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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and all claims depending therefrom are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the new matter is the rotatable drive structure and the connector element are provided with "an engaging structure that only allows the rotatable drive structure to move axially from the first position to the second position when the engaging structure and connector element are aligned such that the rotatable drive structure has been rotated to, and is positioned, in the dose position".
The specification discloses (see pgs.4-5):
The fixed dose to be ejected is thus selected by rotating the connector element relatively to the rotational drive structure whereby the torsion spring is strained. The rotational drive structure and the connector element are for this purpose provided with means allowing the rotational drive structure to move from the first position and into the second position when these means are aligned. Such means could in one example be tracks and protrusions provided on either of the parts or the means could be solely protrusions provided on both parts. Other kind of mechanical means could be envisaged as long as the rotational drive structure is only allowed to be moved axially in the correct rotational position i.e. in the defined dose position.
The "means" described in the specification excerpt above is understood to correspond to the claimed "engaging structure" on both the rotatable drive structure and the connector element. These means cooperate to permit the rotational drive structure to move from the first position to the second position "when these means are aligned".
Permitting the rotational drive structure to move when the means are aligned is different from permitting the movement to occur when "the engaging structure and connector element are aligned."
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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eardley et al (U.S. Pub. 2017/0304551 A1, hereinafter "Eardley").
Regarding claim 1, Eardley discloses:
a torsion spring driven injection device for dispensing a number of predetermined and equally sized fixed dose volumes of a liquid drug,
comprising:
a housing structure 10 (see Fig. 1) securing a cartridge 100 (see Fig. 1) containing the liquid drug to be dispensed,
a piston rod 30 (see Fig. 1) for driving the liquid drug out from the cartridge,
a rotatable drive structure 40 operationally engaging the piston rod such that the piston rod is rotated together with the rotatable drive structure at least during dosing (see para [0148]),
a nut element 50 secured to the housing structure at least during dosing and threaded to the piston rod such that the piston rod is moved helically upon rotation of the piston rod relative to the nut element (see para [0148]),
a connector element 60 which is coupled to the housing structure by a ratchet interface 66 (see Fig. 5) allowing the connector element to rotate relatively to the housing structure,
a torsion spring 90 (see Fig. 2) operable coupled between the rotatable drive structure and the connector element,
such that a torque is built up in the torsion spring 90 by rotation of the connector element relatively to the rotatable drive structure and wherein the ratchet interface between the housing structure and the connector element is able to hold the connector element in its rotational position against the torque of the torsion spring (see para [0124]),
the rotatable drive structure 40 being axially movable between a first position and a second position;
the first position being a position wherein the rotatable drive structure 40 is non-rotationally secured to the housing structure (see para [0135]),
and the second position being a position wherein the rotatable drive structure is released from the housing structure and able to rotate under influence of the torque stored in the torsion spring (see para [0143]),
wherein the torsion spring is strained when selecting one fixed dose volume from a group consisting of predetermined and equally sized fixed dose volumes by rotation of the connector element 60 relative to the rotatable drive structure with the rotatable drive structure maintained in the first position (see para [0132]);
wherein the connector element 60 is rotatable from an initial position (rest position shown in Fig. 3; see also para [0132]) to a dose position (see para [0132]);
wherein the selected fixed dose volume is individually released when the rotational drive structure is moved axially from the first position and to the second position (see para [0145]) allowing the rotatable drive structure to rotate from the dose position to the initial position under influence of the torsion spring (see para [0145], disclosing rotation back to a zero dose), wherein,
the rotatable drive structure 40 and the connector element 60 are provided with engaging structure 43, 61 (see para [0119] and Fig. 7a) that only allows the rotatable drive structure to move axially from the first position to the second position when the engaging structure 43/61 and connector element 60 are aligned such that the rotatable drive structure has been rotated to, and is positioned, in the dose position (see para [0119]; pressing button 70 engages the spline clutch 43, 61 to prevent rotation of the connector element 60; and it is understood that the engaging structure 43/61 and the connector element 60 are coaxially aligned).
Regarding claim 2, Eardley discloses:
the torsion spring driven injection device according to claim 1,
wherein a rotational selection element 80 (see Fig. 2) for rotationally selecting one of the numbers of predetermined and equally sized fixed dose volumes to be ejected is provided at a proximal end of the housing structure (see Fig. 2 and para [0115]).
Regarding claim 3, Eardley discloses:
The torsion spring driven injection device according to claim 2,
wherein the rotational selection element 80 is rotationally coupled to the connector element such that the connector element rotates together with the selection element when selecting the predetermined and equally sized fixed dose volume and wherein the selection element is axially movable relatively to the connector element (see para [0124]),
such that the selection element is allowed to be moved axially in relation to the connector element (see para [0124]).
Regarding claim 2, Eardley discloses:
the torsion spring driven injection device according to claim 2,
wherein the rotational selection element 80 is axially coupled to the rotatable drive structure 40 such that the selection element 80 and the rotatable drive structure move 40 together in the axial direction to move the rotatable drive structure 40 from the first position to the second position to thereby release the rotatable drive structure and wherein the selection element 80 and the rotatable drive structure 40 are allowed to rotate in relation to each other (see para [0143]).
Regarding claim 5, Eardley discloses:
the torsion spring driven injection device according to claim 2,
wherein a compression spring 130 (see Fig. 2) urges the selection element and the rotatable drive structure in the proximal direction (see para [0127]).
Regarding claim 6, Eardley discloses:
the torsion spring driven injection device according to claim 2,
wherein the rotational dose selection element 80 is guided axially by guiding structure 64 (see Fig. 5 and para [0127]) in the housing structure.
Regarding claim 7, Eardley discloses:
the torsion spring driven injection device according to claim 1,
wherein the rotatable drive structure 40 comprises a longitudinal drive tube (tubular portion of drive structure 40) provided with a radial protrusion 42 (see Fig. 2).
Regarding claim 8, Eardley discloses:
the torsion spring driven injection device according to claim 7,
wherein the connector element 60 is provided with a first axial opening (see Fig. 3, showing the connector element 60 with a proximal or distal opening at either end for containing other features such as torsion spring 9).
Regarding claim 9, Eardley discloses:
the torsion spring driven injection device according to claim 8,
wherein the radial protrusion provided on the drive tube is able to pass axially through the first axial opening in the connector element 60 when the first axial opening and the radial protrusion 42 are aligned to thereby initiate an ejection (see Fig. 2, showing the assembled device with the radial protrusion 42 coaxially aligned with, and axially passed through, the opening in the connector element 60).
Regarding claim 10, Eardley discloses:
the torsion spring driven injection device according to claim 9,
wherein the connector element 60 is provided with a second axial opening (i.e., the other of the proximal or distal opening shown in Fig. 3).
Regarding claim 11, Eardley discloses:
the torsion spring driven injection device according to claim 10,
wherein the radial protrusion provided on the drive tube is able to pass axially through the second axial opening in the connector element when the second axial opening and the radial protrusion are aligned at the end of an ejection (see Fig. 2, showing the assembled device with the radial protrusion 42 coaxially aligned with, and axially passed through, the second opening in the connector element 60).
Regarding claim 12, Eardley discloses:
the torsion spring driven injection device according to claim 7,
wherein the piston rod is provided with an outer thread (see Fig. 6 and para [0145]) and a longitudinal guiding surface.
Regarding claim 13, Eardley discloses:
the torsion spring driven injection device according to claim 12,
wherein an inner thread on the nut element 50 (see Fig. 1) engages an outer thread on the piston rod (see threaded interface 44 in Fig. 7a and para [0120]) and wherein a rotatable drive tube is provided with the engaging structure 43, 51 engaging the longitudinal guiding surface on the piston rod such that the piston rod is rotatable together with the rotatable drive tube and moved helically when the drive tube and the piston rod are rotated relatively to the nut element (see paras [0119], [0143]).
Regarding claim 14, Eardley discloses:
the torsion spring driven injection device according to claim 13,
wherein the nut element 50 is axially movable and coupled to the rotatable drive tube to move axially together with the rotatable drive tube (see para [0142]; and see para [0120] disclosing the helical path of the nut element 50).
Regarding claim 15, Eardley discloses:
the torsion spring driven injection device according to claim 14,
wherein the nut element 50 is rotationally released from the housing structure in the first position of the rotatable drive tube (i.e., the nut element 50 can move relative to the housing structure along a threaded path; see para [0138]) in and rotationally secured to the housing structure in the second position of the rotatable drive tube (i.e., the nut element 50 is locked; see para [0148]).
Response to Arguments
Applicant's arguments filed 08/03/2026 have been fully considered but they are not persuasive. The Remarks state that the claims have been amended and request the rejection(s) be withdrawn, but do not specifically address the previously applied rejections.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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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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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 10/08/2026
