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)(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. Claim(s) 1-20 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by U.S. Publication No. 2003/0055380 (“Flaherty”) . Regarding Claim 1, Flaherty discloses a delivery device (220) for a medicament comprising: a barrel (30) having an internal cavity configured for receiving a medication, said barrel having a first end (34) and a second end (i.e. the rear end) ; a plunger (236) positioned in said internal cavity and being movable between said first end and said second end of said barrel (Par. 65) ; and a drive assembly (202, 204) including an actuator (202) and drive member (204) positioned in said internal cavity between said first end and second end of said barrel, said drive member being movable independently of said plunger (Par. 65, 66 – “For partial fills, the second plunger will not be in contact with the first plunger”, whereby it will therefore be understood that movement of the lead screw 202, thereafter, will cause advance of the first plunger/drive member toward the plunger/second plunger constituting independent movement) , said drive member coupled to said actuator for moving said drive member into contact with said plunger and moving said plunger toward said first end of said cavity to dispense said medication (Par. 65-67) . Regarding Claim 2, Flaherty discloses the plunger is movable independent of said drive assembly (Par. 65 – “The second plunger 236 is adapted to slide on lead screw 202 toward the first plunger 204 during filling of the reservoir”) . Regarding Claim 3, Flaherty discloses the plunger is configured to move from said first end of said barrel toward said second end of said barrel by introducing the medication into said barrel at said first end (Par. 65) . Regarding Claim 4, Flaherty discloses the plunger is spaced from said drive member when said plunger is at said first end of said barrel and engages said drive member when said plunger moves toward said second end of said barrel (Par. 65-66 – depending on the fill volume of the container the plunger either moves rearward until it engages the drive member OR for partial filles the plunger is moved rearward a distance and then the drive member is advanced forward into apposition with the plunger) . Regarding Claim 5, in the instant case apposition between the two components (see Fig. 8) is considered a type of coupling whereby after apposition occurs advancement of the drive member in the forward direction will cause a corresponding forward movement of the plunger – i.e. a type of coupled movement). Regarding Claim 6, Flaherty discloses plunger is axially slideable on said actuator (Par. 65) . Regarding Claim 7, Flaherty discloses the actuator comprises a threaded screw that is axially fixed relative to said barrel, and said drive member comprises drive plate having a threaded opening receiving said threaded screw (Abstract; Par. 60) . Regarding Claim 8, Flaherty discloses a controller (inter alia 40, 50) operatively connected to said drive assembly for positioning said drive member in a predetermined location in said barrel corresponding to a predetermined volume of the medication in said barrel (Par. 51) . Regarding Claim 9, Flaherty discloses a medication delivery device (220) for delivering a medicament, said delivery device comprising: a barrel (30) having an interior cavity configured for receiving the medication, said barrel having a first end (34) and second end (i.e. the rearward end) ; a plunger (236) in said internal cavity of said barrel and movable between said first end and said second end (Par. 65) ; a drive assembly having a drive screw (202) and a drive member (204) coupled to said drive screw for moving axially on said drive screw, said drive screw extending axially through said drive member and said plunger (see Fig. 8) , and said plunger being movable axially on said drive screw independently of rotation of said drive screw (Par. 65) ; and a drive motor (40) operatively coupled to said drive screw for rotation of drive screw. Regarding Claim 10, Flaherty discloses the plunger is slideable axially on said drive screw (Par. 65) . Regarding Claim 11, Flaherty discloses the plunger has an opening extending between a proximal face and a distal face for receiving said drive screw (see Fig. 8 – note how the lead screw passes through the body of the plunger thereby demonstrating the presence of the opening between the two faces) . Regarding Claim 12, Flaherty discloses the plunger includes a seal in said opening for forming a fluid tight seal between said drive screw and said plunger (Par. 63) , and where said seal slides axially over said drive screw. Regarding Claim 13, Flaherty discloses the first end of said barrel includes an inlet port (38, 234) for filling said barrel with the medication and an outlet port (36) for dispensing said medication. Regarding Claim 14, Flaherty discloses the plunger is movable from a first position in said barrel to a second position by introducing the medication into said barrel through said inlet port (Par. 65) . Regarding Claim 15, Flaherty discloses the plunger engages said drive member when said plunger moves to said second position (Par. 65-66) . Regarding Claim 16, Flaherty discloses the device comprises a controller (50) operatively coupled to said drive assembly for positioning said drive member in a predetermined location in said barrel corresponding to a predetermined volume of medication in said barrel (Par. 66). Regarding Claim 17, Flaherty discloses a method of dispensing a medication by a delivery device (220; Abstract) , said delivery device comprising: a barrel (30) having an internal cavity for receiving the medication, said internal cavity having an outlet (34 connected to a delivery assembly (72, 70) for delivering the medication to a patient, said internal cavity having an inlet (38) for introducing the medication into said internal cavity, a movable plunger (236) in said internal cavity, and a drive assembly (204, 202) including a drive screw (202) and actuator (204) having internal threads for coupling to said drive screw for moving axially with respect to an axis of said drive screw (Par. 60) , said plunger being movable from a first end toward a second end of said barrel by introducing the medication into said internal cavity (Par. 65) ; wherein said method comprises introducing the medication through said inlet of barrel to move said plunger from a first position toward said second end of said barrel and into contact with said actuator, and rotating said drive screw to move said actuator and plunger toward said first end to dispense the medication through said outlet of said barrel to said delivery assembly (Par. 60-65) . Regarding Claim 18, Flaherty discloses orienting said plunger in said barrel at said first end, and thereafter introducing the medication into said barrel to move said plunger into contact with said actuator (Par. 65) . Regarding Claim 19, Flaherty discloses compris es positioning said actuator at a predetermined location in said barrel corresponding to a predetermined volume in said barrel, and thereafter introducing the medication into said barrel to move said plunger into contact with said actuator (Par. 65-66 – i.e. when complete refills are performed) . Regarding Claim 20, Flaherty discloses rotating said drive screw to move said actuator in said barrel to a position corresponding to said predetermined volume before introducing said medication into said barrel (i.e. in order for a refill to occur it must be understood that the actuator 204 must first move proximally into the predetermined position via rotation of the leadscrew) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT WILLIAM R CARPENTER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3637 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT) . 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT KEVIN SIRMONS can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-4965 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783 03/05/2026