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 Objections
Claim 16 is objected to because of the following informalities: claim 16 recites “the actuation member” this is believed to be “the lever actuation member”. Appropriate correction is required.
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 (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 (Fig. 21 3550 with 3553) 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 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 move 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 with respect to the claim(s) 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carrel et al. (US 2015/0202368 A1) has a parallel plunger and drive as well as a lever.
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 mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783