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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/6/26. As directed by the amendment: claims 1, 2, 5, 6, 8, and 10-16 have been amended, claim 4 has been cancelled, and no new claims have been added. Thus, claims 1-3 and 5-16 are presently pending in this application.
The amendments are sufficient to overcome the rejections under 35 U.S.C. 112(b) from the previous action.
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) 1-3 and 5-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stefansen (US 20160106920).
Regarding claim 1, a drug delivery device 100 (fig. 1) comprising: a housing (150, 300, and 640, fig. 1) defining a longitudinal axis (axis from top to bottom in fig. 1) and having an opening (distal opening of 150, fig. 1), wherein the housing includes a tubular housing 300 and a rear cap 640; a drug storage container 200 including a barrel 210, a stopper 220, and a delivery member 250, the stopper movably positioned within the barrel (par. 0055), the delivery member positioned at a distal end of the barrel and having an insertion end configured to extend at least partially through the opening during a delivery state (see fig. 1-3e); a plunger 400 moveable toward the distal end of the drug storage container to engage the stopper and expel a drug from the drug storage container through the delivery member (par. 0072; fig. 3e); a plunger biasing member 500 coupled with the plunger and configured to urge the plunger toward the distal end of the drug storage container (par. 0072; fig. 3e); a releaser member (311,312) having a first position wherein the releaser member prevents the plunger from moving into the delivery state (fig. 3a) and a second position wherein the releaser member does not prevent the plunger from moving into the delivery state (fig. 3c; par. 0070-0072); and a shock absorber 600 configured to absorb an impact force and prevent unintended movement of the releaser member (par. 0063), wherein the shock absorber includes an annular ring (640 forms an annular ring) configured to permit relative axial movement between the rear cap and the tubular housing (par. 0063-0065; relative movement between 300 and 640 includes an axial component).
Regarding claim 2, Stefansen discloses the tubular housing and the rear cap are operably coupled with each other (see fig. 1), and the shock absorber includes the rear cap (see fig. 1; par. 0063-0065).
Regarding claim 3, Stefansen discloses the rear cap is movable with respect to the tubular housing (par. 0063-0065).
Regarding claim 5, Stefansen discloses the shock absorber further includes an annular ridge 347 configured to be received by the annular ring (par. 0063-0065).
Regarding claim 6, Stefansen discloses the annular ring includes a ramped surface (ramp formed by threads, par. 0064, visible in fig. 1) configured to permit the rear cap to move in a distal direction upon application of the impact force and to urge the rear cap to move in a proximal direction after dissipation of the impact force (par. 0063-0065).
Regarding claim 7, Stefansen discloses the ramped surface is defined by a plurality of longitudinal ribs (par. 0064, the embodiment with more than one thread segment).
Regarding claims 8 and 9, Stefansen discloses a buffer gap between the rear cap and the tubular housing, the buffer gap defining a distance between the rear cap and the tubular housing (space between and end of 640 and the point of 647 to which 347 is engaged, see fig. 1).
Regarding claims 10-11, Stefansen discloses a plunger guide (proximal portion of 300) configured to operatively couple the tubular housing and the rear cap (see fig. 1), wherein the plunger guide defines the annular ridge 347 received by the annular ring of the rear cap and wherein the plunger guide further defines a second annular ridge 354 configured to be received by a second annular ring 654 (fig. 1).
Regarding claim 12, Stefansen discloses a plunger guide (proximal portion of 300) configured to operatively couple the tubular housing and the rear cap (see fig. 1), wherein the plunger guide defines the annular ridge 347 (see fig. 1).
Regarding claim 13, Stefansen discloses the drug delivery device is an autoinjector (par. 0026; see operation in fig. 3a-e).
Regarding claim 14, Stefansen discloses the tubular housing defines a generally cylindrical shape (fig. 1).
Regarding claim 15, Stefansen discloses the tubular housing defines a non-cylindrical shape (at least the conical shape found at the distal end near element 250; see fig. 1).
Regarding claim 16, Stefansen discloses the tubular housing and the rear cap are defined by a single, monolithic structure (see fig. 1; engagement of 600 and 300 creates a monolithic structure) and the shock absorber includes a flexible or compressible portion coupling the tubular housing and the rear cap (par. 0065).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15, in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Stefansen in view of Young et al. (US 7449012).
Regarding claim 15, in the alternative, in addition to what is disclosed by Stefansen (see section 102 above), Young et al. teaches providing an autonjector housing defining non-cylindrical shape in the form of an oval shape (col. 2, ln. 39-46). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the housing of Stefansen to include an oval shape, as taught by Young et al., for the purpose of improving ergonomics of the housing and preventing accidental rolling of the device (col. 2, ln. 39-46)
Response to Arguments
Applicant's arguments filed 12/11/25 have been fully considered but they are not persuasive. Regarding Applicant’s arguments on pages 6-8 of the Remarks as directed to the amended limitations of claim 1, the rejection under 35 U.S.C. 102(a)(1) has been updated to reflect these amendments.
Conclusion
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783