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
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because all the reference characters are not clearly shown in the drawing. For instance, figure 30B is unclear if the reference number is indicating “70” or “10”, figure 8B is unclear if the reference number is indicating “1L3a” or “123a” etc. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The reference character 228 has been used to refer to “proximal surface” in paragraph 0358 and “coupling surface in paragraph 0332.
The reference character “26” has been used to refer to “connector” in paragraph 0346, line 6 and “dose selector” in paragraph 0346, line 8.
The reference character “30” has been used to refer to “knob key” in paragraph 0348, line 1 and “clip element” in paragraph 0348, line 4.
The reference character “42” has been used to refer to “piston rod guide” in paragraph 0352, line 3 and “piston guide” in paragraph 0352, line 1.
Appropriate correction is required.
Claim Objections
Claims 3-5, 8 and 19 are objected to because of the following informalities:
Regarding claim 3, the limitation “dose delivery” in line 3 appears to be amended to recite “the dose delivery” in order to refer to “dose delivery” recited in claim 1, line 8.
Regarding claim 4, the limitation “dose delivery” in line 2 appears to be amended to recite “the dose delivery” in order to refer to “dose delivery” recited in claim 1, line 8.
Regarding claim 5, the limitation “dose setting” appears to be amended to recite “the dose setting” in order to refer to “dose setting” recited in claim 3, line 3.
Regarding claim 8, line 6, the limitation “dose setting” appears to be amended to recite “the dose setting” in order to refer to “dose setting” recited in claim 7, line 5.
Regarding claim 8, line 9, the limitation “dose delivery” appears to be amended to recite “the dose delivery” in order to refer to “dose delivery” recited in claim 7, lines 7-8.
Regarding claim 19, line 3, the limitation “a medicament container” appears to be amended to recite “the medicament container” in order to refer to “a medicament container” in claim 1, line 1.
Regarding claim 19, line 4, the limitation “a plunger” appears to be amended to recite “the plunger” in order to refer to “a plunger” recited in claim 1, line 5.
Appropriate correction is required.
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 1, 3, 6, 12, 14-16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balkwill (US 5,279,586).
Regarding claim 1, Balkwill teaches a dose delivery mechanism (figure 4) for a medicament delivery device 10 (figure 3) comprising:
a housing 20;
a piston rod 26; and
an adjusting element 12,
the housing 20 configured to connect to a medicament container 46 sealed by a plunger 46b,
the dose delivery mechanism having a preassembled state (state when dosage is being set) and an assembled state (state when the drug is being delivered), in the assembled state, the dose delivery mechanism configured to move the piston rod 46 axially in a proximal direction (column 5, lines 9-22) with respect to the housing 20 during dose delivery such that the piston rod 46 exerts an axial force in the proximal direction on the plunger 46b of the medicament container 46 to expel a medicament from the medicament container,
in the preassembled state, the adjusting element 12 configured to perform a rotation with respect to the housing 20, the rotation (column 4, line 66-column 5, line 6) causing axial movement of the piston rod 26 to adjust an axial position of the piston rod 26 with respect to the housing 20 prior to transfer of the dose delivery mechanism from the preassembled state into the assembled state,
an outer rim (outer surface of element 12 that engages with user finger) of the adjusting element accessible such that during assembly of the device in the preassembled state the rotation of the adjusting element 12 and the axial movement of the piston rod is capable of being affected (column 4, line 66-column 5, line 6),
the adjusting element 12 configured to perform the rotation at least while being in a preassembled position (position of element 12 when the counter shows “0”) with respect to the housing 20,
the preassembled position being a most distal position (element 12 is located on most distal position) of the adjusting element 12 with respect to the housing 20 in the preassembled state, the dose delivery mechanism configured to transfer the rotation of the adjusting element into the axial movement of the piston rod via a single threaded connection (connection between element 26 and 28) in the preassembled state, and
the threaded connection (connection between element 26 and 28) comprises a first threaded element (threaded structure located on element 28) threadedly engaged with a second threaded element (thread located on element 26).
Regarding claim 3, Balkwill teaches wherein the first and second threaded elements rotate (column 4, line 66-column 5, line 6, “lead screw 26 which turns and screws forward in the nut”) with respect to each other during one of dose setting and dose delivery in the assembled state, and the first and second threaded elements do not rotate (column 4, lines 9-22, no rotation occurs between element 26 and 28) with respect to each other during the other one of dose setting and dose delivery in the assembled state.
Regarding claim 6, Balkwill teaches wherein the threaded connection (threaded connection between elements 26 and 28 is located in an area that falls between elements 12 and 26) is configured to act between the adjusting element 12 and the piston rod 26.
Regarding claim 12, Balkwill teaches wherein the adjusting element 12 is rotatable with respect to a counter element 36, 38 in the preassembled state (column 5, line 62-column 6, line 3) and rotationally fixed to the counter element 36, 38 in the assembled state (during delivery, elements 12 and 36, 38 does not rotate).
Regarding claim 14, Balkwill teaches wherein the adjusting element 12 protrudes distally from the counter element 36, 38 in the preassembled state.
Regarding claim 15, Balkwill teaches wherein the adjusting element 12 is configured to rotate with respect to the piston rod 26 upon rotation with respect to the housing 20 in the preassembled state.
Regarding claim 16, Balkwill teaches wherein the adjusting element 12 is rotationally fixed (after setting the dose and before delivery of the drug, element 12 is rotationally fixed with respect to element 26 if element 12 is not rotated further) with respect to the piston rod in the preassembled state.
Regarding claim 19, Balkwill teaches a medicament delivery device 10 (figure 3) comprising: the dose delivery mechanism (figure 4); and a medicament container 46 attached to the dose delivery mechanism, the medicament container 46 comprising a plunger 46b, and a bearing 22 located at the piston rod 26 being positioned at a predetermined distance with respect to the plunger 46b.
Regarding claim 20, Balkwill teaches a method (column 4, line 66-column 5, line 6) for adjusting a position of a piston rod 26 of a dose delivery mechanism (figure 4) for a medicament delivery device 10, the dose delivery mechanism comprising a housing 20, a piston rod 26, and an adjusting element 12, the housing 20 configured to connect to a medicament container 46 sealed by a plunger 46b, the method comprising: providing the dose delivery mechanism in a preassembled state (state when dosage is being set), an outer rim (outer surface of element 12 that engages with user finger) of the adjusting element 12 being accessible in the preassembled state to effect rotation of the adjusting element and axial movement of the piston rod (column 4, line 66-column 5, line 6);
adjusting, in the preassembled state, an axial position (column 4, line 66-column 5, line 6) of the piston rod 26 with respect to the housing 20 by rotating the adjusting element 12 in the preassembled state and thereby causing axial movement of the piston rod with respect to the housing, the rotation of the adjusting element transferred into the axial movement of the piston rod via a single threaded connection (thread connection between elements 26 and 28) of the dose delivery mechanism; and transferring the dose delivery mechanism from the preassembled state into an assembled state (state when the drug is being delivered), in the assembled state, the dose delivery mechanism configured to move the piston rod (column 5, lines 9-22) axially in a proximal direction with respect to the housing during dose delivery such that the piston rod exerts an axial force in the proximal direction on the plunger 46b of the medicament container 46 to expel a medicament from the medicament container 46.
Allowable Subject Matter
Claims 2, 4, 5, 7-11, 13, 17 and 18 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 closest prior art of record, Balkwill (US 5,279,586), is silent regarding wherein the dose delivery mechanism comprises a biasing element configured to bias the adjusting element into the preassembled position with respect to the housing in the preassembled state in combination with other claimed limitations of claim 2.
The closest prior art of record, Balkwill (US 5,279,586), is silent regarding wherein, during dose delivery in the assembled state, the first threaded element is rotationally stationary with respect to a third element of the dose delivery mechanism and the second threaded element is rotated with respect to the third element, and during adjustment of the piston rod in the preassembled state, the first threaded element is rotated with respect to the third element of the dose delivery mechanism and the second threaded element is rotationally stationary with respect to the third element in combination with other claimed limitations of claim 4.
The closest prior art of record, Balkwill (US 5,279,586), is silent regarding wherein, during dose setting in the assembled state, the first threaded element is axially stationary with respect to a third element of the dose delivery mechanism and the second threaded element is axially moved with respect to the third element, and during adjustment of the piston rod in the preassembled state, the first threaded element is axially moved with respect to the third element of the dose delivery mechanism and the second threaded element is axially stationary with respect to the third element. in combination with other claimed limitations of claim 5.
The closest prior art of record, Balkwill (US 5,279,586), is silent regarding further comprising a further member, the adjusting element being rotationally decoupled from the further member during adjustment of the piston rod in the preassembled state, the adjusting element being rotationally coupled to the further member during dose setting in the assembled state, and the adjusting element being rotationally decoupled from the further member during dose delivery in the assembled state in combination with other claimed limitations of claim 7.
Claims 8-11 being dependent on claim 7 are also indicated allowable.
The closest prior art of record, Balkwill (US 5,279,586), is silent regarding wherein the counter element is a dose setting element of the dose delivery mechanism, and the dose setting element is configured to be gripped by a user of the dose delivery mechanism in the assembled state to set a dose to be delivered in combination with other claimed limitations of claim 13.
The closest prior art of record, Balkwill (US 5,279,586), is silent regarding wherein the adjusting element is configured to rotate in the assembled state to set a dose of the medicament to be delivered by the dose delivery mechanism in combination with other claimed limitations of claim 17.
Claims 18 being dependent on claim 17 is also indicated allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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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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/NILAY J SHAH/Primary Examiner, Art Unit 3783