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 Objections
Claim(s) 1, 28 is/are objected to because of the following informalities:
Claim 1, line 1, “Drug delivery device”. It should be amended as “A drug delivery device”.
Claim 1, line 7, “piston rod”. It should be amended as “a piston rod”.
Claim 28, line 1, “Drug delivery device”. It should be amended as “A drug delivery device”.
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.
Claim(s) 21-24 is/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 21, the phrase “the dose selector member to be mounted to the housing only in rotation orientations that ensure that ... the connection enables a single rotation orientation only” renders the claim indefinite because it is unclear. Claim 13 recites “the dose selector member is rotationally fixed with respect to the housing”. However, claim 14 recites “the dose selector member to be mounted to the housing only in rotation orientations that ensure that ... the connection enables a single rotation orientation only”. So it is unclear how the dose selector member is rotationally fixed to the housing but also only in rotational orientations with the housing.
Claims 22-24 are rejected by virtue of depending on claim 21.
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) 1-10, 13-16, 19-20, 25, 27-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plumptre et al. (US 2015/0224266).
Regarding claim 1, Plumptre discloses
Drug delivery device (1, figs. 1-19, pars. 0122-0167) comprising:
a housing (10/20, fig. 1 and par. 0122) with a longitudinal axis (longitudinal axis of 10/20, see fig. 1);
a dose setting member (70, fig. 1) actuatable by a user (par. 0164) and rotatable around the longitudinal axis to set a dose to be delivered by the drug delivery device (pars. 0161-0162);
piston rod (30) configured to be axially advanced in a proximal direction (direction towards the injection site) to deliver the set dose (see pars. 0129, 0131, 0165); and
a dosing member (60) configured to define the axial advancement of the piston rod (30) upon delivery of the set dose (Examiner notes: see pars. 0161-0162, during dose setting, 60 winds out of the device to count the number of units to be delivered. See par. 0165, during dose dispensing, 60 spins back into housing 10 and 30 rotates and advances to deliver the set dose. Therefore, 60 is configured to define axial advancement of 30),
the dosing member (60) being axially movable along the longitudinal axis and rotationally movable around the longitudinal axis during dose setting (Examiner notes: see par. 0162, 70/40/60 wind out of housing 10 during dose setting; therefore, 60 axially and rotationally moves during dose setting),
the dosing member (60) being rotationally fixed to the dose setting member (70) during dose setting (Examiner notes: see par. 0162, 60 winds out of housing 10 together with 70 during dose setting; therefore, 60 is rotationally fixed to 70),
the dosing member (60) comprising a maximum dose stop (67, par. 0162),
the maximum dose stop (67) being configured to engage a maximum stop feature (12, fig. 4 and par. 0162) to limit movement of the dosing member (60) with respect to the housing (10/20) when a maximum dose is set (par. 0162), and
the maximum stop feature (12) being disposed at the housing (see fig. 4).
Regarding claim 2, Plumptre discloses
The drug delivery device according to claim 1, wherein the dosing member (60) is rotationally movable with respect to the dose setting member (70) during dose delivery (Examiner notes: see par. 0164, during dose delivery, pushing 70 allows relative rotation between 60 and 70; therefore, 60 is rotationally movable with respect to 70).
Regarding claim 3, Plumptre discloses
The drug delivery device according to claim 1, wherein the dosing member (60) is threadedly connected to the housing (10) (Examiner notes: see par. 0124, 20 has the functions to house the drive mechanism within, guiding the clickers and 50 via internal splines, to provide an internal thread through which 30 is driven, to support and guide 61/62 on an external thread form, to secure 80 and 10 and 130. See par. 0124, 20 is received in 10 and permanently fixed therein to prevent any relative movement of 20 with respect to 10. Therefore, 60 is threadedly connected to 20 and also threadedly connected to 10).
Regarding claim 4, Plumptre discloses
The drug delivery device according to claim 1, wherein the maximum dose stop (67, fig. 7a and pars. 0145, 0162) comprises a stopping surface (surface of 67) that is configured to axially abut the maximum stop feature (12) of the housing (10) upon setting the maximum dose (par. 0123 and par. 0162).
Regarding claim 5, Plumptre discloses
The drug delivery device according to claim 4, wherein the stopping surface (surface of 67) is orientated perpendicular to the longitudinal axis (see fig. 7a and par. 0145).
Regarding claim 6, Plumptre discloses
The drug delivery device according to claim 4, wherein the stopping surface (surface of 67) is an annular surface surrounding the longitudinal axis (Examiner notes: the surface of the two elements 67 form an annular surface surrounding the longitudinal axis as shown in fig. 7a)
Regarding claim 7, Plumptre discloses
The drug delivery device according to claim 1, wherein the maximum dose stop (67) protrudes from an outer surface of the dosing member (outer surface of 60, see fig. 7a).
Regarding claim 8, Plumptre discloses
The drug delivery device according to claim 1, wherein the maximum stop feature (12) protrudes from an inner surface of the housing (10, see fig. 4 and par. 0123).
Regarding claim 9, Plumptre discloses
The drug delivery device according to claim 1, wherein the maximum dose stop (67) is spaced apart from a distal end of the dosing member (distal end of 60, see fig. 7a).
Regarding claim 10, Plumptre discloses
The drug delivery device according to claim 1, wherein the maximum stop feature (12) of the housing (10) has a limiting surface (contacting surface of 12, par. 0123) perpendicularly orientated to the longitudinal axis (see fig. 4 for 12 and fig. 7a for 67, see also pars. 0123 and 0145), the maximum dose stop (67) configured to engage the limiting surface (contacting surface of 12) upon setting the maximum dose (see pars. 0123, 0145, and 0162).
Regarding claim 13, Plumptre discloses
The drug delivery device according to claim 1 wherein the dosing member (60) comprises a zero dose stop (zero unit stop faces on 61 of 60 in pars. 0028, 0127 and 0136) configured to engage with a zero stop feature (25, fig. 5a) to limit movement of the dosing member with respect to the housing (Examiner notes: see par. 0028, the housing comprises an inner body and an outer body wherein a first rotational stop is provided between the inner body and the display member, and a second rotational stop is provided between the outer body and the display member as a zero unit stop and a maximum unit stop) upon the dosing member reaching a zero dose position (see pars. 0028, 0127 and 0136), the zero stop feature (25) provided at the housing (inner body 20 of housing 10/20).
Regarding claim 14, Plumptre discloses
The drug delivery device according to claim 13, wherein the zero dose stop (zero unit stop of 61 of 60, pars. 0028, 0127 and 0136) engages the zero stop feature (25, fig. 5a) in a contact plane (a plane that contains element 25, fig. 5a) that is angled with respect to a radial plane perpendicular to the longitudinal axis (see fig. 5a).
Regarding claim 15, Plumptre discloses
The drug delivery device according to claim 14, wherein the contact plane is orientated perpendicular to the radial plane (Examiner notes: claims 14 and 15 recite “a radial plane is perpendicular to the longitudinal axis” and “the contact plane is perpendicular to the radial plane”. Therefore, Examiner interpreted the contact plane is parallel to the longitudinal axis since both contact plane and longitudinal axis are perpendicular to the radial plane. See fig. 5a, 25 is orientated parallel to the longitudinal axis. Therefore, 25 reads on the limitation of claim 15).
Regarding claim 16, Plumptre discloses
The drug delivery device according to claim 13, wherein the zero dose stop is provided at a proximal end of the dosing member or the zero stop feature is provided at a proximal end of a housing cavity of the housing (Examiner notes: since claim 16 comprises the “OR” language, either part of the OR statement does not positively recited in claim 11. Therefore, Examiner does not examine the first part “the zero dose stop is provided at a proximal end of the dosing member” of the OR statement in claim 11. See fig. 5a, the zero stop feature 25 is provided at the end portion of inner body 20 of housing 10/20 wherein the end portion is towards the injection site).
Regarding claim 19, Plumptre discloses
The drug delivery device according to claim 1, further comprises a dose definition mechanism (mechanism of setting a dose via elements 70/40/60, pars. 0161-0163) configured to define rotational dose positions of the dose setting member (70) with respect to the housing (10, figs. 17-19 and pars. 0161-0163), the dose setting member (70) is connected to the housing (10) via a dose selector member (50, fig. 12, pars. 0132, 0138-0139, 0163), the dose selector member (50) is rotationally fixed (Examiner notes: see par. 0163, 50 and 20 are rotationally locked together at all times. See par. 0124, 20 is received in 10 and permanently fixed therein to prevent any relative movement of 20 with respect to 10. Therefore, 50 is rotationally fixed with respect to housing 10/20) and axially movable with respect to the housing (see par. 0132, 0138-0139 and 0163), and the dose definition mechanism (mechanism of setting a dose via elements 70/40/60) is configured to act between the dose selector member (50) and the dose setting member (70) (see pars. 0161-0163).
Regarding claim 20, Plumptre discloses
The drug delivery device according to claim 19, wherein the dose selector member (50) is axially fixed with respect to the dosing member (60) (Examiner notes: see pars. 0163-0165 for the function of counting the number of dispensed units of member 50 such that 50 is only moved during dose setting and 50 is axially fixed during dose dispensing. Therefore, 50 is axially fixed with respect to 60 during dose dispensing).
Regarding claim 25, Plumptre discloses
The drug delivery device according to claim 1, wherein the dosing member (60) is coupled to the piston rod (30) via an advancement mechanism (pars. 0164-0165) configured to translate axial movement of the dosing member (60) into axial advancement of the piston rod (30) during dose delivery (pars. 0164-0165) so that the axial movement of the dosing member (60) during dose delivery causes the piston rod (30) to axially advance in the proximal direction (towards the injection site).
Regarding claim 27, Plumptre discloses
The drug delivery device according to claim 25, wherein the piston rod (30) is rotationally fixed to the housing (10/20) (Examiner notes: see par. 0162 for 30 remaining fixed throughout dialing), the advancement mechanism (pars. 0164-0165) comprises a nut (43 of 40, see fig. 3 for 40 comprising nut 43) coupled between the piston rod (30) and the dosing member (60) (see pars. 0160-0167 for the coupling of 30, 40, and 60 to allow the user to set a dose and dispense the set dose), the nut (43) threadedly connected to the piston rod (30) (Examiner notes: see par. 0165 for the interaction of mating threads between 30, 40, and 20 during dose delivery), the nut (43) is rotationally fixed with respect to the dosing member (60) and rotatable with respect to the housing (10/20) during dose setting (Examiner notes: see par. 0162 for 40 and 60 winding together out of the housing during dose setting), and the nut (43) is rotatable with respect to the dosing member (60) and rotationally fixed with respect to the housing (10/20) during dose delivery (Examiner notes: see par. 0164-0165 for 40 being rotationally locked together with 70 and 70 is moved axially during dose delivery, while 60 is rotated relative to 70. Since 40 is moved axially not rotationally during dose delivery, 40 is rotationally fixed with respect to the housing 10/20. And since 60 is rotated during dose delivery, 40 is rotatable with respect to 60).
Regarding claim 28, Plumptre discloses
Drug delivery device (1, figs. 1-19, pars. 0122-0167) comprising:
a housing (10/20, fig. 1 and par. 0122) with a longitudinal axis (longitudinal axis of 10/20, see fig. 1);
a dose setting member (70, fig. 1) that is actuatable by a user (par. 0164) and rotatable around the longitudinal axis to set a dose to be delivered by the drug delivery device (pars. 0161-0162);
a piston rod (30) that is configured to be axially advanced in a proximal direction (direction towards the injection site) to deliver the set dose (see pars. 0129, 0131, 0165); and
a dosing member (60) configured to define for defining the axial advancement of the piston rod (30) upon delivery of the set dose (Examiner notes: see pars. 0161-0162, during dose setting, 60 winds out of the device to count the number of units to be delivered. See par. 0165, during dose dispensing, 60 spins back into housing 10 and 30 rotates and advances to deliver the set dose. Therefore, 60 is configured to define axial advancement of 30), the dosing member (60) axially movable along the longitudinal axis and rotationally movable around the longitudinal axis during dose setting (Examiner notes: see par. 0162, 70/40/60 wind out of housing 10 during dose setting; therefore, 60 axially and rotationally moves during dose setting), the dosing member (60) is rotationally fixed to the dose setting member (70) during dose setting (Examiner notes: see par. 0162, 60 winds out of housing 10 together with 70 during dose setting; therefore, 60 is rotationally fixed to 70), the dosing member (60) comprising a zero dose stop (zero unit stop faces on 61 of 60 in pars. 0028 and 0136), wherein the zero dose stop (zero unit stop faces on 61 of 60 in pars. 0028, 0127 and 0136) is configured to engage with a zero stop feature (25, fig. 5a and par. 0127) to limit movement of the dosing member (60) with respect to the housing (10/20) upon setting a zero dose (see pars. 0028, 0127 and 0136), wherein the zero stop feature (25) is provided at the housing (20, fig. 5a).
Regarding claim 29, see the rejection of claim 2.
Regarding claim 30, see the rejection of claim 14.
Regarding claim 31, Plumptre discloses
The drug delivery device according to claim 28, wherein the zero dose stop (zero unit stop faces on 61 of 60 in pars. 0028, 0127 and 0136) of the dosing member (60) comprises a stop surface (stop surfaces of 61) that is configured to abut against a corresponding stop surface of the housing (stop surface of 25 of 20, see fig. 5a and par. 0127).
Regarding claim 32, see the rejection of claim 16.
Claim(s) 1, 13, 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plumptre et al. (US 2015/0224266) (Examiner notes: the limitations “a maximum dose stop” and “a maximum stop feature” are interpreted differently).
Regarding claim 1, Plumptre discloses
Drug delivery device (1, figs. 1-19, pars. 0122-0167) comprising:
a housing (10/20, fig. 1 and par. 0122) with a longitudinal axis (longitudinal axis of 10/20, see fig. 1);
a dose setting member (70, fig. 1) actuatable by a user (par. 0164) and rotatable around the longitudinal axis to set a dose to be delivered by the drug delivery device (pars. 0161-0162);
piston rod (30) configured to be axially advanced in a proximal direction (direction towards the injection site) to deliver the set dose (see pars. 0129, 0131, 0165); and
a dosing member (60) configured to define the axial advancement of the piston rod (30) upon delivery of the set dose (Examiner notes: see pars. 0161-0162, during dose setting, 60 winds out of the device to count the number of units to be delivered. See par. 0165, during dose dispensing, 60 spins back into housing 10 and 30 rotates and advances to deliver the set dose. Therefore, 60 is configured to define axial advancement of 30),
the dosing member (60) being axially movable along the longitudinal axis and rotationally movable around the longitudinal axis during dose setting (Examiner notes: see par. 0162, 70/40/60 wind out of housing 10 during dose setting; therefore, 60 axially and rotationally moves during dose setting),
the dosing member (60) being rotationally fixed to the dose setting member (70) during dose setting (Examiner notes: see par. 0162, 60 winds out of housing 10 together with 70 during dose setting; therefore, 60 is rotationally fixed to 70),
the dosing member (60) comprising a maximum dose stop (stop of thread of 64 that is coupled to 21 of 20 when the maximum dose is set, figs. 5a and 8, pars. 0142 and 0162),
the maximum dose stop (stop of thread of 64) being configured to engage a maximum stop feature (feature of thread of 21 that is coupled to 64 when the maximum dose is set, fig. 5a and 8, pars. 0142 and 0162) to limit movement of the dosing member (60) with respect to the housing (10/20) when a maximum dose is set (par. 0162), and
the maximum stop feature (feature of thread of 21) being disposed at the housing (see par. 0126).
Regarding claim 13, Plumptre discloses
The drug delivery device according to claim 1 wherein the dosing member (60) comprises a zero dose stop (zero unit stop of 61 of 60 in pars. 0028, 0127 and 0136) configured to engage a zero stop feature (25, fig. 5a) to limit movement of the dosing member with respect to the housing (Examiner notes: see par. 0028, the housing comprises an inner body and an outer body wherein a first rotational stop is provided between the inner body and the display member, and a second rotational stop is provided between the outer body and the display member as a zero unit stop and a maximum unit stop) upon the dosing member reaching a zero dose position (see pars. 0028, 0127 and 0136), the zero stop feature (25) provided at the housing (inner body 20 of housing 10/20).
Regarding claim 17, Plumptre discloses
The drug delivery device according to claim 13, wherein the zero stop feature (25) and the maximum stop feature (feature of thread of 21 that is coupled to 64 when the maximum dose is set, fig. 5a and 8, pars. 0142 and 0162) are provided at a same structural element (20) of the housing (10).
Regarding claim 18, Plumptre discloses
The drug delivery device according to claim 13, wherein the structural element (20) comprises a dose thread (21) configured to threadedly engage with the dosing member (60, see figs. 5a and 8, par. 0142)
Allowable Subject Matter
Claim(s) 11-12, 26 is/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.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783