CTNF 18/696,167 CTNF 101578 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-14 are examined in this office action. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-5, 7, 13, and 14 is/are rejected under 35 U.S.C. 102 (1) as being anticipated by Bostrom et al. (WO 2022135947 A1) . Regarding claim 1, Bostrom discloses a drug delivery device (medicament delivery device 10, Fig. 1) comprising a housing (housing 10, Fig. 2A) having a proximal end (proximal end 2, Fig. 1) , a distal end (distal end 1, Fig. 1) , and a longitudinal axis extending between the proximal end and the distal end thereof (longitudinal axis L, Fig. 1) ; an injection assembly (medicament container 20, Fig. 3) at least partially disposed within the housing, the injection assembly including a needle or a cannula (medicament delivery member 36, Fig. 3) ("… medicament delivery member 36, such as an injection needle …" - Para [0073]) ; a drive assembly (medicament delivery actuation mechanism 11, Fig. 2B) at least partially disposed within the housing and operably coupled with the injection assembly, the drive assembly engageable to deliver a medicament via the injection assembly ("The medicament delivery actuation mechanism 11 as shown in Fig. 2B is capable of, upon activation, effecting a delivery of a dose of liquid medicament from the medicament container 20 arranged inside the housing 10 …" - Para [0073]) ; a shield (tubular activation member 14, Fig. 2B) slidably coupled with the housing ("The tubular activation member 14 is movably arranged at the proximal end 2 of the housing 10 …" - Para [0075]) and operably coupled with the drive assembly ("… the needle cover 14 activates and rotates the coupling member 32 …" - Para [0097]) , the shield being positionable in an extended position (Figs. 4A-4B) in which at least a proximal end of the shield extends a distance beyond the proximal end of the housing ("… an extended position, as shown in Fig. 4A, 4B, covering the delivery member 36 …" - Para [0076]) and a retracted position (Figs. 5A-5B) in which the proximal end of the housing protrudes a distance beyond the proximal end of the shield ("… a retracted position, as shown in Fig. 5A, 5B, wherein a penetration may be performed with the needle 36." - Para [0076]) , wherein moving the shield to the retracted position engages the drive assembly to deliver the medicament via the injection assembly ("Rotation of the coupling member 32 from the first locked position to the second unlocked position is caused when the needle cover 14 is pushed against an injection site." - Para [0092]) ; and a retention mechanism (actuator 35, movable coupling member 32, Fig. 7B) adapted to limit movement of the drive assembly ("… the actuator 35, which further comprises a locking member 321 that is provided to prevent the coupling member 32 from moving …" - Para [0106]) to restrict engagement thereof such that the drive assembly is restricted from delivering the medicament via the injection assembly during unintentional movement of the housing ("The resilience of the annular support member 323 allows to re-engage the locking member 321 with the corresponding mating member 322 should they be accidentally moved or disengaged during handling or transport of the power pack." - Para [0107]) . Regarding claim 2, Bostrom discloses the drug delivery device (medicament delivery device 10, Fig. 1) as recited above, wherein the drive assembly (medicament delivery actuation mechanism 11, Fig. 2B) includes a trigger ring (movable coupling member 32, Fig. 3) engageable by the shield ("Rotation of the coupling member 32 from the first locked position to the second unlocked position is caused when the needle cover 14 is pushed against an injection site by a user of the device." - Para [0092]) , wherein the trigger ring is movable between an initial position and releasing position ("… the coupling member 32 is configured to rotate from a first locked position to a second locked position." - Para [0091]) . Regarding claim 3, Bostrom discloses the drug delivery device (medicament delivery device 10, Fig. 1) as recited above, wherein movement of the shield to the retracted position urges the trigger ring to the releasing position ("Rotation of the coupling member 32 from the first locked position to the second unlocked position is caused when the needle cover 14 is pushed against an injection site by a user of the device." - Para [0092]) . Regarding claim 4, Bostrom discloses the drug delivery device (medicament delivery device 10, Fig. 1) as recited above, wherein the shield (tubular activation member 14, Fig. 2B) includes an activator portion (arm 141, Fig. 9) adapted to engage the trigger ring (coupling member 32, Fig. 3) ("This elongated structure 141 or needle cover arm is configured to interact with the coupling member 32." - Para [0092]) . Regarding claim 5, Bostrom discloses the drug delivery device (medicament delivery device 10, Fig. 1) as recited above, wherein the retention mechanism (actuator 35, movable coupling member 32, Fig. 7B) includes at least one arm (locking member 321, Fig. 7B) carried by a nut (actuator 35, Fig. 13A) , the arm adapted to engage a portion of the trigger ring (movable coupling member 32, Fig. 3) to prevent the trigger ring from moving to the releasing position ("… the actuator 35, which further comprises a locking member 321 that is provided to prevent the coupling member 32 from moving …" - Para [0106]) . Regarding claim 7, Bostrom discloses a drug delivery device (medicament delivery device 10, Fig. 1) comprising: a housing (housing 10, Fig. 2A) having a proximal end (proximal end 2, Fig. 1) , a distal end (distal end 1, Fig. 1) , and a longitudinal axis extending between the proximal end and the distal end thereof (longitudinal axis L, Fig. 1) ; an injection assembly (medicament container 20, Fig. 3) at least partially disposed within the housing, the injection assembly including a needle or a cannula (medicament delivery member 36, Fig. 3) ("… medicament delivery member 36, such as an injection needle …" - Para [0073]) , a drug storage container (medicament container 20, Fig. 3), and a container holder (container holder 30, Fig. 3) adapted to at least partially surround the drug storage container ("The medicament container 20 is further arranged within the container holder 30 …" - Para [0073]). a drive assembly (medicament delivery actuation mechanism 11, Fig. 2B) at least partially disposed within the housing and operably coupled with the injection assembly ("The medicament delivery actuation mechanism 11 as shown in Fig. 2B is capable of, upon activation, effecting a delivery of a dose of liquid medicament from the medicament container 20 arranged inside the housing 10 …" - Para [0073]) , the drive assembly including a trigger ring (movable coupling member 32, Fig. 3) being movable being movable between an initial position and a releasing position ("… the coupling member 32 is configured to rotate from a first locked position to a second locked position." - Para [0091]) to deliver a medicament via the injection assembly ("Rotation of the coupling member 32 from the first locked position to the second unlocked position is caused when the needle cover 14 is pushed against an injection site by a user of the device." - Para [0092]) and a nut (actuator 35, Fig. 13A) at least partially disposed around a periphery of the trigger ring (Fig. 13A) ; and a shield (tubular activation member 14, Fig. 2B) slidably coupled with the housing ("The tubular activation member 14 is movably arranged at the proximal end 2 of the housing 10 …" - Para [0075]) and operably coupled with the drive assembly ("… the needle cover 14 activates and rotates the coupling member 32 …" - Para [0097]) , the shield being positionable in an extended position (Figs. 4A-4B) in which at least a proximal end of the shield extends a distance beyond the proximal end of the housing ("… an extended position, as shown in Fig. 4A, 4B, covering the delivery member 36 …" - Para [0076]) and a retracted position (Figs. 5A-5B) in which the proximal end of the housing protrudes a distance beyond the proximal end of the shield ("… a retracted position, as shown in Fig. 5A, 5B, wherein a penetration may be performed with the needle 36." - Para [0076]) , wherein upon moving the shield to the retracted position, a portion of the shield urges the trigger ring to the releasing position to deliver the medicament via the injection assembly ("Rotation of the coupling member 32 from the first locked position to the second unlocked position is caused when the needle cover 14 is pushed against an injection site." - Para [0092]) ; wherein the container holder (container holder 30, Fig. 3) , the nut (actuator 35, Fig. 13A) , and the trigger ring (movable coupling member 32, Fig. 3) cooperate to form a retention mechanism to prevent the trigger ring from activating to deliver the medicament via the injection assembly during unintentional movement of the housing ("… the actuator 35, which further comprises a locking member 321 that is provided to prevent the coupling member 32 from moving …" - Para [0106]) . Regarding claim 13, Bostrom discloses the drug delivery device (medicament delivery device 10, Fig. 1) as recited above, wherein the nut (actuator 35, Fig. 13A) is adapted to guide movement of the drive assembly during medicament delivery ("… actuator 35 … for delivering a dose of medicament through the needle 36." - Para [0077]) . Regarding claim 14, Bostrom discloses the drug delivery device (medicament delivery device 10, Fig. 1) as recited above, wherein the shield (tubular activation member 14, Fig. 2B) includes an activator portion (arm 141, Fig. 9) adapted to engage the trigger ring (coupling member 32, Fig. 3) ("This elongated structure 141 or needle cover arm is configured to interact with the coupling member 32." - Para [0092]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 6, 8-10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom et al. (WO 2022135947 A1) in view of Jugl et al. (WO 2021110801 A1) . Regarding claim 6, Bostrom in view of Jugl discloses the drug delivery device (Bostrom, medicament delivery device 10, Fig. 1) as recited above, further comprising Bostrom does not expressly disclose a container holder operably coupled with the injection assembly, the container holder including an arm adapted to engage the arm during inadvertent movement of the device. Jugl teaches a container holder (drive sleeve 60, Fig. 3) operably coupled with the injection assembly (Fig. 3) , the container holder including an arm (internal cone 62, Fig. 3) adapted to engage the arm during inadvertent movement of the device ("The internal cone 62 urges the tip portions of the flexible arms 92 radially inwardly …" – Page 35) . Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug delivery device of Bostrom to include that a container holder operably coupled with the injection assembly, the container holder including an arm adapted to engage the arm during inadvertent movement of the device as taught by Jugl so the piston rod is prevented from further rotation in the dispense rotational direction (Jugl, Page 36). Regarding claim 8, Bostrom in view of Jugl discloses the drug delivery device (Bostrom, medicament delivery device 10, Fig. 1) as recited above, wherein the retention mechanism includes: at least one arm (Bostrom, locking member 321, Fig. 7B) formed on a portion of the nut (Bostrom, actuator 35, Fig. 13A) ; an arm opening (Bostrom, slot of the mating member 322, Fig. 11A) formed on the trigger ring (Bostrom, movable coupling member 32, Fig. 3) adapted to receive at least a portion of the at least one arm (Bostrom, "… engage the locking member 321 with the corresponding mating member 322 …" - Para [0107]) ; and a container arm (Bostrom, support member 323, Fig. 11A) ; wherein during unintended movement of the device, the container arm is adapted to engage the at least one arm such that at least a portion of the at least one arm enters the arm opening of the trigger ring to prevent the trigger ring from moving to the releasing position (Bostrom, "The resilience of the annular support member 323 allows to re-engage the locking member 321 with the corresponding mating member 322 should they be accidentally moved or disengaged during handling or transport of the power pack." - Para [0107]) Bostrom does not expressly disclose a container arm formed on a portion of the container holder. Jugl teaches a container arm (support member 323, Fig. 11A) formed on a portion of the container holder (drive sleeve 60, Fig. 3) . Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug delivery device of Bostrom to include a container arm formed on a portion of the container holder as taught by Jugl so the piston rod is prevented from further rotation in the dispense rotational direction (Jugl, Page 36). Regarding claim 9, Bostrom in view of Jugl discloses the drug delivery device (Bostrom, medicament delivery device 10, Fig. 1) as recited above, wherein the retention mechanism includes: Bostrom does not expressly disclose that the at least one arm is movable between an initial state and an engaged state, wherein in the engaged state, at least a portion of the at least one arm moves in a radially inward direction towards the longitudinal axis. Jugl teaches that the at least one arm (flexible arms 92, Fig. 4) is movable between an initial state (Fig. 2) and an engaged state (Fig. 3) , wherein in the engaged state, at least a portion of the at least one arm moves in a radially inward direction towards the longitudinal axis ("The internal cone 62 urges the tip portions of the flexible arms 92 radially inwardly …" - Page 35) . Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug delivery device of Bostrom to include that the at least one arm is movable between an initial state and an engaged state, wherein in the engaged state, at least a portion of the at least one arm moves in a radially inward direction towards the longitudinal axis as taught by Jugl so the piston rod is prevented from further rotation in the dispense rotational direction (Jugl, Page 36). Regarding claim 10, Bostrom in view of Jugl discloses the drug delivery device (Bostrom, medicament delivery device 10, Fig. 1) as recited above, wherein during unintended movement of the device (Bostrom, "The resilience of the annular support member 323 allows to re-engage the locking member 321 with the corresponding mating member 322 should they be accidentally moved or disengaged during handling or transport of the power pack." - Para [0107]) , the container arm (Bostrom, support member 323, Fig. 11A) slidably engages the at least one arm (Bostrom, locking member 321, 7B) to urge the at least one arm towards the longitudinal axis and into the arm opening of the trigger ring (Bostrom, slot of the mating member 322, Fig. 11A) . Regarding claim 12, Bostrom in view of Jugl discloses the drug delivery device (Bostrom, medicament delivery device 10, Fig. 1) as recited above, wherein when the at least one arm is in the initial state, the at least one arm is removed from the arm opening of the trigger ring such that the trigger ring may be moved to the releasing position (Bostrom, "However, the locking member 321 is configured to interact with the coupling member 32, such that when the locking member 321 is in the first state, the locking member 321 engages with a mating member 322, causing the coupling member 32 to be immobilized by the locking member 321. When the locking member 321 is moved to the second state, the control member 32 is released by the locking member 321." - Para [0106]) . 07-21-aia AIA Claim (s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom et al. (WO 2022135947 A1) in view of Jugl et al. (WO 2021110801 A1) and in further view of Calderwood et al. (WO 2022078987 A1) . Regarding claim 11, Bostrom in view of Jugl and Calderwood discloses the drug delivery device (Bostrom, medicament delivery device 10, Fig. 1) as recited above, wherein Bostrom in view of Jugl does not expressly disclose that the at least one arm is biased towards the initial state. Calderwood teaches that the at least one arm (arm 104, Fig. 1) is biased towards the initial state ("the arm 104 is biased and is pushing (away from the axis) on the needle guard 60." - Page 15, Lines 1-2) . Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the drug delivery device of Bostrom in view of Jugl to include that the at least one arm is biased towards the initial state as taught by Calderwood so the needle guard is allowed to move in the distal direction again (Calderwood, Page 15, Lines 3-4). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm. 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, 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. 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. /ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/696,167 Page 2 Art Unit: 3783 Application/Control Number: 18/696,167 Page 3 Art Unit: 3783 Application/Control Number: 18/696,167 Page 4 Art Unit: 3783 Application/Control Number: 18/696,167 Page 5 Art Unit: 3783 Application/Control Number: 18/696,167 Page 6 Art Unit: 3783 Application/Control Number: 18/696,167 Page 7 Art Unit: 3783 Application/Control Number: 18/696,167 Page 8 Art Unit: 3783 Application/Control Number: 18/696,167 Page 9 Art Unit: 3783 Application/Control Number: 18/696,167 Page 10 Art Unit: 3783 Application/Control Number: 18/696,167 Page 11 Art Unit: 3783 Application/Control Number: 18/696,167 Page 12 Art Unit: 3783
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