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 § 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 18-21 and 24-26 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 18 recites the limitation "the first sleeve member" in lines 2, 5, and 9. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the examiner will be interpreting “the first sleeve member” in line 2, as “a first sleeve member”. Claims 19-21 are also rejected due to being dependent on claim 18.
Claim 19 recites the limitation "the first sleeve member" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the first sleeve member" in lines 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the second sleeve member" in lines 7-8, 9, and 12. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the examiner will be interpreting “the second sleeve member” in lines 7-8, as “a second sleeve member”.
Claim 24 recites the limitation "the tab" in line 8. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the examiner will be interpreting “the tab” in line 8, as “a tab”.
Claim 24 recites the limitation "the second direction" in lines 9 and 12. There is insufficient antecedent basis for this limitation in the claim. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the examiner will be interpreting “the second direction” in line 9, as “a second direction”.
Claim 25 recites the limitation "the first sleeve member" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For examining purposes, the examiner will be interpreting “the first sleeve member” in lines 3-4, as “a first sleeve member”. Claim 26 is also rejected due to being dependent on claim 25.
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.
Claims 14-17 and 23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Giambattista et al. (US Pub No.20150335829 A1, herein, Giambattista).
Regarding claim 14, Giambattista discloses a disposable cassette front module (12 – Fig.7) for a medicament delivery device (Shown on Fig.1) comprising a reusable rear module (Shown at 10 – Fig.1) which forms a rear portion of the medicament delivery device (Fig.1) and to which the cassette front module is configured to be detachably connected to form a front portion of the medicament delivery device (Fig.2, Para [0051]), the cassette front module comprising:
an outer cover (14 – Fig.5) configured to accommodate a syringe (84 - Fig.3), the outer cover having a proximal outer cover end and a distal outer cover end (See annotated Fig.2 below); and
a power pack assembly (Shown at 102 – Fig.2) comprising a plunger rod (102 – Fig.2) and a drive device (108 – Fig.2) configured to drive the plunger rod from an initial axial position relative to the outer cover towards the proximal outer cover end (“The plunger rod is then forced to move proximally by the force member” – Para [0069]).
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Regarding claim 15, Giambattista discloses the cassette front module as set forth above, wherein the drive device is a drive spring (“compression spiral spring” - Para [0025]), and wherein the cassette front module comprises a first sleeve member (82, 114 – Fig.9) arranged around the plunger rod (“coaxially arranged through the rotator” – Para [0064]) and configured to engage with the plunger rod to hold the plunger rod in the initial axial position (“holding the plunger rod in an initial state” – Para [0064]).
Regarding claim 16, Giambattista discloses the cassette front module as set forth above, wherein the first sleeve member has a distal end (Shown at 82 – Fig.2) provided with a proximal radial surface (112 – Fig.4) and the drive spring has a distal drive spring end bearing against the proximal radial surface (“A distal end of the force member is in contact with a wall section” – Para [0064]).
Regarding claim 17, Giambattista discloses the cassette front module as set forth above, wherein the plunger rod has a hollow interior (“The plunger rod is a hollow rod” – Para [0064]) configured to receive the drive spring (“inside the plunger rod a force member” – Para [0064]), wherein the plunger rod has a distal radial surface (110 – Fig.3), and the drive spring has a proximal drive spring end bearing against the distal radial surface (“compression spiral spring having a proximal end in contact with an end wall” – Para [0064]).
Regarding claim 23, Giambattista discloses a medicament delivery device comprising:
a reusable rear module (Shown at 10 – Fig.1) comprising a housing (10 – Fig.1) having a proximal housing end and a distal housing end, the proximal housing end having a proximal housing opening (See annotated Fig.2 below), and
Giambattista also discloses the cassette front module as set forth above, wherein the outer cover (14 – Fig.5) is configured to be received by the proximal housing opening (“The activator mechanism comprises a contactor operably arranged to the housing at a proximal end thereof” – Para [0049]), the cassette front module being configured to be moved from an extended position (Fig.11) relative to the housing to a retracted position (Fig.12, “distal direction from the extended position to the retracted position” – Para [0075]), wherein the rear module comprises a resilient member (31 – Fig.2) configured to bias the cassette front module towards the extended position (“the contactor force member will urge the contactor in the proximal direction, relative to the housing, from the retracted position to the extended position” – Para [0077]).
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Allowable Subject Matter
Claims 18-21 and 24-26 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 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.
Claim 22 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Holmqvist et al. (US Pub No. 20130324934 A1): discloses a disposable cassette front module for a medicament delivery device, a reusable rear module, an outer cover configured to accommodate a syringe, and a power pack assembly comprising a plunger rod and a drive device.
Lawlis et al. (US Pub No. 20120265136 A1): discloses a disposable cassette front module for a medicament delivery device, a reusable rear module, an outer cover configured to accommodate a syringe, and a power pack assembly comprising a plunger rod and a drive device.
Jennings (US Pub No. 20110098647 A1): discloses a disposable cassette front module for a medicament delivery device, a reusable rear module, an outer cover configured to accommodate a syringe, and a power pack assembly comprising a plunger rod and a drive device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/ Examiner, Art Unit 3783
/MICHAEL J TSAI/ Supervisory Patent Examiner, Art Unit 3783