DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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 second locking structure (claim 1) must be shown or the feature(s) canceled from the claim(s). 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 Objections
Claim 20 is objected to because of the following informalities:
line 2 should be amended to -at least one flexible arm having a hook-shaped end-.
line 4 should be amended to - he hook-shaped end of the at least one flexible arm in a releasably engaging manner-. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: line 6 should be amended to - inserting [[a]] the medicament container in the medicament container carrier to provide a-. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: line 6 should be amended to - inserting [[a]] the medicament container in the medicament container earner to provide a-. 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 19, 21, 22 and 27-30 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.
Regarding claim 19:
The claim limitation “the protrusion, and the second locking structure comprises the other one of the recess and the protrusion” in lines 3-4 are unclear. The term “the protrusion” in the limitation is unclear since a protrusion structure has been established in line 2 of claim 19 and in 15 of claim 1 raising a question of which protrusion structure this limitation refers to. for the sake of examination, the office has assumed that this limitation refers to the protrusion structure established in claim 19 however the applicant should amend the claim to clarify.
Regarding claim 21:
The claim limitation “wherein the protrusion of the second engaging structure is a circumferential protrusion” in lines 1-2 are unclear. The term “the protrusion” in the limitation is unclear since a protrusion structure has been established in line 2 of claim 19 and in 15 of claim 1 raising a question of which protrusion structure this limitation refers to. for the sake of examination, the office has assumed that this limitation refers to the protrusion structure established in claim 19 however the applicant should amend the claim to clarify.
Regarding claim 22:
The claim limitation “a hooked-shaped end engageable with the protrusion of the second engaging structure” in lines 3-4 are unclear. The term “the protrusion” is unclear for the same reason established in claim 21 rejection above. The office has taken the same interpretation.
Regarding claim 27:
The claim limitation “A kit of parts comprising an external fixture and a sub-assembly of a medicament delivery device configured to expel medicament from a medicament container, the sub-assembly comprising” in lines 1-3 are unclear. It’s unclear if the structure of the external fixture and the sub-assembly are positively claimed since they appear to be within the preamble of the claim. For the sake of examination, the office has assumed that the structure of the external fixture and the sub-assembly are positively claimed however the applicant should amend the claim to clarify.
Claims 28-30 are rejected due to their dependence on claim 27.
Regarding claim 29:
The claim recites the limitation "the associated recess" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 is rejected due to its dependence on claim 29.
Regarding claim 30:
The claim recites the limitation "the associated recess" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 16-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120203186 A1 to Vogt et al. (Vogt).
Vogt discloses:
Regarding claim 16:
A sub-assembly for a medicament delivery device (figure 2a) configured to expel medicament from a medicament container (5), the sub-assembly comprising:
a housing (1) having a proximal end (see end B in figure 1 below) and a distal end (see end A in figure 1 below); and
a medicament container carrier (4) extending along a longitudinal axis (axis through the center of 4) from a proximal end (end C in figure 1 below) to a distal end (end D in figure 1 below), the medicament container carrier (4) comprising:
a carrier wall (4) having an open proximal end (end D in figure 1 below), at least one slot (slot F in figure 1 below) extending from the open proximal end in a distal direction (extends toward C in figure 1 below), and at least a first leg portion (G in figure 1 below) and a second leg portion (E in figure 1 below) radially separated by the at least at the open proximal end (as shown in figure 1 below) such that the first and second leg portions (G and E in figure 1 below) are radially movable relative to each other (inherent since they snap into 12);
a tubularly shaped retaining element (12/11) extending along a longitudinal axis (axis through the center of 12/11) from a proximal end (12f) to a distal end (12c), the retaining element (12/11) comprising a proximal end portion (12f) extending distally from the proximal end, a distal end portion (12c) extending proximally from the distal end, and an inner surface (12c/12a/12b) adjacent to the first and second leg portions (G and E in figure 1 below) to radially support the first and second leg portions (inserted into the legs as shown in figure 2a and since 12b snaps into the legs G and E in figure 1 below); and
a cap (3) arranged at least partly proximal the housing (1), the cap (3) comprising a protrusion (3b/3a) extending distally into the proximal end of the housing (1),
wherein the distal end portion (12c) of the retaining element (12/11) comprises a first locking structure (12a/12b) lockable with an associated second locking structure (4a) extending from at least one of the first and second leg portions (G and E in figure 1 below) of the carrier wall (4)(¶0061), such that the retaining element (12/11) is locked to the open proximal end (F in figure 1 below) of the carrier wall (4) by means of the first and second locking structures (12a/12b and 4a)(¶0061), and wherein the proximal end portion (12f) of the retaining element (12/11) comprises a first engaging structure (12f/12e) releasably engageable with an associated second engaging structure (3a) of the distally extending protrusion (3b/3a), such that the retaining element (12/11) is releasably engaged to the distally extending protrusion (3a/3b)(as shown in figure 2c).
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Figure 1 – figure 2a of Vogt, annotated by the examiner
Regarding claim 17:
The sub-assembly according to claim 16, being configured to move from a pre-activation preventing state (as shown in figure 3a where 12/11 is connected with the cap 3) in which the retaining element (12/11) is releasably engaged to the distally extending protrusion (3b/3a), into an activation admittible state (state as shown in figure 4a where the cap 3 is removed) in which the cap (3) is removed and the distally extending protrusion (3b/3a) is released from the retaining element (12/11) by the release of the first engaging structure (12f/12e) from the second engaging structure (3a).
Regarding claim 18:
The sub-assembly according to claim 16, wherein the first and second locking structures (12a/12b and 4a) are configured as a snap-lock (see the snap lock features as shown in figures 2b and 2a).
Regarding claim 19:
The sub-assembly according to claim 18, wherein the snap-lock comprises a recess and a protrusion configured to be snap-locked into the recess, wherein the first locking structure (12a/12b) comprise the recess or the protrusion (protrusion 12b as shown in figure 2b), and the second locking structure (4a) comprises the other one of the recess (recess 4a as shown in figure 2b) and the protrusion.
Regarding claim 20:
The sub-assembly according to claim 18, wherein the first engaging structure (12f/12e) comprises at least one flexible arm (as shown in figure 2b) having a hooked-shaped end (12e as shown in figure 2b), and the second engaging structure (3a) comprises a protrusion (3a) configured to engage with the hook-shaped end (12e) of the flexible arm in a releasably engaging manner (releasable as shown in figure 4a).
Regarding claim 21:
The sub-assembly according to claim 20, wherein the protrusion (3a as shown in figure 2b) of the second engaging structure (3a) is a circumferential protrusion (extends in a circumferential direction).
Regarding claim 22:
The sub-assembly according to claim 20, wherein the first engaging structure (12f/12e) comprises a plurality of flexible arms (arms 12e that deflect to receive 3a) arranged around the periphery (as shown in figure 2b) of the retaining element (12/11), each one of the flexible arms having a hooked-shaped end (see the hooked shaped 12e) engageable with the protrusion (as shown in figure 2c) of the second engaging structure (3a).
Regarding claim 23:
The sub-assembly according to claim 16, wherein the locking between the retaining element (12/11) and the open proximal end of the carrier wall (4) by means of the first and second locking structures (12a/12b and 4a), are stronger than the releasable engagement of the retaining element (12/11) and the distally extending protrusion (3b/3a) of the cap (3) by means of the first and second engaging structures (12f/12e and 3a)(as shown in figure 4a the cap separates from 11/12 indicating the connection between 12a/12b and 4a is greater than the connection between 12/12e and 3a).
Regarding claim 24:
The sub-assembly according to claim 23, wherein the first and second engaging structures (12f/12e and 3a) are configured to be released from each other upon an applied threshold force to the cap (3) in the proximal direction (as shown in figure 4a where cap 3 is removed), wherein the first and second locking structures (12a/12b and 4a) are configured to remained locked to each other upon the application of the threshold force to the cap (3) in the proximal direction (as shown in figure 4a since 12/11 remain connected with 4).
Regarding claim 25:
A method of assembly of the sub-assembly according to claim 16, wherein the method comprises:
providing the retaining element (12/11) in the housing (1)(as shown in figure 3a), the retaining element (12/11) being releasably engaged to the distally extending protrusion (3b/3a) of the cap (3) by means of the first and second engaging structures (12f/12e and 3a)(as shown in figure 2c);
inserting a medicament container (5) in the medicament container carrier (4) to provide a medicament container sub-assembly (4), the medicament container (5) comprising a delivery member (5/5e) for expelling a medicament (product within 5) and a shield (6) covering the delivery member (as shown in figure 3a);
inserting the medicament container sub-assembly (4) into the housing (1) such that the medicament container (5) is arranged in a final proximal position (position as shown in figure 3a) within the housing (1), wherein the retaining element (12/11) is locked to the open proximal end of the carrier wall (4) by means of the first and second locking structures (12a/12b and 4a)(as shown in figure 3a), and wherein the inner surface (12c/12a/12b) of the retaining element (12/11) is arranged adjacent to the first and second leg portions (G and E in figure 1 above) of the carrier wall (4) to radially support the first and second leg portions (G and E in figure 1 above) to prevent the first and second leg portions (G and E in figure 1 above) from moving radially outwards (as shown in figure 3a).
Regarding claim 26:
The method according to claim 25, wherein the carrier wall (4) comprises a proximal supporting collar (11) arranged around an inner periphery of the carrier wall (4), and wherein the step of inserting the medicament container (5) in the medicament container carrier (4) is performed such that the shield (6) passes the open proximal end (end D in figure 1 above) (as shown in figure 3a) and a neck (end of 5) of the medicament container (5) is supported by the proximal supporting collar (11)(as shown in figure 3a since the end of 5 is supported by 11).
Regarding claim 27:
A kit of parts comprising an external fixture (3) and a sub-assembly of a medicament delivery device (figures 1 and 2a) configured to expel medicament from a medicament container (5), the sub-assembly comprising:
a housing (1) having a proximal end (see end B in figure 1 above), a distal end (see end A in figure 1 above) and a window (see the window shown in figure 1 in housing 1) arranged between the proximal and distal ends (A and B in figure 1 above);
a medicament container carrier (4) extending along a longitudinal axis (axis through the center of 4) from a proximal end (end C in figure 1 above) to a distal end (end D in figure 1 above), the medicament container carrier (4) comprising:
a carrier wall (4) having an open proximal end (end D in figure 1 above), at least one slot (slot F in figure 1 above) extending from the open proximal end in a distal direction (extends toward C in figure 1 above), and at least a first leg portion (G in figure 1 above) and a second leg portion (E in figure 1 above) radially separated by the slot (slot F in figure 1 above) at least at the open proximal end (as shown in figure 1 above) such that the first and second leg portions (G and E in figure 1 above) are radially movable relative each other (inherent since they snap into 12); and
a tubular shape retaining element (12/11) extending along a longitudinal axis (axis through the center of 12/11) from a proximal end (12f) to a distal end (12c), the retaining element (12/11) comprising a proximal end portion (12f) extending distally from the proximal end, a distal end portion (12c) extending proximally of the distal end, and inner surface (12c/12a/12b) arranged adjacent to the first and second leg portions (G and E in figure 1 above) to radially support the first and second leg portions (G and E in figure 1 above) (inserted into the legs as shown in figure 2a and since 12b snaps into the legs G and E in figure 1 below), wherein the distal end portion (12c) of the retaining element (12/11) comprises a protrusion (12a/12b) extending radially outwards from an outer surface of the distal end portion (12c) (as shown in figure 2b);
wherein the external fixture (3) is configured to move the retaining element (12/11) into its final position within the housing (1) (as shown in figure 3a the retaining element 12/11 is held in its position by 3).
Allowable Subject Matter
Claims 28-30 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20120053528-A1
Bollenbach
See the retaining element 112
WO-2010136078-A1
VOGT
See the retaining element 12
WO-2013124119-A1
SOERENSEN
See the leg portion 144
WO-2014187814-A1
SØRENSEN
See leg portions of 330 and retaining element 320
EP-3695863-A1
SCHRUL
See the leg portion 14a
WO-2021067209-A1
FINKELSTEIN
See the leg portion 32
WO-2021115706-A1
CHEN
See the leg portion 12/22
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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