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 .
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.
Claims 15-17 and 19-34 are rejected under 35 U.S.C. 103 as being unpatentable over Carrel (US Publication No. 2014/0257184), hereinafter, Carrel.
Regarding Claim 15, Carrel discloses an assembly (injection set 100 in figs. 2-5) for an injection device (injection assistance device 1 in figs. 2-5), the assembly comprising:
a housing (outer sleeve 206 covered by protection cap 224 in fig. 40) comprising a first bearing surface (internal radial step 19 in figs. 2-5) configured to support a medicament container (body 2 with injectable product 25 in figs. 2-5) in a distal direction (external radial rim 11 supports flange 6 of body 2 which holds injectable product 25 in figs. 2-5),
a needle cover (sleeve 4 in figs. 2-5) comprising a second bearing surface (bearing surface 5 in figs. 2-8) configured to protrude from the housing (outer sleeve 206 covered by protection cap 224 in fig. 40) further than a needle of the medicament container in a first position of the needle cover (sleeve 4 protrudes further than needle 7 in a first position in fig. 2; first position known as the initial position in which the needle is not exposed over its insertion length; para [0017]), wherein the needle cover is arranged in the housing such as to move telescopically in the housing when a force is exerted upon it in a proximal direction (plunger rod 10 is axially engaged when user places bearing surface 5 against surface of injection site 27 in figs. 2-5; para [0081-0083]), and wherein the needle cover comprises an opening for the needle to pass through when the needle cover is moved into the housing to a second position (a second position known as the insertion position in which the needle is exposed by a predetermined insertion length L; para [0017]), and
a coupling element (intermediate ring 8 in figs. 2-5) configured to cause the medicament container to move into the proximal direction in parallel with the needle cover (sleeve 4 in figs. 2-5) when the needle cover is moved into the proximal direction past the second position (intermediate ring 8, attached to flange 6, couples the movement with sleeve 4 in figs. 3-5 to move into the second/insertion position; para [0085-0086]).
Although the basic embodiment in figs. 2-5 do not show an outer sleeve/housing, Carrel also discloses an outer sleeve/housing 206 configuration in fig. 40.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify basic embodiment of Carrel in figs. 2-5 to use the outer sleeve 206 as the housing with the first bearing surface (radial step/rim structures in figs. 2-5) integrated therein to support the container, and to use the inner sleeve 4 (or its distal portion) as the telescoping needle cover that contact the skin. One of ordinary skill would have been motivated to do so to provide additional outer protection and structural support while maintaining the telescoping cover function taught in Carrel.
Regarding Claim 16, Carrel discloses the assembly according to claim 15, wherein the coupling element (intermediate ring 8 in figs. 2-5) is arranged on the first bearing surface and configured to be arranged between the first bearing surface and the medicament container (intermediate ring 8 sits on internal radial step 19 and is arranged between that internal radial step 19 and body 2 which holds injectable product 25 in figs. 2-5), wherein the coupling element comprises a distal extension (distal portions of intermediate ring 8 in figs. 2-5) configured to extend along the needle of the medicament container (distal portions of intermediate ring 8 extend along needle 7 of body 2 containing product 25 in figs. 2-5).
Regarding Claim 17, Carrel discloses the assembly according to claim 16, wherein the distal extension is formed as a hollow cylinder (intermediate ring 8 shown as hollow cylinder in fig. 1) configured to surround at least a part of the needle (intermediate ring 8 surrounds part of needle 7 in figs. 2-5).
Regarding Claim 19, Carrel discloses the assembly according to claim 16, comprising a cap (protection cap 224 in fig. 40) configured to cover a distal opening of the housing (outer sleeve 206 covered by protection cap 224 in fig. 40) and comprising a grabber (Wyrick: gripper 81 in fig. 3) for removing a needle shield (Wyrick: sheath 19 in fig. 3) of the medicament container (body 2 with injectable product 25 in figs. 2-5), wherein the grabber is configured to at least partially be arranged radially between the distal extension and the needle (Wyrick: gripper 81 arranged radially between outer structures and needle 17; obvious to combine with Carrel’s distal extension of intermediate ring 8 in figs. 2-5).
Regarding Claim 20, Carrel discloses the assembly according to claim 15, wherein the coupling element (intermediate ring 8 in figs. 2-5) comprises a third bearing surface (abutment surface of intermediate ring 8 in figs. 2-5) arranged on a distal end of the coupling element (distal end abutment surface of intermediate ring 8 in figs. 2-5; para [0085]).
Regarding Claim 21, Carrel discloses the assembly according to claim 20, wherein the third bearing surface is configured to be inserted into the opening of the needle cover when the needle cover is moved into the second position and to contact skin of a patient when the needle cover reaches the second position (distal end abutment surface of intermediate ring 8 against the injection site 27 which brings sleeve 4 into second/injection position in figs. 2-5; para [0085]).
Regarding Claim 22, Carrel discloses the assembly according to claim 20, wherein the third bearing surface is configured to be offset from a needle tip (tip of needle 7 in figs. 2-5) of the needle axially by a predefined injection depth (needle 7 penetrates the injection site 27 to a predetermined insertion length L controlled by the distal end of intermediate ring 8 coming into abutment against the surface of the injection site 27 and the thrusting of the said spring 9 in the partially expanded state against the said radial stop 17 in figs. 2-5; para [0085]).
Regarding Claim 23, Carrel discloses the assembly according to claim 20, wherein the third bearing surface is configured to contact skin of a patient, before the needle cover interacts with a drive mechanism to activate or enable medicament ejection (simplified sectioned views of the injection shown in respective positions: initial, insertion, end-of-injection and final protection in figs. 2-5; para [0080-0086]).
Regarding Claim 24, Carrel discloses the assembly according to claim 15, wherein the coupling element comprises a proximal extension (proximal portions of intermediate ring 8 in figs. 2-5), configured to extend along a medicament container body of the medicament container (proximal portions of intermediate ring 8 extend along needle 7 of body 2 containing product 25 in figs. 2-5).
Regarding Claim 25, Carrel discloses the assembly according to claim 15, wherein the needle cover is configured to interact with a drive mechanism (plunger rod 10 with head 21 coupled to piston plunger 26 in figs. 2-5) of the injection device to activate or enable a medicament ejection (plunger rod 10 with head 21 coupled to piston plunger 26 drives product 25 towards the needle 7, and the injection is performed in figs. 2-5; para [0091]).
Regarding Claim 26, Carrel discloses the assembly according to claim 25, wherein a third bearing surface is arranged on the coupling element and is configured to contact skin of a patient, before the needle cover interacts with the drive mechanism to activate or enable the medicament ejection (abutment surface of intermediate ring 8 is configured to contact the injection site 27 of the patient before sleeve 4 interacts with plunger rod 10 coupled to piston plunger 26 that drives product 25 towards the needle 7, and the injection is performed in figs. 2-5; para [0080-0086]).
Regarding Claim 27, Carrel discloses the assembly according to claim 15, further comprising the medicament container (body 2 with injectable product 25 in figs. 2-5).
Regarding Claim 28, Carrel discloses the assembly according to claim 27, wherein the medicament container is prefilled with a medicament (injection set is in the form of a kit that can be assembled prior to use; para [0052]; injection device 3 comprising a hollow body 2 intended to receive a product 25 that is to be injected in fig. 1-5; para [0071]).
Regarding Claim 29, Carrel discloses the assembly according to claim 15, wherein the coupling element is at least one of rigid or non-deformable (intermediate ring 8 is a rigid structural component comprising external radial rim 11 which supports flange 6 of body 2 which holds injectable product 25 in figs. 2-5; para [0075]).
Regarding Claim 30, Carrel discloses the assembly device according to claim 15, wherein the injection device is an auto-injector device (insertion of the needle 7 into the injection site 27 is performed automatically, without the user having to move the said body 2 by hand; para [0084]).
Regarding Claim 31, Carrel discloses an injection device (injection assistance device 1 in figs. 2-5) comprising an assembly (injection set 100 in figs. 2-5), the assembly comprising:
a housing (outer sleeve 206 covered by protection cap 224 in fig. 40) comprising a first bearing surface (internal radial step 19 in figs. 2-5) configured to support a medicament container (body 2 with injectable product 25 in figs. 2-5) in a distal direction (external radial rim 11 supports flange 6 of body 2 which holds injectable product 25 in figs. 2-5),
a needle cover (sleeve 4 in figs. 2-5) comprising a second bearing surface (bearing surface 5 in figs. 2-8) configured to protrude from the housing (outer sleeve 206 covered by protection cap 224 in fig. 40) further than a needle of the medicament container in a first position of the needle cover (sleeve 4 protrudes further than needle 7 in a first position in fig. 2; first position known as the initial position in which the needle is not exposed over its insertion length; para [0017]), wherein the needle cover is arranged in the housing such as to move telescopically in the housing when a force is exerted upon it in a proximal direction (plunger rod 10 is axially engaged when user places bearing surface 5 against surface of injection site 27 in figs. 2-5; para [0081-0083]), and wherein the needle cover comprises an opening for the needle to pass through when the needle cover is moved into the housing to a second position (a second position known as the insertion position in which the needle is exposed by a predetermined insertion length L; para [0017]), and
a coupling element (intermediate ring 8 in figs. 2-5) configured to cause the medicament container to move into the proximal direction in parallel with the needle cover when the needle cover is moved into the proximal direction past the second position (intermediate ring 8, attached to flange 6, couples the movement with sleeve 4 in figs. 3-5 to move into the second/insertion position; para [0085-0086]).
Regarding Claim 32, Carrel discloses the injection device according to claim 31, wherein the injection device is at least one of a pen-type device or an auto-injector device (insertion of the needle 7 into the injection site 27 is performed automatically, without the user having to move the said body 2 by hand; para [0084]).
Regarding Claim 33, Carrel discloses the injection device according to claim 31, comprising a medicament container (body 2 with injectable product 25 in figs. 2-5), and the medicament container is prefilled with a medicament (injection set is in the form of a kit that can be assembled prior to use; para [0052]; injection device 3 comprising a hollow body 2 intended to receive a product 25 that is to be injected in fig. 1-5; para [0071]).
Regarding Claim 34, Carrel discloses a method of delivering a medicament from an injection device (injection method; para [0082-0087]), the method comprising:
using the injection device, wherein the injection device (injection assistance device 1 in figs. 2-5) comprises an assembly (injection set 100 in figs. 2-5), and wherein the assembly comprises:
a housing (outer sleeve 206 covered by protection cap 224 in fig. 40) comprising a first bearing surface (internal radial step 19 in figs. 2-5) configured to support a medicament container (body 2 with injectable product 25 in figs. 2-5) in a distal direction (external radial rim 11 supports flange 6 of body 2 which holds injectable product 25 in figs. 2-5),
a medicament container prefilled with a medicament (injection set is in the form of a kit that can be assembled prior to use; para [0052]; injection device 3 comprising a hollow body 2 intended to receive a product 25 that is to be injected in fig. 1-5; para [0071]),
a needle cover (sleeve 4 in figs. 2-5) comprising a second bearing surface (bearing surface 5 in figs. 2-8) configured to protrude from the housing (outer sleeve 206 covered by protection cap 224 in fig. 40) further than a needle of the medicament container at least in a first position of the needle cover (sleeve 4 protrudes further than needle 7 in a first position in fig. 2; first position known as the initial position in which the needle is not exposed over its insertion length; para [0017]), wherein the needle cover is arranged in the housing such as to move telescopically in the housing when a force is exerted upon it in a proximal direction (plunger rod 10 is axially engaged when user places bearing surface 5 against surface of injection site 27 in figs. 2-5; para [0081-0083]), and wherein the needle cover comprises an opening for the needle to pass through when the needle cover is moved into the housing to a second position (a second position known as the insertion position in which the needle is exposed by a predetermined insertion length L; para [0017]), and
a coupling element (intermediate ring 8 in figs. 2-5) configured to cause the medicament container to move into the proximal direction in parallel with the needle cover when the needle cover is moved into the proximal direction past the second position (intermediate ring 8, attached to flange 6, couples the movement with sleeve 4 in figs. 3-5 to move into the second/insertion position; para [0085-0086]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Carrel in view of Wyrick (US Publication No. 2006/0173408), hereinafter, Wyrick.
Regarding Claim 18, Carrel discloses the assembly according to claim 17, comprising a cap (protection cap 224 in fig. 40) configured to cover a distal opening of the housing (outer sleeve 206 covered by protection cap 224 in fig. 40) and comprising a medicament container (body 2 with injectable product 25 in figs. 2-5).
Carrel fails, however, to disclose that the cap comprises a grabber for removing a needle shield, wherein the grabber is configured to at least partially be arranged radially between the distal extension and the needle.
Wyrick teaches a grabber (Wyrick: gripper 81 in fig. 3) for removing a needle shield (Wyrick: sheath 19 in fig. 3) of the medicament container, wherein the grabber is configured to at least partially be arranged radially between the distal extension and the needle (Wyrick: gripper 81 arranged radially between outer structures and needle 17; obvious to combine with Carrel’s distal extension of intermediate ring 8 in figs. 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the injection assembly of Carrel to include a needle shield and a grabber for its removal, at taught by Wyrick, in order to provide safe removal of the needle shield while protecting the distal extension and needle, as is conventional in autoinjector designs to prevent needle stick injuries
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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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.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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