DETAILED ACTION
Response to Amendment
The amendment filed April 1, 2026 has been entered. Claims 1, 9, 16, and 18 have been amended with claim 21 having been newly added. Claims 1-21 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to amended claim 1 have been fully considered and are persuasive. The rejection of claims 1-17 has been withdrawn.
Regarding Applicant’s arguments as to amended claim 18, the Examiner respectfully disagrees. The cap remover of Wozencroft is operated via movement of the cap 14 away from the end of the body (which is being called the proximal end and therefore the cap is removed via force in the proximal direction with respect to the orientation of the device; see e.g., ¶¶ [0040]-[0041]). Therefore, the rejection is considered proper and is maintained below.
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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Rosa et al. (US 2014/0378909) in view of Tang (US 2011/0137281), and further in view of Wozencroft (US 2013/0331796).
Regarding claim 18, De Rosa discloses an assembly for a medicament delivery device (2), the assembly comprising: a shell (30) comprising a first shell section and second shell section where each shell section is divisible along a longitudinal plane (Figure 3, top and bottom shell sections; they are split along the longitudinal plane as claimed; it is noted that the claim fails to require the two shell sections to be completely split along an entire length of the shell), where the shell encloses a major part of the medicament delivery device (Figure 3) when the first and second shell sections are connected to each other such that the medicament delivery device is fixed relative to the shell (it’s fixed via walls 47 engaged with flange 5 as well as elements 58 and 59 on the top shell section); an entry passage defined by an inner surface of either the first or second shell portions (Figure 5, the distal end of the shell has an opening for receiving the needle and cap; the syringe is inserted at an angle through the opening and the flange is aligned with the walls for securing the injector within the shell), where the entry passage is configured to hold the major part of the medicament delivery device (Figure 5; the entry passage is the entire receiving portion of the lower shell half); a closure element (indentation 59 on walls 58) defined by proximal ends of the first and second shell sections, where a proximal end of the medicament delivery device extends through the closure element and prevents the major part of the medicament delivery device from moving proximally relative to the shell (paragraph [0066] discloses that the indentations engage the injection device to secure it); a fixation element (slot 48 between walls 47 and portion of top shell 55 covering the walls and slot after attachment; paragraph [0060]) arranged on the shell that fixes the medicament delivery device relative to the shell when the medicament delivery device is positioned inside the shell via an interaction between the fixation element arranged on the shell and the medicament delivery device (the walls are in the bottom shell portion and the securement is final with the closure of the top shell portion thereby constraining the flange from axial and rotational movement relative to the shell after securement), wherein the fixation element is arranged on an inner surface of the shell (Figure 5); and the shell further comprises a contact surface (proximal surface of distal parallel wall 47), wherein a distally directed surface of the medicament delivery device (distal surface of one flange side) abuts a proximal end of the contact surface (the distal surface of the flange abuts the proximal surface of the distal wall segment) when the fixation element and the contact surface contact with and fixate the medicament delivery device inside the shell (both wall segments retain the flange within the lower shell portion and the wall surfaces comprise the contact surface; that in cooperation with the frictional engagement of element 59 on the body of the syringe will prevent movement rotationally and transversally as claimed), and wherein the fixation element prevents movement between the shell and the medicament delivery device in at least a transversal direction and a rotational direction (both wall segments retain the flange within the lower shell portion and the wall surfaces comprise the contact surface; that in cooperation with the frictional engagement of element 59 on the body of the syringe will prevent movement rotationally and transversally as claimed). De Rosa fails to explicitly disclose the ribs on the injection device and the protective cap attached to the shell.
Tang teaches a medical device assembly (30) within a housing (shell parts 10, 11, and 12) wherein the device assembly comprises a feature (positioning groove 34) for engaging with a fixation element on the shell (the rib engages with rib 108 on an inner surface of base 10 as per paragraph [0037]) for providing positioning of the medical device assembly relative to the base (paragraph [0034]); wherein the fixation element is arranged on an inner surface of the shell (Figure 1, elements 108 are on the shell section); wherein the fixation element and the one or more ribs prevent movement between the shell and the medicament delivery device in at least a transversal direction and a rotational direction (the grooves and rib features are discontinuous and will therefore prevent rotational movement beyond the angular range of the rib or groove extensions; similarly, the rib and groove will prevent movement of the injection device at least in a transverse direction toward the rib or housing portion via frictional engagement).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the housing of and injector of De Rosa to comprise the ribs and fixation element of Tang to provide a means of registering the medical device assembly in the proper location within the housing as taught by Tang. Furthermore, it would have been obvious to place the rib feature on the injection device and the groove feature on the housing portion as it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). For this reason, one of ordinary skill in the art could have reversed the groove and rib portions of Tang with a reasonable expectation of success and without deviation from their intended function of retaining the injection in a stationary position within the device as claimed. In the cited combination, the ribs would be applied to the body of the injector to engage with the injector within the housing, thereby positively locating the injector within the shell portions before closing, via the fixation features as claimed. De Rosa/Tang further fail to explicitly disclose a remover within a cap assembly.
Wozencroft teaches (Figures 1 and 11) a cap (14) for an injection device (10) connected to a needle protruding portion of the injector body (Figure 1) and which comprises a remover (fingers 118, 120; Figure 11) for engaging a needle sheath (15) on the needle end of the delivery device when the protective cap is axially moved in an uncovering direction relative to the injector body (paragraphs [0040]-[0041] disclose the use of the fingers for gripping cap 15 during removal to uncover the needle; the cap is moved in a proximal direction as it is removed as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal end of the lower shell of De Rosa to comprise the cap and needle sheath removing features of Wozencroft so as to provide a means for automatically uncovering the needle during removal of the cap structure as taught by Wozencroft. In the cited combination, the cap and remover would be part of the lower shell and the needle shield would pass into the remover during insertion so as to allow the needle to be uncovered during cap removal as taught by Wozencroft.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Rosa in view of Tang in view of Wozencroft, and further in view of Olliffe (US 5,135,509).
Regarding claim 19, De Rosa/Tang/Wozencroft teach the claimed invention substantially as set forth above for claim 18. De Rosa further discloses wherein the first shell section and the second shell section comprise: attachment elements operably arranged to connect the first and second shell sections to each other (recesses on lid 55 which receive pins of outer housing 41; paragraph [0066]); and joints operably arranged to movably open or close the first and second shell sections, the joints comprising hinges (paragraph [0066]; the upper shell pivots via the pin/recess connection relative to the lower shell). De Rosa/Tang/Wozencroft fail to explicitly teach the hinged connection is a snap-in connection.
Olliffe teaches (Figures 1-3) a medical device comprising a connection of elements utilizing a pin (9) and recess (10) for receiving the pin in a snap-fit connection (Col. 2, lines 34-37).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the recess/pin attachment means of De Rosa/Tang/Wozencroft to comprise a snap-fit connection as taught by Olliffe as Olliffe teaches that such a connection means is known in the art for attaching two pivoting elements together via a pin/recess connection.
Regarding claim 20, De Rosa further discloses wherein the fixation element comprises longitudinal slits (openings 48) provided on at least one of the first or second shell sections (on the bottom shell section) and longitudinally extending ledges (syringe flange 5) on the medicament delivery device, where the longitudinal slits are arranged with cut-outs on side surfaces of the longitudinal slits (the slits are open portions between walls 47 for receiving the syringe flange), providing proximally directed contact surfaces (the upper surface of the distal wall segments are proximally directed contact surfaces) and where the longitudinally extending ledges are arranged with a wedge-shaped protrusion (the edges of flange 5 are tapered into a configuration that may be considered “wedge-shaped” as depicted in Figure 5) that fit into the cut-out of the side surfaces of the longitudinal slits (Figure 6).
Allowable Subject Matter
Claims 1-17 and 21 are allowed.
The following is an examiner’s statement of reasons for allowance: the prior art made of record and relied upon does not anticipate or render obvious, alone or in combination, the features of the independent claims. The closest prior art is considered to be Julian et al. (US 2012/0289905), which discloses a medical device assembly comprising a housing and a shell, formed from two halves which are split longitudinally, and which receives the housing therein. As per claim 1, the cited prior art fails to disclose or render obvious wherein the shell further comprises an opening that aligns with a cut-out in the housing of the medicament delivery device to allow for the viewing of a medicament by a user. As taught by Julian, it is known to allow for viewing of a medicament reservoir through a shell, however, the claim requires an opening at least one shell section which aligns with a corresponding opening in the injector housing to allow for such a viewing and since Julian fails to even contemplate a housing for the medicament device, it would not have been obvious to one of ordinary skill to modify the housing of Julian to comprise such a cut-out as the cartridge can already by seen through the outer portion. The configuration of the shell with a viewing window that is aligned with a corresponding viewing window on a separate medicament device housing is not reasonably taught by the prior art. For at least this reason, and including the totality of the structure of claim 1, the claims are allowable over the prior art made of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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