DETAILED ACTION
Response to Amendment
It is noted that, due to a staffing change, this application has been taken up by a new examiner.
Election/Restrictions
Newly submitted claim 29 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 29 is directed to an autoinjector that comprises a plurality of spaced apart grooves in the plunger to adjust the position of the plunger, but is silent as to a needle guard. The originally presented invention recited a needle guard without any mention of spaced-apart grooves in the plunger to adjust the position of the plunger. For this reason, the inventions are directed to related but distinct inventions that can have a materially different design, mode of operation, function, or effect. Further, the inventions are mutually exclusive (as noted above), and are not obvious variants. See MPEP § 806.05(j).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 29 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11, and any claim(s) depending therefrom, is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 11, the new matter is the needle guard "adapted to move the locking member from an engaged position in which the needle guard is spaced apart from the locking member, to a disengaged position in which the needle guard engages the locking member." The original disclosure makes no mention of the relative positions of the needle guard and the locking member in either the disengaged position or the engaged positions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 11-16, 18-20, 23, 24 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersson (U.S. Pub. 2012/0209192 A1, hereinafter "Alexandersson") in view of Holmqvist (U.S. Pub. No. 2012/0029443 A1, hereinafter "Holmqvist").
Regarding claim 11, Alexandersson discloses an auto-injector device (see Fig. 1 and para [0037]) comprising:
a syringe assembly (combination of syringe 16, stopper 92, and plunger rod 90; see Fig. 2) comprising:
a needle (see Fig. 2 and para [0039]) adapted to expel medicaments from the syringe assembly (see para [0039]); and
a barrel 12 (see Fig. 1) adapted to hold the medicaments and to be coupled to the needle, wherein a flow of medicaments is directed out of the barrel through the needle (see paras [0026] and [0047]);
a plunger 90 (see Fig. 1) positioned coaxially with respect to the barrel and adapted to reciprocate within the barrel to expel the medicaments (see para [0047]); and
a locking member 66 (see Fig. 1b and para [0051]) adapted to be engaged with the plunger to hold the plunger in a position with respect to the barrel (plunger is held against a force of spring 94 by ledges 74 (part of tongues 70) of the locking member 66 being situated within the groove 96 of the plunger),
a needle guard 20 (see Fig. 2) adapted to cover the needle (see para [0056]) and move the locking member from an engaged position (when the needle guard covers the needle) in which the needle guard is spaced apart from the locking member (see para [0056]) disclosing that the needle guard 20 is moved proximally in relation to the locking member 66 when the needle guard 20 and first activator 56 are decoupled from the locking member 66) to a disengaged position (i.e., nonactivated position when the needle guard does not cover the needle; see para [0051]]) in which the needle guard engages the locking member (as disclosed in paras [0051] and [0052], the needle guard 20 is engaged to the first activator 56 by tongues 34 that fit the ledge 60 of the first activator, and the first activator 56 is engaged with tongues 70 on the second locking member; therefore, the needle guard 20 is engaged with the locking member via the first activator 56).
Alexandersson does not appear to disclose that the position of the plunger with respect to the barrel is adapted to be adjusted to vary a volume of medicaments to be expelled from the barrel, the position of the plunger is adjusted by engaging the locking member with the plunger at one of a plurality of positions along a length (L) of the plunger.
Holmqvist teaches an auto-injector device (Fig. 1, para [0023], medicament delivery device) wherein the position of the plunger 36 (see Fig. 2) with respect to the barrel 12 (see Fig. 1) is adapted to be adjusted to vary a volume of medicaments to be expelled from the barrel (see para [0030]), the position of the plunger is adjusted by engaging the locking member 44 (see Fig. 1) with the plunger at one of a plurality of positions along a length of the plunger (see Fig. 3 and paras [0030] and [0034]; threads 40 on a distal threaded ridge 38 of plunger rod 36 are mated with dose setting means 44).
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 plunger of Alexandersson to include multiple circumferential ridges along its length, as taught in Holmqvist, in order to reduce the number of components needed for both the dose setting and for the medicament delivery operations (see Holmqvist at para [0009]).
Regarding claim 12, Alexandersson discloses a first body member 10 (See Fig. Fig. 1a) and a second body member 12 (see Fig. 1a), wherein the first body member and the second body member are adapted to be coupled to each other to define a housing therein (see Figs. 1a-1b).
Regarding claim 13, Alexandersson discloses a Pre-filled Syringe holder adapted to hold the syringe assembly within the housing (Alexandersson, Fig. 1a, syringe carrier 36).
Regarding claim 14, Alexandersson discloses that the plunger includes an engaging portion 96, extending along the length (L) of the plunger (see Fig. 2), wherein the locking member engages at one of the plurality of positions in the engaging portion along the length (L) (see para [0048]).
Regarding claim 15, Alexandersson discloses a spring release arm, e.g., 74 (see Fig. 1b and para [0049]) positioned at a proximal end of the auto-injector device and adapted to support the plunger and a plunger spring (see para [0051]).
Regarding claim 16, the Alexandersson discloses that the locking member includes locking teeth adapted to be engaged with the engaging portion of the plunger (see Fig. 2 and para [0051], disclosing the inwardly directed edges of the tongues 70 of the second activator member 66), wherein the locking member is adapted to hold the spring release arm in a locking position to ensure engagement of the spring release arm with the plunger (see paras [0043], [0044], [0051]).
Regarding claim 18, Alexandersson discloses a needle guard spring 102 (see Fig. 1b) adapted to be coupled to the needle guard (see para [0052]), wherein the needle guard spring is adapted to allow a resilient movement of the needle guard (see paras [0052] and para [0056]).
Regarding claim 19, Alexandersson discloses that in the engaged position, the locking teeth of the locking member (inwardly directed edges of the tongues 70 of 66) engage with the engaging portion of the plunger to hold the plunger in the position away from a distal end of the auto injector device (see para [0052]); and
in the disengaged position, the needle guard moves the locking member towards a proximal end of the auto-injector device to disengage the locking teeth from the engaging portion (see para [0052]).
Regarding claim 20, Alexandersson discloses a plunger spring 94 (see Fig. 1a) adapted to be compressed between a head portion of the plunger and the locking member (spring 94 is located between stopper 92 and ledge 74), wherein the plunger spring is adapted to resiliently push the plunger within the barrel to expel the medicaments from the barrel (see para [0051]).
Regarding claim 23, Alexandersson discloses that the needle guard includes a first end 22 (see Fig. 2) that covers the needle and an opposite second end comprising spaced apart arms 34 (see Fig. 2), the arms 34 engaging the locking member when the locking member is in the disengaged position (as noted above, the needle guard 20 is engaged to the first activator 56 by tongues 34 that fit the ledge 60 of the first activator, and the first activator 56 is engaged with tongues 70 on the second locking member; therefore, the needle guard 20 is engaged with the locking member via the first activator 56).
Regarding claim 24, Alexandersson discloses a Pre-filled Syringe (PFS) holder 56 (see Fig. 2), adapted to hold the syringe assembly within the housing, the arms extending through spaced apart openings of the PFS holder (as noted above, arms fit the ledge 60 of the first activator 56).
Regarding claim 30, Alexandersson discloses an auto-injector device comprising:
a syringe assembly comprising:
a needle (not shown in Fig. 12, but referenced in the context of a needle protecting sleeve 39; see para [0083]) adapted to expel medicaments from the syringe assembly;
and a barrel 2 (see Fig. 12) adapted to hold the medicaments and to be coupled to the needle, wherein a flow of medicaments is directed out of the barrel through the needle;
a plunger 15 (see Figs. 12-13) positioned coaxially with respect to the barrel and adapted to reciprocate within the barrel to expel the medicaments;
a locking member 6' (see Fig. 13) adapted to be engaged with the plunger to hold the plunger in a position with respect to the barrel;
a needle guard spring (shown, but not labeled, in Fig. 12) adapted to be coupled to the needle guard (see para [0083], referring to the provision of an elastic movement of the needle guard 39); and
a plunger spring 10' (see Fig. 13) adapted to be compressed between a head portion 3 of the plunger and the locking member 6' (see Fig. 13), the needle guard spring being positioned between the plunger spring and the needle (see Fig. 12),
Alexandersson does not appear to disclose that the position of the plunger with respect to the barrel is adapted to be adjusted to vary a volume of medicaments to be expelled from the barrel, the position of the plunger is adjusted by engaging the locking member with the plunger at one of a plurality of positions along a length (L) of the plunger.
Holmqvist teaches an auto-injector device (Fig. 1, para [0023], medicament delivery device) wherein the position of the plunger 36 (see Fig. 2) with respect to the barrel 12 (see Fig. 1) is adapted to be adjusted to vary a volume of medicaments to be expelled from the barrel (see para [0030]), the position of the plunger is adjusted by engaging the locking member 44 (see Fig. 1) with the plunger at one of a plurality of positions along a length of the plunger (see Fig. 3 and paras [0030] and [0034]; threads 40 on a distal threaded ridge 38 of plunger rod 36 are mated with dose setting means 44).
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 plunger of Alexandersson to include multiple circumferential ridges along its length, as taught in Holmqvist, in order to reduce the number of components needed for both the dose setting and for the medicament delivery operations (see Holmqvist at para [0009]).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersson, in view of Holmqvist, further in view of Shanley et al (U.S. Pat. 5,685,864, hereinafter "Shanley").
Regarding claims 21 and 22, it is noted that Alexandersson, in view of Holmqvist, does not appear to disclose that the plunger includes an engaging portion comprising circular grooves, and as per claim 22, the plunger includes an engaging portion comprising spiral grooves.
Shanley discloses a plunger and a stopper comprising an engaging portion (threaded portion on the plunger that engages the stopper or plunger head; see Fig. 8) where the threads are spiraled, which encompasses a circular shape.
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 plunger of Alexandersson, in view of Holmqvist, by providing an engaging portion comprising circular grooves/spiral grooves, in order to adjust the distance between the plunger and the stopper to optimize the amount of open volume between the stopper and the front end of the syringe, with a reasonable expectation of success (see Shanley at col. 7, lines 9-18).
Allowable Subject Matter
Claims 25-28 are objected to as being dependent upon a rejected base claim.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive. As noted above, Alexandersson discloses a needle guard 20 (see Fig. 2) adapted to cover the needle (see para [0056]) and move the locking member from an engaged position (when the needle guard covers the needle) in which the needle guard is spaced apart from the locking member (see para [0056]) disclosing that the needle guard 20 is moved proximally in relation to the locking member 66 when the needle guard 20 and first activator 56 are decoupled from the locking member 66) to a disengaged position (i.e., nonactivated position when the needle guard does not cover the needle; see para [0051]]) in which the needle guard engages the locking member (as disclosed in paras [0051] and [0052], the needle guard 20 is engaged to the first activator 56 by tongues 34 that fit the ledge 60 of the first activator, and the first activator 56 is engaged with tongues 70 on the second locking member; therefore, the needle guard 20 is engaged with the locking member via the first activator 56).
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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
09/14/2026
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