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 .
Status of Claims
The Amendment filed 08/22/2025 has been entered.
Claims 1-14 were previously canceled.
Claims 15-32 remain pending in the application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 15-25 and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (U.S. Publication No. 20110230827), hereinafter Mori, in view of Klint et al. (U.S. Publication No. 20040054336), hereinafter Klint.
Regarding claim 15, Mori discloses a container holder assembly for a medicament delivery device (device 50, see FIG. 10; the Examiner notes that all reference characters cited below refer to FIGS. 5,6, and 10 unless otherwise stated), the container holder assembly comprising a container holder (ampoule receptacle 30) and a needle assembly (needle unit 100), wherein the container holder comprises:
a distal tubular body (ampoule 40) for receiving a multi-chamber container therein (“The ampoule 40, such as is shown for example in FIGS. 5 and 6, is a so-called two-chamber ampoule (which may also be referred to as a two-chamber carpoule)”, [0057]), the distal tubular body comprising an external surface and a distal body engaging structure (outer thread 33, see [0066]) on the external surface configured to movably engage an actuator device (see wings 57 and button 58 in FIG. 10) of the medicament delivery device in order to releasably connect the container holder to the actuator device (See [0066; 0076]); and
a proximal tubular part (fastening member 20) comprising a proximal body engaging structure (threaded portion 21) configured to connect to the needle assembly (see FIG. 5) wherein the needle assembly is pre-assembled to the container holder before the multi-chamber container is received in the distal tubular body (See [0076-0078]),
wherein the needle assembly comprises a hub (needle support 1) having an injection needle (needle 3) with a distal needle end and a proximal needle end (see both ends of needle 3 in FIG. 3), the distal needle end being isolated from the multi- chamber container when the multi-chamber container is received in the distal tubular body (see FIG. 3). However, Mori does not expressly state wherein a proximal body engaging structure is external.
Klint teaches a needle mounting system and methods for mounting a needle assembly on a needle mount (Abstract) wherein a proximal body engaging structure (needle mount 100) is external (see external threads 200 on exterior surface of mount 100 in FIG. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Mori to include a proximal body engaging structure externally. Doing so allows the needle mount to accept not only needle hubs of the present invention, but also standard, threaded needle-hub assemblies, as taught by Klint (see [0026]).
Regarding claim 16, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the distal tubular body (ampoule 40) is elongated along a longitudinal axis of the container holder assembly (see FIG. 5).
Regarding claim 17, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the distal body engaging structure (outer thread 33) is an external thread (see [0066]).
Regarding claim 18, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the distal body engaging structure (outer thread 33) is configured to threadingly engage a housing part of the medicament delivery device (see [0066] and FIG. 10).
Regarding claim 19, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 18, and Mori further discloses wherein the distal tubular body (ampoule 40) comprises at least one engaging body structure (latching member 36 which traverses the latching elements 54 and 55, see [0067; 0079-0080]) arranged to releasably engage at least one engageable device feature in the housing part (see FIG. 10).
Regarding claim 20, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 19, and Mori further discloses wherein each of the at least one engaging body structure is a flexible protrusion (“latching member 36 which is mounted such that it is biased in the radial direction. The springiness or resiliency is generated by an arm”, see [0067]).
Regarding claim 21, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the proximal body engaging structure (threaded portion 21) is an external thread for threadingly engaging the needle assembly (see [0068] and FIG. 5).
Regarding claim 22, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the proximal tubular part (fastening member 20) comprises a proximal internal engaging structure for threadingly engaging the hub (see [0068] and FIG. 5).
Regarding claim 23, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the needle assembly further comprises a cap (casing 14), and wherein the cap is arranged to cause axial distal displacement of the hub by manual rotation of the cap (see [0068]).
Regarding claim 24, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 23, and Mori further discloses wherein the distal needle end is arranged to penetrate a membrane arranged at a proximal end of the multi- chamber container by means of the axial distal displacement of the hub (ampoule comprises a seal which seals the distal end of the ampoule, wherein the seal can be penetrated by a piercing means, see [0008]; “a piercing means such as a catheter or a needle can penetrate the septum and establish a fluid connection between a distal needle tip of the needle unit and the product container”, see [0018]).
Regarding claim 25, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, and Mori further discloses wherein the needle assembly (needle unit 100) further comprises a needle cover (casing 14) covering the injection needle, the needle cover comprising a distal cover engaging structure (fastening portion 13) engaging the proximal body engaging structure to connect the proximal tubular part to the needle assembly (see [0053;0068]).
Regarding claim 27, Mori in view of Klint teaches a medicament delivery device comprising a container holder assembly according to claim 15 (device 50).
Regarding claim 28, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 27, and Mori further discloses comprising an actuator device having a housing part (sleeve 15), wherein the medicament delivery device is arranged to cause mixing of at least two substances in the multi-chamber container by manually moving the container holder into the housing part (see [0077-0079]).
Regarding claim 29, Mori discloses a container holder assembly for a medicament delivery device (device 50, see FIG. 10; the Examiner notes that all reference characters cited below refer to FIGS. 5,6, and 10 unless otherwise stated), the container holder assembly comprises:
a container holder (ampoule receptacle 30); and
a needle assembly (needle unit 100),
wherein the container holder comprises:
a distal tubular body (ampoule 40) for receiving a multi-chamber container therein (The ampoule 40, such as is shown for example in FIGS. 5 and 6, is a so-called two-chamber ampoule (which may also be referred to as a two-chamber carpoule), see [0057]), the distal tubular body comprising an external surface having an external thread helically engaged with a housing part of the medicament delivery device (outer thread 33, see [0066]) such that the distal tubular body movably engages an actuator device of the medicament delivery device in order to releasably connect the container holder to the actuator device (see wings 57 and button 58 in FIG. 10) of the medicament delivery device in order to releasably connect the container holder to the actuator device (See [0066]); and
a proximal tubular part (fastening member 20) comprising a proximal body engaging structure (threaded portion 21) configured to connect to the needle assembly (see FIG. 5), wherein the needle assembly is pre-assembled to the container holder before the multi-chamber container is received in the distal tubular body (See [0076-0078]);
wherein the needle assembly comprises:
a hub (needle support 1) having an injection needle (needle 3) with a distal needle end and a proximal needle end (see both ends of needle 3 in FIG. 3), the distal needle end being isolated from the multi- chamber container when the multi-chamber container is received in the distal tubular body (see FIG. 3). However, Mori does not expressly state wherein a proximal body engaging structure is external.
Klint teaches a needle mounting system and methods for mounting a needle assembly on a needle mount (Abstract) wherein a proximal body engaging structure (needle mount 100) is external (see external threads 200 on exterior surface of mount 100 in FIG. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Mori to include a proximal body engaging structure externally. Doing so allows the needle mount to accept not only needle hubs of the present invention, but also standard, threaded needle-hub assemblies, as taught by Klint (see [0026]).
Regarding claim 30, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 29, and Mori further discloses wherein the distal tubular body (ampoule 40) further comprises a flexible protrusion (“latching member 36 which is mounted such that it is biased in the radial direction. The springiness or resiliency is generated by an arm”, see [0067]) that releasably engages a engageable device feature in the housing part (see FIG. 10; latching member 36 which traverses the latching elements 54 and 55, see [0067; 0079-0080]).
Regarding claim 31, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 29, and Mori further discloses wherein the needle assembly further comprises a cap (casing 14), and wherein the cap is arranged to cause axial distal displacement of the hub by manual rotation of the cap (see [0068]).
Regarding claim 32, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 31, and Mori further discloses wherein the rotation of the cap causes the distal needle end to penetrate a membrane arranged at a proximal end of the multi-chamber container (ampoule comprises a seal which seals the distal end of the ampoule, wherein the seal can be penetrated by a piercing means, see [0008]; “a piercing means such as a catheter or a needle can penetrate the septum and establish a fluid connection between a distal needle tip of the needle unit and the product container”, see [0018]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Mori et al. (U.S. Publication No. 20110230827), hereinafter Mori, in view of Klint et al. (U.S. Publication No. 20040054336), hereinafter Klint, further in view of Rycroft et al. (U.S. Patent No. 4758230), hereinafter Rycroft.
Regarding claim 26, Mori in view of Klint teaches the claimed invention as discussed above concerning the rejection of claim 15, however, Mori in view of Klint does not expressly state wherein the needle assembly further comprises a tamper indication member.
Rycroft teaches an operable syringe barrel and hypodermic needle assembly (Col 2 Lines 66-67) wherein the needle assembly further comprises a tamper indication member (alternative positioning means; see Col 7 Lines 57-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Mori to include a tamper indication member. Doing so provides evidence of tampering and prevents inadvertent activation, as taught by Rycroft (see Col 7 Lines 57-65).
Response to Arguments
Applicant’s arguments, see pages 7-9 of Remarks filed 08/22/2025, with respect to the rejection(s) of claim(s) 15-32 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 U.S.C. 103 to Mori (U.S. Publication No. 20110230827) in view of Klint (U.S. Publication No. 20040054336).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
01/21/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783