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 preliminary amendment filed on 10/13/23. As directed by the amendment: 1, 3, and 6-15 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-16 are presently pending in this application.
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) 1-7, 9-12, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pedersen et al. (US 20130211330).
Regarding claim 1, Pedersen et al. discloses an injection device (embodiment of fig. 13a-b) comprising: a housing (par. 0120, not fully illustrated in this embodiment) defining a longitudinal axis (top-to-bottom axis of fig. 13a-b); a drive spring 330 disposed within the housing; a drive component 710 configured to transfer drive from the drive spring to a plunger 630 disposed within a medicament container 600 (see fig. 13a-b); and a damper concentrically arranged with respect to the drive component (comprising elements 760 and 761), wherein the damper is longitudinally fixed relative to the housing (at the proximal end of 760, see fig. 13a and par. 0120), wherein the drive component is configured to move along the longitudinal axis relative to the damper under the influence of the drive spring (par. 0120-0124), an wherein the damper is configured to frictionally engage a surface of the drive component during movement of the drive component relative to the damper (par. 0122-0123).
Regarding claim 2, Pedersen et al. discloses the damper is annular (see fig. 13a-b).
Regarding claim 3, Pedersen et al. discloses the drive spring is configured to advance the medicament container from a retracted position to an extended position relative to the housing (par. 0121).
Regarding claim 4, Pedersen et al. discloses the damper is attached to the housing via a longitudinally-extending pin 760.
Regarding claim 5, Pedersen et al. discloses a distal end of the damper defines a socket (opening in 761 through which 760 extends, see fig. 13a-b) configured to receive a corresponding head of a tool for affixing the damper to the pin (tool for affixing being the distal head of 760 and portion connected thereto that extends through 761, see fig. 13a-b).
Regarding claim 6, Pedersen et al. discloses the damper comprises: an elongate body 760 fixed within the housing, wherein the drive component comprises an inner wall defining a channel (channel of 720 comprised by 715, 716, and 717), and the damper is configured to be received by the channel and to engage the inner wall of the drive component (see fig. 13a-b; par. 0120-0124).
Regarding claim 7, Pedersen et al. discloses the damper further comprises at least one deformable damping member 761 disposed on the elongate body.
Regarding claim 9, Pedersen et al. discloses the channel has at least two different diameters along the longitudinal axis (see 715 vs. 716), such that a magnitude of frictional engagement between the drive component and the damper changes as the drive component moves relative to the damper (par. 0123).
Regarding claim 10, Pedersen et al. discloses the deformable damping member comprises an overmolded component (the structural arrangement of 761 and 760 is fully capable of being formed by the process of overmolding).
Regarding claim 11, Pedersen et al. discloses the inner wall of the drive component comprises a plurality of grooves extending in a longitudinal direction (715 being one groove and 716 being another groove).
Regarding claim 12, Pedersen et al. discloses the plurality of grooves comprises a first groove 715 having a first length and a second groove 716 having a second length, wherein the first and second lengths are different (see fig. 13a-b).
Regarding claim 14, Pedersen et al. discloses a percentage of the inner wall comprised by the grooves decreases in a distal direction (decreases to zero defined by the respective groove at each end point of the respective groove; see fig. 13a-b).
Regarding claim 15, Pedersen et al. discloses a method of manufacturing an injection device (embodiment of fig. 13a-b), the method comprising: providing a housing (par. 0120, not fully illustrated in this embodiment) defining a longitudinal axis (top-to-bottom axis of fig. 13a-b); attaching a damper to the housing such that the damper is translationally fixed relative to the housing along the longitudinal axis (comprising elements 760 and 761); disposing a drive spring 330 within the housing; and disposing a drive component 710 within the housing such that the damper is arranged concentrically within the drive component (see fig. 13a-b), wherein the drive component is configured to be driven by the drive spring along the longitudinal axis relative to the damper such that the damper and the drive component frictionally engage (par. 0120-0124).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. in view of Marshall (WO 03097133).
Regarding claim 8, Pedersen et al. discloses the injection device as claimed, except for specifically disclosing the elongate body comprises a head part comprising at least one circumferential groove located at a distal end, the at least one circumferential groove configured to engage a complementary portion of the deformable damping member. However, Marshall teaches utilizing a circumferential groove at a distal end of an elongate body to engage a complementary portion of a deformable member 33 (see 33 in fig. 5 and the unlabeled groove in which it is engaged). 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 connection between 760 and 761 of Pedersen et al. to utilize a groove engaging a complementary portion, as taught by Marshall, for the purpose of providing sufficient structure to attach the two elements together in a known manner.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. in view of Grabenkort (US 5779668).
Regarding claim 13, Pedersen et al. discloses the injection device as claimed, except for specifically disclosing the grooves are circumferentially spaced apart about the longitudinal axis. However, Grabenkort teaches utilizing grooves which are spaced circumferentially about an axis to adjust surface engagement properties between an inner and outer member (see channels 22 in fig. 1-3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pedersen et al. to utilize circumferentially spaced grooves, as taught by Grabenkort, in order to adjust the degree of engagement between the drive component and the damper to a desired profile.
Claim(s) 10 (in the alternative) and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pedersen et al. in view of Sarkorov et al. (US 20190275251).
Regarding claim 10, in the alternative, Sarkarov et al. further teaches forming a contact surface of a damping member by overmolding (par. 0162). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specifically utilize overmolding to form the appropriate portion of the damping member of Pedersen et al., as taught by Sarkorov et al., since such a modification is the result of combining prior art elements according to known methods (overmolding) to yield predictable results (attachment as described in par. 0162 of Sarkorov et al., and required by the combination of elements in Pedersen et al.).
Regarding claim 16, Pedersen et al. discloses the method as claimed, including the damper comprises an elongate body 760 and a damping member 761, except for specifically disclosing the method further comprises: overmolding a deformable damping member onto the elongate body to form the damper. However, Sarkarov et al. teaches forming a contact surface of a damping member by overmolding (par. 0162). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specifically utilize overmolding to form the appropriate portion of the damping member of Pedersen et al., as taught by Sarkorov et al., since such a modification is the result of combining prior art elements according to known methods (overmolding) to yield predictable results (attachment as described in par. 0162 of Sarkorov et al., and required by the combination of elements in Pedersen et al.).
Conclusion
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
