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 § 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 16-21, 24-25, and 28-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanofi (EP 3492123 A1).
Regarding claim 16, Sanofi discloses a cassette (cassette comprised of 26+39+42+21+41+40, Fig 3A) for receiving a medicament container (reservoir 22, Fig 3A), the cassette comprising: a guard (needle sleeve 26, Fig 3A) extending along a longitudinal axis (longitudinal axis A, Fig 3A) between a proximal end (proximal end 1002, Annotated Fig 1) and a distal end (distal end 1001, Annotated Fig 1); a delivery member holder (part 51, Fig 3A); a shell (outer part 39, Fig 3A) axially movable along the longitudinal axis (A) relative to the guard (26) and the delivery member holder (51) (relative movement seen in Fig 3A-3B); a biasing device (spring 42, Fig 3A) adjacent to a proximally directed surface of the shell (39) (internal surface of outer part 39 connected to slot engagement portion 40, Fig 3B) at one end (proximal end of spring 42, Fig 3A), and adjacent to a distally directed surface of the guard (distal end surface in contact with the spring 42, Fig 3A) at the other end (distal end of spring 42, Fig 3A); a blocking device (housing 21, Fig 3A) comprising a blocking structure (internal surfaces forming portion slot 41, Fig 4C) extending in a direction transverse to the longitudinal axis (A) (thickness of transverse portion of slot 41, Fig 4C) and a guide track (slot 41, Fig 4C) axially and circumferentially extending in the of the longitudinal axis (A) (Fig 4C, guide track 41 extends both in an axial and circumferential direction); wherein the blocking device (housing 21, Fig 3A) is movable between a blocking position where the blocking structure is adjacent to a distally directed surface of the shell (39) (position where slot engagement portion 40 is in locking portion 43, Fig 4C) and a releasing position (Fig 3B, position where slot engagement portion 40 is in movement portion 44) where the blocking structure (internal surfaces forming locking portion 43 of slot 41, Fig 4C) is spaced apart to the distally directed surface of the shell (39) (Fig 3) in the direction of the longitudinal axis (A) (housing 21 and outer part 39 rotate relative to each other; if outer part is held with one hand the housing 21 can be rotated); and a locking device (slot engagement portion 40, Fig 4C) movable relative to the blocking device (21); wherein the locking device (40) comprises a protrusion (slot engagement 40 is a protrusion; Fig 3A) protruding into the guide track (41) of the blocking device (21) (Fig 3A).
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Regarding claim 17, Sanofi discloses the cassette according to claim 16, wherein the blocking device (21) is rotatable relative to the longitudinal axis (A) between the blocking position (Fig 3A, position where slot engagement portion 40 is in movement portion 44) and the releasing position (Fig 3B, position where slot engagement portion 40 is in movement portion 44) ([0004]:housing 21 and outer part 39 are structurally capable to rotate relative to each other; if outer part is held with one hand the housing 21 can be rotated).
Regarding claim 18, Sanofi discloses the cassette according to claim 16, wherein the locking device (40) is movable along the longitudinal axis (A) relative to the blocking device (21) from the first position (position where slot engagement portion 40 is in movement portion 44, Fig 3A) to the second position (position where slot engagement portion 40 is in movement portion 44, Fig 3B).
Regarding claim 19, Sanofi discloses the cassette according to claim 17, wherein the guide track (41) comprises an inclination (inclination defined by angled portion and vertex 45, Fig 3A) such that movement of the protrusion (40) along the inclination causes the blocking device (21) to rotate from the blocking position (Fig 3A) to the releasing position (Fig 3B) ([0054]).
Regarding claim 20, Sanofi discloses the cassette according to claim 16, wherein the shell (39) comprises a shell engaging structure (slot engagement portion 40, Fig 3A); wherein the guard (26) comprises a guard slot (slot, not shown; [0050]); and wherein the shell (39) engaging structure is arranged to travel in the guard slot ([0050]).
Regarding claim 21, Sanofi discloses the cassette according to claim 16, comprising a medicament delivery member (needle 31, Fig 3A).
Regarding claim 24, Sanofi discloses the cassette according to claim 21, further comprising a delivery member holder (central portion of needle unit 23, Fig 3B) holding the medicament delivery member (31), wherein the delivery member holder (central portion of needle unit 23 ) is attached to the shell (central portion of needle unit 23 is attached to outer part 39 by means of slot engagement portion 40; Fig 3B-C).
Regarding claim 25, Sanofi discloses the cassette according to claim 20, wherein a delivery member holder (central portion of needle unit 23, Fig 3B) comprises a delivery member engageable structure (inner surface 1009 forming cavity where needle 31 is engaged, Annotated Fig 1), and wherein the shell engaging structure (40) is arranged to engage the delivery member (31) engageable structure (inner surface forming cavity where needle 31 is engaged).
Regarding claim 28, Sanofi discloses the cassette according to claim 16, comprises a housing (housing 21, Fig 3A); wherein the guard (26) is partially arranged within the housing (21) and telescopic relative to the housing (21) along the longitudinal axis (A).
Regarding claim 29, Sanofi discloses the cassette according to claim 28, wherein the shell (39) comprises a second distally directed surface (distalmost surface 1010 of shell 39) configured to abut a proximally directed surface (outer surface of housing 21 in abutment with 1010, Annotated Fig 1) of the housing (21).
Regarding claim 30, Sanofi discloses a medicament delivery device (20) comprising a cassette (26+39+42+21+41+40) according to claim 16, the medicament delivery device comprises a base unit (mounting portion 30 + cartridge 22+ drive mechanism 25, Fig 3A) releasably attached to the cassette (26+39+42+21+41+40) ; wherein the base unit (30+22+25) comprises a stationary structure (part 51, Fig 3A) and wherein the locking device (40) comprises an external engaging structure (locking members 49, Fig 3A) arranged to engage the stationary structure (51) by insertion of the cassette (26+39+42+21+41+40) into the base unit (30+22+25) to cause the locking device (40) to move proximally relative to the cassette (26+39+42+21+41+40) from the first position (Fig 3A) to the second position (Fig 3B).
Regarding claim 31, Sanofi discloses a cassette for receiving a medicament container (reservoir 22, Fig 3A), the cassette comprising: a guard (needle sleeve 26, Fig 3A) extending along a longitudinal axis (longitudinal axis A, Fig 3A) between a proximal end (proximal end D, Fig 3A) and a distal end (distal end P, Fig 3A) (note directional terms are in opposition in the prior art when compared to instant application); a delivery member holder (part 51, Fig 3A); a shell (outer part 39, Fig 3A) axially movable along the longitudinal axis (A) relative to the guard (26) and the delivery member holder (51) (relative movement seen in Fig 3A-3B); a spring (spring 42, Fig 3A) that exerts a distal biasing force against the shell (39); a blocking device (housing 21, Fig 3A) comprising a blocking structure (internal surfaces forming locking portion 43 of slot 41, Fig 4C) extending radially outward from an outer surface (outer surface 1012 of needle sleeve 26, Annotated Fig 2) and a guide track (slot 41, Fig 4C) axially and circumferentially extending along the outer surface (outer surface 1012, Annotated Fig 2), where the blocking device (21) rotates (housing 21 and outer part 39 rotate relative to each other; if outer part is held with one hand the housing 21 can be rotated) between a blocking position (Fig 3A, position where slot engagement portion 40 is in movement portion 44) where the blocking structure (internal surfaces forming locking portion 43 of slot 41, Fig 4C) is adjacent to a distally directed surface (surface 1003 of outer part 39 connected to slot engagement portion 40, Annotated Fig 1) of the shell (39), and a releasing position (Fig 3B, position where slot engagement portion 40 is in movement portion 44) where the blocking structure (internal surfaces forming locking portion 43 of slot 41, Fig 4C) is not adjacent to the distally directed surface of the shell (39) (surface 1003 of outer part 39 connected to slot engagement portion 40, Annotated Fig 2); and a locking device (engagement portion 40, Fig 3A) comprising an inwardly directed protrusion positioned within the guide track (41) of the blocking device (21) such that linear movement of the locking device (40) in a proximal direction (D) causes rotation of the blocking device (21) (rotation of blocking device 21 relative to the shell 39 is prevented when the blocking device is in releasing position, see Fig 3B; movement of locking device 40 in the proximal direction D is structurally possible and removes rotational constrain, which operatively trigger rotation by the user to transition to the initial blocking position, see Fig 3A).
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Regarding claim 32, Sanofi discloses the cassette of claim 31, wherein the spring (42) has one end (1005, Annotated Fig 1) adjacent to a proximally directed surface (1004, Annotated Fig 1) of the shell (39) and another end (1006, Annotated Fig 1) adjacent to a distally directed surface (1007, Annotated Fig 1) of the guard (26).
Regarding claim 33, Sanofi discloses the cassette of claim 32, wherein the blocking device (21) prevents the shell (39) from being moved distally (1001, Annotated Fig 1) by the spring (42).
Regarding claim 34, Sanofi discloses the cassette of claim 32, wherein movement of the locking device (40) from a first position (position of 40 as shown in Fig 3A) to a second position (position of 40 as shown in Fig 3B) is transmitted by a transmission (manual force applied by user +biasing force of spring 42 acts as a transmission) such that the blocking device (21) rotates about the longitudinal axis (A) from the blocking position (Fig 3A) to a releasing position (Fig 3B).
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.
Claim 22, 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Sanofi (EP 3492123 A1) in view of Shields (US 5549568 A).
Regarding claim 22, Sanofi discloses the cassette according to claim 21. Sanofi is silent regarding a flexible tube surrounding the medicament delivery member.
Shields teaches a flexible tube (elastomeric tube 11, Fig 1) connected to the guard (rigid conical needle shield 12, Fig 1) and to the delivery member holder (needle hub 13, Fig 1), where the flexible tube (11) is positioned to surround the medicament delivery member (needle 16, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sanofi with similar elastic tube surrounding the delivery member as taught by Shields for safe transfer of sterile fluids (claim 1).
Regarding claim 27, Sanofi discloses the cassette according to claim 23. Sanofi discloses distal movement (1001, Annotated Fig 1) of the shell (39). Sanofi is silent wherein a flexible tube connected to the guard and to the delivery member holder, the flexible tube being arranged to be unfolded by distal movement of the shell.
Shields teaches a flexible tube (elastomeric tube 11, Fig 1) connected to the guard (rigid conical needle shield 12, Fig 1) and to the delivery member holder (needle hub 13, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sanofi with similar elastic tube connected between the hub and the shield as taught by Shields for safe transfer of sterile fluids (claim 1).
Note: Sanofi/Shields as modified above discloses being arranged to be unfolded by distal movement of the shell (Distal movement 1001, Annotated Fig 1 of shell will cause the unfolding of now connected elastic tube as hub and shell are displaced distally as seen in Fig 3A-3B).
Regarding claim 35, Sanofi discloses the cassette of claim 32 further comprising a medicament delivery member (31) in fluid communication with the medicament container (22). Sanofi is silent where a flexible tube is positioned to surround the medicament delivery member.
Shields teaches a flexible tube (elastomeric tube 11, Fig 1) connected to the guard (rigid conical needle shield 12, Fig 1) and to the delivery member holder (needle hub 13, Fig 1), where the flexible tube (11) is positioned to surround the medicament delivery member (needle 16, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sanofi with similar elastic tube surrounding the delivery member as taught by Shields for safe transfer of sterile fluids (claim 1).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Sanofi (EP 3492123 A1) in view of Bengtsson et al. (US 20170106135 A1).
Regarding claim 23, Sanofi discloses the cassette according to claim 21, wherein the guard (26) comprises an orifice on the proximal end of the guard (orifice 1008, at proximal end 1002, Annotated Fig 1 of guard 26 where needle 31 protrudes, Fig 3C) wherein the medicament delivery member (31) is arranged within the guard (26) and telescopically relative (Fig 3A) to the orifice (1008, Annotated Fig 1) of the guard (26). Sanofi is silent regarding a guard membrane sealed the orifice (1008, Annotated Fig 1) of the guard (26).
Bengtsson teaches a guard (telescopically movable shield 40) comprising a regarding a guard membrane sealed the orifice (proximal septum 51 or distal septum 52; [0064], Fig 3) of the guard (40).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sanofi with teaching of as taught by Bengtsson for the purpose of preventing contamination of the injector internal components ([0064]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Sanofi (EP 3492123 A1) in view of Bitdinger et al. (US 20030004466 A1).
Regarding claim 26, Sanofi discloses the cassette according to claim 21, further comprising a container holder (cartridge mounting portion 30, Fig 3A) for holding the medicament container (22) wherein the medicament delivery member (31) is arranged to pierce the holder membrane when the delivery member holder (central portion of needle unit 23, Fig 3B) is moved distally (1001, Annotated Fig 1) together with the shell (39) under a biasing force of the basing device (42).
Sanofi is silent wherein the container holder comprising a holder membrane.
Bitdinger teaches a cassette (Fig 9) comprising a container holder (cartridge assembly 414, Fig 9) comprising a holder membrane (2000, Annotated Fig 3; similar to elastomeric seal or septum 250 of Fig 7).
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Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Sanofi with similar elastomeric membrane seal of the container holder as taught by Bitdinger for the purpose of sealing the distal end of the holder maintaining a sterile internal environment and preventing leaks (claim 1; [0033])
Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive. Applicant submits that Sanofi fails to disclose the amended subject matter of claim 16 and 31. Please see below examiner interpretation of amended limitations:
“(...) a delivery member holder (part 51, Fig 3A); a shell (outer part 39, Fig 3A) axially movable along the longitudinal axis (A) relative to the guard (26) and the delivery member holder (51) (relative movement seen in Fig 3A-3B) (...)”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
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