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 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 15, 18, 20-23, and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication No. 2013/0035642 to Daniel.
Regarding claim 15, Daniel teaches a rotator (100, Fig. 5) for a medicament delivery device, the rotator comprising a tubular body (100) extending from a proximal end to a distal end relative to an axis and in a circumferential direction relative to the axis (Fig. 5), and one or more ridges (ridges extending from outer surface of 100 including 104) extending from a surface of the tubular body, the one or more ridges defining a track (101/102) on the surface of the tubular body, the track extending from a distal end of the track to a proximal end of the track relative to the axis (Fig. 5), the track comprising one pathway (102) at the distal end of the track and two pathways (101 and path next to 101 adjacent 104) at the proximal end (106) of the track, wherein the two pathways at the proximal end of the track are separated by a ridge portion of the one or more ridges (a ridge separates the two proximal paths, Fig. 5), and wherein the ridge portion comprises a flexible arm (104).
Regarding claim 18, Daniel teaches the rotator of claim 15 as shown above, Daniel further teaching the flexible arm is arranged so that the flexible arm can be flexed by a protrusion (36, Fig. 1B) of a medicament delivery member guard (30) when in use.
Regarding claim 20, Daniel teaches a medicament delivery device (Figs. 1A-1C) comprising the rotator of claim 15.
Regarding claim 21, Daniel teaches the medicament delivery device of claim 20 as shown above, Daneil further comprising a medicament delivery device activation component (30).
Regarding claim 22, Daniel teaches the medicament delivery device of claim 21 as shown above, Daniel further teaching the medicament delivery device activation component is a medicament delivery member guard (30).
Regarding claim 23, Daniel teaches the medicament delivery device of claim 21 as shown above, Daniel further teaching the medicament delivery device activation component comprises a protrusion (36), and wherein the protrusion is in the track defined by the one or more ridges of the rotator ([0038]).
Regarding claim 25, Daniel teaches the medicament delivery device of claim 22 as shown above, Daniel further teaching the medicament delivery member guard is telescopically arranged inside a housing (11) so that the medicament delivery member guard can move in the distal direction relative to the housing for activation of medicament delivery.
Regarding claim 26, Daniel teaches the medicament delivery device of claim 22 as shown above, Daniel further teaching the medicament delivery member guard is rotationally restricted relative to the housing (once pathway 101 or 102, the delivery member guard is rotationally restricted).
Regarding claim 27, Daniel teaches the medicament delivery device of claim 22 as shown above, Daniel further teaching the rotator is arranged inside the housing so that the rotator is restricted from movement relative to the housing in the direction of the axis (once positioned in 102, continued distal movement is restricted) and is able to rotate relative to the housing when the medicament delivery member guard is moved in the distal direction (the rotator rotates when the guard is moved from 106 distally to 102).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 15-17, 19-21, 24, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of U.S. Patent Publication No. 2010/0268170 to Carrel et al. (“Carrel”).
Regarding claim 15, Daniel teaches a rotator (100, Fig. 5) for a medicament delivery device, the rotator comprising a tubular body (100) extending from a proximal end to a distal end relative to an axis and in a circumferential direction relative to the axis (Fig. 5), and one or more ridges (ridges extending from outer surface of 100) extending from a surface of the tubular body, the one or more ridges defining a track (101/102) on the surface of the tubular body, the track extending from a distal end of the track to a proximal end of the track relative to the axis (Fig. 5), the track comprising one pathway (102) at the distal end of the track and two pathways (101 and path next to 101 adjacent 104) at the proximal end (106) of the track, wherein the two pathways at the proximal end of the track are separated by a ridge portion of the one or more ridges (the ridge between the two proximal paths, Fig. 5), but does not teach a flexible arm.
Carrel teaches a ridge comprising a flexible arm (59, Fig. 4). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a flexible arm into Daniel as taught by Carrel in order to provide a safety mechanism to prevent proximal movement of the peg/protrusion into the same path/intermediate portion ([0104]) from which it came in order to only move into the adjacent proximal path. Both Daniel and Carrel provide two adjacent paths where the protrusion/peg moving within an initial path is designed to subsequently move into the adjacent path without moving back into the initial path, and Carrel teaches a desired safety mechanism that ensures that the protrusion/peg does not move back into the initial path.
Regarding claim 16, Daniel and Carrel teach the rotator of claim 15 as shown above, Carrel further teaching a proximal end of the flexible arm is attached to the rest of the rotator and a distal end of the flexible arm is free to flex relative to the rest of the rotator (Fig. 4).
Regarding claim 17, Daniel and Carrel teach the rotator of claim 15 as shown above, Carrel further teaching the flexible arm is arranged so that the flexible arm can flex in a circumferential direction relative to the axis (Fig. 4, the tip of 59 flexes in a circumferential direction).
Regarding claim 19, Daniel and Carrel teach the rotator of claim 15 as shown above, Carrel further teaching the flexible arm comprises a proximal portion (thin part of 59) that extends parallel to the axis and a distal portion (angle formed by thicker portion of 59) that extends at an angle relative to the axis.
Regarding claim 20, Daniel and Carrel teach a medicament delivery device (Daniel, Figs. 1A-1C) comprising the rotator of claim 15 (as shown above).
Regarding claim 21, Daniel and Carrel teach the medicament delivery device of claim 20 as shown above, Daniel further comprising a medicament delivery device activation component (30).
Regarding claim 24, Daniel and Carrel teach the medicament delivery device of claim 21 as shown above, Daniel further teaching the track on the surface of the tubular body is shaped so that a distal movement of the medicament delivery device activation component of the medicament delivery device relative to the rotator results in the protrusion moving from a first (101) of the two pathways at the proximal end of the track to the pathway (102) at the distal end of the track by flexing the flexible arm.
Regarding claim 28, Daniel and Carrel teach the medicament delivery device of claim 23, Carrel further teaching the flexible arm is arranged so that, during use of the medicament delivery device, the protrusion moves out of a first (Daniel 101) of the two pathways at the proximal end of the track and is restricted from moving back into the first of the two pathways at the proximal end of the track by the flexible arm (once modified by the arm of Carrel).
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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