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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
Response to Amendment
Claim 1 has been amended. Claims 1-2 and 4-11 remain pending.
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.
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) 1-2, 4, and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bunch (US 20170014578, henceforth Bunch) in view of Groetzbach et al. (US 20190151565, henceforth Groetzbach).
Regarding claim 1, Bunch discloses a cap assembly (needle sheath 5 and cap 11, fig. 2) for a medicament delivery device (medicament delivery device 1, fig. 2), wherein the medicament delivery device has a housing (case 2, fig. 2) and a needle cover (needle shroud 7, fig. 2) movable in relation to the housing ([0063], [0064]), characterized in that the cap assembly comprises: a locking member (cap 11, fig. 2) including a first engagement member (compliant interlock beams 11.1, fig. 2, which are an engagement member because they engage apertures 7.1 and needle sheath 7 as in [0071]) configured to interact with the needle cover and the housing to limit a movement of the needle cover toward an inside of the housing (see fig. 2; since compliant interlock beams 11.1 are located between case 2 and needle shroud 7 and are shown as being in direct abutment with both case 2 and needle shroud 7, they are configured to interact and are considered to be configured to limit a movement of needle shroud 7 radially outwards towards an inside of case 2 as they occupy the space where needle shroud 7 would need to flex to and because beams 11.1 apply a radially inwards force on needle shroud 7 in reaction to the outward deflection force applied to them from needle shroud 7, see [0066]) when the cap assembly is coupled with the housing to cover the needle cover (see fig. 2, the cap assembly is coupled with case 2 where it is in contact with it and covers needle shroud 7 where it radially surrounds it as shown); wherein the first engagement member has a free end (proximal end of compliant interlock beams 11.1, fig. 2) configured to be inserted in a gap between the needle cover and the housing (see fig. 2, the proximal ends of compliant interlock beams 11.1 are shown as being inserted in a gap between radial stops 2.1 of case 2 and aperture 7.1 of needle shroud 7); and wherein the free end of the first engagement member contacts the housing (see fig. 2, the proximal ends of compliant interlock beams 11.1 are in direct contact with an inner circumferential surface of case 2 as shown) to prevent the engagement member from flexing radially outward (if a force were to be applied radially outwardly to compliant interlock beams 11.1, it would be prevented from movement because of the abutment between beams 11.1 and the inner circumferential surface of case 2 as shown in fig. 2; this is considered to meet the functional limitation as claimed), wherein the free end of the first engagement member has a first inclined surface (the vertical radial exterior surface of interlock beams 11.1 is a surface which is inclined at an angle relative to distal face 11.10 of cap 11 as shown in fig. 2) that contacts the housing (see fig. 2, the radial exterior surface of interlock beams 11.1 is in direct surface contact with the interior surface of radial stop 2.1) at a corresponding inclined surface (see fig. 2, the vertical radial exterior surface of 11.1 is shown in direct surface contact with the vertical radial inner surface of radial stop 2.1 of case 2 as shown; the radial inner surface of radial stop 2.1 is a corresponding inclined surface as claimed where it is inclined at an angle relative to distal face 11.10 of cap 11 as shown in fig. 2, and it is corresponding since it is the surface which comes into direct contact with the radial exterior surface of interlock beams 11.1 as shown in fig. 2) on a proximal end of the housing (see fig. 2, the vertical radial interior surface is shown proximal to case 2 and is thus considered to be at a proximal end of the housing as claimed), and wherein the first inclined surface and the corresponding inclined surface are angled with respect to a remainder of the first engagement member and the housing (the remainder of the engagement member is a radial interior surface of interlock beams 11.1, and the remainder of the housing is a radial interior surface of case 2; both of these surfaces extend vertically up and down in the orientation of fig. 1; the first inclined surface and corresponding surface as called out above are angled with respect to vertical where the first inclined surface, the radial exterior surface of interlock beams 11.1, extend parallel to vertical, or at an angle of 180 degrees, and the corresponding inclined surface, the vertical radial inner surface of radial stop 2.1 of case 2, extends parallel to vertical, or at an angle of 180 degrees); and a cap (needle sheath 5, fig. 2) configured to engage the locking member (see fig. 2, needle sheath 5 and cap 11 are engaged via their direct abutment with each other as shown) and movably arranged in relation to the housing and the locking member between a first position in which the cap is engaged to the housing (see the position of fig. 2 in which needle sheath 5 is fully inserted onto needle 4 at the distal end of medicament container 3 which is arranged within case 2; this constitutes needle sheath 5 being engaged to case 2 via intervening structures of the medicament delivery device 1) and a second position in which the cap disengages the housing (this is the position at which the proximal end of compliant interlock beams 11.1 are no longer in direct abutment with the inner circumferential surface of case 2 due to cap 11 being axially separated from medicament delivery device 1), and between the second position and a third position in which the cap is moved away from the housing and in which the locking member disengages the needle cover and no longer limits the movement of the needle cover (this is the position in which cap 11 and needle sheath 5 are no longer in direct contact with needle shroud 7; note that needle shroud 7 extends further in a distal direction than case 2, and thus the third position comes after the second position with regards to the axial separation of the cap assembly and the medicament delivery device), wherein the locking member is configured to move together with the cap with respect to the housing (due to the engagements between ledges 11.6 and needle sheath 5 as shown in fig. 2, cap 11 and needle sheath 5 move together relative to case 2 when being axially separated from medicament delivery device 1) when the cap and the locking member are moved away from the housing from the second position to the third position (see above, the change between the second and the third positions is denoted by an axial separation between the cap assembly and case 2). Bunch additionally discloses the housing having a proximal portion (see fig. 2, the proximal portion of case 2 is the portion which is proximal to radial stop 2.1 and distal to rib 11.5 as shown).
Bunch does not disclose the cap assembly where when the cap assembly is coupled with the housing, it is configured to cover both a proximal portion of the housing and the needle cover. Groetzbach teaches a cap (device cap 2, fig. 1) as a part of a cap assembly (device cap 2 and needle protection cap 5 make up a cap assembly, see fig. 1) for use with a medicament delivery device (injection device shown in fig. 1), wherein the medicament delivery device has a housing (housing 1, fig. 1) and a needle cover (needle protection sleeve 7, fig. 1) movable in relation to the housing ([0089]), and that the cap assembly can be coupled to the housing (see [0078], cap 2 can be connected to housing 1 via snap connection; this appears to also be shown in fig. 1 where the end of housing 1 closest to needle 3e appears to be rounded such as to form an engagement with a curved portion which is an engagement member 2a of sleeve 2b of cap 2) such that it covers a proximal portion of the housing (see fig. 1, engagement member 2a of cap 2 is shown being arranged radially outside of the proximal end of housing 1 which is the end closest to needle 3e, this is a covering as it is shown to be radially surrounding it) and the needle cover (see fig. 1, cap 2 is shown to be radially surrounding needle protection sleeve 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cap assembly of Bunch to cover the proximal portion of the housing as in Groetzbach for the benefit of allowing a secure snap fit to couple the housing and cap assembly together, possibly preventing accidental removal of the cap assembly from the housing and preventing unwanted needlestick injuries and loss of sterility (see at least [0013] and [0028], the cap is meant to be removably attached to the housing, and see [0008] and [0016], proper and desired assembly of the cap prevents injuries and loss of sterility). Such a modification could include adding an engagement element to rib 11.5 of Bunch which protrudes distally to the cap 11 of Bunch such as to form a snap fit with an added engagement element on the proximal portion of housing 2 such that the engagement element added to cap 11 covers housing 2 when the cap 11 is coupled to housing 2 similar to the arrangement shown in Groetzbach.
Regarding claim 2, Bunch as modified by Groetzbach (henceforth Bunch as modified) discloses the assembly characterized in that an end of the housing is configured to engage the first engagement member (see fig. 2, the distal end of case 2 is shown as being in direct contact with compliant interlock beams 11.1) to prevent the first engagement member from moving away from the needle cover when the cap is located between the first and second positions (see [0071], axial separation between cap 11 and needle sheath 5 from medicament delivery device 1 involves compliant interlock beams 11.1 being removed from radial stops 2.1 which are at the distal end of case 2, and this removal allows for outward deflection of beams 11.1 from needle shroud 7, thus it is the engagement between case 2 and beam 11.1 which prevents beams 11.1 from moving radially away from shroud 7 as the cap assembly is removed as claimed).
Regarding claim 4, Bunch as modified discloses the assembly characterized in that the needle cover includes a second engagement member (aperture 7.1, fig. 2) configured to engage the first engagement member when the cap is between the first position or the second position (see fig. 2; compliant interlock beam 11.1 is in direct contact with, or in engagement with, aperture 7.1 in the first position as shown, and thus there is a moment between the movement from the first position to the second position directly after the first position shown in fig. 2 which still includes direct contact between compliant interlock beam 11.1 and aperture 7.1), wherein the first engagement member disengages the second engagement member when the cap is moved from the second position to the third position (as the cap assembly is fully removed from medicament delivery device 1 between the second and third positions, there is a moment at which compliant interlock beams 11.1 and aperture 7.1 would no longer be in contact; note that the contacting engagement would include the sliding movement of compliant interlock beams 11.1 along the exterior of needle shroud which provides an intervening structure for engagement between aperture 7.1 and beam 11.1, and since the third position involves beam 11.1 not contacting needle shroud 7 at all, the movement between the second and third position involves disengagement between beam 11.1 and aperture 7.1 as claimed).
Regarding claim 6, Bunch as modified discloses the assembly characterized in that the cap includes a third engagement member (proximal-facing proximal surface of needle sheath 5, fig. 2) and the locking member includes a fourth engagement member (inward ledges 11.6, fig. 2), the third engagement member is configured to engage the fourth engagement member when the cap moves from the first position to the second position (as the cap assembly is moved from the first to the second position, the proximal surface of needle sheath 5 and ledges 11.6 engage each other as they are in direct abutment with each other as shown, and this direct abutment provides for the removal of needle sheath 5 when cap 11 is axially separated from medicament delivery device 1 by a user), the third engagement member moves the locking member away from the housing when the cap moves from the second position to the third position (as needle sheath 5 is moved axially away from medicament delivery device 1, the interaction between the proximal edge of needle sheath 5 and ledges 11.6 keep the components of the cap assembly together and moving together away from case 2).
Regarding claim 7, Bunch as modified discloses the assembly characterized in that the cap includes a plurality of gripping protrusions on an outer surface of the cap (grip features 11.2, fig. 2) configured to interact with a user when the user grips the cap ([0062]).
Regarding claim 8, Bunch as modified discloses the assembly characterized in that the first engagement member is radially flexible (see [0071], compliant interlock beams 11.1 are disclosed as being deflectable in an outward, or radial direction) and disposed between the housing and the needle cover (see fig. 2, compliant interlock beams 11.1 are disposed between case 2 and needle shroud 7 as shown), wherein the housing prevents the first engagement member from flexing radially outward and away from the needle cover when the cap is located between the first and second positions (see [0071], axial separation between cap 11 and needle sheath 5 from medicament delivery device 1 involves compliant interlock beams 11.1 being removed from radial stops 2.1 which are at the distal end of case 2, and this removal allows for outward deflection of beams 11.1 from needle shroud 7, thus it is the engagement between case 2 and beam 11.1 which prevents beam 11.1 from moving radially away from shroud 7 as the cap assembly is removed as claimed).
Regarding claim 9, Bunch as modified discloses the assembly wherein the free end abuts the needle cover (see fig. 2 and [0071], “compliant interlock beams 11.1 may abut an edge of the aperture 7.1” means that the proximal end of compliant interlock beam 11.1 would at some point be in direct abutment with needle sheath 7 during the removal of cap 11 as well) to limit the movement of the needle cover (the abutment between compliant interlock beams 11.1 and needle sheath 7 is considered to limit movement of needle sheath 7 where compliant interlock beams 11.1 are exerting an inward radial force towards needle 4 against needle sheath 7 as cap 11 is removed, and thus a radially outward force which is applied to needle sheath 7 in that state would be limited since there is a force acting against it; since the limitation is functional, the structures only need to be capable of limiting such a movement, which is understood to be true as explained above) and the housing prevents the free end from moving away from the needle cover (see [0071], axial separation between cap 11 and needle sheath 5 from medicament delivery device 1 involves compliant interlock beams 11.1 being removed from radial stops 2.1 which are at the distal end of case 2, and this removal allows for outward deflection of beams 11.1 from needle shroud 7, thus it is the engagement between case 2 and beam 11.1 which prevents beam 11.1 from moving radially away from shroud 7 as the cap assembly is removed as claimed).
Regarding claim 10, Bunch as modified discloses a medicament delivery device (medicament delivery device 1, fig. 2), comprising: a housing (case 2, fig. 2); a needle cover (needle shroud 7, fig. 2) movably placed at least partially in the housing ([0063], [0064]); characterized in that the medicament delivery device further comprises a medicament container (medicament container 3, fig. 2) disposed within the needle cover (see fig. 2, medicament container 3 is shown being disposed inside of needle shroud 7) and the housing (see fig. 2, medicament container 3 is shown being disposed inside of case 2); and the cap assembly of claim 1 (see rejection of claim 1 above and see fig. 2), wherein the cap assembly is configured to be mounted to the housing (see fig. 2) to cover a proximal opening of the housing (this is the needle end of case 2, which Bunch has referred to as the distal direction; Examiner notes that references throughout this rejection to direction are following the convention of Bunch unless otherwise explicitly noted).
Regarding claim 11, Bunch as modified discloses the device characterized in that the housing includes a fifth engagement member (stop 2.5, see fig.3 and see [0069] which discloses that the stop 2.5 is a part of case 2) on an outer surface of the housing (see fig. 3, stop 2.5 is understood to be an outer surface of the housing where it is a distal most end of case 2 which would then be a distal outer surface of case 2 once the cap assembly is removed and since it points outwards from medicament delivery device 1), the cap includes at least a sixth engagement member (proximal end 5.1 of needle sheath 5, see fig. 2) on an inner surface of the cap (proximal end 5.1 is an inner surface of needle sheath 5 where it points inwardly towards the interior of medicament delivery device 1 in the assembled state of fig. 2 and during axial separation of the cap assembly and the medicament delivery device 1 as in fig. 3), and the sixth engagement member is configured to engage the fifth engagement member (see figs. 2 and 3, proximal end 5.1 of needle sheath 5 is configured to engage stop 2.5 of case 2 via an intervening structure which is neck portion 3.1 of medicament container 3; since sheath 5 and proximal end 5.1 thereof are mounted onto neck portion 3.1 and neck portion 3.1 directly abuts stop 2.5, proximal end 5.1 and stop 2.5 are engaged; see also [0069]) in order for the cap to be mounted to the housing (see [0069], this engagement is how sheath 5 is disclosed as being mounted to medicament delivery device 1 which case 2 is a part of).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bunch (US 20170014578) and Groetzbach (US 20190151565) as applied to claim 1 above, and further in view of Bjork et al. (US 20170165433, henceforth Bjork).
Regarding claim 5, Bunch as modified discloses the assembly characterized in that the cap assembly further comprising a needle shield remover (sheath removal beams 11.3, fig. 2) configured to engage the locking member (sheath removal beams 11.3 are configured to engage cap 11 where they are integrally formed with it, and thus they are considered to be in a state of permanent engagement) and a medicament container (medicament container 3, fig. 2) arranged within the needle cover and the housing (see fig. 2, medicament container 3 is arranged radially within needle sheath 7 and case 2 as shown). Bunch as modified also discloses an arrangement such that when the cap is moved from the second position to the third position the cap moves the locking member to move the needle shield remover away from the medicament container to pull the cap away from the medicament container (as the assembly of Bunch is axially separated from the medicament delivery device 1 of Bunch in a movement from the second position to the third position as claimed, needle sheath 5 moves together with cap 11 to further move sheath removal beams 11.3 in an axial separation movement from medicament delivery device 1 needle sheath 5 and sheath removal beams 11.3 are in direct abutment with each other during this movement, and thus since all of the claimed structures are moving together axially away from medicament container 3 and since the claim limitation is functional, it is the Examiner’s position that the structures are capable of such relative movement as claimed).
Bunch as modified does not disclose the assembly comprising a needle shield attached to a medicament container such that when the cap is moved from the second position to the third position the cap moves the locking member to move the needle shield remover away from the medicament container to pull the needle shield away from the medicament container. Bjork teaches a cap (needle shield 22, see fig. 2 and see annotated fig. 1 below; this cap is a rigid needle shield which is understood to be equivalent to the cap of Bunch); Bjork also teaches a needle shield (inner tubular sheath of elastic material within needle shield 22, see [0059] and see annotated fig. 1 below) attached to a medicament container (medicament container 16, fig. 1) inside of a housing (front shell 10, figs. 1 and 2) of a medicament delivery device (medicament delivery device pictured as an assembly in fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the needle shield of Bjork to the inside of the cap of Bunch for the benefit of ensuring a tight grip and a good seal between the cap and the injection device (see Bjork [0004], the referred to inner cap made of rubber is understood to be the inner tubular sheath of elastic material of [0059]) which protects from unintentional needle sticks and keeps the needle sterile (Bjork [0001]). This needle shield of Bjork would be reasonably added to the assembly of Bunch in the same manner of arrangement of Bjork; the needle shield would be added to the inside of the cap of Bunch. Thus, in the modified assembly of Bunch, the arrangement would be such that when the cap is moved from the second position to the third position the cap moves the locking member to move the needle shield remover away from the medicament container to pull the needle shield away from the medicament container (see above), because in the modified assembly, the cap of Bunch and the added needle shield from Bjork are understood to be moving together.
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Annotated fig. 1 from Bjork for the rejection of claim 5 (structures in parenthesis are listed claim elements, names outside of parenthesis are how they are referred to in Bjork)
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
Applicant has argued that Bunch does not disclose that the inclined surfaces of the free end and of the housing are angled as claimed. Examiner respectfully disagrees. As indicated in the body of the rejection above, Bunch discloses these features as being angled in parallel to, or at an angle of 180 degrees (or a multiple thereof), a remainder of the first engagement member and the housing. Thus, claims 1-2 and 4-11 are rejected as indicated in the body of the rejection above.
Examiner notes that the claim does not specify a particular angle or range of angles which the inclination must be provided at relative to other structures, nor are the remainders of the housing or engagement member particularly called out.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL J MARRISON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783