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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 56 is/are rejected under 35 U.S.C. 102(a)(2) as being 102 (a)(2) by Saussaye et al. (US 2019/0298934 A1).
With regard to claim 56, Saussaye et al. teach a drug delivery device comprising: a housing configured to contain a drug container with a needle, wherein the drug container is not movable relative to the housing (Fig. 1 member 1); a needle shroud that is telescopically arranged with the housing (Fig. 2 member 10, showing pre-use state); and a cap that is configured to be releasably connected to the drug delivery device before use of the drug delivery device (Fig. 1 member C), wherein at least one of the cap and the needle shroud is configured such that when an attempt is made to re-apply the cap onto the drug delivery device after use of the drug delivery device, the cap does not release a post-use shroud lock (Fig. 9, [0071], [0076], the shroud is locked in place after use and would not be released by contact from the cap, the claim does not recite what constitutes an attempt to re-apply the cap), wherein the needle shroud comprises a shroud beam, wherein the shroud beam comprises a locking tab protruding radially outwards from the shroud beam, wherein the locking tab is configured to abut the housing when the post-use shroud lock is engaged (Fig. 37, [0076] not numbered in 36 but cutouts shown in 37 provide a beam which can include tab 112 which has a proximally-facing surface which abuts a distally facing ramp surface of the housing in zone 106 in Fig. 36, due to the shape of the groove/ramp the beam flexes as claimed [0064], [0071]), and wherein the cap is configured such that a proximal cap end is distally spaced from the locking tab after attempting to re-apply the cap onto the drug delivery device after use of the drug delivery device (the user may hold the cap such that after touch the device it is held space from the locking tab).
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) 36, 44-47, and 51-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye et al. (US 2019/0298934 A1) in view of Mesa et al. (US 2009/0270804 A1).
With regard to claims 36, 44, 46, 47, 53, and 55, Saussaye et al. teach a drug delivery device comprising: a housing (Fig. 1 member 1) configured to contain a drug container with a needle, wherein the drug container is not movable relative to the housing (Figs. 1-8 member S, position of S within 1 is unchanged); a needle shroud that is telescopically arranged with the housing (Fig. 2 member 10, showing pre-use state); and a cap that is configured to be releasably connected to the drug delivery device before use of the drug delivery device (Fig. 1 member C), wherein at least one of the cap and the needle shroud is configured such that when an attempt is made to re-apply the cap onto the drug delivery device after use of the drug delivery device, the cap does not release a post-use shroud lock (Fig. 9, [0071], [0076], the shroud is locked in place after use and would not be released by contact from the cap, the claim does not recite what constitutes an attempt to re-apply the cap), wherein the needle shroud comprises a shroud beam, wherein the shroud beam comprises a locking tab protruding radially outwards from the shroud beam, and wherein the locking tab is configured to abut the housing when the post-use shroud lock is engaged (Fig. 37, [0076] not numbered in 36 but cutouts shown in 37 provide a beam which can include tab 112 which has a proximally-facing surface which abuts a distally facing ramp surface of the housing in zone 106 in Fig. 36, due to the shape of the groove/ramp the beam flexes as claimed [0064], [0071]). Saussaye et al. do not disclose that in the post-use state the shroud is arranged further distally than the pre-use state. However, Mesa et al. teach an autoinjector in which after use the shroud extends further out to indicate the device has been used to indicate to the user correct orientation and prevent incorrect use to enhance safety (Figs. 60 and 61, [0114]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the shroud extend father our after use and use a marking in Saussaye et al. as Mesa et al. teach this is beneficial to ensure correct use and enhance safety. One of ordinary skill in the art would be able to adjust the groove to extend the shroud as needed.
With regard to claim 45, the cap may be spaced as recited after an attempt to re-apply the cap.
With regard to claims 51 and 52, see Fig. 36 connection with initial zone 102 ([0068]).
With regard to claim 54, a user may take the cap and touch the proximally facing surface of the cap to the distally facing surface of tab 11 of member 10 (Fig. 2).
Claim(s) 37-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye et al. (US 2019/0298934 A1) and Mesa et al. (US 2009/0270804 A1) as applied to claim 36 above, and further in view of Bernhard et al. (US 2019/0151561 A1).
With regard to claims 37-42, Saussaye et al. teach a cap but does not disclose how such a cap may prevent re-capping. However, Bernhard et al. teach a cap with projecting arms 32 that prevent a cap from being remounted which is beneficial in ensuring the device does not mistakenly get reused (Fig. 2a, [0005], [0072]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a safety feature in Saussaye et al. as in Bernhard et al. to prevent remounting of the cap to ensure the device does not get mistakenly reused. As combined the cap would include arms which could abut the shroud in an attempt to re-apply the cap.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye et al. (US 2019/0298934 A1) and Mesa et al. (US 2009/0270804 A1) as applied to claim 36 above, and further in view of Glover et al. (WO 2017/046556 A1).
With regard to claim 43, Saussaye et al. teach a device substantially as claimed but do not disclose an inner wall reinforcement. However, Glover et al. teach a shroud with an inner wall reinforcement at 28b around opening 29 which retains the spring (Fig. 2, Pg. 9 lines 10-11). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a reinforcement in Sauaasye et al. as in Glover et al. for providing a retention surface for the needle.
Claim(s) 48 and 49 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Saussaye et al. (US 2019/0298934 A1) and Mesa et al. (US 2009/0270804 A1) as applied to claim 36 above, and further in view of Ruan et al. (US 2011/0160675 A1).
With regard to claims 48 and 49, Saussaye et al. teach a device substantially as claimed but do not disclose a projection holding the shroud in position during assembly. However, Ruan et al. teach a protrusion which moves through a groove to extend and retract a shield may be releasably locked prior to use by a projection in the cover which extends inward into the groove to abut the protrusion or the shield may be free to move ([0040]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include a projection extending inward from the cover to abut the needle shroud in Ruan et al. prior to use (during assembly) as Ruan et al. teach equivalently releasably locking or having the shield free to move. Such a projection enhances the safety of the device. As arranged it would protrude inwards at the proximal end of the needle shroud.
Response to Arguments
Applicant’s arguments with respect to claim(s) 36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Regarding the 112 rejection, the Examiner is interpreting the claim such that the drug container is not movable relative to the housing at least at some point during the lifetime of the device. Regarding claims 45 and 56, the recitation to the cap is functional. A user is capable of holding the cap in their hand attempting to re-apply the cap and then holding the cap such that the proximal end of the cap is spaced distally from the locking tab. The user can simply hold the cap spaced from the device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
