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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 230a. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 –
Claims 15, 17-18, 19-20, and 27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chu et al. (WO 2018/069031 A1).
Regarding claim 15, Chu et al. discloses a method of assembling (p. 1, line 5-9, method of assembling) a medicament delivery device (Fig. 1, medicament delivery device 1), the method comprising: providing a housing (Fig. 1 housing 3) of the medicament delivery device; wherein the housing (Fig. 1 housing 3) extends along a longitudinal axis (L) (see ‘Modified Fig. 1’ below, longitudinal axis) between a proximal end (Fig. 1 tubular proximal portion 5a) and a distal end (Fig. 1 distal end of delivery member 5b) wherein the distal end (Fig. 1 distal end of delivery member 5b) of the housing (Fig. 1 housing 3) is pointing away from a medicament delivery site during use of the medicament delivery device (wherein the distal end is understood to be the reverse of the common practice in the field , i.e. distal is at the end near the needle and injection site) (see Fig 1, where distal end is pointing away from medicament delivery site); and wherein the proximal end of the housing (Fig. 1 tubular proximal portion 5a) is pointing towards the medicament delivery site during use of the medicament delivery device (wherein the proximal end is understood to be the reverse of the common practice in the field , i.e. proximal is at the end near the operator of the device) (see Fig 1, where proximal end is pointing toward medicament delivery site and the delivery member can be inserted into the delivery site when uncovered); providing a power unit (see p. 9, lines 10-17, power pack) of the medicament delivery device (Fig. 1, medicament delivery device 1); wherein the power unit (see p. 9, lines 10-17, power pack) comprises a plunger rod (see p. 9, lines 10-17, plunger rod) and a holder (see p. 9, lines 10-17, movable sleeve) engaged with the plunger rod (see p. 9, lines 10-17, plunger rod); assembling the power unit (see p. 9, lines 10-17, power pack) into the housing (Fig. 1 housing 3) (see such assembling as described in p. 13, lines 23-25, the sub-assembly 15 may subsequently be assembled with the “the power pack" to obtain a fully assembled medicament delivery device 1); providing a cap assembly (2) (Fig. 1 cap assembly 9) extending along the longitudinal axis (L) (Fig. 1’ below, longitudinal axis) between a proximal end (Fig. 1 tubular proximal portion 5a) and a distal end (Fig. 1 distal end of delivery member 5b); wherein the cap assembly (Fig. 1 cap assembly 9) comprises a cover (20) (Fig. 1 delivery member shield 7c) configured to cover a medicament delivery member (Fig. 1 delivery member 7b) of the medicament delivery device (Fig. 1, medicament delivery device 1); connecting the cap assembly (2) (Fig. 1 cap assembly 9) to either the plunger rod (11) (see p. 9, lines 10-17, plunger rod) or the holder (13) (see p. 9, lines 10-17, movable sleeve) (see such connecting as described in p. 9, lines 10-17, the previously mentioned "power pack" may for example include a plunger rod, and a moveable sleeve which is configured to engage with and cooperate with a distal end 5b of the delivery member cover 5, such that linear displacement of the delivery member cover 5 in the distal direction, i.e. from the extended position to the retracted position, is translated to rotational motion of the movable sleeve, thereby releasing the plunger rod, enabling it to move in the proximal direction. Medicament expulsion may thus be initiated); and moving the cap assembly (2) (Fig. 1 cap assembly 9) relative to the housing (10) (Fig. 1 housing 3) in the distal direction (see distal direction which is toward direction of Fig. 1 distal end of delivery member 5b) of the housing (10) (Fig. 1 housing 3) until the cap assembly (2) (Fig. 1 cap assembly 9) attaches to the proximal end of the housing (10) (Fig. 1 tubular proximal portion 5a) (see such moving as described in p. 9, lines 2-9, medicament delivery device 1 comprises a housing or main body 3, of which for illustrative purposes only a proximal portion is shown, and a proximally biased delivery member cover 5 which has a tubular proximal portion 5a. The delivery member cover 5 is configured to be displaced relative to the housing 3, from an extended position relative to the housing 3, in which the delivery member cover 5 extends proximally from the housing 3, to a retracted position, in which the delivery member cover 5 has been displaced in the distal direction and further received by the housing 3 ), wherein during the step of moving the cap assembly (2) (Fig. 1 cap assembly 9) relative to the housing (10) (Fig. 1 housing 3), the cap assembly (2) (Fig. 1 cap assembly 9) moves: (i) the plunger rod (11) (see p. 9, lines 10-17, plunger rod) relative to the housing (10) (Fig. 1 housing 3) when the cap assembly (2) (Fig. 1 cap assembly 9) is connected to the plunger rod (11) (see p. 9, lines 10-17, plunger rod).
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Regarding claim 17, Chu et al. discloses before assembling the power unit (see p. 9, lines 10-17, power pack) into the housing (Fig. 1 housing 3) the method comprises the further steps of:providing a delivery member guard (p. 9, lines 2-9, delivery member cover 5); and assembling both the delivery member guard (p. 9, lines 2-9, delivery member cover 5) and the power unit (see p. 9, lines 10-17, power pack) into the housing (Fig. 1 housing 3).
Regarding claim 18, Chu et al. discloses the method comprises the further steps of:engaging the delivery member guard (p. 9, lines 2-9, delivery member cover 5) to the holder (see p. 9, lines 10-17, movable sleeve) either before or after assembling both the delivery member guard (p. 9, lines 2-9, delivery member cover 5) and the power unit (see p. 9, lines 10-17, power pack) into the housing (Fig. 1 housing 3).
Regarding claim 19, Chu et al. discloses the step of moving the plunger rod (see p. 9, lines 10-17, plunger rod) relative to the housing (Fig. 1 housing 3) comprises moving the plunger rod (see p. 9, lines 10-17, plunger rod) relative to the holder (see p. 9, lines 10-17, movable sleeve) while the holder (see p. 9, lines 10-17, movable sleeve) is immovable relative to the housing (Fig. 1 housing 3).
Regarding claim 20, Chu et al. discloses during the step of moving the holder (see p. 9, lines 10-17, movable sleeve) relative to the housing (Fig. 1 housing 3), the plunger rod (see p. 9, lines 10-17, plunger rod) is immovable relative to the housing (Fig. 1 housing 3).
Regarding claim 27, Chu et al. discloses when the cap assembly (Fig. 1 cap assembly 9) is attached to the proximal end of the housing (Fig. 1 housing 3) (see p. 9, lines 28-29, the cap assembly 9 is configured to be mounted to a proximal end of the housing 3), the cap assembly (Fig. 1 cap assembly 9) moves axially towards the distal end of the housing (Fig. 1 housing 3) relative to the housing (Fig. 1 housing 3) until the cap assembly (Fig. 1 cap assembly 9) snap-fits to the housing (Fig. 1 housing 3).
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.
Claims 16, 21-26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (WO 2018/069031 A1) in view of Egerström et al. (WO 2014/111371 A1).
Regarding claim 16, Chu et al. discloses before connecting the cap assembly (Chu et al., Fig. 1 cap assembly 9) to either the plunger rod (Chu et al., see p. 9, lines 10-17, plunger rod) or the holder (Chu et al., see p. 9, lines 10-17, movable sleeve). However, Egerström et al. teaches inserting the medicament container (Egerström et al, Fig. 2 medicament container 26) into the housing (Fig. 2 housing part 16) from the proximal end of the housing (Egerström et al, Fig. 2 housing part 16) (see Egerström et al, p. 12, lines 29-33, now the proximal part 12 is connected to the proximal end of the distal part 14. First, an appropriate medicament container 26 is placed in the medicament container holder 24 together with the medicament container guide member 40 such that its arms snap in engagement with the medicament holder. The medicament holder is subsequently inserted into the housing part 16). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chu et al. for inserting the medicament container into the housing from the proximal end of the housing, as taught by Egerström et al., as
Chu et al. discloses a medicament delivery device (as described in p. 11, lines 23-26, the housing 3 is furthermore provided with an internal structure 3a. According to the present example, the internal structure 3a forms part of the housing 3. It is however envisaged that the internal structure alternatively could form part of a medicament container holder, or of the delivery member cover) wherein the internal structure of the housing could form part of a medicament container holder instead of the delivery member cover which would allow the opening necessary for the medicament container to be inserted from the proximal end of the housing as opposed to from the distal end of the housing.
Regarding claim 21, the modified device of Chu et al. discloses the step of connecting the cap assembly (Fig. 10 cap 11 and remover 13 (which form cap assembly 9 as described in lines p. 7, 27-28, the cap assembly comprises a cap and a tubular remover) to the plunger rod (see p. 9, lines 10-17, plunger rod) comprises the steps of: contacting a proximal end (see proximal end of medicament container 7a in Fig. 10 as described in p. 7, lines 13-25, the term "proximal end" as used herein, when used in conjunction with a cap assembly, refers to that end of the cap assembly which is farthest from the proximal end of the medicament delivery device, when the cap assembly is properly mounted onto a medicament delivery device. The proximal end of a medicament delivery device is that end which is to be pointed towards the injection site during medicament injection. The same considerations also apply when referring to any component of the cap assembly. The "distal end" is the opposite end relative to the proximal end. With "proximal direction" and, equivalently, "proximally" is meant a direction from the distal end towards the proximal end, along the central axis of the safety mechanism. With "distal direction" or "distally" is meant the opposite direction to "proximal direction". The same definition also applies for the medicament container and any component thereof) of the medicament container (Fig. 10 medicament container 7a) with the cap assembly (Fig. 10 cap 11 and remover 13 (which form cap assembly 9 as described in p. 7, lines 27-28, the cap assembly comprises a cap and a tubular remover) from the distal end (see the distal end of the cap assembly which is the opposite side to the Fig. 2 proximal end remover 13a (the remover is inside cap 11 to make on assembly as described in p. 7, lines 27-28, the cap assembly comprises a cap and a tubular remover) of the cap assembly (Fig. 10 cap 11 and remover 13 (which form cap assembly 9 as described in p. 7, lines 27-28, the cap assembly comprises a cap and a tubular remover).
Regarding claim 22, the modified device of Chu et al. discloses the step of moving the plunger rod (see p. 9, lines 10-17, plunger rod) relative to the holder (see p. 9, lines 10-17, movable sleeve comprises the steps of: using the cap assembly (see Fig. 1 cap assembly 9) to move the medicament container (Fig. 1 medicament container 7a) in the distal direction relative to the housing (Fig. 1 housing 3) contacting a proximal end of the plunger rod (see p. 9, lines 10-17, plunger rod) with a distal end of the medicament container (Fig. 1 medicament container 7a; using the distal end of the medicament container (Fig. 1 medicament container 7a) to move the plunger rod (see p. 9, lines 10-17, plunger rod) in the distal direction relative to the housing (Fig. 1 housing 3); disengaging the plunger rod (see p. 9, lines 10-17, plunger rod) from the holder (see p. 9, lines 10-17, movable sleeve) by moving the plunger (see p. 9, lines 10-17, plunger rod) in the distal direction relative to the housing (Fig. 1 housing 3); and attaching the cap assembly (Fig. 1 housing 3) to the proximal end of the housing (Fig. 1 housing 3).
Regarding claim 23, the modified device of Chu et al. discloses the step of connecting the cap assembly (Fig. 1 cap assembly 9) to the holder (see p. 9, lines 10-17, movable sleeve) comprises the step of: moving the cap assembly (Fig. 1 cap assembly 9) in the proximal direction relative to the delivery member guard (p. 9, lines 2-9, delivery member cover 5) (see such movement as described in p. 9, lines 27-30, the cap 11 is configured to receive the remover 13. The cap assembly 9 is configured to be mounted to a proximal end of the housing 3, thereby covering the delivery member cover 5, and the delivery member 7b), such that the cap assembly (Fig. 1 cap assembly 9) contacts a proximal end of the delivery member guard (p. 9, lines 2-9, delivery member cover 5).
Regarding claim 24, the modified device of Chu et al. discloses the step of moving the plunger rod (see p. 9, lines 10-17, plunger rod) relative to the holder (see p. 9, lines 10-17, movable sleeve) comprises the steps of: using the cap assembly (Fig. 1 cap assembly 9) to move the delivery member guard (p. 9, lines 2-9, delivery member cover 5) in the distal direction relative to the housing (Fig. 1 housing 3); using the distal movement of the delivery member guard (p. 9, lines 2-9, delivery member cover 5) to move the holder (see p. 9, lines 10-17, movable sleeve) relative to the plunger rod (see p. 9, lines 10-17, plunger rod); and attaching the cap assembly (Fig. 1 cap assembly 9) to the proximal end of the housing (Fig. 1 housing 3).
Regarding claim 25, the modified device of Chu et al. discloses the step of moving the holder (see p. 9, lines 10-17, movable sleeve) relative to the plunger rod (see p. 9, lines 10-17, plunger rod) comprises a step of using the distal movement of the delivery member guard (p. 9, lines 2-9, delivery member cover 5) to rotate the holder (see p. 9, lines 10-17, movable sleeve) relative to the plunger rod (see p. 9, lines 10-17, plunger rod).
Regarding claim 26, the modified device of Chu et al. discloses the step of moving the holder (see p. 9, lines 10-17, movable sleeve) relative to the plunger rod (see p. 9, lines 10-17, plunger rod) comprises a step of using the distal movement of the delivery member guard (p. 9, lines 2-9, delivery member cover 5) to linearly move the holder (see p. 9, lines 10-17, movable sleeve) relative to the plunger rod (see p. 9, lines 10-17, plunger rod) in a direction transverse to the longitudinal axis (see ‘Modified Fig. 1’ above, longitudinal axis).
Regarding claim 28, the modified device of Chu et al. discloses after the cap assembly (Fig. 1 cap assembly 9 formed from cap 11 and remover 13 as described in p. 7, lines 27-28, the cap assembly comprises a cap and a tubular remover) is attached to the proximal end of the housing (Fig. 1 housing 3), the medicament delivery device (Fig. 1 medicament delivery device 1) is functionally completed (see such attachment for functional completion as described in p. 13, lines 15-25, when the sub-assembly 15 has been set in the state shown in Fig. 7a, the medicament container assembly 7 may be inserted therein. The medicament container assembly 7 may be inserted through the rear end, or distal end, of the housing 3 and brought forward in the proximal direction through the housing 3 until the delivery member 7b with the delivery member shield 7c protecting it, is received by the remover 13, as shown in Fig. 8. Due to the radially expanded state of the legs 13b, a neck portion of the medicament container 7a as well as the delivery member shield 7b is able to slide past the remover 13 without physical contact. The sub-assembly 15 may subsequently be assembled with the "power pack" to obtain a fully assembled medicament delivery device 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISSA J GHANNOUM whose telephone number is (571) 272-8591. The examiner can normally be reached Monday through Friday 8:30 AM to 5:00 PM.
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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