DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Griffin (US 2008/0051738 A1) in view of Hunn et al. (US 2004/0158207 A1).
With regard to claim 2, Griffin discloses A system (Fig. 2-6) comprising: a pump assembly (20) comprising: a body (44) defining a through-bore (see at axis A in Fig. 4) extending therethrough; a reservoir (28) disposed within the body and configured to contain medicament therein ([0062]); a fluid path extending between the reservoir and the through-bore (84); and a pump mechanism ([0054] drive device) configured to drive medicament from the reservoir through the fluid path ([0054]); a cannula (48) defining a lumen extending therethrough, the cannula configured to be disposed in an inserted position within the through-bore of the pump assembly such that the fluid path of the pump assembly is in fluid communication with the cannula lumen (as shown in Fig. 6); and an insertion tool (59 and 42) configured to releasably receive the cannula therein, the insertion tool configured to: be releasably mated to the pump assembly body (59 is removed after it has inserted the cannula); while releasably mated to the pump assembly body, move the cannula into the inserted position within the through-bore (see between Fig. 4-6); and after moving the cannula into the inserted position within the through-bore (in Fig. 6), be separated from the pump assembly body while leaving the cannula in the inserted position within the through-bore (Fig. 6).
However, Griffin does not disclose the cannula is positioned external to the pump assembly body to be moved into the inserted position within the through-bore.
Hunn teaches a similar system having a pump assembly (Fig. 1, element 9 and 1) having a body (1) with a through bore (can be seen in Fig. 9, the body 1 includes a bore starting from the top of element 1 through the adhesive piece 2). Hunn further teaches an insertion tool (Fig. 9, element 6) that contains the needle and cannula (8 and 3) that releasably connects to the pump assembly body (Fig. 9) and moves the cannula from a position external to the pump assembly body into the inserted position within the through bore (Fig. 10-12), after moving the cannula into the inserted position within the through-bore, be separated from the pump assembly body while leaving the cannula in the inserted position within the through bore (Fig. 12). Thus rather than having the cannula already be part of the pump assembly, the cannula can be a part of the insertion tool such that is located external to the pump body such that the cannula can be protected prior to use and improve the insertion of the cannula in to the body ([0005], [0006]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Griffin with the cannula external to the pump assembly as taught by Hunn for the purpose of the cannula can be protected prior to use and improve the insertion of the cannula in to the body ([0005], [0006]).
With regard to claim 3, Griffin discloses wherein the cannula comprises a cannula head (46) having a bottom opening in fluid communication with the cannula lumen (see Fig. 4), a side opening (at 50), a medicament fluid path between the side and bottom openings (see Fig. 4), an upper sealing device (52) above the side opening and a lower sealing device (54) below the side opening, and wherein in the inserted position the side opening is in fluid communication with the fluid path extending between the reservoir and the through-bore (fig. 6).
With regard to claim 4, Griffin discloses wherein in the inserted position a portion of the cannula extends beyond a bottom surface of the pump assembly body (as shown in Fig. 6).
With regard to claim 5, Griffin discloses wherein the insertion tool comprises a movable member (piston portion 41) disposed within a housing (see the housing surrounding the piston 41), and an actuator (the plunger rod that is connected to the piston 41) that causes the movable member to move within the housing, wherein the cannula is removably coupled to the movable member (59 pushes the cannula into the patient and is then removed).
With regard to claim 6, Griffin discloses wherein the actuator is configured to be manually activated by a user ([0067], user pushes the plunger/piston 41 to insert the cannula).
With regard to claim 7, Griffin discloses wherein the actuator comprises a spring (see spring around the plunger rode of 41 in Fig. 5).
With regard to claim 8, Griffin discloses wherein the insertion tool further comprises a trocar (42) configured to extend through the cannula lumen (considered part of the insertion tool as it is only used for the insertion of the cannula and then removed from the cannula).
With regard to claim 9, Griffin discloses wherein the insertion tool is configured to be releasably mated to the pump assembly body by abutting a lower portion of the insertion tool against an upper surface of the pump assembly body at a region adjacent the through-bore (the housing of the insertion tool 59 would sit on the top of the housing as shown in Fig. 4).
With regard to claim 10, Griffin discloses wherein the cannula comprises a securement mechanism (60) to secure the cannula to the body of the pump assembly while in the inserted position (Fig. 6).
With regard to claim 11, Griffin discloses wherein the securement mechanism comprises a latch (60).
With regard to claim 12, Griffin discloses A system (Fig. 2-6) comprising: a pump assembly (20) comprising: a body (44) defining a receptacle; a reservoir (28) disposed within the body and configured to contain medicament therein ([0062]); a fluid path (84) extending between the reservoir and the receptacle; and a pump mechanism (drive device [0054]) configured to drive medicament from the reservoir through the fluid path ([0054]); and a cannula (48) configured to be mated with the pump assembly by being placed within the receptacle via an insertion tool (59 and 42), the cannula comprising: a lower portion (at 48 in Fig. 6) configured to extend beyond a bottom surface of the pump assembly body when mated with the pump assembly (Fig. 6); and a lumen extending therethrough and configured to be in fluid communication with the reservoir via the fluid path (84) when mated with the pump assembly (shown in Fig. 6).
However, Griffin does not disclose the cannula is positioned external to the pump assembly body to be moved into the inserted position within the through-bore.
Hunn teaches a similar system having a pump assembly (Fig. 1, element 9 and 1) having a body (1) with a through bore (can be seen in Fig. 9, the body 1 includes a bore starting from the top of element 1 through the adhesive piece 2). Hunn further teaches an insertion tool (Fig. 9, element 6) that contains the needle and cannula (8 and 3) that releasably connects to the pump assembly body (Fig. 9) and moves the cannula from a position external to the pump assembly body into the inserted position within the through bore (Fig. 10-12), after moving the cannula into the inserted position within the through-bore, be separated from the pump assembly body while leaving the cannula in the inserted position within the through bore (Fig. 12). Thus rather than having the cannula already be part of the pump assembly, the cannula can be a part of the insertion tool such that is located external to the pump body such that the cannula can be protected prior to use and improve the insertion of the cannula in to the body ([0005], [0006]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Griffin with the cannula external to the pump assembly as taught by Hunn for the purpose of the cannula can be protected prior to use and improve the insertion of the cannula in to the body ([0005], [0006]).
With regard to claim 13, Griffin discloses wherein the cannula comprises a cannula head (46) having a bottom opening in fluid communication with the cannula lumen, a side opening (50), a medicament fluid path between the side and bottom openings (see Fig. 4), an upper sealing device (52) above the side opening and a lower sealing device (54) below the side opening, and wherein in the inserted position the side opening is in fluid communication with the fluid path extending between the reservoir and the receptacle (Fig. 6).
With regard to claim 14, Griffin discloses wherein the cannula comprises a securement mechanism (60) to secure the cannula to the body of the pump assembly while in the inserted position (Fig. 6).
With regard to claim 15, Griffin discloses wherein the securement mechanism comprises a latch (60).
With regard to claim 16, Griffin discloses wherein the receptacle comprises a through-bore (at axis A in Fig. 4) extending through the pump assembly body.
With regard to claim 17, Griffin discloses A method comprising: disposing a pump assembly over a patient's skin ([0055], [0056]), the pump (20) assembly comprising: a body (44) defining a through-bore (along axis A in Fig. 4) extending therethrough; a reservoir (28) disposed within the body and configured to contain medicament therein ([0062]); and a pump mechanism (drive device [0054]) configured to drive medicament out of the reservoir ([0054]); and mating an insertion tool (59) with the pump assembly, the insertion tool carrying a cannula (48) therein; actuating the insertion tool to drive the cannula into the through-bore such that the cannula is in fluid communication with the reservoir and at least a portion of the cannula penetrates the patient's skin (as shown in Fig. 6).
However, Griffin does not disclose the cannula is positioned external to the pump assembly body to be moved into the inserted position within the through-bore.
Hunn teaches a similar system having a pump assembly (Fig. 1, element 9 and 1) having a body (1) with a through bore (can be seen in Fig. 9, the body 1 includes a bore starting from the top of element 1 through the adhesive piece 2). Hunn further teaches an insertion tool (Fig. 9, element 6) that contains the needle and cannula (8 and 3) that releasably connects to the pump assembly body (Fig. 9) and moves the cannula from a position external to the pump assembly body into the inserted position within the through bore (Fig. 10-12), after moving the cannula into the inserted position within the through-bore, be separated from the pump assembly body while leaving the cannula in the inserted position within the through bore (Fig. 12). Thus rather than having the cannula already be part of the pump assembly, the cannula can be a part of the insertion tool such that is located external to the pump body such that the cannula can be protected prior to use and improve the insertion of the cannula in to the body ([0005], [0006]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Griffin with the cannula external to the pump assembly as taught by Hunn for the purpose of the cannula can be protected prior to use and improve the insertion of the cannula in to the body ([0005], [0006]).
With regard to claim 18, Griffin discloses further comprising delivering medicament from the reservoir through the cannula and into the patient ([0054], [0062]).
With regard to claim 19, Griffin discloses further comprising, after actuating the insertion tool, separating the insertion tool from the pump assembly while leaving the pump assembly in position over the patient's skin (as shown in Fig. 6 after insertion tool has inserted the cannula and is removed).
With regard to claim 20, Griffin discloses wherein the insertion tool is a handheld device (59), and wherein actuating the insertion tool comprises manually actuating the insertion too (plunger 41 is pushed through housing of 59 in order to acuate the insertion tool and push cannula through the through bore).
With regard to claim 21, Griffin discloses wherein the insertion tool is configured to be releasably mated to the pump assembly body by abutting a lower portion of the insertion tool against an upper surface of the pump assembly body at a region adjacent the through-bore (the housing of the insertion tool 59 would sit on the top of the housing as shown in Fig. 4).
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.
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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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