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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Claim Objections
The following claims are objected to because of the informalities set forth below:
Claim 1 recites "operational engaging"; it could be amended to "operationally engaging" to overcome the error.
Claim 1 recites "relatively to "; it could be amended to "relative to" to overcome the error.
Claim 1 recites "relatively to "; it could be amended to "relative to" to overcome the error.
Claim 1 recites "build up "; it could be amended to "built up to overcome the error.
Claim 1 recites "first position; being a position"; it could be amended to "first position being a position" to overcome the error.
Claim 1 recites "second position; being a position"; it could be amended to "second position being a position" to overcome the error.
Claim 2 recites "rotational selecting"; it could be amended to "rotationally selecting" to overcome the error.
Claim 15 recites "rotational released"; it could be amended to "rotationally released" to overcome the error.
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 11-13 and all claims depending therefrom 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.
Regarding claim 11, the limitation " rotatable drive tube" lacks antecedent basis in the claim. For the purpose of examination, the limitation will be interpreted to refer to the "longitudinal drive tube" originally recited in claim 7.
Regarding claim 12, the limitation "such as a groove" lacks definiteness as to the metes and bounds of the claim; it is unclear whether Applicant intended to recite a groove, or whether a groove is merely optional. For the purpose of examination, the limitation will be interpreted to refer an optional groove.
Regarding claim 13, the limitation "a nut element" is unclear because claim 1 (upon which claim 13 depends) already recites a "nut element". Therefore, it is unclear whether the "nut element" in claim 13 refers back to the same "nut element" in claim 1, or a new "nut element". For the purpose of examination, the limitation will be interpreted to refer back to the same "nut element" originally recited in claim 1.
Regarding claim 13, the limitation "provided with engaging structure" is unclear because claim 1 (upon which claim 13 depends) already recites an "engaging structure". Therefore, it is unclear whether the "engaging structure" in claim 13 refers back to the same "engaging structure" in claim 1, or a new "engaging structure". For the purpose of examination, the limitation will be interpreted to refer back to the same "engaging structure" originally recited in claim 1.
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 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 of the numbers 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]);
the connector element 60 being 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 one of the numbers of predetermined and equally sized fixed dose volumes 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), allowing the rotatable drive structure to move axially from the first position to the second position when the rotatable drive structure has been rotated to, and is positioned, in the dose position (see para [0119]).
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 (see splined interface in para [0118]; the limitation "such a groove" is interpreted to be optional).
Regarding claim 13, Eardley discloses:
the torsion spring driven injection device according to claim 12,
wherein the housing structure internally carries the nut element 50 (see Fig. 1) having an inner thread engaging the outer thread on the piston rod (see threaded interface 44 in Fig. 7a and para [0120]) and wherein the 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 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
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.
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, 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.
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.
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 04/20/2026
Prosecution Insights