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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 17-35) in the reply filed on 02 January 2026 is acknowledged.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17, 18, 22, 27, 33, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kohlbrenner et al (US 2009/0247951).
Regarding claim 17, Kohlbrenner discloses:
A mechanism unit (Fig. 3) for a drug delivery device (Fig. 1), the mechanism unit comprising: a housing (20) having a proximal end and a distal end; a piston rod (90) movable relative to the housing (20); and a dose setting and drive mechanism (60, 80) configured to perform a dose setting operation for setting a dose to be delivered and to perform a dose delivery operation for delivering the set dose by transferring a delivery force to the piston rod (90) in order to drive the piston rod (90) in a distal direction relative to the housing (20) in the dose delivery operation (¶0076-0078), the dose setting and drive mechanism comprising a first drive member (180; ¶0096) in mechanical cooperation with the piston rod (90) to transfer the delivery force to the piston rod (90), the first drive member (180) being axially secured and rotatable (Fig. 10; ¶0096) relative to the housing (20), wherein a rotation of the first drive member (180) in a delivery direction relative to the housing (20) results in a movement of the piston rod (90) in the distal direction (¶0096) and a rotation in a direction opposite to the delivery direction results in a proximal movement of the piston rod (90) (¶0096), a second drive member (120) arranged to be mechanically coupled to the first drive member (180) to transfer the delivery force to the first drive member (180) (¶0096), and a clutch mechanism (K3; Fig. 16; ¶0123) having at least a setting state and a delivery state (¶0124)), wherein, in the setting state (initial state), the second drive member (120) is rotationally secured with respect to the housing (20) at least against a rotation in the delivery direction (¶0130), and wherein, in the delivery state (pushing in of push button), the second drive member (120) is rotatable relative to the housing (20) in the delivery direction (¶0130), wherein, in the setting state, the first drive member (180) is rotatable relative to the second drive member (120) and the housing (20) at least in the delivery direction (¶0096), and wherein, in the delivery state, the second drive member (120) is rotationally locked to the first drive member (180) at least against a rotation of the second drive member (120) relative to the first drive member (180) in the delivery direction (¶0136).
Regarding claim 18, Kohlbrenner discloses:
The mechanism unit according to claim 17, wherein the dose setting and drive mechanism comprises a dose setting member (220) that is moveable relative to the housing (20) in the setting state from an initial position to a dose set position in order to set a dose of drug (¶0098).
Regarding claim 22, Kohlbrenner discloses:
The mechanism unit according to claim 17, wherein the first drive member (180) is engaged to the piston rod (90), and wherein the piston rod (90) is engaged to the housing (20) (all of the elements of the mechanism are engaged to one another, directly or indirectly).
Regarding claim 27, Kohlbrenner discloses:
The mechanism unit according to claim 17, wherein the first drive member (180) is secured against proximal and distal movements relative to the housing (20) (¶0096).
Regarding claim 33, Kohlbrenner discloses:
A drug delivery device (Fig. 1) comprising: a mechanism unit (Fig. 3); and a reservoir unit (30) comprising or being provided to retain a reservoir (40) holding a drug (¶0075), wherein the mechanism unit (Fig. 3) comprises a housing (20) having a proximal end and a distal end; a piston rod (90) movable relative to the housing (20); and a dose setting and drive mechanism (60, 80) configured to perform a dose setting operation for setting a dose to be delivered and to perform a dose delivery operation for delivering the set dose by transferring a delivery force to the piston rod (90) in order to drive the piston rod (90) in a distal direction relative to the housing (20) in the dose delivery operation (¶0076-0078), the dose setting and drive mechanism comprising a first drive member (180; ¶0096) in mechanical cooperation with the piston rod (90) to transfer the delivery force to the piston rod (90), the first drive member (180) being axially secured and rotatable (Fig. 10; ¶0096) relative to the housing (20), wherein a rotation of the first drive member (180) in a delivery direction relative to the housing (20) results in a movement of the piston rod (90) in the distal direction (¶0096) and a rotation in a direction opposite to the delivery direction results in a proximal movement of the piston rod (90) (¶0096), a second drive member (120) arranged to be mechanically coupled to the first drive member (180) to transfer the delivery force to the first drive member (180) (¶0096), and a clutch mechanism (K3; Fig. 16; ¶0123) having at least a setting state and a delivery state (¶0124)), wherein, in the setting state (initial state), the second drive member (120) is rotationally secured with respect to the housing (20) at least against a rotation in the delivery direction (¶0130), and wherein, in the delivery state (pushing in of push button), the second drive member (120) is rotatable relative to the housing (20) in the delivery direction (¶0130), wherein, in the setting state, the first drive member (180) is rotatable relative to the second drive member (120) and the housing (20) at least in the delivery direction (¶0096), and wherein, in the delivery state, the second drive member (120) is rotationally locked to the first drive member (180) at least against a rotation of the second drive member (120) relative to the first drive member (180) in the delivery direction (¶0136).
Regarding claim 34, Kohlbrenner discloses:
The drug delivery device according to claim 33, wherein the first drive member (180) is engaged to the piston rod (90), and wherein the piston rod (90) is engaged to the housing (20) (all of the elements of the mechanism are engaged to one another, directly or indirectly).
Allowable Subject Matter
Claims 19-21, 23-26, 28-32, and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783