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.
(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) 1, 3, 6, 12, 14-16, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balkwill (US 5,279,586)
Regarding claim 1, Balkwill discloses
A dose delivery mechanism (fig. 4) for a medicament delivery device (10, fig. 3) comprising:
a housing (20);
a piston rod (26); and
an adjusting element (12),
the housing (20) is configured to connect to a medicament container sealed by a plunger (Examiner notes: the limitation “is configured to connect…a plunger” is interpreted as functional limitation. And, the limitations “a medicament container” and “a plunger” are not positively recited in claim 1. See figs. 1-11 for medicament container 46 and a plunger 46b),
the dose delivery mechanism having has 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 is configured to move the piston rod (26) axially in a proximal direction (col. 5 lines 9-22) with respect to the housing (20) during dose delivery such that the piston rod is capable of exerting an axial force in the a proximal direction on the plunger of the medicament container to expel a medicament from the medicament container (see col. 5 lines 9-22), and
in the preassembled state, the adjusting element (12) is configured to perform a rotation with respect to the housing (20), the rotation causing an 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 (see col. 4 line 66 to col. 5 line 6),
an outer rim of the adjusting element (outer rim/surface of 12 that engages with user finger) is accessible to an assembler of the dose delivery mechanism in the preassembled state to effect the rotation of the adjusting element (12) and the axial movement of the piston rod (26, col. 4 line 66 to col. 5 line 6),
the adjusting element (12) is configured to perform the rotation at least while being in a preassembled position with respect to the housing (20, see col. 4 line 66 to col. 5 line 6),
the preassembled position is a most distal position of the adjusting element (12) with respect to the housing (20) in the preassembled state (see fig. 1),
the dose delivery mechanism is configured to transfer the rotation of the adjusting element (12) into the axial movement of the piston rod (26) via a single threaded connection (threaded connection between 26 and 28) in the preassembled state,
the threaded connection (threaded connection between 26 and 28) comprising a first threaded element (thread of 28) that is threadedly engaged with a second threaded element (thread of 26).
Regarding claim 3, Balkwill discloses
The dose delivery mechanism of claim 1,
wherein the first and second threaded elements (thread of 28 and thread of 26) are configured to rotate with respect to each other during one of dose setting and dose delivery in the assembled state (col. 4 line 66 to col. 5 line 6),
wherein the first and second threaded elements are not capable of rotating with respect to each other during an other one of dose setting and dose delivery in the assembled state (col. 4 lines 9-22 for no rotation occurs between 26 and 28).
Regarding claim 6, Balkwill discloses
The dose delivery mechanism of claim 1,
wherein the threaded connection (threaded connection between 26 and 28, located in an area that falls between 12 and 26) is configured to act between the adjusting element (12) and the piston rod (26).
Regarding claim 12, Balkwill discloses
The dose delivery mechanism of claim 1,
wherein the adjusting element (12) is rotatable with respect to a counter element (36/38) in the preassembled state (col. 5 line 62 to col. 6 line 3) and rotationally fixed to the counter element (36/38) in the assembled state (during delivery, 12 and 36/38 do not rotate).
Regarding claim 14, Balkwill discloses
The dose delivery mechanism of claim 12 wherein the adjusting element (12) protrudes distally from the counter element (36/38) in the preassembled state (fig. 5b).
Regarding claim 15, Balkwill discloses
The dose delivery mechanism of claim 1,
wherein the adjusting element (12) is configured to rotate with respect to the piston rod (26) upon the rotation with respect to the housing (20) in the preassembled state (see col. 4 line 66 to col. 5 line 6).
Regarding claim 16, Balkwill discloses
The dose delivery mechanism of claim 1,
wherein the adjusting element (12) is rotationally fixed with respect to the piston rod (26) in the preassembled state (after setting the dose and before delivering the set dose, 12 is rotationally fixed with respect to 26 if 12 is not rotated further).
Regarding claim 19, Balkwill discloses
A medicament delivery device, comprising:
a dose delivery mechanism according to claim 1 (see the rejection of claim 1 above); and
a medicament container (46) attached to the dose delivery mechanism (figs. 1-11), the medicament container (46) comprising a plunger (46b), and
a bearing (22) located at the piston rod (26) is positioned at a predetermined distance with respect to the plunger (see figs. 7-9).
Regarding claim 20, Balkwill discloses
A method (col. 4 line 66 to col. 5 line 6) for adjusting a position of a piston rod (26) of a dose delivery mechanism for a medicament delivery device (10),
the dose delivery mechanism (figs. 1-11) comprising
a housing (20);
a piston rod (26); and
an adjusting element (12),
the housing (20) is configured to connect to a medicament container (46) sealed by a plunger (46b),
the method comprising:
providing the dose delivery mechanism (figs. 1-11) in a preassembled state (state when dosage is being set),
an outer rim of the adjusting element (outer rim/surface of 12 that engages with user finger) is accessible to an assembler of the dose delivery mechanism in the preassembled state to effect rotation of the adjusting element (12) and axial movement of the piston rod (26, col. 4 line 66 to col. 5 line 6);
adjusting, in the preassembled state, an axial position of the piston rod (26) with respect to the housing (20) by rotating the adjusting element (12) in the preassembled state and thereby causing an axial movement of the piston rod (26) with respect to the housing (col. 4 line 66 to col. 5 line 6),
the rotation of the adjusting element (12) being transferred into the axial movement of the piston rod (26) via a single threaded connection (threaded connection between 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 being configured to move the piston rod (26) axially in a proximal direction (col. 5 lines 9-22) with respect to the housing (20) during dose delivery such that the piston rod (26) 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, 17-18 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DUNG T ULSH/Primary Examiner, Art Unit 3783
