DETAILED ACTION
Response to Amendment
The amendment filed January 7, 2026 has been entered. Claims 16, 23, 25, 29, and 31 have been amended with claims 21-22 having been cancelled, and claims 36-37 having been newly added. Claims 16-20 and 23-37 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive as the claims now require a user to be able to twist the movable portion. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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) 16-20 and 23-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sall et al. (US 2018/0236185) in view of Wotton et al. (US 2013/0303985).
Regarding claim 16, Sall et al. (henceforth Sall) teaches a system comprising a monitoring device (10 and recording unit 60 as per paragraph [0030]) and a medicament delivery device (50) wherein the monitoring device is configured to be releasably attached to the medicament delivery device and to monitor an operation of the medicament delivery device (paragraphs [0027]-[0028] and [0030] which discloses the recording or monitoring unit as storing and performing elements of the procedure as well as communication elements), wherein the monitoring device comprises: a body defining a cavity (14) for receiving the medicament delivery device; a biased holding unit (16, 30, 40) arranged in the body and configured to retain the medicament delivery device to the body in a secure state (Figure 4, paragraph [0028]); wherein the biased holding unit is movable within the body between a first position in which the medicament delivery device is in an unsecure state and a second position in which the medicament delivery device is in the secure state (paragraph [0034] states when the medicament device 50 is installed into the recording device it enters at an unsecured state when the locking and release elements are moved proximally before securing the device against the recording unit in the secured second state); wherein the biased holding unit comprises an enclosing member (16, 30) having an engagement structure (20); and a locking element (32 on 30) fixed to or integral with the enclosing member (Figure 2), wherein the engagement structure is configured to interact with an engagement member (ledges of the medicament delivery device) on the medicament delivery device (ledges 22 interact with the delivery device to lock it in place after insertion as per paragraph [0034]) and the locking element is configured to interact with a counter locking element (34) arranged to the body when the biased holding unit is in the second position (32 of 30 interacts with 34 as the release element moves into the second distal position to retain the delivery device). Sall fails to explicitly disclose the body comprising a movable portion which is twistable by a user in relation to a longitudinal axis as claimed.
Wotton et al. (henceforth Wotton) teaches (Figure 1) an autoinjector device which comprises a housing (combination of body 14 and cap 110) which further comprises a movable portion (the cap is removable and is therefore movable) which is twisted by a user in relation to a longitudinal axis (about the body; paragraph [0066], the cap is twisted to remove it from the main body portion before an injection).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the body assembly of Sall to comprise a twistable cap for surrounding the entire distal end of the assembly so as to provide a means of protecting the injection device within the housing until use as taught by Wotton). It is noted that this modification would retain the medicament delivery cap 52 of Sall, with the added benefit of a redundant cap, for increased protection of the assembly prior to use.
Regarding claim 17, Sall further disclose wherein a biasing element (48) is positioned between the biased holding unit and the body; Figure 1 and paragraph [0029]; the spring is located between element 40 and recording unit 60 forming the proximal end of the body).
Regarding claim 18, Sall further discloses wherein the biasing element is configured to be in a compressed state when the biased holding unit is in the second position, and in a released state when the biased holding unit is in the first position (paragraph [0034] discloses that the spring is compressed when the delivery device is attached to the housing).
Regarding claim 19, Sall further disclose wherein the engagement structure is a flexible element (legs 20 are considered flexible as they are required to move radially to allow passage of 50 and to retain it within the housing after insertion).
Regarding claim 20, Sall further discloses wherein the engagement structure is configured to be releasably engaged with the engagement member on the medicament delivery device when the medicament delivery device is in the secure state (ledges 22 interact with the delivery device to lock it in place after insertion as per paragraph [0034]).
Regarding claim 23, Sall further discloses wherein the counter locking element is arranged to the movable portion of the body (button 32 is on the compressible element 30 which moves proximally and distally during insertion of the medical device 50).
Regarding claim 24, Sall further discloses wherein the biased holding unit is rotationally locked and slidable in relation to the body between a first position and a second position (the portion of the biasing unit 30 which comprises 32 is rotationally locked and slidable relative to the body within channel 34 which maintains the alignment of 30 within body 10).
Regarding claims 25 and 33, Sall further discloses wherein the locking element further comprises a locking arm extending distally (32 is a button and comprises a distal portion extending from a central section as claimed) and whereby the distal end of the locking arm is formed as a wedge shape structure or as a hook (a portion of the radiused curve of the button may be considered substantially hook shaped).
Regarding claims 26 and 35, Sall further discloses wherein the counter locking element comprises a ledge arranged to receive the locking arm (the surface of 34 which engages with the button 32 is a ledge).
Regarding claim 27, Sall further discloses wherein the engagement structure is an axial stop rib (legs 20 comprise ledges 22) configured to interact with the engagement member on the medicament delivery device for axially locking the medicament delivery device with the biased holding unit (paragraph [0034], the ledges engage the device to retain it within the assembly).
Regarding claim 28, Sall further discloses wherein the engagement structure is a radial stop rib (legs 20 comprise ledges 22; the legs and ledges have both axial and radial components) configured to interact with the engaging member on the medicament delivery device for radially locking the medicament delivery device with the biased holding unit (paragraph [0034], the ledges engage the device to retain it within the assembly).
Regarding claim 29, Sall further discloses wherein the axial stop rib is a wedge shape structure (ledges 22 are wedge shaped as depicted in Figure 2).
Regarding claim 30, Sall further discloses wherein the medicament delivery device is an injection device (paragraph [0029]).
Regarding claim 31, Sall discloses system comprising a monitoring device (10 and recording unit 60 as per paragraph [0030]) and a medicament delivery device (50) having a longitudinal axis, where the monitoring device is configured to be releasably attached to the medicament delivery device and monitors an operation of the medicament delivery device (paragraphs [0027]-[0028] and [0030] which discloses the recording or monitoring unit as storing and performing elements of the procedure as well as communication elements), wherein the monitoring device comprises: a body defining a cavity (14, also inside of 30 which receives the device) for receiving the medicament delivery device and having a movable portion (all of the internal biasing portions are movable to engage the delivery device; e.g., body 30 is movable via element 36; paragraph [0028]); a biased holding unit (16, 30, 40) arranged in the body and configured to retain the medicament delivery device to the body in a secure state; wherein the biased holding unit is movable within the body between a first position in which the medicament delivery device is in an unsecure state and a second position in which the medicament delivery device is in the secure state (paragraph [0034] states when the medicament device 50 is installed into the recording device it enters at an unsecured state when the locking and release elements are moved proximally before securing the device against the recording unit in the secured second state), wherein the biased holding unit comprises an enclosing member (16, 30) having an engagement structure (20) and a locking element (32 on 30) fixed to, or integral with, the enclosing member (Figure 2), and wherein the engagement structure is configured to interact with an engagement member on the medicament delivery device and the locking element is configured to interact with a counter locking element (34) operatively connected to the movable portion of the body when the biased holding unit is in the second position (32 of 30 interacts with 34 as the release element moves into the second distal position to retain the delivery device). Sall fails to explicitly disclose the body comprising a movable portion which is twistable by a user in relation to a longitudinal axis as claimed.
Wotton et al. (henceforth Wotton) teaches (Figure 1) an autoinjector device which comprises a housing (combination of body 14 and cap 110) which further comprises a movable portion (the cap is removable and is therefore movable) which is twisted by a user in relation to a longitudinal axis (about the body; paragraph [0066], the cap is twisted to remove it from the main body portion before an injection).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the body assembly of Sall to comprise a twistable cap for surrounding the entire distal end of the assembly so as to provide a means of protecting the injection device within the housing until use as taught by Wotton). It is noted that this modification would retain the medicament delivery cap 52 of Sall, with the added benefit of a redundant cap, for increased protection of the assembly prior to use.
Regarding claim 32, Sall further discloses wherein twisting of the movable portion (36) relative to the longitudinal axis causes rotational movement of the counter locking element (if the shaft 30, and therefore portion 36, is twisted when connected with the housing it will impart a rotational force on the surfaces of the opening 34).
Regarding claim 34, Sall further discloses wherein a distal end of the locking arm is formed as a wedge shape structure or as a hook (a portion of the radiused curve of the button 32 may be considered substantially hook shaped).
Regarding claims 36-37, Sall/Wotton further teach wherein the movable portion is positioned at a distal end of the body (cap 110 of Wotton covers the distal injection end of the device).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783