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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rotator” and “medicament container holder” recited in Claim 29 must be shown or the features canceled from the claim. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 17 and 23-30 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 17 recites “the second spring supports”. There is insufficient antecedent basis for this limitation in the claim. Similarly, claim 23 recites “the at least two second spring supports” which lacks antecedent basis. Appropriate action is required.
Regarding Claim 24, the recited “plunger rod” on line 6 renders the claim indefinite because it is unclear whether the plunger rod is the same plunger rod from claim 16, in which this claim depends on. Likewise, “the plunger rod support” on line 7, the “drive spring” and the “second spring support” on line 8, the “first spring support” on line 10 and the “activation button” on line 13” render the claim indefinite. Under broadest reasonable interpretation, the examiner interprets the limitations as defined in claim 16 and recommends amending the claim to clearly distinguish between the components listed in claims 16 and 24 if they are separate features.
Additionally, Claims 25-26 recite "the rear subassembly of claim 14", however, claim 14 is canceled. There is insufficient antecedent basis for these claims as they depend on a canceled claim. Under broadest reasonable interpretation, the examiner will interpret these claims as dependent on claim 24. Appropriate action is required.
Claims 25-30 are rejected by virtue of dependency on claim 24.
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 16-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grunhut et al. (US 20100262083 A1, herein, Grunhut).
Regarding claim 16, Grunhut discloses an inner tubular body (inner cylinder 32 – Fig.2) for a medicament delivery device (device 1 – Fig.2), wherein the inner tubular body extends along a longitudinal axis from a proximal end to a distal end, the inner tubular body comprising (“device 1 has a longitudinal axis designated by the letter A on the figures”, see para [0081], Fig.2):
a distal part and a proximal part (“inner cylinder 32 is also provided at its distal end with outer flexible tongues 34 extending in the proximal direction and having proximal ends 34a”, see para [0083], Fig.2),
wherein the distal part comprises a flexible arm (flexible legs 33 – Fig.3) extending distally, wherein the flexible arm comprises a first spring support (protrusion of 33 – Fig.3) at the distal end of the flexible arm and a plunger rod support (inclined end surface of 33) at the distal end of the flexible arm, wherein the first spring support is inclined in a radially inward direction and is configured to support a distal end of a drive spring (first spring 100 – Fig.7) of the medicament delivery device when the medicament delivery device (device 1 – Fig.2) is in a non-activated state (“the flexible legs 33 of the inner cylinder 32 of the top body 30a are engaged in the abutment rim 72 of the piston rod 70”, see para [0100], Fig.7), the distal part further comprising a second spring support (radial rim 31 – Fig.2) extending distally and being configured to support the distal end of the drive spring (first spring 100 – Fig.7) of the medicament delivery device (device 1 – Fig.2) when the medicament delivery device is in an activated state (Fig.25),
wherein the plunger rod support (inclined end surface of 33) is configured to engage with a plunger rod (piston rod 70 – Fig.2) of the medicament delivery device (device 1 – Fig.2) in order to inhibit a proximal movement of the plunger rod (piston rod 70 – Fig.2) when the medicament delivery device is in the non-activated state (“flexible legs 33 of the inner cylinder 32 of the top body 30a are engaged in the abutment rim 72 of the piston rod 70….act as third retaining means for maintaining the first spring 100 in its compressed condition”, see paras [0100]-[0101], Figs.7-8), and
wherein the first spring support (protrusion of 33 – Fig. 3) is configured to interact with an activation button (push button 80 – Fig. 2) that is at a distal end of the medicament delivery device (device 1 – Fig.2), with triggering of said activation button allowing a radial outward deflection of the flexible arm thereby disengaging the plunger rod support from the plunger rod and disengaging the first spring support (protrusion of 33 – Fig.25) from the distal end of the drive spring (“by pushing distally on the push button 80, the inner legs 82 of the push button 80 deflect the flexible legs 33 of the top body 30a and therefore free the spring 100 which extends in the distal direction” see para [0117], Fig.25).
Regarding claim 17, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein the flexible arm (flexible legs 33 – Fig.25), and the second spring supports (radial rim 31 – Fig.24) are spaced apart so that the flexible arm (flexible legs 33 – Fig.25) can move relative to the second spring supports (deflected flexible legs 33 as shown in Fig.25).
Regarding claim 18, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein the second spring support (radial rim 31 – Fig.7) comprises a second spring support surface, spaced apart in the distal direction with respect to a first spring support surface of the first spring support (protrusion of flexible legs 33 – Fig.8) such that, when in the non-activated state, the distal end of the drive spring (first spring 100 – Fig.7) is supported by the first spring support surface and the distal end of the drive spring is spaced apart by a distance from the second spring support surface ( “the radial rim 31 and the outer rim 71 on one hand, and the flexible legs 33 and the abutment rim 72 on the other hand, act as third retaining means for maintaining the first spring 100 in its compressed condition”, see para [0101], Figs.7-8).
Regarding claim 19, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein when in the activated state the flexible arm (flexible legs 33 – Fig.25) is configured to flex outwardly and disengage the drive spring (first spring 100 – Fig.25) in the distal direction such that the distal end of the drive spring (first spring 100 – Fig.25) abuts the second spring support surface thereby the distal end of the drive spring has been displaced by the distance in the distal direction (“by pushing distally on the push button 80, the inner legs 82 of the push button 80 deflect the flexible legs 33 of the top body 30a and therefore free the spring 100 which extends in the distal direction in view of returning to an uncompressed condition. By extending, the spring 100 draws with him the container 20 which, because it is in its active state, is allowed to move distally”, see para [0117], Fig.25).
Regarding claim 20, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein each plunger rod support (inclined end surface of 33, Fig.3) has a radially inwards extending protrusion configured to form a stop surface for engagement with a distal portion of the plunger rod (abutment rim 72, Figs.2-3).
Regarding claim 21, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein each first spring support (protrusion of 33 – Fig. 7) comprises a protrusion or step extending radially inwards and having a proximally facing support surface configured to support the distal end of the drive spring (first spring 100 – Fig.7).
Regarding claim 22, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein when in the activated state the distal end of the drive spring (first spring 100 – Fig.12) exerts a radially outwardly directed force on the flexible arm (flexible legs 33 – Fig.12) such that the flexible arm is further pushed outwardly, thereby abutting inwardly inclined surfaces of inwardly extending protrusions of an activation button (push button 80 – Fig.12) such that the activation button is prevented from moving in the distal direction (“the container 20 is now in its active state. In this position, as shown on FIG. 13, the distal end 81b of the distal leg 81 of the push button 80 still faces the proximal end 34a of the flexible tongue 34 of the inner cylinder 32 of top body 30a of the housing 30. Distal movement of the push button 80 is therefore still restricted”, see para [0109], Fig.13).
Regarding claim 23, Grunhut discloses the inner tubular body (inner cylinder 32 – Fig.2) of claim 16, wherein the flexible arm (flexible legs 33 – Fig.3) and the at least two second spring supports (radial rim 31 – Figs.7-8) are alternately arranged in the circumferential direction (under the broadest reasonable interpretation, the examiner interprets the spring supports to be located in the space between the flexible arms (“the radial rim 31 and the outer rim 71 on one hand, and the flexible legs 33 and the abutment rim 72 on the other hand, act as third retaining means for maintaining the first spring 100”, see para [0101], Figs.7-8)).
Regarding claim 24, Grunhut discloses a rear subassembly (top body 30a – Fig.2) for a medicament delivery device (device 1 – Fig.2), the rear subassembly comprising:
a distal housing (“housing 30 comprising a top body 30a”, see para [0082], Fig.2);
the inner tubular body (inner cylinder 32 – Fig.2) according to claim 16, wherein the tubular body is coaxially arranged within the distal housing (top body 30a – Fig.2);
a plunger rod (piston rod 70 – Fig.2) coaxially arranged within the inner tubular body (inner cylinder 32 – Fig.2) and releasably connected to the plunger rod support (inclined end surface of 33 – Fig.3) of the inner tubular body;
a drive spring (first spring 100 – Fig.3) coaxially arranged between the plunger rod (piston rod 70 – Fig.2) and second spring supports (radial rim 31 – Fig.2) of the inner tubular body (inner cylinder 32 – Fig.2), wherein a distal end of the drive spring is supported by the first spring support (protrusion of 33 – Fig.3) when in a first non-activated state (Fig.7) or the distal end of the drive spring is supported by the second spring supports when in a second activated state and a proximal end of the drive spring is supported by a proximal ledge of the plunger rod;
an activation button (push button 80 – Fig.2) connected to the distal housing (top body 30a – Fig.2), wherein the activation button comprises a radially inwardly extending protrusion (distal leg 81 – Fig.7), the radially inwardly extending protrusion comprising a radially inwardly inclined surface (distal end 81b – Fig.7), wherein the inclined surface is facing in the distal direction, the protrusion comprising a step extending radially inwards (distal end 81b – Fig.7), the step having a proximally facing support surface configured to support a radially outwardly extending protrusion of the flexible arm when the medicament delivery device is in the non-activated state (“the distal end 81b of the distal leg 81 and the proximal end 34a of the flexible 34 act as second retaining means for maintaining the device 1 in a passive state”, see para [0099], Fig.7); and
a distal spring (first spring 100 – Fig.3) arranged between the activation button (push button 80 – Fig.2) and the inner tubular body (inner cylinder 32 – Fig.2), wherein the distal spring is configured to apply a biasing force on the inner tubular body (“the injection is completed by virtue of first spring 100 acting as a biasing means on the piston rod 70”, see para [0123], Figs.29-31).
Regarding claim 25, Grunhut discloses the rear subassembly (top body 30a – Fig.2) of claim 14, wherein the activation button (push button 80 – Fig.) comprises a guide hole along the longitudinal axis of the medicament delivery device configured to axially guide the distal end of the plunger rod when the inner tubular body is distally displaced (under broadest reasonable interpretation, examiner interprets the gap/opening in between the inner legs 82 of the push button as the axially guide along the longitudinal axis A, see annotated Fig.11 below).
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Expanded top portion of Figure 11 Grunhut
Regarding claim 26, Grunhut discloses the rear subassembly (top body 30a – Fig.2) of claim 14, wherein the activation button comprises a displacement structure (inner legs 82 – Fig.25) configured to interact with an inclined distal end surface of the flexible arm (flexible legs 33 – Fig.25) in order to radially deflect the flexible arm such that the plunger rod support is disengaged from the plunger rod when the inner tubular body is distally displaced (“the inner legs 82 of the push button 80 deflect the flexible legs 33 of the top body 30a and therefore free the spring 100 which extends in the distal direction”, see para [0117], see annotated Fig.25 below).
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Expanded top portion of Figure 25 of Grunhut
Regarding claim 27, Grunhut discloses the rear subassembly (top body 30a – Fig.2) of claim 26, wherein the displacement structure (inner legs 82 – Fig.25) is rigid and is radially inclined, preferably with the same angle of inclination as the inclined end surface of the flexible arm (flexible legs 33, see annotated Fig.25 above).
Regarding claim 28, Grunhut discloses a medicament delivery device (device 1 – Fig.2) comprising a distal subassembly and a proximal subassembly (“the device 1 further comprises a housing 30 comprising a top body 30a and a bottom body 30b”, see para [0082], Fig.2), wherein the distal subassembly is a rear subassembly (top body 30a – Fig.2) according to claim 24.
Regarding claim 29, Grunhut discloses the medicament delivery device (device 1 – Fig.2) of claim 28, wherein the proximal subassembly (bottom body 30b – Fig.2) comprises:
a proximal housing (bottom body 30b – Fig.2) connectable to the distal housing (“device 1 further comprises a housing 30 comprising a top body 30a and a bottom body 30b, said top and bottom bodies being coupled together after assembly”, see para [0082], Fig.2);
a rotator (cam 26 – Fig.6) coaxially connected to a distal inner part of the proximal housing and movable in relation to the proximal housing (“the bottom body 30b is provided in its proximal region with a cam 36”, see para [0085], Fig.6);
a displaceable medicament delivery member cover (safety shield 40 – Fig.1) partially arranged within the proximal housing (bottom body 30b – Fig.2);
a medicament container holder (container 20 – Fig.2) connected to the medicament delivery member cover (safety shield 40 – Fig.2) and configured to receive a medicament container (“said container 20 being intended to receive a product 2 to be injected”, see para [0081], Fig.2); and a medicament delivery member cover spring (second spring 110 – Fig.3) disposed between the medicament delivery member cover (safety shield 40 – Fig.2) and the medicament container holder (container 20 – Fig.2) and configured to apply a biasing force to the medicament delivery member cover (“return means (110) for biasing the safety shield (40) from its third position to its second position after activation of the triggering means (80) but before the container (20) reaches its insertion position”, see claim 10),
wherein the medicament delivery member cover (safety shield 40 – Figs.33,36) is axially movable inside at least the proximal housing (bottom body 30b – Fig.36) such that a distal end of the medicament delivery member cover (safety shield 40 – Figs.33,36) contacts the contact surface of the inner tubular body (inner cylinder 32 – Fig.11) whereby the inner tubular body is distally displaced (“as shown on FIGS. 35-39, the safety shield 40 has moved from its fourth position to its fifth position and it now covers the needle 3… the safety shield 40 is now locked in its fifth position by means of flexible tongues 42 being blocked against the radial projections 35 of the bottom body 30b in the proximal direction”, see paras [00125]-[0126]).
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.
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.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Grunhut in view of Shabudin (US 11364342 B2, herein, Shabudin).
Regarding claim 30, Grunhut discloses the medicament delivery device of claim 28, recited above.
Grunhut does not appear to expressly disclose wherein the medicament delivery device is a disposable single-dose auto-injector.
Shabudin teaches that it is known in the art for a medicament delivery device to be a disposable single-dose auto-injector (“the invention relates to an autoinjector type device… such devices may be either single use “disposable” devices”, see Col.1 lines 15-32).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the medicament delivery device disclosed by Grunhut so that it can be used as a disposable single-dose auto-injector, as taught by Shabudin in order to improve “the convenient administration of medicaments” (Shabudin, see Col.1 lines 21-22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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