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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/15/2025 has been entered.
Status of the Claims
Claims 1-12, 21-22, 29, 31-32, and 34 are cancelled. Claims 35-38 are newly added. Claims 13-15, 17-18, 29, 23-25, 27, 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 12/02/2025, with respect to the rejection of claim 13 and claim 25 under 35 U.S.C. 102 have been fully considered but are moot because the new ground of rejection does not rely on the same interpretation of the prior art used in the previous rejection of record for any teaching or matter specifically challenged in the argument.
Examiner acknowledges that the amendments to claim 13 overcome the previous claim objection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-28, 33, and 35-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites the limitation “such that distal axial movement triggers the drive mechanism” on line 11. This limitation is unclear since the “distal axial movement” is not tied to any particular structure. Thus, it is unclear whether distal axial movement of the activation member, the housing, the drive mechanism itself, or a different structure entirely triggers the drive mechanism. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 28 recites the limitation "of proximal tubular portion" in lines 3-4. This is unclear since “proximal tubular portion” is not preceded by an article. If “proximal tubular portion” in this claim is meant to refer back to “a proximal tubular portion” in claim 25, from which claim 28 depends, then this limitation should read “of the proximal tubular portion”. If this limitation is meant to introduce a different “proximal tubular portion”, then the naming convention should be altered to clarify that this limitation refers to a different portion and/or structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 35 recites the limitation “such that distal axial movement triggers the drive mechanism” on line 11. This limitation is unclear since the “distal axial movement” is not tied to any particular structure. Thus, it is unclear whether distal axial movement of the activation member, the housing, the drive mechanism itself, or a different structure entirely triggers the drive mechanism. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 38 recites the limitation "of proximal tubular portion" in lines 3-4. This is unclear since “proximal tubular portion” is not preceded by an article. If “proximal tubular portion” in this claim is meant to refer back to “a proximal tubular portion” in claim 35, from which claim 38 depends, then this limitation should read “of the proximal tubular portion”. If this limitation is meant to introduce a different “proximal tubular portion”, then the naming convention should be altered to clarify that this limitation refers to a different portion and/or structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 26-28, 33, and 36-38 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
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) or alternatively over 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 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 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).
Stefanov teaches all elements of the claimed invention except for the friction member to laterally engage with an inner surface of the tubular housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the friction member within the tubular housing such that it laterally engaged with an inner surface of the tubular housing since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of preventing relative movement of the activation member and the housing prior to cap removal which would allow the friction member to relax inward, disengaging from the inner surface of the housing.
Alternatively, Stefanov is silent to the friction member engaging laterally 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 engages 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)
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 abut 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 Gagnigeux, 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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 (see 112b interpretation above) 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).
Stefanov teaches all elements of the claimed invention except for the friction member to laterally engage with an inner surface of the tubular housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the friction member within the tubular housing such that it laterally engaged with an inner surface of the tubular housing since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of preventing relative movement of the activation member and the housing prior to cap removal which would allow the friction member to relax inward, disengaging from the inner surface of the housing.
Alternatively, Stefanov is silent to the friction member engaging laterally 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 engages 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)
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 abut 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 Gagnigeux, 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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 proximal tubular portion (see 112b interpretation above) ([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, or alternatively Stafanov 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, or alternatively Stafanov 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 (see 112b interpretation above) 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 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).
Stefanov teaches all elements of the claimed invention except for the friction member to laterally engage with an inner surface of the tubular housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the friction member within the tubular housing such that it laterally engaged with an inner surface of the tubular housing since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of preventing relative movement of the activation member and the housing prior to cap removal which would allow the friction member to relax inward, disengaging from the inner surface of the housing.
Alternatively, Stefanov is silent to the friction member engaging laterally 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 engages 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)
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 abut 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 Gagnigeux, 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, or alternatively Stafanov 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, or alternatively Stafanov 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, or alternatively Stafanov 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 proximal tubular portion (see 112b interpretation above) ([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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 03/05/2026