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 § 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) 13-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dasbach (US 2021/0346608).
Regarding claim 13, Dasbach discloses a cap assembly (Fig. 1A 12) of a medicament delivery device (Fig. 1A), the cap assembly comprising:
a tubular outer shell (Fig. 3, 21);
a shield remover (Fig. 3, 24); and
a connector (Fig. 3, 27),
wherein the tubular outer (21) shell extends along a longitudinal axis between a proximal end and a distal end (see annotated figure below), wherein the shield remover is at least partially arranged within the tubular outer shell (Fig. 3, where 24 is within 21), wherein the shield remover is movable relative to the tubular outer shell in the direction of the longitudinal axis, wherein the connector is arranged within the tubular outer shell, wherein the connector is movably connected to both the tubular outer shell and the shield remover (¶[0077]-[0078], where the part 24 engages with a shield part and the housing and moves within the housing relative to the connector),
wherein the connector is configured to be moved in the proximal direction by a movement of the tubular outer shell in the proximal direction such that the shield remover is moved a distance smaller than a distance moved by the tubular outer shell (¶[0085], where the ramp 34 is the distance moved by 27 and is smaller than the proximal movement of the part 21 when operation occurs), wherein the connector is rotatably attached to the tubular outer shell (¶[0082], where 27 and 21 are axially fixed to each other), wherein the connector is pivotally attached to the tubular outer shell (¶[0082], where the connection allows for pivoting movement when operation occurs using the ramp on 27), wherein the connector comprises a connector body (Fig. 3, 28), and wherein the connector body comprises a ring or a circlip (Fig. 11, where 27 is a ring shaped member).
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Regarding claim 14, Dasbach teaches the cap assembly according to claim 13, wherein the connector is rotatably attached to either the tubular outer shell or the shield remover (¶[0078], [0085], where the part 27 is rotatably attached to the housing 11 and part 24), so that a movement of the tubular outer shell relative to the shield remover in the direction of the longitudinal axis causes the connector to rotate relative to the tubular outer shell (¶[0085], where the connector rotates relative to 21 through the ramp which connects 24 to 27 when 21 is lifted).
Regarding claim 15, Dasbach discloses the cap assembly according to claim 13, wherein the cap assembly comprises an axial extension extending in the direction of the longitudinal axis (Fig. 11, 29, where 28 extends upward from the connector 27) , and wherein the axial extension is arranged between the shield remover and the connector body (Fig. 9, 29, where 29 is between 27 and 24 as shown in the figure) .
Regarding claim 16, Dasbach discloses the cap assembly according to claim 15, wherein the connector body comprises the axial extension extending in the direction of the longitudinal axis from the connector body towards the shield remover (Fig. 9, where the extension 29 extends upward from 27 and toward 24 as it is arranged on the longitudinal axis).
Regarding claim 17, Dasbach discloses the cap assembly according to claim 16, wherein the axial extension of the connector body is adjacent to a distally directed surface of the shield remover (Fig. 9, where the portion 29 is adjacent to a distal surface of 24).
Regarding claim 18, Dasbach discloses the cap assembly according to claim 12, wherein the connector body comprises a transverse extension extending from the connector body in a direction transverse to the longitudinal axis (see annotated figure below); and wherein the transverse extension is pivotally attached to the tubular outer shell (¶[0083], where the connection can be as shown in figure 11 or another thread, protrusion or groove that allows for pivotal attachment of 27 and 21).
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Regarding claim 19, Dasbach discloses the cap assembly according to claim 18, wherein a cut-out or recess is arranged in a wall of the tubular outer shell, and wherein the transverse protrusion of the connector is positioned within the cut-out or recess (¶[0083], where there is a clipping portion of 21 that engages with 27 to form a connection, this clipping portion engages with the cutouts of 27 shown in figure 11).
Regarding claim 20, Dasbach discloses the cap assembly according to claim 12, wherein the shield remover comprises an inner body (Fig. 13, see annotated figure below), the inner body comprising a gripper for engaging a delivery member shield of the medicament delivery device, and wherein the gripper extends from a wall of the inner body (¶[0077], where 24 includes a gripper portion that creates a frictional lock between 24 and the shield 1).
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Regarding claim 21, Dasbach discloses the cap assembly according to claim 20, wherein the inner body extends along the longitudinal axis between a proximal end and a distal end, and wherein the gripper is arranged closer to the distal end of the inner body than to the proximal end of the inner body (Fig. 13, where the inner body extends longitudinally and the gripper portion as shown in the annotated figure above, is arranged towards a distal end).
Regarding claim 22, Dasbach discloses the cap assembly according to claim 12, wherein the shield remover is movably attached to the tubular outer shell of the cap assembly by a snap-fit engagement (¶[0077], where 21 and 24 are connected by 33 which is a snapping connection through the clips).
Regarding claim 23, Dasbach discloses the cap assembly according to clause 22, wherein the snap-fit engagement is formed by a snap-fit groove and a snap-fit arm, and wherein the snap-fit arm is movable within the snap-fit groove in a predetermined distance (Fig. 12, where the clip 33 is shown as an arm with a clipping end that fits into a groove 32).
Regarding claim 24, Dasbach discloses a sub-assembly (Fig. 1A, 10) of a medicament delivery device, the sub-assembly comprising the cap assembly according to claim 12, wherein the sub-assembly comprises a housing (Fig. 1A, 11) for receiving a medicament container of the medicament delivery device (¶[0071], where the syringe houses a liquid medicament), wherein the housing extends along the longitudinal axis between a proximal end (Fig. 1A, P) and a distal end (Fig. 1A, D), wherein the cap assembly is removably attached to the proximal end of the housing (Fig. 1A-B, 12, where 12 is shown as being removable), wherein the housing comprises a proximally directed surface at the proximal end of the housing (Fig. 1A, where P has a tiered surface at 13 that includes angular portions), wherein the proximally directed surface inclines from a first side to a second side relative to a plane perpendicular to the longitudinal axis (Fig. 1A, where the tiered portion has an angled portion that protrudes relative to a perpendicular plan), wherein the connector is adjacent to the proximally directed surface (where 27 is adjacent to 18 and to the housing 11 at a proximal end when the device is assembled as the proximal end extends in a longitudinal direction until it becomes the distal end), wherein the connector is pivotally attached to the tubular outer shell at a point next to the first end of the proximally directed surface (¶[0079], [0082], where 27 is fixed rotationally to the housing 11 and 21 which allows for a pivoting or rotating relative to the outer shell).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dumet et al. (US 2020/0254189) teaches a removal member including a shield remover, outer shell and connector. The connector of Dumet is attached in a pivotal fashion as shown in figures 1A-C where the part 101 rotates to engage with part 3. The device also includes a sub-assembly with a portion for medicament for delivery.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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