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 .
Status of the Claims
Claims 13, 25, 28, 35, and 38 are currently amended. Claims 13-20, 23-28, 30, 33, and 35-38 are currently pending. Claims 13-20, 23-28, 30, 33, and 35-38 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/13/2026, with respect to the rejection(s) of claim(s) 13-38 under 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, Applicant’s arguments with respect to the rejection(s) of claim(s) 13-38 under 103 have been fully considered and are not persuasive. An updated ground(s) of rejection is made in view of a modified interpretation of Stefanov and Gagnieux to address the amended claim limitations.
Examiner acknowledges that the amendments to claims 25, 28, 35, and 38 obviate the previous 112b rejections.
Applicant argues that Gagnieux does not disclose “the rib 58 laterally presses against and frictionally engages with the inside surface of the holder 26”, but instead discloses “a mechanical interlock” with “a rib 58 that engages a radial groove 48 positioned on an inner surface of a holder 26”. Examiner notes that the radial groove 48 is formed on the inner surface of the holder 26, so the rib 58 does engaged with the inner surface of the holder 26. Furthermore, Examiner notes that additional structures (such as an abutting surface) are not prevented by the claim language. Additionally, since the friction member and the inner surface of the tubular housing are in contact (such as through the engagement of the rib 58 and the radial groove 48), then there is frictional resistance generated between the noted structures.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 13-20, 23-28, 30, 33, and 35-38 are rejected under 35 U.S.C. 103 as being obvious over Stefanov et al (US-20180272075-A1; hereafter Stefanov) in view of Gagnieux et al (US-20030050607-A1; hereafter Gagnieux).
Regarding claim 13, Stefanov discloses a medicament delivery device (injector 1, [0030] auto-injector is shown in fig. 1) comprising:
a tubular housing (tubular housing 2, fig. 3, [0030]) comprising a distal end and a proximal end (see fig. 1, also [0030] housing 2 has proximal end 61 and distal end 62);
a medicament container (barrel 5a of syringe 5, fig. 3, [0030]) arranged with a medicament delivery member (needle 19 shown connected to syringe 5 in fig. 2, see [0032]) and placed in the tubular housing (housing 2) ([0030] syringe 5 is viewed through an opening 4 in housing 2, see fig. 1);
a cap (cap assembly 60 including cap 6, fig. 6, [0030]) removably arranged on the proximal end (see fig. 1) of the tubular housing ([0032] cap assembly 60 is ultimately removed from the device 1 prior to use) and configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to cover the medicament delivery member (see fig. 1 and 2 which show that cap 6 covers the needle 19);
a drive mechanism ([0039] activator assembly 30 comprises a drive mechanism) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to act on the medicament container (barrel 5a of syringe 5) to expel a medicament through the medicament delivery member (needle 19) upon the drive mechanism is triggered ([0039] drive mechanism expels medicament);
an activation member (needle shield 40, fig 2) arranged coaxially movable in relation to the tubular housing ([0043] needle shield sleeve 40 and the first activator member 39 connected to it are arranged to be moved coaxially and distally in relation to the housing 2), associated with the drive mechanism ([0039] activator assembly 30 is connected to needle shield sleeve 40; activator assembly 30 comprises a drive mechanism) and comprising a proximal tubular portion which extends from the proximal end of the tubular housing ([0031] the proximal part of the needle shield sleeve 40 protrudes a distance outside the proximal part of the housing 2) and wherein for triggering the drive mechanism the activation member is axially moved towards the distal end of the tubular housing after removing the cap from the tubular housing ([0031] the housing 2 is pushed proximally relative to the needle shield 40 to begin the injection activation sequence),
wherein the proximal tubular portion of the activation member (40) comprises a resilient element (flexible fingers 42 and 45, housing finger 42 and cap finger 45, see fig. 7, [0033]) arranged with a friction member (housing nib 43, fig. 7, [0033]) and an interaction protrusion (inward protrusion 47, fig. 10, [0035]), and
wherein the cap (cap assembly 60, fig. 3) comprises an interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to directly contact the interaction protrusion (inward protrusion 47, fig. 10, [0035] notes abutment of inward protrusion 47 with RSR 20) such as to radially force the resilient element (42) ([0035] abutment of inward protrusion 47 with outer surface of RSR 20 prevents any portion housing finger 42 from bending inward radially, thus keeping housing nib 43 firmly positioned against the terminal end face 25 of housing 2 and preventing any axial movement of the needle shield 40 in the distal direction) and thereby causes the friction member (43) to press against and frictionally engage with the tubular housing (2) when the cap (60) is arranged on the proximal end of the tubular housing ([0035] housing nib 43 is kept in direct abutment with terminal end face 25 of housing 2 when cap assembly 60 is attached), whereby an accidental axial movement of the activation member is prevented ([0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward; the needle shield 40 cannot prematurely move axially inside the housing 2 to cause an unwanted triggering or activation of the device 1) by frictional resistance generated between the friction member and the housing (Examiner notes that friction is present between the housing finger 42/nib 43 and the housing 2, and this friction contributes to preventing relative movement.).
Stefanov is silent to the friction member laterally pressing against and frictionally engaging with an inner surface of the tubular housing.
Gagnieux, in the field of safety shields for syringes, teaches wherein a proximal tubular portion (see proximal portion of substantially cylindrical tubular body 56 in fig. 6) of an activation member (shield 28, fig. 6, [0031] The shield 28 is comprised of a substantially cylindrical tubular body 56.) comprises a friction member (rib 58, figs. 6 and 7, [0033]), and wherein the friction member (58) laterally presses against and frictionally engages (see fig. 6 which shows that friction member 58 presses against the inner surface of the housing; Examiner notes that since the friction member presses against the housing/holder 26, then there must be frictional engagement present, since frictional engagement occurs whenever two objects press against each other) with an inner surface (groove 48, figs. 6 and 7, [0029] A radial groove 48 or stop, best shown in FIGS. 6 and 7, is provided on the inside surface of the holder adjacent its distal end 37) of a tubular housing (holder 26, fig. 7, [0027]; [0029] The radial groove is provided in an arcuately inwardly projecting distal end portion 50 of the holder), such that accidental axial movement is prevented by frictional resistance generated between the friction member and the inner surface of the housing ([0033] sufficient force is required to disengage the rib 58 from the groove 48; Examiner notes that this force must overcome the frictional force of the rib and groove pressing together in order to allow the holder 26 to slide relative to the shield 28).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Stefanov to have a friction member engage with a groove formed on the inner surface of the tubular housing instead of the end face of the tubular housing, as taught by Gagnieux fig. 6, since both references deal with friction members between needle shields/activation members and tubular housings. One would have been motivated to make the modification because the cooperation of the friction member and the inner surface of the housing, as shown in fig. 6 of Gagnieux, better prevents unwanted relative movement in either direction prior to device activation and better protects the friction member prior to use since the friction member is initially within the housing itself.
Regarding claim 14, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the friction member (housing nib 43, fig. 7) is laterally arranged on the resilient element (flexible fingers 42 and 45, fig. 7) and is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to interact with the inner surface of a proximal portion of the tubular housing ([0047] when the end face 46 of the needle shield 40 is pressed against the injection site, the end face 46 is flush with the terminal end face 25 of housing 2 and the friction member/housing nib 43 is positioned inside and covered by housing 2).
Regarding claim 15, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the proximal tubular portion ([0031] the proximal part of the needle shield sleeve 40 protrudes a distance outside the proximal part of the housing 2, see fig. 7) comprises a lateral cut-out (cut-out portion 41, see fig. 7, which shows [0033] the proximal end of the needle shield 40 has a cut-out portion 41),
wherein the lateral cut-out (cut-out portion 41) defines the resilient element (flexible fingers 42 and 45, fig. 7) with a fixed end and a free end (see fig. 7 which shows the fixed end on the distal end of resilient element/flexible finger 42 and the free end on the proximal end of the resilient element/flexible finger 42) which is radially movable in relation to the proximal tubular portion ([0036] housing finger 42 is free to flex radially inward when the needle shield 40 is pushed against an injection site), and
wherein the friction member (housing nib 43, fig. 7) is arranged on an outer surface of the free end of the resilient element (see fig. 7 which shows the friction member 43 on the free distal end of the resilient element part 42).
Regarding claim 16, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the proximal tubular portion comprises a laterally arranged pair of slots (cut-out portion 41, see fig. 7, which shows [0033] the proximal end of the needle shield 40 has a cut-out portion 41), wherein the pair of slots defines the resilient element (see fig. 7 which shows the pair of slots which make up cut-out portion 41 defining resilient element/flexible fingers 42 and 45),
and wherein the friction member (housing nib 43, fig. 7) is arranged on an outer surface of the resilient element (see fig. 7 which shows the friction member/housing nib 43 on the outer surface of resilient element/housing finger 42).
Regarding claim 17, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the friction member (housing nib 43, fig. 7) is radial outwardly protruding from the resilient element (housing finger 42, fig. 7) and the proximal tubular portion (see fig. 7 which shows the friction member/housing nib 43 on the outer surface of resilient element/housing finger 42; see also fig. 12).
Regarding claim 18, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein an outer surface of the proximal tubular portion where the resilient element (housing fingers 42/45, fig. 7) and the friction member (housing nib 43, fig. 7) is located, is at least partially surrounded by the inner surface of the proximal portion of the tubular housing ([0047] when the end face 46 of the needle shield 40 is pressed against the injection site, the end face 46 is flush with the terminal end face 25 of housing 2 and the friction member/housing nib 43 is positioned inside and covered by housing 2).
Regarding claim 19, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032] cap assembly 60 include a rigid shield remover 20) of the cap (cap assembly 60, fig. 3) is coaxially arranged (fig. 1 and 2 show that these elements are arranged coaxially when assembled) within the proximal tubular portion ([0033] the proximal end of the needle shield 40 has a cut-out portion 41; [0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward, see fig. 6).
Regarding claim 20, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the activation member (needle shield 40, fig 2) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to trigger the drive mechanism (activator assembly 30, fig. 3, [0039]; [0040] drive mechanism comprises a plunger rod 34) when the activation member (needle shield 40, fig 2) axially moves towards the distal end of the tubular housing (housing 2, fig. 1) ([0043] when needle shield sleeve 40 and connected first activation member 39 is pressed distally into housing 2 the plunger rod 34 is urged forward).
Regarding claim 23, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the proximal tubular portion ([0031] the proximal part of the needle shield sleeve 40 protrudes a distance outside the proximal part of the housing 2, Examiner reiterates that the proximal tubular portion is part of the activation member / needle shield 40, fig. 2) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to completely surround the medicament delivery member (needle 19 shown in fig. 2 surrounded by activation member 40) when the activation member (40, fig. 3) extends from the proximal end of the tubular housing (see fig. 6 which shows activation member 40 extending from housing 2) and the cap (cap assembly 60, fig. 3) is removed from the proximal end of the tubular housing (fig. 6 shows the cap assembly 60 removed from the housing 2).
Regarding claim 24, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032]) is coaxially arranged with the medicament delivery member (needle 19 shown connected to syringe 5 in fig. 2, [0032] the rigid shield remover 20 and the rigid needle shield 21 cooperate with each other to engage needle safety cover 22 which is part of the pre-filled syringe 5 assembly and covers needle 19) when the cap (cap assembly 60 including cap 6, fig. 6, [0030]) is arranged on the proximal end of the tubular housing (see fig. 1, cap 6 shown at proximal end 61 of housing 2).
Regarding claim 25, Stefanov discloses a medicament delivery device comprising: a housing (2, fig. 1) comprising a distal end (62, fig. 1) and a proximal end (61, fig. 1) (see fig. 1, [0030] housing 2 has proximal end 61 and distal end 62);
a medicament container (barrel 5a of syringe 5, fig. 3, [0030]) having an attached medicament delivery member (needle 19 shown connected to syringe 5 in fig. 2, see [0032]) positioned within the housing (housing 2) ([0030] syringe 5 is viewed through an opening 4 in housing 2, see fig. 1);
a cap (cap assembly 60 including cap 6, fig. 3, [0030]) removably attached to the proximal end of the housing ([0032] cap assembly 60 is ultimately removed from the device 1 prior to use), where the cap (60, fig. 3) has an attached interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032]) surrounding the medicament delivery member (needle 19; [0032] the rigid shield remover 20 and the rigid needle shield 21 cooperate with each other to engage needle safety cover 22 which is part of the pre-filled syringe 5 assembly and covers needle 19, see cap assembly 60 in fig. 3 and fully assembled in fig. 6);
a drive mechanism (drive mechanism mentioned in [0039] which notes that activator assembly 30 comprises a drive mechanism) that is biased ([0040] first compression spring 35 is pre-tensioned and acts on plunger rod 34 which is part of the drive mechanism) such that when the medicament delivery device (device 1) is triggered, a plunger rod (plunger rod 34, fig. 5) moves proximally relative to the medicament container (barrel 5a of syringe 5, fig. 2) to expel medicament through the medicament delivery member (needle 19) ([0040] when urged by first compression spring 35, plunger rod 34 acts on stopper 16 inside the syringe 5 to expel medicament through the needle 19);
and an activation member (needle shield 40, fig. 2) slidably arranged within the housing ([0043] needle shield sleeve 40 are arranged to be moved coaxially and distally in relation to the housing 2) and operatively engaged with the drive mechanism ([0043] activation member / needle shield 40 is connected to the first activator member 39) such that distal axial movement of the activation member (40) triggers the drive mechanism ([0043] distal axial movement of the activation member / needle shield 40 triggers compression spring 35 to move plunger rod 34 and needle 19 toward the injection site),
where the activation member comprises a proximal tubular portion ([0031] the proximal part of the needle shield sleeve 40 protrudes a distance outside the proximal part of the housing 2) having a resilient element (flexible fingers 42/45, fig. 7, [0033] the proximal end of the needle shield 40 has a cut-out portion 41 which defines a flexible finger 42) arranged with a friction member (housing nib 43, fig. 7, [0033] tab of flexible finger 42 terminates with a housing nib 43) and an interaction protrusion (inward protrusion 47, fig. 10, [0035]),
wherein the interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032]) directly engages with the interaction protrusion (inward protrusion 47, fig. 10, [0035] describes abutment of inward protrusion 47 and RSR 20) and exerts an outward radial force on the resilient element (42) ([0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward) that causes the friction member (43) to engage with the housing ([0035] housing nib 43 is kept in direct abutment with terminal end face 25 of housing 2 when cap assembly 60 is attached), and
wherein the engagement of the interaction member (20/6) with the interaction protrusion (inward protrusion 47, fig. 10, [0035]) of the resilient element (42/45) prevents an unintended axial movement of the activation member (40) and the triggering of the medicament delivery device ([0035] engagement of inward protrusion 47 and RSR 20 prevents housing finger 42 from flexing inward, when the housing finger 42 is unable to flex inward, the needle shield 40 cannot prematurely move axially inside the housing 2 to cause an unwanted triggering or activation of the device 1) by frictional resistance generated between the friction member and the housing (Examiner notes that friction is present between the housing finger 42/nib 43 and the housing 2, and this friction contributes to preventing relative movement.).
Stefanov is silent to the friction member laterally pressing against and frictionally engaging with an inner surface of the tubular housing.
Gagnieux, in the field of safety shields for syringes, teaches wherein a proximal tubular portion (see proximal portion of substantially cylindrical tubular body 56 in fig. 6) of an activation member (shield 28, fig. 6, [0031] The shield 28 is comprised of a substantially cylindrical tubular body 56.) comprises a friction member (rib 58, figs. 6 and 7, [0033]), and wherein the friction member (58) laterally presses against and frictionally engages (see fig. 6 which shows that friction member 58 presses against the inner surface of the housing; Examiner notes that since the friction member presses against the housing/holder 26, then there must be frictional engagement present, since frictional engagement occurs whenever two objects press against each other) with an inner surface (groove 48, figs. 6 and 7, [0029] A radial groove 48 or stop, best shown in FIGS. 6 and 7, is provided on the inside surface of the holder adjacent its distal end 37) of a tubular housing (holder 26, fig. 7, [0027]; [0029] The radial groove is provided in an arcuately inwardly projecting distal end portion 50 of the holder) such that accidental axial movement is prevented by frictional resistance generated between the friction member and the inner surface of the housing ([0033] sufficient force is required to disengage the rib 58 from the groove 48; Examiner notes that this force must overcome the frictional force of the rib and groove pressing together in order to allow the holder 26 to slide relative to the shield 28).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Stefanov to have the friction member engage with a groove formed on the inner surface of the tubular housing instead of the end face of the tubular housing, as taught by Gagnieux fig. 6, since both references deal with friction members between needle shields/activation members and tubular housings. One would have been motivated to make the modification because the cooperation of the friction member and the inner surface of the housing, as shown in fig. 6 of Gagnieux, better prevents unwanted relative movement in either direction prior to device activation and better protects the friction member prior to use since the friction member is initially within the housing itself.
Regarding claim 26, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 25, as described above. Stefanov further discloses wherein the interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032] cap assembly 60 includes a rigid shield remover 20) is coaxially arranged (fig. 1 and 2 show that these elements are arranged coaxially when assembled) within the proximal tubular portion (fig. 6 which shows cap 6 and proximal tubular portion of activation member 40; [0033] the proximal end of the needle shield 40 has a cut-out portion 41; [0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward).
Regarding claim 27, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 25, as described above. Stefanov further discloses wherein the friction member (housing nib 43, fig. 7) interacts with the inner surface of the proximal end of the housing ([0047] when the end face 46 of the needle shield 40 is pressed against the injection site, the end face 46 is flush with the terminal end face 25 of housing 2 and the friction member/housing nib 43 is positioned inside and covered by housing 2).
Regarding claim 28, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 25, as described above. Stefanov further discloses the resilient element (flexible fingers 42/45, fig. 7) is formed from and defined by a lateral cut-out ([0033] the proximal end of the needle shield 40 has a cut-out portion 41 which defines a flexible fingers 42/45, see fig. 7) such that the resilient member (42/45) has a fixed end and a free end (see fig. 7 which shows the fixed end on the distal end of resilient element/flexible finger 42 and the free end on the proximal end of the resilient element/flexible finger 42) which is radially movable relative to an outer surface of the proximal tubular portion ([0036] housing finger 42 is free to flex radially inward when the needle shield 40 is pushed against an injection site), where the friction member (housing nib 43, fig. 7) is arranged on the outer surface of the free end of the resilient element (see fig. 7 which shows the friction member 43 on the free distal end of the resilient element 42).
Regarding claim 30, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 13, as described above. Stefanov further discloses wherein the interaction protrusion (inward protrusion 47, fig. 10, [0035]) is arranged on an inner surface of the resilient element (flexible fingers 42/45, fig. 7) (see fig. 10 and [0035]).
Regarding claim 33, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 25, as described above. Stefanov further discloses wherein the interaction protrusion (inward protrusion 47, fig. 10, [0035]) is arranged on an inner surface of the resilient element (flexible fingers 42/45, fig. 7) (see fig. 10 and [0035]).
Regarding claim 35, Stefanov discloses a medicament delivery device comprising (injector 1, [0030] auto-injector is shown in fig. 1):
a housing (housing 2, fig. 3, [0030]) comprising a distal end and a proximal end (see fig. 1, also [0030] housing 2 has proximal end 61 and distal end 62);
a medicament container (barrel 5a of syringe 5, fig. 3, [0030]) having an attached medicament delivery member (needle 19 shown connected to syringe 5 in fig. 2, see [0032]) positioned within the housing (2) ([0030] syringe 5 is viewed through an opening 4 in housing 2, see fig. 1);
a cap (cap assembly 60 including cap 6, fig. 6, [0030]) removably attached to the proximal end (see fig. 1) of the housing ([0032] cap assembly 60 is ultimately removed from the device 1 prior to use), where the cap has an attached interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032]) surrounding the medicament delivery member (needle 19; [0032] the rigid shield remover 20 and the rigid needle shield 21 cooperate with each other to engage needle safety cover 22 which is part of the pre-filled syringe 5 assembly and covers needle 19, see cap assembly 60 in fig. 3 and fully assembled in fig. 6);
a drive mechanism ([0039] activator assembly 30 comprises a drive mechanism) that is ([0040] first compression spring 35 is pre-tensioned and acts on plunger rod 34 which is part of the drive mechanism) such that when the medicament delivery device (device 1) is triggered, a plunger rod (plunger rod 34, fig. 5) moves proximally relative to the medicament container (barrel 5a of syringe 5, fig. 2) to expel medicament through the medicament delivery member (needle 19) ([0040] when urged by first compression spring 35, plunger rod 34 acts on stopper 16 inside the syringe 5 to expel medicament through the needle 19); and
an activation member (needle shield 40, fig 2) slidably arranged within the housing ([0043] needle shield sleeve 40 and the first activator member 39 connected to it are arranged to be moved coaxially and distally in relation to the housing 2) and operatively engaged with the drive mechanism ([0039] activator assembly 30 is connected to needle shield sleeve 40; activator assembly 30 comprises a drive mechanism) such that distal axial movement of the activation member (40) triggers the drive mechanism ([0043] distal axial movement of the activation member / needle shield 40 triggers compression spring 35 to move plunger rod 34 and needle 19 toward the injection site),
where the activation member comprises a proximal tubular portion ([0031] the proximal part of the needle shield sleeve 40 protrudes a distance outside the proximal part of the housing 2) having a resilient element (flexible fingers 42 and 45, housing finger 42 and cap finger 45, see fig. 7, [0033]) arranged with a friction member (housing nib 43, fig. 7, [0033]),
wherein the interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032]) engages with and exerts an outward radial force on the resilient element (42) ([0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward) that causes the friction member (43) to press against and frictionally engage with the housing ([0035] housing nib 43 is kept in direct abutment with terminal end face 25 of housing 2 when cap assembly 60 is attached), and
wherein the engagement of the interaction member (20/6) with the resilient element (42) prevents an unintended axial movement of the activation member (40) and the triggering of the medicament delivery device ([0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward; the needle shield 40 cannot prematurely move axially inside the housing 2 to cause an unwanted triggering or activation of the device 1) by frictional resistance generated between the friction member and the housing (Examiner notes that friction is present between the housing finger 42/nib 43 and the housing 2, and this friction contributes to preventing relative movement.).
Stefanov is silent to the friction member laterally pressing against and frictionally engaging with an inner surface of the tubular housing.
Gagnieux, in the field of safety shields for syringes, teaches wherein a proximal tubular portion (see proximal portion of substantially cylindrical tubular body 56 in fig. 6) of an activation member (shield 28, fig. 6, [0031] The shield 28 is comprised of a substantially cylindrical tubular body 56.) comprises a friction member (rib 58, figs. 6 and 7, [0033]), and wherein the friction member (58) laterally presses against and frictionally engages (see fig. 6 which shows that friction member 58 presses against the inner surface of the housing; Examiner notes that since the friction member presses against the housing/holder 26, then there must be frictional engagement present, since frictional engagement occurs whenever two objects press against each other) with an inner surface (groove 48, figs. 6 and 7, [0029] A radial groove 48 or stop, best shown in FIGS. 6 and 7, is provided on the inside surface of the holder adjacent its distal end 37) of a tubular housing (holder 26, fig. 7, [0027]; [0029] The radial groove is provided in an arcuately inwardly projecting distal end portion 50 of the holder) such that accidental axial movement is prevented by frictional resistance generated between the friction member and the inner surface of the housing ([0033] sufficient force is required to disengage the rib 58 from the groove 48; Examiner notes that this force must overcome the frictional force of the rib and groove pressing together in order to allow the holder 26 to slide relative to the shield 28).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Stefanov to have a friction member engage with a groove formed on the inner surface of the tubular housing instead of the end face of the tubular housing, as taught by Gagnieux fig. 6, since both references deal with friction members between needle shields/activation members and tubular housings. One would have been motivated to make the modification because the cooperation of the friction member and the inner surface of the housing, as shown in fig. 6 of Gagnieux, better prevents unwanted relative movement in either direction prior to device activation and better protects the friction member prior to use since the friction member is initially within the housing itself.
Regarding claim 36, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 35, as described above. Stefanov further discloses wherein the interaction member (rigid shield remover 20 and cap 6, part of cap assembly 60, fig. 6, [0032] cap assembly 60 includes a rigid shield remover 20) is coaxially arranged (fig. 1 and 2 show that these elements are arranged coaxially when assembled) within the proximal tubular portion (fig. 6 which shows cap 6 and proximal tubular portion of activation member 40; [0033] the proximal end of the needle shield 40 has a cut-out portion 41; [0035] when the cap assembly 60 is in place the outer surface of the RSR 20 prevents the housing finger 42 from flexing radially inward).
Regarding claim 37, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 35, as described above. Stefanov further discloses wherein the friction member (housing nib 43, fig. 7) is radial outwardly protruding from resilient element (housing finger 42, fig. 7) and the proximal tubular portion (see fig. 7 which shows the friction member/housing nib 43 on the outer surface of resilient element/housing finger 42; see also fig. 12).
Regarding claim 38, Stefanov modified by Gagnieux discloses the medicament delivery device according to claim 35, as described above. Stefanov further discloses the resilient element (flexible fingers 42/45, fig. 7) is formed from and defined by a lateral cut-out ([0033] the proximal end of the needle shield 40 has a cut-out portion 41 which defines a flexible fingers 42/45, see fig. 7) such that the resilient member (42/45) has a fixed end and a free end (see fig. 7 which shows the fixed end on the distal end of resilient element/flexible finger 42 and the free end on the proximal end of the resilient element/flexible finger 42) which is radially movable relative to an outer surface of the proximal tubular portion ([0036] housing finger 42 is free to flex radially inward when the needle shield 40 is pushed against an injection site), where the friction member (housing nib 43, fig. 7) is arranged on the outer surface of the free end of the resilient element (see fig. 7 which shows the friction member 43 on the free distal end of the resilient element 42).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Olson et al (US 20130204229 A1) - frictional dampers, fig. 24c, [0138]
Newby et al (US-20030093009-A1) - “non-threaded mounting means that provide sufficient frictional or interlocking forces to resist housing 80 from unintentionally releasing from holder 12” [0065]
Wendland et al (US-20180339112-A1 - friction reducing during cap removal, [0072]
Hillman (US-20090082732-A1) - tab feature used to reduce frictional drag during disengagement of a needle shield [0056]
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 07/08/2026
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