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 .
Claims 1-15 are cancelled.
Claims 16-30 are new.
Claims 16-30 are being examined in this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the proximally directed surface of the tubular housing and a distally directed surface of the delivery member cover as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Specification
The disclosure is objected to because of the following informalities:
Page 9 line 7, there appears to be unnecessary spacing in the word “tongue”.
Reference numeral 32 is used to refer to both a flexible section and a protrusion, Page 8 line 24 and Pages 12 on.
Appropriate correction is required.
Claim Objections
Claims 17-19, 28, 29, and 30 are objected to because of the following informalities:
Claim 17 recites the limitation “bevelled” in line 2, this appears to be a typographical error and should read “beveled”.
Claims 17, 19, 28, and 29 recite the limitation “the housing”. Examiner recommends keeping the language consistent across the claims, i.e. “the tubular housing”.
Claim 30, recites the limitation “wherein the fastener and the counter fastener formed a bayonet connection” this should read “wherein the fastener and the counter fastener form.
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 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 16 recites the limitation “the proximal direction” in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “the flexible wall” in lines 9 and 11. It is unclear which flexible wall this is referring to, whether it is the flexible wall of the delivery member or the flexible wall of the cap. For examination purposes, Examiner interprets “the flexible wall” to be referring to the flexible wall of the cap.
Claim 22 recites the limitation “the direction transverse to the longitudinal axis” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the direction transverse to the longitudinal axis” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation “the direction transverse to the longitudinal axis” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation “the outside” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation “the medicament delivery device” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation “the direction transverse to the longitudinal axis” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation “the drive unit” in line 2. There is insufficient antecedent basis for this limitation in the claim.
All remaining claims are rejected by virtue of their dependence on a rejected claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-23 and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daniel (Pub. No. US 20190001065 A1)
Regarding Claim 16, Daniel discloses a sub-assembly of a medicament cassette unit (Fig. 3), the sub-assembly comprising:
a tubular housing (102);
a cap (132); and
a delivery member cover (118),
wherein the tubular housing extends along a longitudinal axis (between 132 and 156 in Fig. 3) between a proximal end (end at 132 in Fig. 3) and a distal end (end at 156 in Fig. 4), wherein the tubular housing is configured to receive a medicament container (104, Fig. 3);
wherein the delivery member cover comprises a tubular section (120) arranged telescopically relative to the proximal end of the tubular housing (Paragraph [0057], Fig. 3), wherein the delivery member cover comprises a distally directed surface (where proximally directed surface of 252 interfaces with 260, Fig. 32),
wherein the cap is releasably attached to the tubular section of the delivery member cover (Paragraph [0090], Fig. 29), wherein the cap comprises a proximally directed surface (See annotated Fig. 28B below) adjacent to the distally directed surface of the delivery member cover (Figs 29-31), and
wherein the delivery member cover is movable between a first position where the distally directed surface of the delivery member cover is adjacent to the proximally directed surface of the cap (Paragraph [0065], Fig. 5) and a second position where the distally directed surface of the delivery member cover is away from the proximally directed surface of the cap such that the cap can be removed from the delivery member cover by being moved in the proximal direction relative to the delivery member cover (When removable cap 132 has been unlocked, “FIG. 6 illustrates outwardly protruding element 180 moved out of engagement with the inwardly protruding element 182. After these elements have been moved out of engagement with each other, the device 100 is unlocked and the removable cap 132 and delivery member shield unit 118 are movable in the distal direction indicated by arrow 183. In order to move the cap 132 and the delivery member shield unit 118, a user may pull on the cap 132 in distal direction 183. “Paragraph [0066], Fig. 6).
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Regarding Claim 17, Daniel discloses the sub-assembly according to claim 16, wherein at least one of the distally directed surface and the proximally directed surface is a chamfered surface bevelled relative to the longitudinal axis (252 demonstrating chamfered surface beveled relative to longitudinal axis in Fig. 28B), wherein the proximally directed surface is formed on a protrusion (252) that extends from an inner surface of a flexible wall of the cap in the direction transverse to the longitudinal axis (Annotated Fig. 28B, Examiner interprets the wall of 132 is flexible since it forms a snap-fit engagement with 253, Paragraph [0090]), and wherein the delivery member cover is axially movable relative to the tubular housing from a distal position where a support surface of the tubular housing (portion of 102 in contact with 132 in Fig. 2A) is aligned with an outer surface of the flexible wall in the direction transverse to the longitudinal axis such that the delivery member cover is in the first position (Fig. 2A) and a proximal position where the support surface of the tubular housing is closer to the distal end of the housing than the flexible wall such that the delivery member cover is in the second position (when cap 132 has been unlocked, “FIG. 6 illustrates outwardly protruding element 180 moved out of engagement with the inwardly protruding element 182. After these elements have been moved out of engagement with each other, the device 100 is unlocked and the removable cap 132 and delivery member shield unit 118 are movable in the distal direction indicated by arrow 183. In order to move the cap 132 and the delivery member shield unit 118, a user may pull on the cap 132 in distal direction 183.” – Paragraph [0066], delivery member guard 120 included in delivery member shield unit which moves distally within housing 102).
Regarding Claim 18, Daniel discloses the sub-assembly according to claim 17, wherein the flexible wall is defined by a flexible arm extending in the direction of the longitudinal axis (Flexible wall on arm of 132 in annotated Fig. 28B).
Regarding Claim 19, Daniel discloses the sub-assembly according to claim 18, wherein the cap comprises the flexible arm extending towards the distal end of the housing (Flexible arm of 132 extending toward 128 in Fig. 2A).
Regarding Claim 20, Daniel discloses the sub-assembly according to claim 16, wherein the distally directed surface of the delivery member cover extends from an outer surface of the tubular section of the delivery member cover (Fig. 32).
Regarding Claim 21, Daniel discloses the sub-assembly according to claim 16, the sub-assembly comprising a biasing member (146) extending along the longitudinal axis between a proximal end (end at 132) and a distal end (end at 156, Fig. 3), and wherein the distal end of the biasing member is adjacent to a proximally directed surface of the tubular housing and the proximal end of the biasing member is adjacent to a distally directed surface of the delivery member cover (Fig. 3).
Regarding Claim 22, Daniel discloses the sub-assembly according to claim 16, wherein the delivery member cover comprises a ledge (260) extending in the direction transverse to the longitudinal axis (Fig. 32), and wherein the distally directed surface of the delivery member cover is defined by the ledge (Fig. 32).
Regarding Claim 23, Daniel discloses the sub-assembly according to claim 16, wherein the delivery member cover comprises a flexible section (area where delivery member shield link connecting interface 268 resides, Fig. 32, Examiner interprets that this area is flexible since 268 engages with 270 and some degree of flexion is required in order for the components to interlock, Paragraphs [0091] and [0092]) at a distal end of the delivery member cover, and wherein the flexible section comprises a protrusion (268) extending from the delivery member cover towards the tubular housing in the direction transverse to the longitudinal axis (Fig. 32).
Regarding Claim 29, Daniel discloses the sub-assembly according to claim 16, wherein the sub-assembly comprises a lock ring (130) attached to the housing (Fig. 3), wherein the lock ring is axially immovable (“Prior to a dose being set, outwardly protruding element 180 and inwardly protruding element 182 engage one another and prevent axial movement of the delivery member shield unit 118 with respect to the dose stop 130” – Paragraph [0065]) and rotatable around the longitudinal axis relative to the housing (Paragraph [0066]), wherein the lock ring comprises a rotational surface facing in the direction transverse to the longitudinal axis (outer surface of 130 which rotates with dose knob 126, Fig. 5), wherein the delivery member cover comprises a counter rotational surface (inner surface of 122, Fig. 5) adjacent to the rotational surface of the lock ring (Fig. 6) such that the delivery member cover is configured to be rotated from the first position to the second position by a rotation of the lock ring (Paragraph [0066]).
Claim(s) 16 and 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLoughlin et al. (Pub. No. US 20150182691 A1, herein McLoughlin).
Regarding Claim 16, McLoughlin discloses a sub-assembly (Fig. 1) of a medicament cassette unit (1), the sub-assembly comprising:
a tubular housing (330, being a slight variation of inner housing sleeve 30, Paragraph [0339]);
a cap (50); and
a delivery member cover (20),
wherein the tubular housing extends along a longitudinal axis (between 54 and 40) between a proximal end (at 54, Fig 3) and a distal end (at 40, Fig. 3), wherein the tubular housing is configured to receive a medicament container (10, Fig. 3);
wherein the delivery member cover comprises a tubular section (outer circumference of 20) arranged telescopically relative to the proximal end of the tubular housing (Fig. 3), wherein the delivery member cover comprises a distally directed surface (25, Fig. 8A),
wherein the cap is releasably attached to the tubular section of the delivery member cover (Paragraph [0324], Fig. 3), wherein the cap comprises a proximally directed surface (52) adjacent to the distally directed surface of the delivery member cover (Fig. 3), and
wherein the delivery member cover is movable between a first position where the distally directed surface of the delivery member cover is adjacent to the proximally directed surface of the cap (Figs 8A, 9A, 10A, and 11A) and a second position where the distally directed surface of the delivery member cover is away from the proximally directed surface of the cap such that the cap can be removed from the delivery member cover by being moved in the proximal direction relative to the delivery member cover (Figs 8B, 9B, 10B, and 11B).
Regarding Claim 23, McLoughlin discloses the sub-assembly according to claim 16, wherein the delivery member cover comprises a flexible section (flexible locking arms 94) at a distal end of the delivery member cover (Examiner interprets a distal end of the delivery member cover to be any component above viewing window 22 in Fig. 3), and wherein the flexible section comprises a protrusion (94a) extending from the delivery member cover towards the tubular housing in the direction transverse to the longitudinal axis (Paragraph [0345], Fig. 28A).
Regarding Claim 24, McLoughlin discloses the sub-assembly according to claim 23, wherein a cut-out (3104, Fig. 28A) is arranged in a wall of the tubular housing (Fig. 28A), and wherein the flexible section is movable in the direction transverse to the longitudinal axis relative to the delivery member cover between an engaged position (Fig. 28A) where the protrusion of the flexible section is positioned within the cut-out of the tubular housing (“Raised central portion 3104 of the latching arm 3100 is arranged for push-receiving interaction with inwardly protruding nib 94a of flexible locking arms 94 of cassette unit housing 20” – Paragraph [0345]) and a released position where the protrusion of the flexible section is positioned out of the cut-out or recess of the tubular housing (Fig. 28C).
Regarding Claim 25, McLoughlin discloses the sub-assembly according to claim 24, wherein the flexible section of the delivery member cover is moved from the engaged position where the protrusion of the flexible section is positioned within the cut-out (Fig. 28A) to the released position where the protrusion of the flexible section is positioned out of the cut-out when the protrusion of the flexible section is pressed from the outside of the tubular housing (Fig. 28C).
Regarding Claim 26, McLoughlin discloses the sub-assembly according to claim 25, wherein the flexible section of the delivery member cover is configured to be moved from the engaged position to the released position by a section (88a, 88b, 89a, 89b) of a drive unit (70) of the medicament delivery device when the cassette unit with the sub-assembly is attached to the drive unit (Paragraph [0360]).
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) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel in view of McLoughlin.
Regarding Claim 30, Daniel discloses the sub-assembly according to claim 29, wherein the lock ring comprises a fastener (180).
Daniel does not expressly disclose where the fastener is configured to be engaged with a counter fastener of the drive unit.
McLaughlin teaches wherein a cassette unit holder (75) of a drive unit (70) comprises locking apertures (96).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sub-assembly disclosed by Daniel wherein the fastener is configured to be engaged with a counter fastener of the drive unit as taught by McLaughlin so that the sub-assembly is able to be secured to a drive unit (McLaughlin, Paragraph [0371]).
Modified Daniel in view of McLaughlin does not expressly disclose wherein the fastener and the counter fastener formed a bayonet connection.
Daniel teaches wherein engagement features between one or more components of the medicament delivery device may be any suitable connecting mechanism, such as a bayonet connection (Paragraph [0096]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Daniel in view of McLaughlin wherein the fastener and the counter fastener formed a bayonet connection as taught by Daniel so that there may be a suitable engagement between the lock ring and drive unit (Daniel, Paragraph [0096]).
Allowable Subject Matter
Claims 27 and 28 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.
Claims 27 and 28 are 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 fails to disclose or make obvious the claimed invention, including the following features:
Regarding Claim 27, wherein the flexible section is moved by the drive unit via the protrusion.
Regarding Claim 28, wherein the protrusion is configured to extend out from the housing through the cut-out of the housing.
The combination of the claimed limitations is novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant’s claimed invention.
Examiner notes that the limitations indicated as containing allowable subject matter above are done so in context of the claims as a whole – e.g. the cited portions of claim 27 are allowable in combination with the rest of the limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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