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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 3, 2026 has been entered.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 4, 6, 9, 10, 12, 14, 15, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards et al. (US 2013/0023825 A1).
With regard to claims 1, 4, 6, 9, 12, Edwards et al. teach a drug delivery device comprising: a housing (Figs. 14, 15, and 50 housing portions of 3100 surrounding 3157 and 3139); a syringe assembly comprising a barrel, a stopper, and a cannula, at least a portion of the syringe assembly positioned within the housing (Figs. 22 and 28, barrel 3210, stopper 3217, cannula 3216); a drive assembly associated with a motor body (Fig. 18 body surrounding 3152), the drive assembly including a plunger body having a plunger rod portion (Fig. 18 rod 3310) and a drive member (Fig. 52 including at least 3576 and 3410), the plunger rod portion engageable with the stopper configured to move the stopper within the barrel upon actuation of the drive assembly, at least a portion of the drive assembly positioned within the housing, wherein the plunger rod portion and the drive member are spaced from and parallel to each other and extend in a longitudinal direction with respect to a longitudinal length of the drug delivery device (see at least [0149] regarding the operation and Fig. 18 showing the parallel alignment); a needle cover movable between a pre-use position where the cannula is positioned within the needle cover, an actuation position where the needle cover is configured to actuate the drive assembly, and a post-use position where the cannula is positioned within the needle cover (member 3510, see transition from Fig. 50-Fig. 54, cannula and needle cover are relatively positioned as recited); a cap receiving a portion of the needle cover, the cap configured to prevent movement of the needle cover from the pre-use position to the actuation position (Fig. 50 member 3700), wherein the cap includes a protrusion received by a cap opening defined by the needle cover (Figs. 42, 47, 49, and 50 protrusion 3727 within opening 3514, maintains connection were the device to drop and the cover to jostle); and a lever actuation member rotatable about a rotation axis extending perpendicular to the longitudinal length of the drug delivery device, the lever actuation member (Fig. 21 3550 with 3553, members 3553 pivot about an axis into the page which is perpendicular to the longitudinal length) including a needle cover contact surface (Fig. 21 3557 contacts 3522) and a motor body contact surface (Fig. 21 3554 and 3555 contact 3126), the lever actuation member moveable between a locked position, where actuation of the drive assembly is prevented (Fig. 21), and a released position, where actuation of the drive assembly is allowed, wherein movement of the needle cover to the actuation position is configured to cause the needle cover contact surface of the lever actuation member to engage a lever contact portion of the needle cover and rotate the lever actuation member about the rotation axis to the released position and is configured to cause the motor body contact surface to disengage from the motor body allowing movement of the drive assembly ([0186]).
With regard to claim 2, see Fig. 42 3727 engages the housing ([0179]).
With regard to claim 10, see shield 3810 and retainer 3721 (Fig. 45).
With regard to claims 14 and 15, see surface in contact with 3702, surface is angled and also has a gap (Fig. 21).
With regard to claim 17, see the area between members 3553 (Fig. 21).
With regard to claim 18, see at least [0186] and [0195] 3553 moves into a recessed area therebetween upon the cover and lever contact connect to rotate the lever.
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(s) 5, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al. (US 2013/0023825 A1) as applied to claim 1 above, and further in view of Mosebach et al. (US 2016/0144129 A1).
With regard to claims 5, 7, and 8, Edwards et al. teach a device substantially as claimed but does not teach the protrusion to be movably radially outward. However, Mosebach et al. teach a cap which engages a cover via a radially outward displaceable protrusion at the end of an extension arm which has a cammed engagement with an opening in the cover and is held by the housing to prevent accidental disengagement until the necessary time (Figs. 1b, 5, and 11, protrusion 11.3, opening 7.6, housing 2.15 [0051]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a connection between the cap, cover, and housing, in Edwards et al. as Mosebach et al. as this prevent accidental disengagement.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al. (US 2013/0023825 A1) as applied to claim 1 above, and further in view of Edwards et al. (US 2007/0239114 A1).
With regard to claim 16, Edwards et al. teach a pin 3702 which goes through an opening between member 3553 to engage the actuation member and prevent rotation (Figs. 21 and 42) but this is not in a perpendicular direction. However, Edwards et al. ‘114 teach a similar mechanism which may be perpendicularly or parallelly oriented (perpendicular in Figs. 7, 11 pin 3722, parallel in Fig. 42). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a perpendicular pin as Edwards et al. ‘114 teach such to be an equivalent configuration which would yield the same predictable result.
Response to Arguments
Applicant's arguments filed June 3, 2026 have been fully considered but they are not persuasive. The new limitations are addressed with the current reference. Applicant argues members 3553 move inward, the inward movement is a result of rotation about an axis perpendicular to the longitudinal length. Applicant argues 3522 is a surface of 3510 which is a base, 3510 moves to cover the needle. Applicant remarks activation of the needle is achieved by removal of safety lock 3700 and safety lock protrusion 3702. The Examiner is not clear to which claim limitation this is relevant or to which part of the rejection. The objection to claim 16 is withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 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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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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