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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/26/2026 has been entered.
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.
Claims 1, and 4-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Olson et al. (WO 2014150201 A1).
Regarding claim 1, Olson discloses a device (delivery device 300, Fig 22A-30F) configured to administer a medication ([0127]), the device comprising: a lower housing (lower housing 304, Fig 23) configured to support a medication retaining syringe (syringe 324, Fig 23; [0138]) having a needle (needle 332, Fig 23), the lower housing (304) comprising a housing latch (housing latch 510, Fig 26A-B), the housing latch (510) comprising: a leg (leg 512, Fig 26A-B) proximally extending from a portion of the lower housing (portion of the lower housing body 494; Fig 26A; [0143]), the leg (512) being laterally elastically flexible (See Fig 29A-29B) relative to an axial central axis (central axis A; Fig 22B) of the device ([0144]); a free terminal end (Free terminal end 1000, Annotated Fig 1); and a protrusion that extends radially from the leg (protrusions 514, Fig 29A, 26B); a needle guard (needle guard 316, Fig 23) supported by, and in sliding engagement with, the lower housing (304) ([0127];[0156], Fig 29A-B), the needle guard (316) being movable relative to the lower housing (304) in a proximal direction (proximal direction X1 towards the proximal end P; Fig 22B) from a first position (first position; [0127]), wherein a distal end of the needle guard (distal end of 316; Fig 22C) is configured to conceal a distal tip of the needle (tip of needle 332, Fig 22C) ([0127]), to a second position (second position, [0127]), the distal tip of the needle (tip of needle 332, Fig 22C; [0127]) is exposed, the needle guard (316) comprising: an elongate extension portion (pair of extensions 604, Fig 23) defining an opening (opening 616, Fig 28) that receives the radially extending protrusion (514) of the housing latch (510) therethrough, and a protrusion (1001, Annotated Fig 3) that extends laterally into a distal region (1002, Annotated Fig 3) the opening (616), the protrusion (1001, Annotated Fig 3) comprising a cam (adjacent slanted portion 1003 of protrusion 1001, Annotated Fig 3) extending radially inwardly therefrom (slanted portion 1003 extends radially inwards from the outer surface of the protrusion 1001); and a stop (stop 612, Fig 29A) that is spaced proximally from the protrusion (protrusion 1001, Annotated Fig 3) at a proximal region of the opening (proximal region of opening 616 where 612 is located); and an upper housing (upper housing 308, Fig 23) supported relative to the lower housing (304) (Claim 1) and configured to receive a distally directed manual force (manual force in distal direction X2, Fig22B; [0128]) to cause movement of the upper housing (308) relative to the lower housing (304) in a distal direction (direction X2 towards distal end D; Fig 22B) from a pre-use position (pre-use position; [0067]) to a dispensed position (Claim 1), the upper housing (308) comprising an abutment surface (abutment surfaces 398, Fig 29A), wherein: the protrusion (514) of the housing latch (510) releasably interferes with the abutment surface (398) of the upper housing (308) to prevent the upper housing (308) from moving relative to the lower housing (304) toward the dispensed position ([0066]), when the upper housing (308) is in the pre- use position ([0153]) and the needle guard (316) is in the first position (Fig 29A), and the stop (612) releasably interferes with the protrusion (514) of the housing latch (510) to maintain the releasable interference (releasable interference 1004 seen in Fig 29A and Annotated Fig 3) of the protrusion (514) of the housing latch (510) with the abutment surface (398) of the upper housing (308) when the upper housing (308) is in the pre-use position ([0153]) and the needle guard (316) is in the first position (Fig 29A), the protrusion (514) of the housing latch (510) is configurated to release from the stop (612) of the needle guard (316) when the needle guard (316) moves proximally (proximal movement d1, Fig 30B-30C) from the first position (Fig 30B) towards the second position (Fig 30C), the cam (1003, Annotated Fig 3) of the needle guard (316) moves into abutment with the leg (512) of the housing latch (510) ([0153]), after the protrusion (514) of the housing latch (510) releases from the stop (612) of the needle guard (316) when the needle guard (316) moves proximally from the first position (Fig. 30B) to towards the second position (Fig. 30C), to laterally flex the leg (512), and move the protrusion (514) of the housing latch (510) out of interference with the abutment surface (398) of the upper housing (308) ([0153]; claim 33), thereby freeing the upper housing (308) for movement from the pre-use position (pre-use position; [0067]) to the dispensed position in response to the distally directed manual force ([0153]).
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Regarding claim 4, Olson discloses the device of claim1, wherein the protrusion (514) of the housing latch (510) extends from the free terminal end of the leg (free terminal end at proximal end of leg 512, Fig 26A) (Fig 26A-B).
Regarding claim 5, Olson discloses the device of claim1, wherein the leg (512) of the housing (510) latch comprises a first portion (first portion, Annotated Fig 1) that extends from the portion of the lower housing (494) in a direction generally parallel (parallel direction, Annotated Fig 1) with the axial central axis (central axis A; [0144], Annotated Fig 1), and a second portion (second portion, Annotated Fig 1) laterally extending from a proximal end of the first portion (Annotated Fig 1) toward the free terminal end of the leg (free terminal end at proximal end of leg 512, Fig 26A) at an angle (angle, Annotated Fig 1) with respect to the first portion (first portion, Annotated Fig 1), such that the second portion (second portion, Annotated Fig 1) is not parallel with the axial central axis (Annotated Fig 1) and proximal movement (movement along proximal direction X1, Fig 22B) of the needle guard (316) from the first position (first position; [0153]) to the second position (first position; [0153]) moves the cam (adjacent slanted portion 1003 of protrusion 1001, Annotated Fig 3) of the needle guard (316) into abutment with the second portion (Annotated Fig 1) of the leg (512) of the housing latch (510) to laterally elastically flex the leg, thereby moving the protrusion of the housing latch out of interference with the abutment surface of the upper housing ([0144]; [0153]; claim 33; Fig 29A-C)
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Regarding claim 6, Olson discloses the device of claim1, wherein the leg (512) further comprises a laterally-facing surface (laterally-facing surface, Annotated Fig 2) and a rib ( distal portion of 514 connecting with laterally-facing surface; Annotated Fig 2) extending laterally from a portion of the laterally-facing surface (Annotated Fig 2).
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Regarding claim 7, Olson discloses the device of claim 6, wherein the rib (Annotated Fig 2) of the lower housing (304) is positioned radially inwardly of the cam (adjacent slanted portion 1003 of protrusion 1001, Annotated Fig 3) of the needle guard (316) (Fig29A).
Regarding claim 8, Olson discloses the device of claim 6, wherein the cam (adjacent slanted portion 1003 of protrusion 1001, Annotated Fig 3) of the needle guard (316) is laterally spaced apart from the laterally-facing surface (laterally-facing surface, Annotated Fig 2) of the leg (512) of the lower housing latch (510) in the pre-use position (pre-use position; [0067])of the upper housing (308) and the first position (first position; [0127]) of the needle guard (316).
Regarding claim 9, Olson discloses the device of claim1, wherein the needle guard (316) further comprises a housing (housing 600, Fig 28), and the elongate extension portion (604) is one of a pair of opposing elongate extension portions (elongated extension portion 604 comprises a pair of opposing elongate extension portions) extending proximally from the housing (Fig 28), the pair of opposing elongate extension portions defining a gap therebetween (gap between opposite elongate extension portions, Fig 28).
Regarding claim 10, Olson discloses the device of claim 9, wherein the leg (512) of the housing latch (510) is positioned within the gap (gap between opposite elongate extension portions, Fig 28), and the cam (adjacent slanted portion 1003 of protrusion 1001, Annotated Fig 3) extends radially inwardly into the gap (gap between opposite elongate extension portions, Fig 28)
Regarding claim 11, Olson discloses the device of claim1, further comprising the medication retaining syringe (324) having the needle (332) (Fig 23).
Regarding claim 12, Olson discloses the device of claim 11, further comprising a plunger rod (plunger rod 328, Fig 22E) carried by the upper housing (308) and movable with the upper housing (308) so as to advance relative to the syringe (324) when the upper housing (308) is moved from the pre-use position (pre-use position;[0128]]) to the dispensed position (dispensed position; [0128]), wherein advancement of the plunger rod (328) relative to the syringe (324) causes the syringe (324) to deliver the medication ([0127]) out the needle (332) ([0138]).
Regarding claim 13, Olson discloses the device of claim1, wherein the needle guard (316) is configured to move in the distal direction (X2, towards distal end D, Fig 22B) from the second position (second position, [0127]) to a final position (final position; [0153]) when the upper housing (308) is in the dispensed position, wherein the needle guard (316) covers the needle (332) in the final position (final position; [0153])
Regarding claim 14, Olson discloses the device of claim 13, wherein the final position (final position; [0153]) of the needle guard (316) is distal to the first position (first position; [0127]) of the needle guard (316).
Regarding claim 15, Olson discloses the device of claim 13, wherein a visual indication (visual indication 640) on the needle guard (316) is covered by the lower housing (304) when the needle guard (316) is in the first and second positions ([0158]), and wherein the visual indication (640) is spaced distally from the lower housing (304) when the needle guard (316) is in the final position ([0158]).
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Olson et al. (WO 2014150201 A1) in view of Fabien (US 20160375195 A1).
Regarding claim 1, Olson discloses a device (delivery device 300, Fig 22A-30F) configured to administer a medication ([0127]), the device comprising: a lower housing (lower housing 304, Fig 23) configured to support a medication retaining syringe (syringe 324, Fig 23; [0138]) having a needle (needle 332, Fig 23), the lower housing (304) comprising a housing latch (housing latch 510, Fig 26A-B), the housing latch (510) comprising: a leg (leg 512, Fig 26A-B) proximally extending from a portion of the lower housing (portion of the lower housing body 494; Fig 26A; [0143]), the leg (512) being laterally elastically flexible (See Fig 29A-29B) relative to an axial central axis (central axis A; Fig 22B) of the device ([0144]); a free terminal end (Free terminal end 1000, Annotated Fig 1); and a protrusion that extends radially from the leg (protrusions 514, Fig 29A, 26B); a needle guard (needle guard 316, Fig 23) supported by, and in sliding engagement with, the lower housing (304) ([0127];[0156], Fig 29A-B), the needle guard (316) being movable relative to the lower housing (304) in a proximal direction (proximal direction X1 towards the proximal end P; Fig 22B) from a first position (first position; [0127]), wherein a distal end of the needle guard (distal end of 316; Fig 22C) is configured to conceal a distal tip of the needle (tip of needle 332, Fig 22C) ([0127]), to a second position (second position, [0127]), the distal tip of the needle (tip of needle 332, Fig 22C; [0127]) is exposed, the needle guard (316) comprising: an elongate extension portion (pair of extensions 604, Fig 23) defining an opening (opening 616, Fig 28) that receives the radially extending protrusion (514) of the housing latch (510) therethrough, and a protrusion (1001, Annotated Fig 3) that extends laterally into a distal region (1002, Annotated Fig 3) the opening (616), the protrusion (1001, Annotated Fig 3) comprising a cam (slanted portion 1003 of protrusion 1001, Annotated Fig 3); and a stop (stop 612, Fig 29A) that is spaced proximally from the protrusion (protrusion 1001, Annotated Fig 3) at a proximal region of the opening (proximal region of opening 616 where 612 is located); and an upper housing (upper housing 308, Fig 23) supported relative to the lower housing (304) (Claim 1) and configured to receive a distally directed manual force (manual force in distal direction X2, Fig22B; [0128]) to cause movement of the upper housing (308) relative to the lower housing (304) in a distal direction (direction X2 towards distal end D; Fig 22B) from a pre-use position (pre-use position; [0067]) to a dispensed position (Claim 1), the upper housing (308) comprising an abutment surface (abutment surfaces 398, Fig 29A), wherein: the protrusion (514) of the housing latch (510) releasably interferes with the abutment surface (398) of the upper housing (308) to prevent the upper housing (308) from moving relative to the lower housing (304) toward the dispensed position ([0066]), when the upper housing (308) is in the pre- use position ([0153]) and the needle guard (316) is in the first position (Fig 29A), and the stop (612) releasably interferes with the protrusion (514) of the housing latch (510) to maintain the releasable interference (releasable interference 1004 seen in Fig 29A and Annotated Fig 3) of the protrusion (514) of the housing latch (510) with the abutment surface (398) of the upper housing (308) when the upper housing (308) is in the pre-use position ([0153]) and the needle guard (316) is in the first position (Fig 29A), the protrusion (514) of the housing latch (510) is configurated to release from the stop (612) of the needle guard (316) when the needle guard (316) moves proximally (proximal movement d1, Fig 30B-30C) from the first position (Fig 30B) towards the second position (Fig 30C), the cam (1003 of 612, Fig 28) of the needle guard (316) moves into abutment with the leg (512) of the housing latch (510) ([0151]), after the protrusion (514) of the housing latch (510) releases from the stop (612) of the needle guard (316) when the needle guard (316) moves proximally from the first position (Fig. 30B) to towards the second position (Fig. 30C), to laterally flex the leg (512), and move the protrusion (514) of the housing latch (510) out of interference with the abutment surface (398) of the upper housing (308) ([0153]; claim 33), thereby freeing the upper housing (308) for movement from the pre-use position (pre-use position; [0067]) to the dispensed position in response to the distally directed manual force ([0153]).
Olson is silent regarding the cam extending radially inwardly therefrom.
Fabien teaches a device (autoinjector, Fig 1) comprising a needle guard (actuator sleeve 10, Fig 1) the protrusion (4000, Annotated Fig 4) comprising a cam (4001, Annotated Fig 4) extending radially inwardly therefrom (Cam 4001, extends both laterally and radially inwards from protrusion 4000, Annotated Fig 4).
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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 Olson with similar laterally and radially protruding cam as taught by Fabien for the purpose of causing lateral deformation to enable actuation of autoinjector ([0037]).
Response to Arguments
Applicant’s arguments with respect to claims 1, and 4-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Current rejection relies in an alternative interpretation of Olson et al. (WO 2014150201 A1). In effort to advance prosecution please see additional rejection over Olson et al. (WO 2014150201 A1) in view of Fabien (US 20160375195 A1).
Conclusion
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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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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