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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: claim 7 recites the first and second axis are parallel; the axes identified in Fig. 29 are not parallel.
Claim Objections
Claim 8 is objected to because of the following informalities: claim 8 repeats “and the flow restriction member” in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards (WO 2017/004345 A1).
With regard to claims 1, 14, and 20, Edwards teaches an apparatus, comprising: a housing (Figs. 12 and 13 housing 4100, gas chamber 4139, [1130]); an energy storage member positioned within the housing and configured to produce a pressurized gas on a condition that the energy storage member is actuated (Figs. 34 and 35 member 4576, [1174], [1175]); a first gas flow path in fluid communication with the energy storage member, a first portion of the pressurized gas being within the first gas flow path on the condition that the energy storage member is actuated (Fig. 13 flow path through 4139, [1141]); a second gas flow path in fluid communication with the energy storage member, a second portion of the pressurized gas being within the second gas flow path on the condition that the energy storage member is actuated (flow path through 4346, Figs. 40 and 41) and a medicament container assembly positioned within the housing, the medicament container assembly including a container body, an elastomeric member positioned within the container body, and a delivery member coupled to a distal end portion of the container body (Fig. 34 container 4210, delivery member 4216, elastomeric member 4217, [1140]), wherein: a proximal end portion of the container body is in fluid communication with the first gas flow path ([1158]) and is fluidically isolated from the second gas flow path ([1158], 4346 not initially open), and on the condition that the energy storage member is actuated, the container body is moved from a first position to a second position by the first portion of the pressurized gas ([1158], first portion of gas is gas that moves the container body), the elastomeric member is in fluid communication with the second gas flow path ([1176]-[1181]) and is fluidically isolated from the first gas flow path (the elastomeric member is fluidically isolated from 4139 prior to the carrier moving as shown in exemplary Fig. 19), and on a condition that the container body is at the second position, the elastomeric member is moved in the direction of the distal end portion of the container body by the second portion of the pressurized gas ([1178]-[1180], second portion of gas is gas that moves the elastomeric member and then is vented).
With regard to claims 2-5, the first body portion is considered as at least 4340 (Fig. 29) which has a first axis along the longitudinal axis which is coaxial with the medicament container, the second body portion is considered as at least 4110 which has an axis which is orthogonal to the longitudinal axis of 4340 (Fig. 34), the flow restriction member includes 4330 and 4320 (Figs. 29 and 34), 4413 isolates the elastomeric member from the gas path as it retains the gas initially (Figs. 17 and 19, the first portion and an inner face of the container body are in plane above and below 4413).
With regard to claim 6, as the portions are three-dimensional they have axis which are parallel.
With regard to claim 7, after injection the second portion of gas is released through the flow restriction member to dissipate thus having a lower magnitude ([1164]).
With regard to claim 8, see 4115 (Fig. 34).
With regard to claim 9, see Figs. 15, 19, and 20 flange formed on the distal face of 4110 around where the O-ring is inserted and mounts on 4101, considered as a carrier.
With regard to claims 10-13, alternatively the embodiment shown in exemplary Fig. 67 is relied upon, this has the same features as relied upon in claim 1 which are considered as the first medicament container, elastomeric member, delivery member, and delivery control assembly. The second medicament container, elastomeric member, delivery member, and delivery control assembly, are those replicated as the second set of components. See the simultaneous movement of the containers in the transition to Fig. 75, see at least [1226], [1263]).
With regard to claim 15, see Figs. 35 and 37 member 4360 ([1158]).
With regard to claim 16, see at least components 4112, 4113, and 4345 (Fig. 20).
With regard to claims 17 and 18, the expandable assembly includes at least first member 4320, second member 4330 moveable within 4360, and third member 4340 (Figs. 20 and 28), the movable valve member includes previously considered components 4112, 4113, and 4345 (Fig. 20, [1135], [1164]).
With regard to claim 19, 4413 isolates the elastomeric member from the gas path as it retains the gas initially (Figs. 17 and 19, in contact via intervening structures).
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
