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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Objections
Claim 9 recites "configured to next", which should be amended to "configured to nest" to correct a typographical error. Further, claim 9 is recited to be dependent on "claims 4", which should be amended to "claim 4" to correct a typographical error.
Claim 13 recites "The pump holder of claim 12, wherein further comprising…" which contains an apparent typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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:
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.
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 1-20 are rejected under 35 U.S.C. 102 as being anticipated by Cook et al (U.S. Pat. 11,033,677, hereinafter "Cook"), or in the alternative, Cooke in view of Zhang (CN 201220161713 U, hereinafter "Zhang"; English translation attached).
Regarding claim 1, Cooke discloses an ambulatory infusion pump system, comprising:
an ambulatory infusion pump 102 (see Fig. 1C) configured to contain a medicament, the infusion pump including a switch disposed on a perimeter of the infusion pump (i.e., recesses 238; see Fig. 2F), the switch movable between a first position and a second position (enabled by a sliding motion of the pump, as further described below),
a pump holder 104 (see Fig. 1A) configured to releasably hold the infusion pump and including an adhesive patch 108 (see Fig. 1A) configured to retain the pump holder on a body of a user, the pump holder comprising:
a frame base 106 (see Fig. 1A) having a shape generally matching the perimeter of the infusion pump, and
a locking projection (an inwardly projecting tab 214; see Fig. 2B) extending from the frame base and configured to interface with the switch disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base (the infusion pump is placed on the base, and then slid in the direction of the arrow depicted in Fig. 2B—this movement constitutes moving the switch between the first position and the second position—and in so doing, the recesses 238 interface with the tabs 214 to lock the pump to the frame base; see col. 4, lines 29-63).
Even assuming that Cooke does not disclose that the infusion pump includes a switch disposed on a perimeter of the infusion pump, the switch movable between a first position and a second position; and the pump holder comprises a locking projection extending from the frame base and configured to interface with the switch disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base:
Zhang discloses an infusion pump, including a switch 2-2 (see Fig. 6) disposed on a perimeter of the infusion pump, the switch movable between a first position and a second position (see Figs. 6-8); and a pump holder comprising a locking projection 1-2 (see Fig. 8) extending from a frame base of the pump, and configured to interface with the switch disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base (see Figs. 6-8; movement of the switch in the direction "P" causes the switch to move along the ramp A-1 and into engagement with a shoulder under the ramp, which locks the pump into place).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Cooke to provide the switch and locking mechanism of Zhang, with a reasonable expectation of success. Cooke suggests a number of different locking mechanisms were useful to lock the pump to the frame of the pump holder (for example, tabs 114 on the pump holder interfacing with wings 136 on the pump; see Fig. 1D and para [0024]). Substituting one locking mechanism for another was suggested in Cooke (see various locking mechanisms taught in Figs. 1D, 2A-2D, 3A-3F, 4A-4F, and 5A-5D). It would have been within the level of ordinary creativity for a skilled artisan to contemplate another such mechanism in the art by looking to Zhang (which was a well-known means for locking a pump to a pump housing in a similar mechanical way to the locking features of Cooke), as a matter of design choice, and with a reasonable expectation of success in carrying out the same function as the structure in Cooke (namely, locking the pump to the frame of the pump holder).
Regarding claim 2, Cooke discloses that the infusion pump includes a drive unit 118 (see Fig. 1A) and a cartridge 116 (see Fig. 1A) including a reservoir configured to contain the medicament selectively attachable to the drive unit (see col. 3, lines 40-60), and wherein, in the combination of Cooke and Zhang, the switch is disposed on the cartridge (see Zhang, Fig. 7).
Regarding claims 3-5 and 9, the combination of Cooke and Zhang teaches the following features:
the switch is mounted in an elongate slot (see Zhang at cavity of button B2; see para [0044]) in the infusion pump, and wherein the switch is laterally slidable within the elongate slot between the first position and the second position (against the bias force of the spring 3; see Fig. 7);
in the second position the switch is aligned with the locking projection to prevent the infusion pump from being slid back laterally off of the frame base (see Zhang at Fig. 8 and para [0039]);
the switch further includes an inwardly extending projection (where slope A2 is located) configured to nest beneath the locking projection when the switch is in the second position, the inwardly extending projection configured to prevent the infusion pump from being removed vertically off of the frame base (see Zhang at Fig. 8 and para [0039]); and
the portion of the infusion pump configured to nest beneath the locking projection is a projection extending outwardly from the infusion pump (see Zhang at Figs. 6 and 9, showing element 2-2 has a projection 2-A that projects outwardly from the infusion pump).
Regarding claims 6-8, Cooke discloses the pump holder includes an upwardly extending guiderail 407 (see Fig. 4A) and the infusion pump includes an elongate recess 417/419 (see Figs. 4F) on a bottom surface of the infusion pump, and wherein the guiderail is configured to be inserted into the recess to guide the infusion pump onto the pump holder; and
the pump holder further comprises one or more perimeter walls 205 (see Fig. 2B) extending upwardly from an outer perimeter of the frame base; and
the least one perimeter wall includes a locking projection 214 (see Fig. 2B) extending inwardly towards the frame base, and wherein a portion of the infusion pump is configured to nest beneath the locking projection to aid in retaining the infusion pump on the pump holder (see col. 4, lines 47-62).
Regarding claim 10, Cooke discloses that the pump holder further comprises a cannula interface (associated with cannula 130; see Fig. 1F) through which a cannula is configured to be inserted for delivery of the medicament from the infusion pump directly beneath the pump holder (see col. 3, lines 38-45).
Regarding claim 11, Cooke discloses a pump holder 104 (see Fig. 1A) for an ambulator infusion pump 102, comprising:
an adhesive patch 108 (see Fig. 1A) configured to retain the pump holder on a body of a user;
a frame base 106 (see Fig. 1A) having a shape generally matching the perimeter of the infusion pump, and
a locking projection (an inwardly projecting tab 214; see Fig. 2B) extending from the frame base and configured to interface with a switch (i.e., recesses 238; see Fig. 2F) disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base (the infusion pump is placed on the base, and then slid in the direction of the arrow depicted in Fig. 2B—this movement constitutes moving the switch between the first position and the second position—and in so doing, the recesses 238 interface with the tabs 214 to lock the pump to the frame base; see col. 4, lines 29-63).
Even assuming that Cooke does not disclose that the infusion pump includes a switch disposed on a perimeter of the infusion pump, the switch movable between a first position and a second position; and the pump holder comprises a locking projection extending from the frame base and configured to interface with the switch disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base:
Zhang discloses an infusion pump, including a switch 2-2 (see Fig. 6) disposed on a perimeter of the infusion pump, the switch movable between a first position and a second position (see Figs. 6-8); and a pump holder comprising a locking projection 1-2 (see Fig. 8) extending from a frame base of the pump, and configured to interface with the switch disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base (see Figs. 6-8; movement of the switch in the direction "P" causes the switch to move along the ramp A-1 and into engagement with a shoulder under the ramp, which locks the pump into place).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Cooke to provide the switch and locking mechanism of Zhang, with a reasonable expectation of success. Cooke suggests a number of different locking mechanisms were useful to lock the pump to the frame of the pump holder (for example, tabs 114 on the pump holder interfacing with wings 136 on the pump; see Fig. 1D and para [0024]). Substituting one locking mechanism for another was suggested in Cooke (see various locking mechanisms taught in Figs. 1D, 2A-2D, 3A-3F, 4A-4F, and 5A-5D). It would have been within the level of ordinary creativity for a skilled artisan to contemplate another such mechanism in the art by looking to Zhang (which was a well-known means for locking a pump to a pump housing in a similar mechanical way to the locking features of Cooke), as a matter of design choice, and with a reasonable expectation of success in carrying out the same function as the structure in Cooke (namely, locking the pump to the frame of the pump holder).
Regarding claim 12, Cooke discloses that in the second position the locking projection is configured to be aligned with the switch to prevent the infusion pump from being slid back laterally off of the frame base (see col. 4, lines 47-62).
Further, the combination of Cooke and Zhang teaches that the switch is mounted in an elongate slot (see Zhang at cavity of button B2; see para [0044]) in the infusion pump, and wherein the switch is laterally slidable within the elongate slot between the first position and the second position (against the bias force of the spring 3; see Fig. 7); such that in the second position the switch is aligned with the locking projection to prevent the infusion pump from being slid back laterally off of the frame base (see Zhang at Fig. 8 and para [0039]).
Regarding claim 13, the combination of Cooke and Zhang teaches a recess 417/419 (see Figs. 4F of Cooke) on a bottom surface of the infusion pump, such that it would be beneath the locking projection in the combination of Cooke and Zhang, and wherein an inwardly extending projection of the switch (where slope A2 is located in Zhang) is configured to nest beneath the locking projection when the switch is in the second position, the inwardly extending projection configured to prevent the infusion pump from being removed vertically off of the frame base (see Zhang at Fig. 8 and para [0039]).
Regarding claims 14-16, Cooke discloses that the pump holder includes an upwardly extending guiderail 407 (see Fig. 4A) to interface with a recess 417/419 (see Figs. 4F) in the infusion pump to guide the infusion pump onto the pump holder; and
the pump holder further comprises one or more perimeter walls 205 (see Fig. 2B) extending upwardly from an outer perimeter of the frame base; and
the least one perimeter wall includes a locking projection 214 (see Fig. 2B) extending inwardly towards the frame base, and wherein a portion of the infusion pump is configured to nest beneath the locking projection to aid in retaining the infusion pump on the pump holder (see col. 4, lines 47-62).
Regarding claim 17, Cooke discloses that the pump holder further comprises a cannula interface (associated with cannula 130; see Fig. 1F) through which a cannula is configured to be inserted for delivery of the medicament from the infusion pump directly beneath the pump holder (see col. 3, lines 38-45).
Regarding claim 18, Cooke discloses an ambulatory infusion pump 102 (see Fig. 1C) configured to contain a medicament, the infusion pump including a switch disposed on a perimeter of the infusion pump (i.e., recesses 238; see Fig. 2F), the switch movable between a first position and a second position the switch movable between a first position and a second position (enabled by a sliding motion of the pump, as further described below),
wherein when the infusion pump is disposed on a pump holder 104 (see Fig. 1A), the infusion pump is releasably locked on the pump holder when the switch is moved from the first position to the second position causing the switch to interface with a locking projection on the pump holder (the infusion pump is placed on the base, and then slid in the direction of the arrow depicted in Fig. 2B—this movement constitutes moving the switch between the first position and the second position—and in so doing, the recesses 238 interface with the tabs 214 to lock the pump to the frame base; see col. 4, lines 29-63).
Even assuming that Cooke does not disclose that the infusion pump includes a switch disposed on a perimeter of the infusion pump, the switch movable between a first position and a second position in order to releasably lock the infusion pump to the frame base:
Zhang discloses an infusion pump, including a switch 2-2 (see Fig. 6) disposed on a perimeter of the infusion pump, the switch movable between a first position and a second position (see Figs. 6-8); and a pump holder comprising a locking projection 1-2 (see Fig. 8) extending from a frame base of the pump, and configured to interface with the switch disposed on the infusion pump, wherein when the switch is moved from the first position to the second position with the infusion pump disposed on the pump holder, the infusion pump is releasably locked on the frame base (see Figs. 6-8; movement of the switch in the direction "P" causes the switch to move along the ramp A-1 and into engagement with a shoulder under the ramp, which locks the pump into place).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Cooke to provide the switch and locking mechanism of Zhang, with a reasonable expectation of success. Cooke suggests a number of different locking mechanisms were useful to lock the pump to the frame of the pump holder (for example, tabs 114 on the pump holder interfacing with wings 136 on the pump; see Fig. 1D and para [0024]). Substituting one locking mechanism for another was suggested in Cooke (see various locking mechanisms taught in Figs. 1D, 2A-2D, 3A-3F, 4A-4F, and 5A-5D). It would have been within the level of ordinary creativity for a skilled artisan to contemplate another such mechanism in the art by looking to Zhang (which was a well-known means for locking a pump to a pump housing in a similar mechanical way to the locking features of Cooke), as a matter of design choice, and with a reasonable expectation of success in carrying out the same function as the structure in Cooke (namely, locking the pump to the frame of the pump holder).
Regarding claim 19, Cooke discloses that the infusion pump includes a drive unit 118 (see Fig. 1A) and a cartridge 116 (see Fig. 1A) including a reservoir configured to contain the medicament selectively attachable to the drive unit (see col. 3, lines 40-60), and wherein, in the combination of Cooke and Zhang, the switch is disposed on the cartridge (see Zhang, Fig. 7).
Regarding claim 20, the combination of Cooke and Zhang teaches that the switch is mounted in an elongate slot (see Zhang at cavity of button B2; see para [0044]) in the infusion pump, and wherein the switch is laterally slidable within the elongate slot between the first position and the second position (against the bias force of the spring 3; see Fig. 7);
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 06/16/2026
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