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 .
Status of Claims
This action is in response to Applicant’s remarks and claim amendments filed July 27, 2026.
Claims 1-17 are pending.
Claim 1 has been amended. Objection to claim 1 is withdrawn.
Claims 16-17 are newly added.
Claims 1-17 are currently under examination.
Response to Arguments
Applicant’s arguments filed July 27, 2026 have been fully considered but they are not persuasive.
Applicant argues in lines 11- 15 of page 6 of the remarks filed July 27, 2026, regarding claim 1, that Besson (CA Patent No. 3127575), hereinafter, Besson, fails to disclose at least one cassette body clip extending from the sidewalls and configured to engage a lower shell clip of the lower housing shell, and that the Office Action’s mapping of the motor-body clips is incorrect because the motor body is not the lower housing shell.
However, Examiner respectfully disagrees, because Besson continues to disclose the overall drug-delivery-device architecture (upper housing shell, lower housing shell, cassette body with sidewalls, syringe, drive assembly, and motor body). The Examiner acknowledges that Besson does not expressly show the cassette-body clip engaging a deflectable lower-shell clip. That specific engagement is supplied by Carrel (US Publication No. 2021/0016017), hereinafter, Carrel, which teaches an outer shell/casing having snap features (tabs) that flex outwardly during insertion of an inner projecting structure so that the structure slides past the distal face of the snap features and is retained. One of ordinary skill in the art would have found it obvious to provide the cassette-body / lower-housing-shell deflectable snap-feature arrangement to obtain a secure, easily assembled axial snap-fit and to prevent separation of those parts.
Therefore, the rejection of claim 1 still stands.
Applicant argues in line 26 of page 6 – line 6 of page 7 of the remarks filed July 27, 2026, regarding claim 1, that Lee (US Patent No. 8,783,494), hereinafter, Lee, fails to teach a lower shell clip that deflects so that a cassette body clip can slide past the lower shell clip, and that Lee is not concerned with creating a strong, tamper-proof assembly.
However, Examiner respectfully disagrees, because the present rejection relies on Carrel (not Lee) for the independent claim. Carrel expressly teaches the outer snap feature flexing outwardly so the inner flanges can slide past and lock. Even if Lee were considered, the test is not whether the secondary reference shares the identical commercial purpose; snap-fit geometry that resists separation is well-known. Applicant’s “tamper-proof” language does not add a structural limitation that distinguishes the claims.
Therefore, the rejection of claim 1 still stands.
Applicant argues in lines 24-27 of page 7 of the remarks filed July 27, 2026, regarding claims 11 and 15, that Wiens (US Publication No. 2003/0082986), hereinafter, Wiens, (directed to construction toys) fails to overcome the deficiencies of the Besson/Lee combination with respect to independent claim 1.
However, Examiner respectfully disagrees, because claims 11 and 15 depend from claim 1. Claim 1 remains unpatentable over Besson in view of Carrel for the reasons set forth above. Wiens continues to supply the additional teachings of clearance during insertion (claim 11) and relative rigidity (claim 15); Applicant has not shown those specific teachings to be deficient.
Therefore, the rejections of claims 11 and 15 still stand.
Applicant’s remarks concerning newly added claims 16 and 17 are addressed in the rejection below. Claim 16 requires outward deflection of the lower shell clip caused by a ramped leading face; Carrel teaches the outward deflection and Lee (where needed) teaches a ramped leading face on the projecting member. Claim 17 requires that the engagement prevents separation; Carrel teaches positive axial retention that prevents withdrawal.
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 1-2, 5-8, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Besson in view of Carrel.
Regarding claim 1, Besson discloses a drug delivery device (Besson; drug delivery device 10 in figs. 1-12) comprising: an upper housing shell (Besson: upper housing shell 46 in figs. 5-8, 10, 12);
a lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42);
a syringe (Besson; syringe assembly 16 is inside cassette body 26 in figs. 1-3) comprising a barrel, a stopper, and a needle (Besson; barrel 52, stopper 54, and cannula 56 in figs, 2, 4, 6, 8, 12), at least a portion of the syringe positioned within the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42);
a drive assembly (Besson; drive assembly 40 in figs, 2, 4, 6, 8-9, 12) comprising a plunger body (Besson; plunger body 80 in figs. 2, 4, 6, 8-9, 12), configured to move the stopper within the barrel upon actuation of the drive assembly (Besson; drive assembly 40 actuates plunger body 80 to move stopper 54 within barrel 52; para [0086]);
a cassette body (Besson; cassette body 26 in figs. 1-8, 12) configured to receive the syringe (Besson; syringe assembly 16 is inside cassette body 26 in figs. 1-3; para [0083]); and
a motor body (Besson; motor body 42 in figs. 4, 6, 15-16, 18-19) configured to engage the cassette body (Besson; motor body 42 in part of second subassembly and cassette body is part of first subassembly, each configured to engage the other; para [0083]),
wherein the cassette body comprises: a pair of sidewalls (Besson; walls on first and second side of cassette body 26 that have clip openings 126 which are configured to be aligned with clip surfaces 124 of motor body 42 as seen in figs. 13 and 15).
Besson does not, however, disclose at least one cassette body clip extending from the sidewalls and configured to engage a lower shell clip of the lower housing shell causing at least the lower shell clip to deflect such that the cassette body clip slides past the lower shell clip.
Carrel teaches at least one cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) extending from the sidewalls and configured to engage a lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) of the lower housing shell causing at least the lower shell clip to deflect such that the cassette body clip slides past the lower shell clip (Carrel: snap features 60 / tabs 40 are configured to flex outwardly during insertion of finger flanges 31 so that they may be inserted distally from a distal face of the snap features 60 as shown in sequence in figs. 16a-16c; para [0011], [0020], and [0103]).
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 cassette body and lower housing shell interface of Besson to include at least one clip extending from a sidewall of the cassette body that engages a complementary, deflectable clip on the lower housing shell, as taught by Carrel, in order to provide a robust, secure, and easily assembled axial snap-fit connection between the cassette body and the lower housing shell.
Regarding claim 2, modified Besson discloses the drug delivery device of claim 1, wherein the at least one cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) comprises an orthogonal proximal face (Carrel: proximal face of finger flange 31 is orthogonally oriented to shell axis 105 in fig. 7; para [0095]) extending outward from the sidewall (Besson; walls on first and second side of cassette body 26 in figs. 13 and 15) in a direction substantially perpendicular to a longitudinal axis of the drug delivery device (Carrel: proximal face of finger flange 31 is perpendicular to longitudinal axis and engages distal face 61 of snap feature 60 to provide axial retention in figs. 7, 16a-16c; para [0095] and [0103]).
Regarding claim 5, modified Besson discloses the drug delivery device of claim 1, wherein the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) extends inward from the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42) toward the cassette body (Besson; cassette body 26 in figs. 1-8, 12).
Regarding claim 6, modified Besson discloses the drug delivery device of claim 1, wherein the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) comprises a hinge integrally formed (Carrel: line 44 may form a hinge allowing the tab 40 to be deformed or to pivot outwardly in fig. 7; para [0094]) with the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42).
Regarding claim 7, modified Besson discloses the drug delivery device of claim 6, wherein the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) extends distally from the hinge and is rotatable about the hinge (Carrel: line 44 may form a hinge allowing the tab 40 to be deformed or to pivot outwardly in fig. 7; para [0094]).
Regarding claim 8, modified Besson discloses the drug delivery device of claim 2, wherein the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) is configured to engage the orthogonal proximal face (Carrel: proximal face of finger flange 31 is orthogonally oriented to shell axis 105 in fig. 7; para [0095]; proximal face of finger flange 31 is perpendicular to longitudinal axis and engages distal face 61 of snap feature 60 to provide axial retention in figs. 7, 16a-16c; para [0095] and [0103]) to prevent withdrawal (Carrel: the snap feature 60 may act as an axial abutment which prevents the safety device 103 from being uncoupled from the shell 50; para [0019], [0091], and [0104]) of the cassette body (Besson; cassette body 26 in figs. 1-8, 12) from the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42).
Regarding claim 17, modified Besson discloses the drug delivery device of claim 1, wherein engagement between the at least one cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) and the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) of the lower housing shell prevents separation of the cassette body from the lower housing shell (Carrel: the snap feature 60 may act as an axial abutment which prevents the safety device 103 from being uncoupled from the shell 50; para [0019], [0091], and [0104]).
Claims 3-4, 9-10, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Besson in view of Carrel, as applied to claim 1 above, and further in view of Lee.
Regarding claim 3, modified Besson discloses the drug delivery device of claim 1, wherein the at least one cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]).
Modified Besson fails, however, to disclose that the at least one cassette body clip comprises a ramped leading face.
Lee teaches a cassette body clip that comprises a ramped leading face (Lee; snap-fit tabs 61 show a ramped leading surface that rides over the mating edges of snap-fit notches 62).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the cassette body clip of the modified Besson device with a ramped leading face, as taught by Lee, in order to facilitate smooth axial insertion and reduce the force required for the clip to ride over and engage the complementary lower shell clip.
Regarding claim 4, modified Besson discloses the drug delivery device of claim 1 with sidewalls comprising at least one cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) into which the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) at least partially extends when the cassette body (Besson; cassette body 26 in figs. 1-8, 12) is fully inserted into the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42; col. 6, lines 40-48; snap-fit tabs 61 are received in complementary snap-fit notches 62).
Modified Besson fails, however, to disclose that each of the sidewalls defines a pocket proximally of the at least one cassette body clip.
Lee teaches that each of the sidewalls defines a pocket (Lee; snap-fit notches 62 in fig. 9) proximally of the at least one cassette body clip.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sidewalls of the cassette body of the modified Besson device to define a pocket proximally of the cassette body clip into which the lower shell clip at least partially extends when fully inserted, as taught by Lee, in order to provide a stable seated position for the engaged clip and improve the security of the assembled connection.
Regarding claim 9, modified Besson discloses the drug delivery device of claim 1 comprising a lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42) with a sidewall (Besson; walls on first and second side of cassette body 26 in figs. 13 and 15) of the cassette body (Besson; cassette body 26 in figs. 1-8, 12).
Modified Besson fails, however, to explicitly disclose that the lower housing shell comprises a rigid wall configured to limit inward deflection of the sidewall of the cassette body.
Lee teaches a rigid wall (Lee; proximal wall in fig. 9) configured to limit inward deflection (Lee; proximal wall 63 extending from base 14 defines the snap-fit recess and provides a stiff wall adjacent the snap-fit tabs 61 and flanges 65 in fig. 9; col. 6, lines 60-67) of a sidewall.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the lower housing shell of the modified Besson device with a rigid wall configured to limit inward deflection of the sidewall of the cassette body, as taught by Lee, in order to control the maximum inward movement of the cassette body clip under load and prevent over-deflection or disengagement.
Regarding claim 10, modified Besson discloses the drug delivery device of claim 9, wherein, with a withdrawal force is applied to the cassette body (Besson; cassette body 26 in figs. 1-8, 12), the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) is configured to deflect the cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) inward until the cassette body clip contacts the rigid wall (Lee; proximal wall 63 in fig. 9; when a withdrawal force is applied to shield 23 in the direction of arrow A, shoulder 66 of hooked end 64 is brought into abutment with the underside of flange 65, causing the snap-fit tabs 61 to deflect within the recess defined between base 14 and proximal wall 63; col. 6, lines 45-53; in combined structure, this deflection of the cassette body clip toward the adjacent rigid wall results in the clip being driven inward until it is stopped by the rigid wall).
Regarding claim 12, modified Besson discloses the drug delivery device of claim 9, wherein the rigid wall (Lee; proximal wall 63 in fig. 9) comprises a gusset connecting the rigid wall to an orifice wall (Besson; figs. 41-42 include rigid wall/ rib structures with multiple integrally formed gussets/structural fins that connect the main rigid wall to the orifice wall (cylindrical/distal opening that receives and at least surrounds the needle shield) at least partially surrounding a needle shield (Besson; needle shield 58 in fig. 2A) of the syringe (Besson; syringe assembly 16 is inside cassette body 26 in figs. 1-3).
Regarding claim 13, modified Besson discloses the drug delivery device of claim 2, wherein, with the cassette body (Besson; cassette body 26 in figs. 1-8, 12) assembled with the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42), a gap is defined (Lee; fig. 9 shows a gap between shoulder 66 and underside of flanges 65 which would be brought into abutment if a force was applied in the direction of arrow A) between the orthogonal proximal face (Carrel: proximal face of finger flange 31 is orthogonally oriented to shell axis 105 in fig. 7; para [0095]) of the cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) and the distal end of the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]).
Regarding claim 14, modified Besson discloses the drug delivery device of claim 4, wherein, with the cassette body (Besson; cassette body 26 in figs. 1-8, 12) assembled with the lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42), a gap is defined (Lee; recess 69 in fig. 9; col. 6, lines 45-48) between the pocket (Lee; snap-fit notches 62 in fig. 9) and the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]).
Regarding claim 16, modified Besson, as modified in claims 1 and 3, discloses the drug delivery device of claim 1, wherein the cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) includes a ramped leading face (Lee; snap-fit tabs 61 show a ramped leading surface that rides over the mating edges of snap-fit notches 62) and wherein the ramped leading face causes the lower shell clip (Carrel: snap features 60 formed on tabs 40 of outer shell 50 / casing 52 in figs. 16a-16c; para [0091-0093]) to deflect outward (Carrel: snap features 60 / tabs 40 are configured to flex outwardly during insertion of finger flanges 31 so that they may be inserted distally from a distal face of the snap features 60 as shown in sequence in figs. 16a-16c; para [0011], [0020], and [0103]) allowing the cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) to slide past the lower shell clip (Carrel: once the tab flexes outward, finger flanges 31 pass the distal face 61 of snap features 60 and is retained in a mounted position in figs. 16a-16c; para [0091] and [0095]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Besson in view of Carrel and Lee, as applied to claims 1 and 9 above, and further in view of Wiens.
Regarding claim 11, modified Besson discloses the drug delivery device of claim 9 comprising at least one cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to receive finger flange 31 in figs. 16a-16c; para [0083]) on a cassette body (Besson; cassette body 26 in figs. 1-8, 12) and a lower housing shell (Besson; lower housing shell 28 in figs. 2-10, 41-42) with a rigid wall (Lee; proximal wall 63 in fig. 9).
Modified Besson fails, however, that the at least one cassette body clip is configured to not contact the rigid wall during insertion of the cassette body into the lower housing shell.
Wiens teaches that the at least one cassette body clip is configured to not contact (Wiens; para [0326], contemplates small clearances between mating surfaces such as male connection elements 102 and female connection elements 104 to avoid hangups in figs. 5-7) the rigid wall during insertion of the cassette body into the lower housing shell.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the cassette body clip of the modified Besson device so that it does not contact the rigid wall during insertion, as taught by Wiens, in order to avoid hang-ups or binding during assembly and ensure smooth axial insertion of the cassette body into the lower housing shell.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Besson in view of Carrel, as applied to claim 1 above, and further in view of Wiens.
Regarding claim 15, modified Besson discloses the drug delivery device of claim 1 comprising a lower shell clip and a cassette body clip (Carrel: finger flanges 31 of shield 30, which are projecting structures that engage the outer shell 50 / casing 52 configured to flex and receive finger flange 31 in figs. 16a-16c; para [0083]).
Besson fails, however, to explicitly disclose that the lower shell clip is less rigid than the cassette body clip.
Wiens teaches that the lower shell clip is less rigid than the cassette body clip (Wiens; para [0405-0406] contemplates rigidity of opposing mated parts ribs 476 and opposed walls 470 in figs. 70A-70B).
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 lower shell clip of the modified Besson device to be less rigid than the cassette body clip, as taught by Carrel, in order to ensure that the outer clip preferentially deflects during insertion, thereby enabling reliable snap-fit assembly while the inner clip maintains its shape.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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