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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/25/23 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Preliminary Amendment and Acknowledgements
The preliminary amendment filed 05/25/23 has been entered. Claims 1-15 are cancelled. Claims 16-35 are newly presented. Thus, claims 16-35 are pending.
The current Application discloses the proximal direction as the direction toward the needle end of the device/ toward an injection site and the distal direction as the direction toward a gripping area of the device (see [0009]). Thus, the prior art is applied using this same directional convention as defined by Applicant.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-23, 26, and 31-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Holmqvist et al. (U.S. PGPUB No. 2013/0324934), hereinafter Holmqvist.
Regarding claim 16, Holmqvist discloses a sub-assembly for a medicament delivery device cassette unit (FIGs. 5-13, see [0045]), the sub-assembly comprising:
a body (102, see Fig. 7 or ‘Modified FIG. 11’ below)
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extending along a longitudinal axis (L) (longitudinal axis through center of device) from a proximal end to a distal end (see ‘Modified FIG. 11’ above);
a delivery member guard (104) coaxially attached to the body (see [0045]: 104 attached to 102 by protrusion 106 into grooves 108) and being axially movable relative to the body along the longitudinal axis (L) (see [0050-0054]);
a latch (184 with arms 186, best seen in FIG. 13) adjacent to (184 is adjacent/ near delivery guard 104 as shown in FIG. 11. 184 and 104 only separated by lock member 132) the delivery member guard (104) and axially movable relative to the body (see [0050-0052]); and
a lock member (132, see [0047]: locking member 132) attached to the body (see [0047]: 134 of member 132 cooperate with arms 136 of housing part);
wherein the lock member (132) is movable (see [0050-0052]: 132 rotatable) relative to the latch (184) between a locked position (described in [0050] where the button cannot be pressed) and an unlocked position (described in [0051-0052] when 132 is rotated and allows medicament delivery);
wherein the lock member (132) comprises a distally directed surface (see ‘Modified FIG. 11’ above and [0050]: 188 of arms 186 of latch 184, see FIG.13, contact a distally directed surface of the lock member 132) facing a proximally directed surface (188, see Fig. 13 and ‘Modified FIG. 11’ above) of the latch in the locked position (see [0050]: button cannot be pressed due to engagement of surfaces, thus forming the “locked” position); and wherein the distally directed surface (see [0050]) of the lock member (132) is further apart from the proximally directed surface (188) of the latch (184) in the unlocked position (see [0051-0052]: person rotates lock member 132 causing arms 186 of latch to move into cutout 148. Thus the surface 188 on arm 186 is farther away/ by a distance of the cutout in unlocked position compared to the locked position when the surfaces are abutting/ directly contacting. In the position after rotation, medicament can be delivered thus describing an “unlocked” position) than in the locked position (as in [0050]).
Regarding claim 17, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 16, and Holmqvist further discloses wherein the body (102, see ‘Modified FIG. 11’ above) comprises a protrusion (see [0047]: inwardly extending protrusion on arm 136) extending radially relative to the longitudinal axis (L) (see [0047]: protrusion is “inwardly extending” and thus extends radially relative to longitudinal axis), the delivery member guard (104) comprises an arm (116) with a distally directed surface (118, see [0045]) facing (surfaces as shown are “facing”/ directed in opposite directions relative the longitudinal axis. 118 is distally directed while the protrusion proximally directed surface is proximally directed) a corresponding proximally directed surface (see ‘Modified FIG. 11i’ below) of the protrusion (see [0047]: inwardly extending protrusion on arm 136) of the body (102),
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wherein the arm (116) is flexible in the radial direction relative to the longitudinal axis (L) (see [0053-0054]: 116 “flex”es in circumferential==radial direction), and wherein the latch (184 with arms 186) comprises a radially directed surface (see ‘Modified FIG. 13’ below with inside radially directed surface )
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facing (latch has radial surface directed toward center of device and arm has radial surface directed to the outer circumference of the device and therefore the surfaces are “facing”/ opposed in opposite directions) a corresponding radially directed surface (see ‘Modified FIG. 9’ below)
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on the arm (116) of the delivery member guard (104), so that when the lock member (132) is in the locked position (described in [0050] where the button cannot be pressed), the latch (184 with arms 186) is restricted from moving in the proximal direction (see [0050-0054]: 184/186 cannot move in locked position and only moves once lock member 132 rotates to release 186 to move into 148) relative to the body (104), and wherein when the lock member (132) is in the unlocked position (see [0051-0054]: once 132 rotates), the latch (184 including arms 186) is able to move in the proximal direction (see [0051-0054]: arms 186 move proximally into cutouts 148) relative to the body (104), thereby providing space for the delivery member guard to travel in the distal direction (see [0051-0054]) by allowing the flexible arm (116) to travel in the axial direction (see [0051]: 104 travels distally allowing surfaces 118 of arm to engage lock member 132. If 118 is moving distally, 116 is also moving distally) by moving axially past the radially directed surface of the latch and then moving radially past the protrusion of the body (device allows flexible arms to travel distally and thus “allows” the flexible arm to travel in the axial direction in any manner such as “by moving axially past…” as functionally recited).
Regarding claim 18, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 16, and Holmqvist further discloses wherein the delivery member guard (104, see Fig. 11) is partially arranged (see [0045]) within the body (102).
Regarding claim 19, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 17, and Holmqvist further discloses wherein the latch (184) is radially, relative to the longitudinal axis (L), arranged between (outside circumferential surface of latch 184 is between at least the inwardly extending groove surface 110 and the body 102) the body (102) and the delivery member guard (104), and the latch (184) is axially movable relative to the delivery member guard (104) in a proximal direction (see [0051-0054]: latch moves in proximal direction into cutouts 148).
Regarding claim 20, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 19, and Holmqvist further discloses (see Modified figure ‘Claim 20’ below) wherein the latch (184 with arms 186) comprises a distally directed surface (distal surface on arm, see Modified figure ‘Claim 20’ below) adjacent to (latch 184 with arms 186 is only separated from guard 104 by lock member 132. Thus, all surfaces of the latch and guard are “adjacent” or nearby one another because the latch and guard are only separated by one intermediary component, 132) a proximally directed surface (such as proximal surface of the protrusion 106, see Modified figure ‘Claim 20’ below) of the delivery member guard (104).
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Regarding claim 21, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 16, and Holmqvist further discloses wherein the device comprises a biasing member (164, see [0048]: a drive spring) arranged between (spring is radially between the guard and body and therefore between any distally directed surface of the guard and proximally directed surface of the body) a distally directed surface (ledge/ edge at distal end of arm 116, see FIG. 7) of the delivery member guard (104) and a proximally directed surface (such as proximal surface of the inwardly extending protrusion of arm 136 as described in [0047]) of the body (102).
Regarding claim 22, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 17, and Holmqvist further discloses wherein the distally directed surface (118, see Fig. 9 and [0045]) of the arm (116) of the delivery member guard (104) is spaced apart from (see [0047]: 118 engages 140 while protrusion of 136 engages groove 134. Therefore, the surfaces are always spaced by the gap between proximal edge of 140 and distal edge of 134, see Fig. 11) the proximally directed surface (see ‘Modified FIG. 11i’ above) on the protrusion (see [0047]) of the body (102) when the delivery member guard (104) is in the proximal position (see [0051-0054]).
Regarding claim 23, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 16, and Holmqvist further discloses wherein the lock member (132, see FIG. 11) is rotatable (see [0051]) around the longitudinal axis (L) relative to the body (102) between the locked position (described in [0050] where the button cannot be pressed) and the unlocked position (described in [0051-0052] when 132 is rotated and allows medicament delivery).
Regarding claim 26, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 20, and Holmqvist further discloses wherein the body (102, see FIG. 8) comprises an inner body (120, see [0046]) for accommodating a medicament container (122) and an outer shell (wall forming cylindrical shape of 102); and wherein at least a part of the delivery member guard (104) and the latch (184 including arms 186) are radially arranged between (see [0046-0047]: medicament container 122 on inside of 120 and 122 also extends through lock member 132. Thus, the guard 104 and the latch must be “between” the inner body and the inner surface of the outer shell as shown in FIG. 8 and 11) the inner body (120) and the inner surface (see ‘Modified FIG. 8’ below)
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of the outer shell (wall forming cylindrical shape of 102).
Regarding claim 31, Holmqvist discloses a sub-assembly for a medicament delivery device cassette unit (FIGs. 5-13, see [0045]), the sub-assembly comprising:
a body (102, see Fig. 7 or ‘Modified FIG. 11’ below)
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extending along a longitudinal axis (L) (longitudinal axis through center of device) from a proximal end to a distal end (see ‘Modified FIG. 11’ above) and having a protrusion (see [0047]: inwardly extending protrusion on arm 136) extending radially relative to the longitudinal axis (see [0047]: protrusion is “inwardly extending” and thus extends radially relative to longitudinal axis);
a delivery member guard (104) coaxially attached to the body (see [0045]: 104 attached to 102 by protrusion 106 into grooves 108) and being axially movable relative to the body along the longitudinal axis (L) (see [0050-0054]) and having two distally extending flexible arms (116, best seen in FIG. 9 or ‘Modified FIG. 11’ above, see also [0045]: distally directed tongues 116) configured to move radially relative to the protrusion (see [0053-0054]: 116 “flex” in circumferential direction);
a latch (184 with arms 186, best seen in FIG. 13) adjacent to (184 is adjacent/ near delivery guard 104 as shown in FIG. 11. 184 and 104 only separated by lock member 132) the delivery member guard (104) and axially movable relative to the body (see [0050-0052]); and
a lock member (132, see [0047]: locking member 132) attached to the body (see [0047]: 134 of member 132 cooperate with arms 136 of housing part);
wherein the lock member (132) is movable (see [0050-0052]: 132 rotatable) relative to the latch (184) between a locked position (described in [0050] where the button cannot be pressed) and an unlocked position (described in [0051-0052] when 132 is rotated and allows medicament delivery),
wherein the lock member (132) comprises a distally directed surface (see ‘Modified FIG. 11’ above and [0050]: 188 of arms 186 of latch 184, see FIG.13, contact a distally directed surface of the lock member 132) facing a proximally directed surface (188, see Fig. 13 and ‘Modified FIG. 11’ above) of the latch in the locked position (see [0050]: button cannot be pressed due to engagement of surfaces, thus forming the “locked” position); and wherein the distally directed surface (see [0050]) of the lock member (132) is further apart from the proximally directed surface (188) of the latch (184) in the unlocked position (see [0051-0052]: person rotates lock member 132 causing arms 186 of latch to move into cutout 148. Thus the surface 188 on arm 186 is farther away/ by a distance of the cutout in unlocked position compared to the locked position when the surfaces are abutting/ directly contacting. In the position after rotation, medicament can be delivered thus describing an “unlocked” position) than in the locked position (as in [0050]).
Regarding claim 32, Holmqvist discloses the sub-assembly of claim 31, and Holmqvist further discloses wherein the latch (184 including arms 186, see ‘Modified FIG. 11’ above) is axially movable relative to the delivery member guard (104) in a proximal direction (see [0051-0054]: latch moves in proximal direction into cutouts 148) and has a distally directed surface (see modified figure ‘Claim 32’ below) adjacent to (latch 184 with arms 186 is only separated from guard 104 by lock member 132. Thus, all surfaces of the latch and guard are “adjacent” or nearby one another because the latch and guard are only separated by one intermediary component, 132) a proximally directed surface (such as proximal surface of the protrusion 106, see Modified figure ‘Claim 32’ below) of the delivery member guard (104).
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Regarding claim 33, Holmqvist discloses the sub-assembly of claim 31, and Holmqvist further discloses wherein the lock member (132, see FIG. 11) is rotatable (see [0051]) around the longitudinal axis relative to the body (102) between the locked position (described in [0050] where the button cannot be pressed) and the unlocked position (described in [0051-0052] when 132 is rotated and allows medicament delivery).
Regarding claim 34, Holmqvist discloses the sub-assembly of claim 31, and Holmqvist further discloses wherein a spring (126, see FIG. 8) biases the delivery member guard (104) in the proximal direction (see [0050]).
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.
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist as applied to claim 23 above, and further in view of Holland et al. (U.S. PGPUB No. 2020/0316311), hereinafter Holland.
Regarding claim 24, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 23, but Holmqvist is silent to “wherein the lock member comprises a helical distally directed surface; and wherein the distally directed surface of the lock member is a part of the helical distally directed surface.”
However, Holland teaches a sub-assembly for a medicament delivery device with a lock member (308, see Figs. 4a-d and [0074-0076]: 308 not rotatable until positional condition is met and [0077]: after rotation, lock member 308 may move) and a latch (300) forming a threaded helical coupling between the lock member and latch (see [0072-0073]), wherein the lock member (308) comprises a helical distally directed surface (distally directed surface of channel 322).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the abutment between the distally directed surface of the lock member and the proximally directed surface of the latch disclosed in Holmqvist to be formed as a helical threaded surface engagement (such as by forming the distally directed surface as a channel surface, see Holland [0074]) as taught by Holland for the purpose of more precisely controlling the linear movement of the latch engaged with the lock member (see [0072-0073]), which is advantageous to Holmqvist because Holmqvist has only two relative positions between the latch and lock member and therefore dose amounts cannot be manipulated, thus achieving “wherein the lock member comprises a helical distally directed surface; and wherein the distally directed surface of the lock member is a part of the helical distally directed surface.”
Regarding claim 25, the modified system of Holmqvist teaches the sub-assembly for a medicament delivery device cassette unit as claimed in claim 24, but Holmqvist is silent to “wherein the helical distally directed surface comprises a distal end and a proximal end; wherein the distal end of the helical distally directed surface is adjacent to the proximally directed surface of the latch when the lock member is in the locked position; and wherein the proximally directed surface of the latch is configured to rotate, relative to the lock member, from the distal end of the helical distally directed surface towards proximal end of the helical distally directed surface when the lock member is rotated from the locked position to the unlocked position.”
However, Holland teaches a sub-assembly for a medicament delivery device with a lock member (308, see Figs. 4a-d and [0074-0076]: 308 not rotatable until positional condition is met and [0077]: after rotation, lock member 308 may move) and a latch (300) forming a threaded helical coupling between the lock member and latch (see [0072-0073]), wherein the lock member (308) comprises a helical distally directed surface (distally directed surface of channel 322, see ‘Modified FIG. 4c’ below), wherein the helical distally directed surface (distally directed surface of channel 322) comprises a distal end (see ‘Modified FIG. 4c’ below) and a proximal end (see ‘Modified FIG. 4c’ below);
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wherein the distal end (see ‘Modified FIG. 4c’ above) of the helical distally directed surface (distally directed surface of channel 322) is adjacent to (see [0074] and FIG. 2(b)) a proximally directed surface (proximal surface of lugs 317a/b, see FIG. 2(b) for visual clarity of similar lug structures 117a/b as in [0071], and see [0074-0076]) of the latch (300, see [0074]) when the lock member (308) is in the locked position (see [0074-0075]); and wherein the proximally directed surface (proximal surface of lugs 317a/b) of the latch (300) is configured to rotate, relative to the lock member, from the distal end of the helical distally directed surface towards proximal end of the helical distally directed surface when the lock member is rotated from the locked position to the unlocked position (see [0071-0078]: lugs rotatable in channels from distal to proximal end as in Figs. 4a-d is therefore configured to rotate when the lock member is rotated from the locked to unlocked position).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the abutment between the distally directed surface of the lock member and the proximally directed surface of the latch disclosed in Holmqvist to be formed as a helical threaded surface engagement (such as by forming the distally directed surface as a channel surface and forming the proximally directed surface of the latch as a protrusion/ lug, see Holland [0074]) as taught by Holland for the purpose of more precisely controlling the linear movement of the latch engaged with the lock member (see [0072-0073]), which is advantageous to Holmqvist because Holmqvist has only two relative positions between the latch and lock member and therefore dose amounts cannot be manipulated, thus achieving “wherein the helical distally directed surface comprises a distal end and a proximal end; wherein the distal end of the helical distally directed surface is adjacent to the proximally directed surface of the latch when the lock member is in the locked position; and wherein the proximally directed surface of the latch is configured to rotate, relative to the lock member, from the distal end of the helical distally directed surface towards proximal end of the helical distally directed surface when the lock member is rotated from the locked position to the unlocked position.”
Claims 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist as applied to claims 23 and 16, respectively, above, and further in view of Wozencroft (U.S. PGPUB No. 2011/0202011).
Regarding claim 28, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 23, and Holmqvist further discloses wherein the body (102, see FIG. 11) comprises a connection of the body (see [0045]: proximal housing part 102 connects to distal housing part and thus must have some connection) for attachment to a part of a medicament delivery device (such as 162 of distal housing part, see FIG. 7 and [0048]).
Holmqvist is silent to the connection being specifically a “bayonet” connection and the connection being specifically “on an outer surface” of the body.
However, Wozencroft teaches a sub-assembly for a medicament delivery device cassette unit with a body (10, see FIG. 2(a)), wherein the body (10) comprises a bayonet connection (see [0037]: bayonet type fitting to connect front housing 10 to rear housing 12) on an outer surface (collar 30, see FIG. 4(b) and [0041-0042]: fitting 86 formed on collar 30 of body that fits with bayonet fitting 84 of rear housing part 12) of the body (10) for attachment to a part of a medicament delivery device (12).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of the body disclosed in Holmqvist to be a bayonet connection on an outer surface of the body as taught by Wozencroft for the purpose of allowing easy insertion and withdrawal of the medicament container by facilitating assembly of the front and rear housing portions (see [0037] and [0041-0042]), thus achieving the connection being specifically a “bayonet” connection and the connection being specifically “on an outer surface” of the body.
Regarding claim 30, Holmqvist discloses a medicament delivery device comprising: a medicament delivery device cassette unit (see FIGs. 5-13 and [0045]) for accommodating a medicament container (122, see Fig. 8); wherein the medicament delivery device cassette unit comprises the sub-assembly as claimed in claim 16 (see rejection of claim 16 above). Holmqvist further discloses wherein the body (102, see FIG. 11) comprises a connection of the body (see [0045]: proximal housing part 102 connects to distal housing part and thus must have some connection) for attachment to a part of a medicament delivery device (such as 162 of distal housing part, see FIG. 7 and [0048]).
Holmqvist is silent to “a medicament delivery device drive unit releasably attached to the medicament delivery device cassette unit; wherein the medicament delivery device drive unit comprises a driver for actuating the medicament contained in the medicament container accommodated by the medicament delivery device cassette unit.”
However, Wozencroft teaches a medicament delivery device comprising: a medicament delivery device cassette unit (10, see FIG. 1) for accommodating a medicament container (see [0037] a syringe containing medicament); wherein the medicament delivery device cassette unit (10) comprises a sub-assembly (see FIG. 2a-b); and a medicament delivery device drive unit (12) releasably attached (see [0037] and [0041-0042]) to the medicament delivery device cassette unit (10); wherein the medicament delivery device drive unit (12) comprises a driver (90, seen best in FIG. 4(b)) for actuating the medicament contained in the medicament container accommodated by the medicament delivery device cassette unit (see [0044]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of the body disclosed in Holmqvist to releasably connect the sub assembly of the cassette unit to the driver assembly as taught by Wozencroft for the purpose of allowing easy insertion and withdrawal of the medicament container by facilitating assembly of the front and rear housing portions (see [0037], [0041-0042], and [0046]), thus achieving “a medicament delivery device drive unit releasably attached to the medicament delivery device cassette unit; wherein the medicament delivery device drive unit comprises a driver for actuating the medicament contained in the medicament container accommodated by the medicament delivery device cassette unit.”
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Holmqvist as applied to claim 31 above, and further in view of Holland (U.S. PGPUB No. 2020/0316311).
Regarding claim 35, Holmqvist discloses the sub-assembly of claim 31, but Holmqvist is silent to “wherein a helical distally directed surface on the lock member comprises a distal end and a proximal end, where the distal end of the helical distally directed surface is adjacent to the proximally directed surface of the latch when the lock member is in the locked position and where the proximally directed surface of the latch rotates relative to the lock member from the distal end of the helical distally directed surface towards proximal end of the helical distally directed surface when the lock member is rotated from the locked position to the unlocked position.”
However, Holland teaches a sub-assembly for a medicament delivery device with a lock member (308, see Figs. 4a-d and [0074-0076]: 308 not rotatable until positional condition is met and [0077]: after rotation, lock member 308 may move) and a latch (300) forming a threaded helical coupling between the lock member and latch (see [0072-0073]), wherein a helical distally directed surface (distally directed surface of channel 322, see ‘Modified FIG. 4c’ below) on the lock member (308) comprises a distal end (see ‘Modified FIG. 4c’ below) and a proximal end (see ‘Modified FIG. 4c’ below),
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where the distal end (see ‘Modified FIG. 4c’ above) of the helical distally directed surface (distally directed surface of channel 322) is adjacent to (see [0074] and FIG. 2(b)) a proximally directed surface (proximal surface of lugs 317a/b, see FIG. 2(b) for visual clarity of similar lug structures 117a/b as in [0071], and see [0074-0076]) of the latch (300, see [0074]) when the lock member (308) is in the locked position (see [0074-0075]) and where the proximally directed surface (proximal surface of lugs 317a/b) of the latch (300) rotates relative to the lock member from the distal end of the helical distally directed surface towards proximal end of the helical distally directed surface when the lock member (308) is rotated from the locked position to the unlocked position (see [0071-0078]: lugs rotatable in channels from distal to proximal end as in Figs. 4a-d).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the abutment between the distally directed surface of the lock member and the proximally directed surface of the latch disclosed in Holmqvist to be formed as a helical threaded surface engagement (such as by forming the distally directed surface as a channel surface and forming the proximally directed surface of the latch as a protrusion/ lug, see Holland [0074]) as taught by Holland for the purpose of more precisely controlling the linear movement of the latch engaged with the lock member (see [0072-0073]), which is advantageous to Holmqvist because Holmqvist has only two relative positions between the latch and lock member and therefore dose amounts cannot be manipulated, thus achieving “wherein a helical distally directed surface on the lock member comprises a distal end and a proximal end, where the distal end of the helical distally directed surface is adjacent to the proximally directed surface of the latch when the lock member is in the locked position and where the proximally directed surface of the latch rotates relative to the lock member from the distal end of the helical distally directed surface towards proximal end of the helical distally directed surface when the lock member is rotated from the locked position to the unlocked position.”
Allowable Subject Matter
Claims 27 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 27, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 26, and Holmqvist further discloses the protrusion (see [0047]: inwardly extending protrusion on arm 136) and inner body (see rejection of claim 26 above) of the body (102, see rejection of claim 17 above), but Holmqvist is silent to “the proximally directed surface protrudes from an outer surface of the inner body.”
A modification of Holmqvist to include the proximally directed surface of the body such that the surface “protrudes from an outer surface of the inner body” would require extensive reengineering of Holmqvist’s device. Holmqvist is designed to operate in the specific configuration as disclosed and changing the configuration (by moving the proximally directed surface of the protrusion to protrude from an outer surface of the inner body) would change the basic principle under which Holmqvist’s construction was designed to operate (see MPEP § 2143.01(VI)). Therefore, a person of ordinary skill in the art would not find the combination of Holmqvist in view of another reference obvious to arrive at the limitation of “the proximally directed surface protrudes from an outer surface of the inner body”, especially in view of the intervening claim tree. Therefore, claim 27 is indicated as having allowable subject matter but is objected to for depending from a rejected base claim.
Regarding claim 29, Holmqvist discloses the sub-assembly for a medicament delivery device cassette unit as claimed in claim 28, and Holmqvist further discloses wherein the lock member (132, see FIG.11) comprises a flange (see annular rim shape of 132), but Holmqvist is silent to “wherein the flange protrudes from the outer surface of the body; and wherein the flange is aligned with the bayonet connection of the body in the longitudinal direction.”
Holmqvist discloses that the lock member (132, see FIG. 7 and 11) flange (see annular rim shape of 132) is disposed within the body (102). Therefore, a modification of Holmqvist to include “wherein the flange protrudes from the outer surface of the body” would require extensive reengineering of Holmqvist’s device. Holmqvist is designed to operate in the specific configuration as disclosed and changing the configuration (by forming the flange such that it protrudes from the outer surface of the body) would change the basic principle under which Holmqvist’s construction was designed to operate (see MPEP § 2143.01(VI)). Therefore, a person of ordinary skill in the art would not find the combination of Holmqvist in view of another reference obvious to arrive at the limitation of “wherein the flange protrudes from the outer surface of the body; and wherein the flange is aligned with the bayonet connection of the body in the longitudinal direction”, especially in view of the intervening claim tree. Therefore, claim 29 is indicated as having allowable subject matter but is objected to for depending from a rejected base claim.
Conclusion
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783