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
The amendments filed August 10, 2026, have been entered.
Claims 1 and 3 have been amended.
Claims 1-15 are pending.
Response to Arguments
Applicant argues on page 6, lines 5-14 of the remarks filed August 10, 2026, regarding claim 1, that Wilmot does not disclose a removable cap and that of one ordinary skill in the art would not look to the teachings of Wilmot when modifying the cap/housing interaction of Besson because, in Wilmot, the cap 17 is not removable from the housing (citing col. 3, lines 59-68), and therefore one would not be motivated to look to Wilmot to design a cap geometry that facilitates reliable sealing when the cap is assembled and reduces the risk of inadvertent cap dislodgement while maintaining user-acceptable opening force.
However, the Examiner respectfully disagrees, because claim 1, as amended, does not require the cap to be removable. Claim 1 requires that “the proximal end of the cap is engageable with the first end of the housing” and that, “when the housing and the cap are engaged,” the wall of the cap is in contact with the plateau region of the housing and the clip resides in the recess of the housing. The terms “engageable” and “engaged” do not require that the engagement be releasable or that the cap be configured for user removal. Claim 1 likewise does not require the first end of the housing to be the distal (needle) end of the device. Because claim 1 is not limited to a user-removable distal protective outer cap, Applicant’s reliance on the non-removable nature of Wilmot’s end piece is not commensurate with the scope of the claim. Wilmot remains relevant for its teaching of a housing end profiled with a raised surface relative to an adjacent region, an adjacent recess, and a gap between opposing distal surfaces of the engaging members (Wilmot, Figs. 3-6, col. 4, lines 15-16; col. 5, lines 47-51). Even under a narrower reading limited to a removable protective outer cap, Besson already discloses a drug delivery device having a housing and a cap (316) engageable with a first end of the housing via clips (384) cooperating with a cap interface (386) (Besson, Figs. 37-43; para [0088]). 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 housing engagement interface of Besson to incorporate the raised plateau region, adjacent recess, and distal-end gap, as taught by Wilmot, in order to provide controlled contact between the wall of the cap and a raised plateau region of the housing while defining a gap at the distal end of the clip, thereby improving stabilization of the engaged cap and reducing the risk of unintended separation while maintaining an acceptable engagement force (see present specification, para [0057-0058]). Therefore, the rejection to claim 1 still stands.
Applicant argues on page 7, lines 7 – page 8, line 2 of the remarks filed August 10, 2026, regarding claim 1 (and former claim 3), that groove (31) of Wilmot does not disclose the claimed gap between a distal end of the clip and a distal end of the recess because groove (31) is provided to aid in the escape of gas to the atmosphere during use of the device (citing col. 5, lines 47-51), is necessary because the cap remains attached during use, and is not used to reduce the force needed to remove the cap from the housing.
However, the Examiner respectfully disagrees, because Wilmot discloses groove (31) that creates a space between opposing distal surfaces of the engaging members (Wilmot, Fig. 3; col. 5, lines 47-51). The claim requires only the structural arrangement of a gap between a distal end of the clip and a distal end of the recess. The particular purpose stated in Wilmot does not negate the structural teaching (see MPEP §2114 (II)). The motivation to adopt that geometry in the interface of Besson is supplied by the desire for controlled contact and stabilization discussed above. Therefore, the rejection to claim 1 still stands.
Applicant argued on page 8, lines 6-7 of the remarks filed August 10, 2026, regarding claims 2-15, that the remaining claims depend from and further limit independent claim 1 and should likewise be considered allowable.
However, the Examiner respectfully disagrees, because claim 1 remains rejected under 35 U.S.C. §103 as being unpatentable over CA Patent No. 3127575 to Besson (hereinafter “Besson”) in view of US Patent No. 5,391,151 to Wilmot (hereinafter “Wilmot”) for the reasons set forth above, and claims 2-15 depend from claim 1.
Therefore, the rejection to claims 2-15 still stand.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Besson in view of Wilmot.
Regarding claim 1, Besson discloses a drug delivery device (drug delivery device 300 in figs. 43-44), comprising:
a housing (housing shell comprised of upper housing shell 320 and lower housing shell 322 in figs. 40-42) having a first end (lower housing shell 322 in figs. 41-43) and a second end (upper housing shell 320 in figs. 40, 43), wherein the first end comprises a distal region defining a perimeter of the housing and an adjacent proximal region defining the perimeter of the housing (distal and adjacent proximal regions define respective perimeters in figs. 41-42), wherein in a first region configured to engage a clip from a cap (lower housing shell comprises a region configured to engage cap 316 via clips 384 through cap interface 386 as shown in figs. 37-38, 41; pages 18-19, para [0088]), and
the cap (cap 316 in figs. 37-38) comprising a distal end and a proximal end, wherein the proximal end of the cap is engageable with the first end of the housing (lower housing shell 322 comprises a region configured to engage cap 316 via clips 384 through cap interface 386 as shown in figs. 37-38, 41; pages 18-19, para [0088]), wherein the cap comprises a wall defining a perimeter and the clip protruding from the wall at the proximal end of the cap (cap 316 comprises a wall defining a perimeter with protruding clips 384 at the proximal end of the cap in figs. 37-38),
wherein the housing and the cap are engaged (lower housing shell 322 comprises a region configured to engage cap 316 via clips 384 through cap interface 386 by way of a snap-fit as shown in figs. 37-38, 41; pages 18-19, para [0088]), and
wherein the clip resides in the recess of the housing (lower housing shell 322 comprises a region configured to engage cap 316 via clips 384 through cap interface 386 as shown in figs. 37-38, 41; pages 18-19, para [0088]).
Besson fails, however, to disclose that the distal region of the first end comprises a raised plateau region relative to an adjacent region of the distal region and the proximal region comprises a recess adjacent to the plateau region,
and that the wall of the cap is in contact with the plateau region of the housing, and the clip resides in the recess of the housing,
wherein the arrangement of the clip residing in the recess of the housing defines a gap between a distal end of the clip and a distal end of the recess.
Wilmot teaches that the distal region of the first end comprises a raised plateau region relative to an adjacent region of the distal region and the proximal region comprises a recess adjacent to the plateau region (Wilmot: figs. 3-6 show distal end of body/barrel 1 with raised surfaces or stepped plateaus relative to adjacent region of distal end and chamfered edges at the most distal end of body/barrel 1. Each stepped plateau is proximally followed by and adjacent to a recessed region),
and that the wall of the cap is in contact with the plateau region of the housing, and the clip resides in the recess of the housing (Wilmot: figs. 3-6 show engagement geometry of distal end of body/barrel 1 and cap 17 with raised surfaces or stepped plateaus relative to adjacent region of distal end and chamfered edges at the most distal end of body/barrel 1 and cap 17. Each stepped plateau is proximally followed by and adjacent to a recessed region that allows contact between plateaus of cap 17 and recesses of body/barrel 1),
wherein the arrangement of the clip residing in the recess of the housing defines a gap between a distal end of the clip and a distal end of the recess (Wilmot: distal extremities of the stepped plateaus and chamfered edges are shaped so that opposing distal surfaces do not form a continuous flush contact and, instead, leave open spaces that define a gap; col 5 lines 61-63).
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 housing engagement interface of Besson to include a raised plateau region relative to an adjacent region of the distal region, an adjacent recess in the proximal region, and a gap between a distal end of the clip and a distal end of the recess, as taught by Wilmot, in order to provide controlled contact between the wall of the cap and a raised plateau region of the housing while defining a gap at the distal end of the clip, thereby improving stabilization of the engaged cap and reducing the risk of unintended separation while maintaining an acceptable engagement force.
Regarding claim 2, modified Besson discloses the drug delivery device of claim 1, wherein the housing comprises a plurality of first regions, each configured to engage a clip from the cap (lower housing shell 322 forms a circumferential rim that engages the plurality of clips 384 of cap 316 in figs. 37-38, 41-42. Because each clip engages the rim at a distinct circumferential location, the rim comprises a plurality of first regions, each configured to engage a respective clip from the cap).
Regarding claim 3, modified Besson discloses the drug delivery device of claim 1 with an arrangement of the clip residing in the recess of the housing (lower housing shell 322 comprises a region configured to engage cap 316 via clips 384 through cap interface 386 as shown in figs. 37-38, 41; pages 18-19, para [0088]), but fails to disclose that the clip residing in the recess of the housing defines a gap between a bottom of the clip and a base of the recess.
Wilmot teaches an arrangement of the clip residing in the recess of the housing that defines a gap between a bottom of the clip and a base of the recess (Wilmot: groove 31 in fig. 3; col 5 lines 61-63; form a gap between cap 17 and body/barrel 1).
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 housing engagement interface of Besson to include an arrangement in which the clip residing in the recess defines a gap between a bottom of the clip and a base of the recess, as taught by Wilmot, in order to provide controlled contact between the engaging surfaces while avoiding full bottoming-out of the clip, thereby improving stabilization of the engaged cap and reducing the risk of unintended separation while maintaining an acceptable engagement force.
Regarding claim 4, modified Besson discloses the drug delivery device of claim 3, wherein the distal end of the clip and the distal end of the recess form substantially the same angle relative to the plateau region (Wilmot: the plateau region is substantially parallel to the longitudinal axis of the injector and the angles formed relative to the plateau by both the distal end of the recess and the distal end of the cooperating cap clip are substantially the same angle as shown in figs. 3-4).
Regarding claim 5, modified Besson discloses the drug delivery device of claim 3, wherein the distal end of the recess is chamfered (Wilmot: figs. 3-4 show that the distal end of the recess is not a sharp or square stepped edge, but instead has a transitional or chamfered surface).
Regarding claim 6, modified Besson discloses the drug delivery device of claim 1, wherein the housing (housing shell comprised of upper housing shell 320 and lower housing shell 322 in figs. 40-42) comprises a chamfered distal end adjacent a distal end of the plateau region (Wilmot: the distal end of body/barrel 1 is not a sharp or square edge, but instead is formed with a chamfered edge immediately adjacent the stepped plateau in figs. 3-6).
Regarding claim 7, modified Besson discloses the drug delivery device of claim 1, wherein the adjacent region of the distal region is recessed relative to an adjacent region of the proximal region (Wilmot: figs. 3-6 show distal end of body/barrel 1 with raised surfaces or stepped plateaus relative to adjacent region which, itself, is recessed relative to the opposite proximal region).
Regarding claim 8, modified Besson discloses the drug delivery device of claim 1, wherein the housing (housing shell comprised of upper housing shell 320 and lower housing shell 322 in figs. 40-42), but fails to disclose that the housing further comprises a second region to engage the rib from the cap and wherein in the second region, the distal region comprises a second raised plateau region relative to an adjacent region of the distal region.
Wilmot teaches that the housing further comprises a second region to engage a rib from the cap (Wilmot: housing further comprises a second region configured to engage a rib from the cap wherein the second region (distal region) comprises a second raised plateau regions relative to an adjacent region of the distal region (multiple stepped plateaus on body/barrel 1) in figs. 3-6), and that in a second region, the distal region comprises a second raised plateau region relative to an adjacent region of the distal region (Wilmot: the proximally located clip/rib engages the second region of the body/barrel 1 where the wall bears against a corresponding body/barrel surface to guide and support in a frictional/contact manner rather than snap-fit locking).
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 proximal end of the housing of modified Besson to include a second raised plateau region in the distal region relative to an adjacent region of the distal region, as taught by Wilmot, in order to provide an additional, circumferentially distributed support band that stabilizes the cap relative to the housing and thereby further reduces the risk of inadvertent cap dislodgement while maintaining predictable opening force.
Regarding claim 9, modified Besson discloses the drug delivery device of claim 8, wherein the cap comprises the rib (ribs 380 in figs. 37-38) protruding from the wall of the cap (figs. 37-38 show ribs 380 on cap 316), wherein, when the housing and the cap are engaged, the rib of the cap is in contact with the second plateau region of the housing region (Wilmot: housing further comprises a second region configured to engage a rib from the cap wherein the second region (distal region) comprises a second raised plateau regions relative to an adjacent region of the distal region (multiple stepped plateaus on body/barrel 1) in figs. 3-6).
Regarding claim 10, modified Besson discloses the drug delivery device of claim 9, wherein the cap (cap 316 in figs. 37-38) comprises a gap (Wilmot: groove 31 in fig. 3; col 5 lines 61-63; form a gap between the cap and body/barrel 1) between a top of the rib (ribs 380 in figs. 37-38) and the proximal end of the cap such that a gap is formed between the proximal region of the housing and the wall of the cap when the housing and the cap are engaged (Wilmot: analogous to the clearance formed between cap 17 and groove 31 in fig. 3; col 5 lines 61-63; form a gap between the cap and body/barrel 1).
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 interface between the ribs on the cap and the proximal end region of the housing of modified Besson so that, instead of the rib top fully bottoming out against the proximal end of the cap/housing interface, a clearance is provided therebetween, thereby forming a gap between the proximal region of the housing and wall of the cap when assembled, as suggested by Wilmot, in order to localize contact to selected plateau surfaces, permit limited elastic flexure of the cap wall, and obtain a secure yet not overly tight snap-fit.
Regarding claim 11, modified Besson discloses the drug delivery device of claim 8, wherein the housing (housing shell comprised of upper housing shell 320 and lower housing shell 322 in figs. 40-42) comprises a plurality of second regions (lower housing shell 322 forms a circumferential rim that engages the plurality of clips 384 of cap 316 in figs. 37-38, 41-42. Because each clip engages the rim at a distinct circumferential location, the rim comprises a plurality of first regions, each configured to engage a respective clip from the cap), each configured to engage a rib (ribs 380 in figs.37-38) from the cap (Wilmot: corresponding supporting surfaces on body/barrel 1 shaped as second plateau regions occur at multiple circumferential locations configured to engage a respective rib portion of the cap wall).
Regarding claim 12, modified Besson discloses the drug delivery device of claim 9 comprising a housing (housing shell comprised of upper housing shell 320 and lower housing shell 322 in figs. 40-42), the housing comprising ribs (ribs 380 in figs. 37-38), but fails to disclose that the housing comprises a chamfered distal end adjacent a distal end of the second plateau region, and that the rib comprises a distal end shaped so as to define a gap between the rib and the chamfered distal end adjacent the distal end of the second plateau region when the housing and the cap are engaged.
Wilmot teaches that the housing comprises a chamfered distal end adjacent a distal end of the second plateau region (Wilmot: the proximally located clip/rib of cap 17 engages the second region of the body/barrel 1 where the cap wall bears against a corresponding body/barrel surface to guide and support the cap in a frictional/contact manner rather than snap-fit locking), and that the rib comprises a distal end shaped so as to define a gap (Wilmot: groove 31 in fig. 3; col 5 lines 61-63; form a gap between the cap and body/barrel 1) between the rib and the chamfered distal end adjacent the distal end of the second plateau region when the housing and the cap are engaged (Wilmot: distal extremities of the stepped plateaus and chamfered edges are shaped so that opposing distal surfaces do no form a continuous flush contact and, instead, leave open spaces that define a gap in figs. 3-6; col 5 lines 61-63).
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 distal end of the second plateau region and the distal end of the rib of modified Besson to have chamfered edges and partial contact at the forward body end so that a chamfered distal edge is provided adjacent the distal end of the second plateau and the rib’s distal end does not fully conform to that chamfer, thereby defining a gap between the rib and the chamfered distal end, as taught by Wilmot, in order to maintain controlled clearances that allow elastic flexing and avoid over-constraint while still stabilizing the cap on the housing.
Regarding claim 13, modified Besson discloses the drug delivery device of claim 1, wherein the cap engages an outside surface of the housing (cap 316 is positioned over and around the proximal end of lower housing shell 322 at cap interface 386 in figs. 37-38, 41-42).
Regarding claim 14, modified Besson discloses the drug delivery device of claim 8, wherein an entire surface of the plateau region and/or second plateau region are substantially parallel to the wall of the cap when the cap and the housing are engaged (Wilmot: plateau surface of second plateau regions is parallel to wall portion of cap 17 when engaged as shown in figs. 3-6)
Regarding claim 15, modified Besson discloses the drug delivery device of claim 14, wherein the wall of the cap is in contact with the plateau region of the housing across the entire surface of the plateau region, and/or the rib (ribs 380 in figs.37-38) of the cap is in contact with the second plateau region of the housing across the entire surface of the second plateau region (Wilmot: plateau surface of corresponding plateau regions is parallel to wall portion of the cap when engaged and forms a flush contact as shown in figs. 3-6).
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
/WESLEY G HARRIS/Examiner, Art Unit 3783
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