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 .
Response to Amendment
The Amendment filed 07/09/2025 has been entered.
Claims 12-14 are new.
Claim 1 is amended.
Claims 1-14 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 03/19/2025.
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 1-5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tschirren et al. (U.S. 20160367763), hereinafter Tschirren, in further view of Olson et al. (U.S. 20130204229), hereinafter Olson.
Regarding claim 1, Tschirren discloses an injection device (see [0027]) for injecting a substance into a body, comprising:
a syringe comprising (syringe 2, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated);
an injection needle (see needle at distal end of product container 2 in FIG. 2) to prick the body;
a barrel (barrel of syringe 2) arranged to contain the substance to be injected;
a stopper (plug 2d) arranged in sliding engagement inside the barrel (see [0045]); and
a plunger unit (piston 9 and drive spring 10) coupled to the stopper and moveable from an initial, proximal position to a final, distal position to inject the substance (see [0034]);
a case (housing portion 1) accommodating and securing the barrel and provided with elastic means (needle protection spring 13) and an operating stop (spring arms 12a); and
a needle shield (needle protection sleeve 8) adapted to be moveable under the force of the elastic means from an injection position into which the needle shield is moveable with regard to the injection needle to a safety position into which the needle shield permanently covers the injection needle (see [0045-0046]), the needle shield being provided with a flexible leg (flexible arms 7d). However, Tschirren does not expressly state comprising a shield stop, wherein the operating stop is configured to prevent the needle shield to move to the safety position by abutting against the shield stop, wherein the plunger unit comprises a triggering portion configured to deflect the flexible leg of the needle shield when the plunger unit has reached a triggering position during its injection movement from the initial, proximal position to the final, distal position, in order to remove the shield stop from abutting the operating stop and to allow the needle shield to reach the safety position under the force of the elastic means.
Olson teaches a medication administration device (Abstract) comprising a shield stop (latch 122),
wherein the operating stop (surface 133) is configured to prevent the needle shield (needle guard 108 of lower housing 102) to move to the safety position by abutting against the shield stop (see FIG. 6),
wherein the plunger unit comprises a triggering portion configured to deflect the flexible leg (surface 134) of the needle shield when the plunger unit has reached a triggering position during its injection movement from the initial, proximal position to the final, distal position, in order to remove the shield stop from abutting the operating stop and to allow the needle shield to reach the safety position under the force of the elastic means (see [0094-0096]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Tschirren to comprise a shield stop, wherein the operating stop is configured to prevent the needle shield to move to the safety position by abutting against the shield stop, wherein the plunger unit comprises a triggering portion configured to deflect the flexible leg of the needle shield when the plunger unit has reached a triggering position during its injection movement from the initial, proximal position to the final, distal position, in order to remove the shield stop from abutting the operating stop and to allow the needle shield to reach the safety position under the force of the elastic means. Doing so would create a latch that prevents movements between a pre use and use state as taught by Olson (see [0094-0096]).
Regarding claim 2, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Tschirren further teaches wherein the injection device further comprises a safety lock (blocking means 14b and spring arms 12a and insertion sleeve 4) arranged for locking the needle shield and/or the shield stop in the safety position of the needle shield (see [0046]).
Regarding claim 3, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 2, and Tschirren further teaches wherein the safety lock (blocking means 14b and spring arms 12a) comprises at least one flexible tab (flexible arms 4a) provided on the case and the triggering portion (peripheral groove 9a) is further configured to deflect the flexible tab in order to place it in an abutment position with the shield stop when the plunger unit has reached a safety lock position during its injection movement from the initial, proximal position to the final, distal position (see [0038]).
Regarding claim 4, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Tschirren further teaches wherein the case comprises at least one longitudinal window (window 1d and window opening 8b) allowing a user to view the substance at least when the plunger unit is in the initial, proximal position (see [0029]; see FIG. 1).
Regarding claim 5, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Tschirren further teaches wherein the triggering position of the plunger unit (piston 9 and drive spring 10) is located in an end portion of the movement of the plunger unit to the final, distal position or in the final, distal position of the plunger unit (see location of piston rod 9 in FIGS. 12 and 13).
Regarding claim 11, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Tschirren further teaches wherein a safety lock (blocking means 14b and spring arms 12a) position of the plunger unit is located on or after the triggering position during the movement of the plunger unit from the initial, proximal position to the final, distal position (see [0046]).
Regarding claim 12, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, and Tschirren further teaches wherein the elastic means (needle protection spring 13) comprises a spring circumscribing an exterior portion of the needle shield (the Examiner notes spring 13 circumscribes element 14, see FIGS. 4-5).
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tschirren et al. (U.S. 20160367763), hereinafter Tschirren, in further view of Olson et al. (U.S. 20130204229), hereinafter Olson, in further view of Jacobs et al. (U.S. Patent Pub. 20070191784), hereinafter Jacobs.
Regarding claim 6, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Tschirren in view of Olson does not expressly state wherein the injection device further comprises plunger locking means arranged for locking the plunger unit to the case when the plunger unit is in the final, distal position.
Jacobs teaches a portable injector pen (Background) wherein the injection device further comprises plunger locking means (lock bar 180; see FIG. 14) arranged for locking the plunger unit to the case when the plunger unit is in the final, distal position (see FIG. 14; “When plunger button 92 of the cocked pen is then moved distally to shift drive member pieces 68 and 70 distally to administer the final dose, the distal face 188 of lip 119 slides along and cams upward the underside 189 of lock bar 180, thereby camming up cam 186 and resilient arm 188 sufficiently to allow button 92 to pass distally until latching surface 184, due to the returning tendency of arm 188, snaps into a latching relationship with a proximal face of lip 119 to thereby lock the plunger to the housing.”, [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Tschirren in view of Olson to include a plunger locking means arranged for locking the plunger unit to the case when the plunger unit is in the final, distal position. Doing so would provide a mechanical lock that activates during the injection of the final dose, as taught by Jacobs (see [0063]).
Regarding claim 7, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Tschirren in view of Olson does not expressly state wherein the plunger unit comprises a tubular member arranged to accommodate at least part of the case when the plunger unit is in the final, distal position.
Jacobs teaches a portable injector pen (Background) wherein the plunger unit (plunger button 92) comprises a tubular member (tubular portion 100; see FIGS. 3 and 6) arranged to accommodate at least part of the case when the plunger unit is in the final, distal position (see [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify Tschirren in view of Olson to include the plunger unit comprising a tubular member arranged to accommodate at least part of the case when the plunger unit is in the final, distal position. Doing so would provide a lock for the injector pen after administration of the final dose, as taught by Jacobs (see [00]).
Regarding claim 8, Tschirren in view of Olson in view of Jacobs teaches the claimed invention as discussed above concerning the rejection of claim 7, and Jacobs further teaches wherein the case comprises a distal ring (the Examiner notes the circumference of housing halves 30 and 31 form a ring, see FIG. 6) defining an abutment surface and the tubular member comprises an end surface, the end surface and the abutment surface being configured to be in contact in the final, distal position of the plunger unit (“The outward faces of flanges 101 and 102 include curved ribs 104 and 105 that, during pen cocking, abut inward lips 106 and 107 formed into the distal ends of housing halves 30, 31 to limit withdrawal of the plunger member from the housing”, [0047]; see FIG. 6).
Regarding claim 9, Tschirren in view of Olson in view of Jacobs teaches the claimed invention as discussed above concerning the rejection of claim 6, and Jacobs further teaches wherein the plunger locking means (“FIG. 14 abstractly shows another embodiment of a mechanical lock that activates during the injection of the final dose”, [0063]) comprises an oblique arm (arm 188) provided on one of tubular member (drive member cartridge-engaging piece 68) and the case, and a locking recess (proximal face of lip 119) on the other one of tubular member and the case (the Examiner notes FIG. 6 depicts lip 119 is connected to and extends from flange 102. Further, “The outward faces of flanges 101 and 102 include curved ribs 104 and 105 that, during pen cocking, abut inward lips 106 and 107 formed into the distal ends of housing halves 30, 31 to limit withdrawal of the plunger member from the housing” [0047]), the oblique arm and the locking recess being configured to be engaged in the final, distal position of the plunger unit (see [0063]; see FIG. 14).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tschirren et al. (U.S. 20160367763), hereinafter Tschirren, in further view of Olson et al. (U.S. 20130204229), hereinafter Olson, in further view of Basile et al. (U.S. Patent Pub. 20150343157), hereinafter Basile.
Regarding claim 10, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Tschirren in view of Olson does not expressly state an end-of-dose indicator accommodated in said case and moveable under the force of the elastic means from a hidden position into which the end-of dose indicator, is not visible to a user to a visible position into which at least one portion of the end-of-dose indicator is visible to a user; and hiding means for maintaining the end-of-dose indicator in the hidden position and configured to be unlocked by the triggering portion of the plunger unit, when the plunger unit has reached an indicator position during its injection movement from the initial, proximal position to the final, distal position, so as to allow automatic movement of the end-of-dose indicator to the visible position.
Basile teaches a medication injector that has an alert indicator (Abstract) with an end-of-dose indicator (alert indicator disc 30) accommodated in said case and moveable under the force of the elastic means from a hidden position into which the end-of dose indicator, is not visible to a user to a visible position into which at least one portion of the end-of-dose indicator is visible to a user (see FIGS. 9A and 9B; see [0048]); and
hiding means for maintaining the end-of-dose indicator in the hidden position (see [0046-0047]; see FIGS. 7A and 7B) and configured to be unlocked by the triggering portion of the plunger unit (piston rod 10), when the plunger unit has reached an indicator position during its injection movement from the initial, proximal position to the final, distal position, so as to allow automatic movement of the end-of-dose indicator to the visible position (see FIGS. 9A and 9B; see [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Tschirren in view of Olson to include an end-of-dose indicator accommodated in said case and moveable under the force of the elastic means from a hidden position into which the end-of dose indicator, is not visible to a user to a visible position into which at least one portion of the end-of-dose indicator is visible to a user; and hiding means for maintaining the end-of-dose indicator in the hidden position and configured to be unlocked by the triggering portion of the plunger unit, when the plunger unit has reached an indicator position during its injection movement from the initial, proximal position to the final, distal position, so as to allow automatic movement of the end-of-dose indicator to the visible position. Doing so alerts the user that the medication injector is in near-empty condition, as taught by Basile (see [0048]).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tschirren et al. (U.S. 20160367763), hereinafter Tschirren, in further view of Olson et al. (U.S. 20130204229), hereinafter Olson, in further view of Kemp et al. (U.S. Patent Pub. 20160199588), hereinafter Kemp.
Regarding claim 13, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Tschirren in view of Olson does not expressly state wherein the elastic means comprises a spring engaging the needle shield distally of each of the shield stop and the operating stop.
Kemp teaches an autoinjector translatable from a retracted to extended position (Abstract) wherein the elastic means (spring 8) comprises a spring engaging the needle shield (needle shroud 7) distally of each of the shield stop (shroud boss 7.2) and the operating stop (plunger boss 10.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Tschirren in view of Olson wherein the elastic means comprises a spring engaging the needle shield distally of each of the shield stop and the operating stop. Doing so allows for limiting the distal extension abilities of the needle, as taught by Kemp (see [0046-0047]).
Regarding claim 14, Tschirren in view of Olson teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Tschirren in view of Olson does not expressly state wherein the elastic means comprises a spring engaging the case distally of the plunger unit.
Kemp teaches an autoinjector translatable from a retracted to extended position (Abstract) wherein the elastic means (spring 8) comprises a spring engaging the case (case 2; “needle shroud 7 may be biased in the distal direction D relative to the case 2 by a shroud spring 8.”, [0043]) distally of the plunger unit (plunger 10; see FIG. 1C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Tschirren in view of Olson wherein the elastic means comprises a spring engaging the case distally of the plunger unit. Doing so allows for limiting the distal extension abilities of the needle, as taught by Kemp (see [0046-0047]).
Response to Arguments
Applicant’s arguments, see Page 5, filed July 9, 2025, with respect to the 35 U.S.C. 112(b) rejections of claims 1-11 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 in view of under 35 U.S.C. 103 over Tschirren et al. (U.S. 20160367763) in further view of Olson et al. (U.S. 20130204229).
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 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
7/17/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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