Bazargan does not expressly disclose the controller comprises at least one of a hardened keypad and a sealed keypad configured to be operated by a chemical resistant glove.
Davis teaches a controller (Fig. 5, medical device 14) comprising a sealed keypad (Fig. 5 and 19B, display screen 122 can have a numerical keypad) configured to be operated by a chemical resistant glove (a thin impermeable membrane overlays screen 122, allowing operation with wet or dry gloves).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the controller of Schieve in view of Couillaud and Bazargan such that the controller comprises at least one of a hardened keypad and a sealed keypad configured to be operated by a chemical resistant glove as taught by Davis in order to allow the screen to be impermeable to fluids and allow functional use with or without gloves (Davis: para. 0060).
Response to Arguments
Applicant’s arguments, see page 7-8, filed 20 April 2026, with respect to the rejections of claims 1-13 and 19 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues that Coulliaud relies upon vertically arranged spaces, which teaches away from the present invention.
As described above, the slots of Coulliaud can be considered horizontally arranged when viewed from an alternative frame of reference. The claims do not explicitly recite a particular frame of reference. Therefore, the rejection is maintained.
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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