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 § 112
Claim 100 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 100 recites the first output includes translation of the mixing activation mechanism housing. Claim 1 previously recites a first output is received from the mixing activation slide. It is not clear if the translation of the mixing activation housing is in addition to the output from the mixing activation slide. For purposes of the rejection it is taken as in addition to the output from the slide.
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.
Claim(s) 1-20 and 100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarnoff et al. (US 4,689,042) in view of KraMer et al. (US 2013/0331788 A1), Edwards et al. (US 2008/0103490 A1), Choi (US 2021/0213202 A1), and Harper et al. (US 2005/0177100 A1).
With regard to claims 1 and 3-11, Sarnoff et al. teach a mixing and drug delivery system comprising: a housing (Fig. 1 member 12) configured to hold a first container (Fig. 1 member 18) and a second container (Fig. 1 member 20), wherein the first container contains a first medicament component (Fig. 1 member 104) and the second container contains a second medicament component (Fig. 1 member 108); a first seal associated with the first container (Fig. 1 member 90); a second seal associated with the second container (Fig. 1 member 100); a mixing activation slide (Fig. 1 member 136 and 116); a fluid communication assembly (Fig. 1 member 48) having a fluidic channel (Fig. 1, channel includes the channel in 62, 56 provides a fluid transfer channel) configured to receive a first output from the mixing activation slide, whereupon receiving the first output from the mixing activation slide causes the fluid communication assembly to open, remove or otherwise pierce the first seal and the second seal and create a fluidic pathway between the first container and the second container (Col. 7 lines 28-64); a mixing system configured to alternately transfer the first and second medicaments between the first and second containers during a mixing phase (Fig. 1 at least members 106 and 110); and a needle delivery assembly configured to be in fluid communication with the first and second containers during a delivery phase (Fig. 1 including at least 50). Sarnoff et al. do not disclose a mixing activation housing, a pressurized gas chamber, or a trigger. However, KraMer et al. teach equivalently using a spring or gas as an energy source ([0057]). Further, Edwards et al. teach a gas pressurized injection system in which gas is directed to a plurality of plungers which may be separately actuated, a tab is removed to allow the pressurized gas canister to be punctured to release the gas (Fig. 2 [0050], tab 11710). Additionally, Choi teaches using a valve actuated by a trigger to control the flow of gas relative to a piston for delivery ([0045], Fig. 5 trigger 310 the face of which forms a button, valve including at least components of 100, 200 and necessary flow channels). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pressurized gas cartridge as an energy source in place of the springs in Sarnoff et al. as KraMer et al. teach such is an art effective equivalent means for delivery and further to arrange such a gas canister and to use a valve to control the flow of gas into the respective chambers of Sarnoff et al. as in Edwards as this prevents premature delivery and to actuate the plungers as in Choi as Choi teaches this to be an art effective means for regulating gas flow and would yield the same predictable result of actuating the plungers for mixing and delivery.
Sarnoff et al. teach shaking the device to mix the substances (Col. 8 lines 40-41) but do not disclose the combined substances move from the second container back to the first. However, Harper et al. teach transferring the substances back and forth between chambers to more thoroughly mix components than just by shaking ([0055]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to move the combined substances back and forth between the containers in Sarnoff et al. as Harper et al. teach this provides more thoroughly mixed substances as compared to shaking.
As combined a gas canister would be arranged in parallel with the containers of Sarnoff et al. similar to Edwards et al., as per claim 3 no specific angle is recited, parallel components can be considered as having an angle of 0 or 180 degrees between them. A safety tab would be incorporated around the canister the exterior would form a mixing activation housing and the slide components are in mechanical communication with the housing via intervening structural connection as well as the removal of the tab is necessary for movement of the slide components. The removal of the tab would allow the gas canister to be activated to release gas to initially move the first plunger in conjunction with operation of the valve as combined by Choi, the valve would then be moved after the contents from the first container are transferred to allow the gas pressure into the space in the area of the former spring which works with to move the substances back to the first container. The operation of the valves may continue to mix the substances, once delivery is desired the process for needle insertion may be carried out and the gas controlled for delivery.
With regard to claim 2, Sarnoff et al. has base and sidewalls which are at a right angle, further 40 is at a right angle to 34, a lower portion may be held forming a handle (Fig. 1).
With regard to claim 12, the embodiment of Fig. 1 does not disclose a delivery seal. However, the embodiment of Fig. 5 shows a seal 264 in the fluid transfer channel. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a seal in the channel in the embodiment of Fig. 1 as this would additionally prevent mixing prior to activation and since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. As combined the fluid transfer channel is taken as the portion cut-off from the needle and the mixing phase begins at initial activation.
With regard to claim 13, see the bottom face of 52 which covers the outlet (Fig. 1).
With regard to claims 14 and 15, member 34 is taken as the needle shield it is locked in place to the housing via 36 (Fig. 1). There is no recitation as to the functionality of a ‘bump trigger.’ The stored energy member is 52 (Fig. 1).
With regard to claims 16-20, Choi discloses openings are used to vent air to the outside which would be necessary to allow the piston to move back and forth (see at least [0047]), o rings 230 obstruct openings (Fig. 5, [0034]). The rod of 200 forms a slide actuator and the flanges of 210 and 220 form at least one ramped portion and a camming component (Fig. 5).
With regard to claim 100, the tab taken as the housing is removed (translated) in order for the slide components to operate. Further, prior to use the device may be picked up and rotated to orient it properly for use which would rotate the housing prior to removal and this rotation is included as part of the second output.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. The rejection has been updated in light of the claim amendments. In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
Regarding Applicant’s arguments with respect to Sarnoff’s one way transfer and use of a spring, as combined the spring is substituted for gas and two-way transfer is further found obvious and Sarnoff is not relied on to teach this, nor does it constitute a teaching away.
Applicant remarks Edwards teaches away, however, the embodiment of Edwards relied upon in the arguments is not used in the rejection.
Applicant remarks Choi does not disclose transferring medicaments back and forth, Choi is not relied upon to teach this.
Regarding Harper, Applicant argues that the teachings of Harper are directed to an unmodified Sarnoff. As combined the device of Sarnoff is still for mixing and transferring components, the initial combination would still have Sarnoff operate for one way mixing. The teachings of Harper are applied to the overall combination which has substituted the spring components for gas. The end of the rejection does indicate how the incorporated valves would function to allow the plungers to move back and forth. Applicant remarks Choi is for a single injection. The valve would work both ways.
The amendments are sufficient to overcome the previous rejections under 35 U.S.C. 112.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
