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 22 is objected to because of the following informalities: Claim 22 recites: “wherein the distal directed surface is defined on an inner edge of the annular protrusion.” The phrase “distal directed surface” appears to be an informal wording of “distally directed surface,” as recited in claim 19. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20, 24-30 and 34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites: “wherein the housing comprises at least two protrusions, and wherein a distal opening of the housing is defined between the two protrusions.” The phrase “the two protrusions” is unclear because the claim first recites “at least two protrusions,” which encompasses more than two protrusions, but then refers to “the two protrusions” without specifying which two protrusions define the distal opening.
Claim 24 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites: “wherein the inner wall extends from the distal opening towards the proximal end of the housing, wherein the protrusion extends from the inner wall of the housing to an outer wall of the housing.” Claim 24 depends from claim 20, which recites “at least two protrusions,” and therefore the phrase “the protrusion extends” is ambiguous as to whether one protrusion, each protrusion, or all of the protrusions extend from the inner wall to the outer wall. Claims 25-28, which depend directly or indirectly from claim 24, are rejected under 35 U.S.C. 112(b) because they depend from and therefore incorporate the indefiniteness of claim 24.
Claim 26 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites: “configured to interact with the click element of the housing to generate an audible/tactile indication.” The phrase “audible/tactile indication” is ambiguous because the slash does not clearly indicate whether the claim requires an audible indication, a tactile indication, both an audible and tactile indication, or either one.
Claim 29 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites: “wherein the protrusion of the plunger rod comprises the counter click element.” Claim 19 recites that “the flexible arm comprises a protrusion,” not a separately identified “protrusion of the plunger rod,” and therefore the phrase “the protrusion of the plunger rod” lacks clear antecedent basis and creates ambiguity as to whether the claim refers to the protrusion of the flexible arm or another protrusion on the plunger rod.
Claim 30 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites: “wherein the click element of the plunger rod is a cut-out/recess in a sidewall of the flexible arm.” Claim 26 recites a “counter click element” on the flexible arm of the plunger rod, but claim 30 refers to “the click element of the plunger rod,” which lacks antecedent basis and is inconsistent with the terminology used in claim 26.
Claim 34 is rejected under 35 U.S.C. 112(b) as indefinite because the claim recites: “wherein the actuator extends from the tubular section towards the distal end of the housing.” Claim 34 depends from claim 32, which recites a delivery member cover, but does not recite “the tubular section.” Therefore, “the tubular section” lacks antecedent basis unless claim 34 depends from claim 33 or independently introduces the tubular section.
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.
Claim(s) 19-25, 31-34 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2011/075524 A1 to Shang.
As to claim 19, Shang discloses a sub-assembly of a medicament delivery device (10’), the sub-assembly comprising: a housing (12b) extending along a longitudinal axis between a distal end and a proximal end, wherein the housing comprises a protrusion (12c) extending in a direction transverse to the longitudinal axis, wherein the protrusion comprises a distally directed surface (fig 10b); an actuator (34) comprising a support wall extending towards the proximal end of the housing; a plunger rod (700’) comprising a flexible arm (788a’/788b’) extending towards the distal end of the housing, wherein the flexible arm comprises a protrusion (789’) extending radially outwardly relative to the longitudinal axis, wherein the protrusion comprises a proximally directed surface adjacent to the distally directed surface of the housing (fig 8), wherein the flexible arm is arranged between the support wall of the actuator and an inner wall of the housing in a direction transverse to the longitudinal axis (fig 10b); and a biasing member (88) extending in the direction of the longitudinal axis between a proximally directed surface of the housing and a distally directed surface of the plunger rod, wherein the actuator is axially moveable relative to the housing between a proximal position where the support wall is adjacent to an inner surface of the flexible arm of the plunger rod and a distal position where the support wall is axially offset to the inner surface of the flexible arm (pg 43, lines 18-24; figs 11a-11c).
As to claim 20, Shang discloses the sub-assembly according to claim 19, wherein the housing comprises at least two protrusions (12c), and wherein a distal opening of the housing is defined between the two protrusions (fig 10b).
As to claim 21, Shang discloses the sub-assembly according to claim 19, wherein the protrusion of the housing is an annular protrusion, and wherein a distal opening of the housing is defined in a surrounded center of the annular protrusion (fig 10b).
As to claim 22, Shang discloses the sub-assembly according to claim 21, wherein the distal directed surface is defined on an inner edge of the annular protrusion (fig 10b).
As to claim 23, Shang discloses the sub-assembly according to claim 20, wherein the flexible arm of the plunger rod protrudes through the distal opening of the housing (fig 10b).
As to claim 24, Shang discloses the sub-assembly according to claim 20, wherein the inner wall extends from the distal opening towards the proximal end of the housing, wherein the protrusion extends from the inner wall of the housing to an outer wall of the housing (fig 10b).
As to claim 25, Shang discloses the sub-assembly according to claim 24, wherein the flexible arm of the plunger rod extends along the inner wall of the housing towards the distal end of the housing (fig 10b).
As to claim 31, Shang discloses the sub-assembly according to claim 19, wherein the protrusion of the flexible arm of the plunger rod extends from a distal end of the flexible arm (fig 8).
As to claim 32, Shang discloses the sub-assembly according to claim 19, wherein the sub-assembly comprises a delivery member cover (12d) axially movable relative to the housing.
As to claim 33, Shang discloses the sub-assembly according to claim 32, wherein the delivery member cover comprises a tubular section configured to surround a medicament delivery member of the medicament delivery device (fig 9).
As to claim 34, Shang discloses the sub-assembly according to claim 32, wherein the actuator extends from the tubular section towards the distal end of the housing (fig 9).
As to claim 36, Shang discloses the sub-assembly according to claim 19, wherein at least one of the distally directed surface of the housing and the proximally directed surface of the plunger rod is bevelled (fig 11a).
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.
Claim(s) 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Shang as rejected in claim 19 above in view of WO 2012/022810 A2 to Pederson et al.
As to claim 26, Shang discloses the sub-assembly according to claim 25 substantially as claimed, however fails to disclose a click element. Pederson et al disclose wherein the inner wall of the housing (370) comprises a click element (374), and wherein the flexible arm of the plunger rod (310) comprises a counter click element (315) configured to interact with the click element of the housing to generate an audible/tactile indication (pg 16, lines 28-32; figs 3b, 4b, 5b). Hence it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the inner wall of the distal housing component of Shang with the flexible arm that can interact with a protrusion as taught by Pederson et al for the purpose of generating an audible/tactile feedback to indicate release of the plunger.
As to claim 27, Shang as modified by Pederson et al, Pederson et al disclose the sub-assembly according to claim 26, wherein the click element of the housing is a protrusion facing towards the longitudinal axis (fig 3b).
As to claim 28, Shang as modified by Pederson et al, Pederson et al disclose the sub-assembly according to claim 26, wherein the inner wall of the housing comprises a flexible tab, and wherein the click element of the housing is arranged on the flexible tab (pg 16, lines 28-32).
As to claim 29, Shang as modified by Pederson et al, Pederson et al disclose the sub-assembly according to claim 26, wherein the protrusion of the plunger rod comprises the counter click element (fig 3b).
As to claim 30, Shang as modified by Pederson et al, Pederson et al disclose the sub-assembly according to claim 26, wherein the click element of the plunger rod is a cut-out/recess in a sidewall of the flexible arm (fig 3b).
Allowable Subject Matter
Claim 35 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art of record does not disclose the sub-assembly according to claim 32, wherein the sub-assembly is arranged so that, when the delivery member cover is moved in the distal direction relative to the housing, the delivery member cover abuts the actuator, thereby moving the actuator from the proximal position to the distal position, which allows the flexible arm to move towards the longitudinal axis, thereby releasing the plunger rod to be moved in the proximal direction by the biasing member.
Conclusion
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/IMANI N HAYMAN/Supervisory Patent Examiner, Art Unit 2841
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