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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2016/0151562 to MAGERS et al. (“Magers”) in view of U.S. Patent No. 5,431,509 to Anderson et al. (“Anderson”).
Regarding claim 1, Magers teaches a drug delivery system for delivering a medicament (Figs. 12A & 12B), comprising a pump first housing (900) at least partially supporting and/or surrounding a fluid displacement assembly (Fig. 13b), the fluid displacement assembly comprising a positive displacement pump (942, [0226]), a pump second housing (1000) at least partially supporting and/or surrounding a drive component (1042, Fig. 13F) for driving medicament through the fluid displacement assembly, a fluid path assembly comprising an inlet (Fig. 12A, tube attached to 912) connected to the fluid displacement assembly and configured to deliver medicament to the fluid displacement assembly, the inlet comprising a flexible inlet tubing portion (as better seen as 52 in Fig. 1A, [0068]) connected to the fluid displacement assembly and extending external to the pump first housing, an outlet (Fig. 12A, tube attached to 914) connected to the fluid displacement assembly and configured to receive medicament from the fluid displacement assembly, the outlet comprising a flexible outlet tubing portion (as better seen as 54 in Fig. 1A) connected to the fluid displacement assembly and extending external to the pump first housing, wherein the fluid path assembly defines an enclosed flow path (923) through which the medicament flows, from the inlet to the outlet, without directly contacting the fluid displacement assembly (the medicament does not contact pump drive mechanism 942, which is defined above as the fluid displacement assembly), wherein the pump first housing and the pump second housing are removably coupled with each other (Figs. 12A/12B) at least by a slot (1074) and tab (974), but does not show the dovetail configuration.
Anderson teaches a first housing and a second housing being removably coupled with each other at least by slots and tabs having a sliding dovetail configuration (column 8, lines 54 to column 9, lines 1-5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted one type of slot/tab configuration with another type of slot/tab configuration to obtain the predictable results of providing releasable attachment between two housings.
Regarding claim 8, Magers teaches a drug delivery system for delivering a medicament (Fig. 1A), comprising a drug delivery device (Figs. 12A & 12B), a medicament container ([0068], IV bag) containing a medicament, the medicament container disposed external to the drug delivery device ([0068], Fig. 1A), a fluid path assembly comprising an inlet (Fig. 12A, tube attached to 912) comprising a flexible inlet tubing portion (as better seen as 52 in Fig. 1A, [0068]) connected to the drug delivery device and extending external to the drug delivery device, and an outlet (Fig. 12A, tube attached to 914) comprising a flexible outlet tubing portion (as better seen as 54 in Fig. 1A) connected to the drug delivery device and extending external to the drug delivery device, and the drug delivery device having a pump first housing (900) at least partially supporting and/or surrounding a fluid displacement assembly (Fig. 13b) connecting the inlet to the outlet, the fluid displacement assembly comprising a positive displacement pump (942, [0226]), a pump second housing (1000) at least partially supporting and/or surrounding a drive component (1042, Fig. 13F) for driving the medicament through the fluid displacement assembly, the inlet fluid path configured to receive the medicament from the medicament container and deliver the medicament to the fluid displacement assembly (medicament from the IV is sent to 912 to be driven through 900), the outlet fluid path configured to receive the medicament from the fluid displacement assembly and deliver the medicament to a patient (the outlet tubing portion delivers fluid to the patient), wherein the pump first housing and the pump second housing are removably coupled with each other (Figs. 12A/12B) at least by a slot (1074) and tab (974), wherein the fluid path assembly defines an enclosed flow path (923) through which the medicament flows, from the inlet to the outlet, without directly contacting the fluid displacement assembly (the medicament does not contact pump drive mechanism 942, which is defined above as the fluid displacement assembly), but does not show the dovetail configuration.
Anderson teaches a first housing and a second housing being removably coupled with each other at least by slots and tabs having a sliding dovetail configuration (column 8, lines 54 to column 9, lines 1-5). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have simply substituted one type of slot/tab configuration with another type of slot/tab configuration to obtain the predictable results of providing releasable attachment between two pump housings.
Claims 2-4, 6, 7, 55-57, and 59-62 are rejected under 35 U.S.C. 103 as being unpatentable over Magers in view of Anderson as applied to claims 1 and 8 above, and further in view of U.S. Patent Publication No. 2007/0073235 to Estes et al. (“Estes”).
Regarding claim 2, Magers and Anderson teach the drug delivery device as in claim 1 as shown above, once modified by the slot/tab configuration of Anderson, Magers and Anderson teach the pump first housing and the pump second housing being removably coupled with each other by a second component (Anderson, Fig. 5, 32B/34) including the slots and tabs having the dovetail configuration, to resist movement along a second axis (as best shown in Magers Fig. 14D, axis 195, once modified by the dovetail slots/tabs, movement would be resisted in the vertical direction), but do not teach the first component.
Estes teaches a pump first housing (200) and a pump second housing (220) being removably coupled with each other by a first component to resist movement ([0031], magnetic attachment) along a first axis (Estes Fig. 7, axis going in and out of 110). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated magnets to supplementally couple the pump first housing and pump second housing of Magers and Anderson, as taught by Estes, as magnets are a readily available type of attachment means that may be employed to releasably secure components of a pump device by, for example, retaining a pump housing structure within a cavity in conjunction with other connector devices such as mounting protrusions with mating cavities ([0031]). Once combined, the first axis (Magers, Fig. 14D, axis 197) and the second axis (axis 195) would be perpendicular to each other in the device of Magers, Anderson, and Estes.
Regarding claim 3, Magers, Anderson, and Estes teach the drug delivery device as in claim 2 as shown above, and Magers further teaching the first axis (197, Fig. 14D) is parallel with an axis of the drive component (the pin of 1042 runs parallel to 197), and the second axis is generally perpendicular with the axis of the drive component (since the first and second axis are already perpendicular).
Regarding claim 4, Magers, Anderson, and Estes teach the drug delivery device as in claim 2 as shown above, Estes previously teaching the first component being at least one magnet ([0031]).
Regarding claim 6, Magers, Anderson, and Estes teach the drug delivery device as in claim 1 as shown above, Magers further teaching at least one isolation mount (seals 946) coupled with the first housing assembly and/or the fluid displacement assembly.
Regarding claim 7, Magers, Anderson, and Estes teach the drug delivery device as in claim 1 as shown above, Magers further teaching the drug delivery device when the pump first housing and the pump second housing are removably coupled, at least a portion of the drive component (pin of 1042) is slidably received within at least a component (942) of the fluid displacement assembly.
Regarding claim 55, Magers and Anderson teach the drug delivery system as in claim 8 as shown above, Anderson previously teaching the pump first housing and the pump second housing being removably coupled with each other along by a second component to resist movement along a second axis, the second component including the slots and table having the dovetail configuration (see above) but do not teach the first component.
Estes teaches a pump first housing (200) and a pump second housing (220) being removably coupled with each other by a first component to resist movement ([0031], magnetic attachment) along a first axis (Estes Fig. 7, axis going in and out of 110). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated magnets to supplementally couple the pump first housing and pump second housing of Magers and Anderson, as magnets are a readily available type of attachment means that may be employed to releasably secure components of a pump device by, for example, retaining a pump housing structure within a cavity in conjunction with other connector devices such as mounting protrusions with mating cavities ([0031]). Once combined, the first axis (Magers, Fig. 14D, axis 197) and the second axis (axis 195) would be perpendicular to each other in the device of Magers, Anderson, and Estes.
Regarding claim 56, Magers, Anderson, and Estes teach the drug delivery system as in claim 55 as shown above, Magers further teaching the first axis (197, Fig. 14D) is parallel with an axis of the drive component (the pin of 1042 runs parallel to 197) and the second axis is generally perpendicular with the axis of the drive component (since the first and second axis are already perpendicular).
Regarding claim 57, Magers, Anderson, and Estes teach the drug delivery system as in claim 55 as shown above, Estes previously teaching the first component being at least one magnet (see above).
Regarding claim 59, Magers and Anderson teach the drug delivery system as in claim 8 as shown above, Magers further teaching at least one isolation mount (seals 946) coupled with the first housing assembly and/or the fluid displacement assembly.
Regarding claim 60, Magers and Anderson teach the drug delivery system as in claim 8 as shown above, Magers further teaching that when the pump first housing and the pump second housing are removably coupled, at least a portion of the drive component (pin of 1042) is slidably received within at least a component (942) of the fluid displacement assembly.
Regarding claim 61, Magers, Anderson, and Estes teach the drug delivery device as in claim 2 as shown above, Magers further teaching the flexible inlet tubing portion and the flexible outlet tubing portion are parallel to the second axis (as previously described in the rejection of claim 2, the second axis 195 runs vertically which is parallel to the inlet and outlet tubing as shown in Fig. 14B).
Regarding claim 62, Magers, Anderson, and Estes teach the drug delivery system as in claim 55 as shown above, Magers further teaching the flexible inlet tubing portion and the flexible outlet tubing portion are parallel to the second axis (as previously described in the rejection of claim 55, the second axis 195 runs vertically which is parallel to the inlet and outlet tubing as shown in Fig. 14B).
Response to Arguments
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are not persuasive. Claims 1 and 8 have been amended to recite, inter alia, that the fluid path assembly defines an enclosed flow path through which the medicament flows without directly contacting the fluid displacement assembly. [emphasis added] Applicant argues that the fluid displacement assembly 945 of Magers directly contacts the medicament at 923 as shown in Fig. 13E. As shown above, the fluid displacement assembly of claims 1 and 8 has now been mapped as pump drive mechanism 942 of Magers which is operatively coupled to piston 945, and element 942 does not directly contact the medicament.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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