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- 5 , 13 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Riedel et al. (WO. 2013079429A1) (“ Riedel ”). Re claim 1 , Riedel discloses a drug delivery arrangement (Fig. 2, abstract) , comprising: a drug delivery device (2) for dispensing a liquid drug from a reservoir (Pg. 18, lines 10-14, insulin within the a reservoir inside 2) , the delivery device comprising a device housing (housing of 2) and a movable member ( 19, Pg. 20, lines 16-25 ) ; and an electronic module releasably attachable to the device housing (3, 5 and 6) and comprising a module housing (3) , an actuator (5) , and an engaging member ( 10, 9) , movable, by the actuator, relative to the module housing, wherein the engaging member can be brought into engagement with the movable member such that a movement of one of the engaging member and the movable member causes a movement of the other of the movable member and the engaging member when the electronic module is attached to the drug delivery device (Pg. 20, lines 16-32) . Re claim 2 , Riedel discloses wherein the device housing comprises an opening ( opening for 9) and wherein the engaging member extends through the opening to the movable member (Fig. 2) when the electronic module is attached to the delivery device (Fig. 2) . Re claim 3 , Riedel discloses wherein the engaging member is movable in a plane ( plane of 9) perpendicular to a longitudinal axis (22) of the electronic module or the drug delivery device (Fig. 2) . Re claim 4 , Riedel discloses that the movement of the engaging member (gear wheel, 10) is a rotational movement relative to the module housing (Pg. 20, lines 30-32) . Re claim 5 , Riedel discloses wherein the engaging member is a toothed wheel (gear 10) , and wherein the movable member (19) comprises teeth (Fig. 2) configured to engage the toothed wheel when the electronic module is attached to the delivery device (Pg. 20, lines 30-32) . Re claim 13 , Riedel discloses wherein the delivery device is a pen- shaped injection device (Fig. 2) . Claim(s) 14-15 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lavi (US. 20160114109A1). Re claim 14 , Lavi discloses an electronic module (50, Figs. 1-4c) releasably attachable to a device housing (12) of a drug delivery device (¶0019, ¶0062, ¶0090) , the electronic module comprising: a module housing (50, Fig. 4a) ; a coupling structure ( left side of the housing and 36, ¶0090 ) for releasably attaching the electronic module to a side of the device housing (Fig. 4a, ¶0090) such that the electronic module is radially offset in a plane perpendicular to a longitudinal axis of the delivery device (Fig. 4a) ; and an actuator (32) , wherein an engaging member (28) is movable, by the actuator, relative to the module housing (¶0065) and adapted to engage with a movable member of the drug delivery device (26, 19, ¶0090) . Re claim 15 , Lavi discloses a method (Figs/ 1-4c, abstract, ¶0090) for interacting with an engaging member of an electronic module (50) to a movable member (26, 19) of a drug delivery device (¶0090) , the method comprising the steps of: attaching the electronic module to a device housing of the drug delivery device (12, ¶0090) ; engaging the movable member (26. 19) with the engaging member (28, ¶0090) ; and moving, by an actuator of the electronic module (32, ¶0065,¶0069) , the engaging member (28) relative to a module housing (52) of the electronic module and thereby moving the movable member relative to the device housing or moving, by the movable member, the engaging member relative to the module housing (¶0069, ¶0098) . 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) 6-7 , 10 -11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riedel et al. (WO. 2013079429A1) (“ Riedel ”) in view of Lavi (US. 20160114109A1). Re claim 6 , Riedel discloses wherein the movable member is a rotatable drive member of a dispensing mechanism adapted to be rotated in a dispensing direction to dispense the liquid drug. However, Lavi discloses a drug delivery device (Figs. 1-4, abstract) and wherein the movable member (19) is a rotatable drive member (¶0064) of a dispensing mechanism adapted to be rotated in a dispensing direction to dispense the liquid drug (¶0064) and an electronic module (30) . Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify engaging member and movable member ( motion/transition elements) of Riedel so that the movable member is a rotatable drive member of a dispensing mechanism adapted to be rotated in a dispensing direction to dispense the liquid drug as taught by Lavi for the purpose of using an art recognizing plunger so it can be motorized dispensing ( Lavi, ¶0064- ¶0065) . Re claim 7 , Riedel fails to disclose wherein the movable member is a dose setting member of a dose mechanism. However, Lavi discloses a drug delivery device (Figs. 1-4, abstract) and wherein the movable member (19 , 26 ) is a rotatable drive member (¶0064 , decrease or increase the volume so 26 is a dosing member ) of a dispensing mechanism adapted to be rotated in a dispensing direction to dispense the liquid drug (¶0064) and an electronic module (30) . Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify engaging member and movable member ( motion/transition elements) of Riedel so that the movable member is a dose setting member of a dose mechanism as taught by Lavi for the purpose of using an art recognizing plunger so it can be motorized dispensing ( Lavi, ¶0064- ¶0065). Re claim 10 , Riedel fails to disclose wherein the actuator is an electric motor adapted to drive the engaging member. However, Lavi discloses a drug delivery device (Figs. 1-4, abstract) and wherein the movable member (19, 26) is a rotatable drive member (¶0064, decrease or increase the volume so 26 is a dosing member) of a dispensing mechanism adapted to be rotated in a dispensing direction to dispense the liquid drug (¶0064) and an electronic module (30 and the actuator (32) an electric motor (¶0065) adapted to drive the engaging member (28) . Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify engaging member and movable member (motion/transition elements) of Riedel so that the actuator is an electric motor adapted to drive the engaging member as taught by Lavi for the purpose of using an art recognizing plunger so it can be motorized dispensing ( Lavi, ¶0064- ¶0065). Re claim 11 , Riedel fails to disclose wherein the electronic module comprises a sensing arrangement adapted to detect a movement of the engaging member. However, Lavi discloses a drug delivery device (Figs. 1-4, abstract) and wherein the movable member (19, 26) is a rotatable drive member (¶0064, decrease or increase the volume so 26 is a dosing member) of a dispensing mechanism adapted to be rotated in a dispensing direction to dispense the liquid drug (¶0064) and electronic module comprises a sensing arrangement adapted to detect a movement of the engaging member (¶0069-¶0070). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the electronic module of Riedel to include a sensor so that the electronic module comprises a sensing arrangement adapted to detect a movement of the engaging member as taught by Lavi for the purpose of using the sensor for improve controlling the device to recording a data of using the device ( Lavi, ¶0070 ). Re claim 1 2 , Riedel fails to disclose wherein the electronic module comprises a radial coupling structure to attach the electronic module to a side of the device housing such that the electronic module is radially offset to a longitudinal axis of the delivery device. However, Lavi discloses a drug delivery device (Figs. 1-4, abstract) and wherein the electronic module (50) comprises a radial coupling structure (left side of the housing 52, Fig. 4a) attach the electronic module to a side of the device housing such that the electronic module is radially offset to a longitudinal axis of the delivery device (Fig. 4a). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the electronic module of Riedel so that the electronic module comprises a radial coupling structure to attach the electronic module to a side of the device housing such that the electronic module is radially offset to a longitudinal axis of the delivery device as taught by Lavi for the purpose of attaching the electronic module to the delivery device so that the shaft gear can be engage with the actuator ( Lavi, ¶0070 , ¶0019 ). Claim (s) 7 -9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Riedel in view of Higgins et al. (US. 20160 058952 A1) (“Higgins”) . Re claim 7 , Riedel fails to disclose wherein the movable member is a dose setting member of a dose mechanism. However, Higgins discloses a drug delivery device (Figs. 1- 11 , abstract) and wherein the movable member is a dose setting member of a dose mechanism (50, 130) and the engaging member (142, 141) . Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify engaging member and movable member ( motion/transition elements) of Riedel so that the movable member is a dose setting member of a dose mechanism as taught by Higgins for the purpose of rotating the dosing mechanism ( Higgins, ¶0147 ). Re claim 8 , Riedel fails to disclose wherein the engaging member is a cam adapted to selectively prevent a movement of the dose setting member. However, Higgins discloses a drug delivery device (Figs 1-11, abstract) and wherein the movable member is a dose setting member of a dose mechanism (50, 130) and the engaging member is a cam (one tooth of 142 and or 141) adapted to selectively prevent a movement of the dose setting member (¶0147). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify engaging member and movable member ( motion/transition elements) of Riedel so that the engaging member is a cam adapted to selectively prevent a movement of the dose setting member as taught by Higgins for the purpose of rotating the dosing mechanism ( Higgins, ¶0147 ). Re claim 9 , Riedel fails to disclose wherein the dose setting member comprises indentations adapted to accommodate at least a part of the cam. However, Higgins discloses a drug delivery device (Figs 1-11, abstract) and wherein the movable member is a dose setting member of a dose mechanism (50, 130) and the engaging member is a cam (one tooth of 142 and or 141) the dose setting member comprises indentations ( space between the teeth 131 or space between 56. 131) adapted to accommodate at least a part of the cam (¶0147). Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify engaging member and movable member ( motion/transition elements) of Riedel so that the dose setting member comprises indentations adapted to accommodate at least a part of the cam as taught by Higgins for the purpose of rotating the dosing mechanism ( Higgins, ¶0147 ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT HAMZA A. DARB whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1202 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 8:00-5:00 M-F (EST) . 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 Chelsea Stinson can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-1744 . 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. /HAMZA A DARB/ Examiner, Art Unit 3783 /CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783