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 .
Response to Amendment
The amendment filed 4/6/2026 has been entered. Claims 1-2, 6-20, and 24-25 are pending in the application.
Claim Objections
Claims 10, 13, 18, and 24 are objected to because of the following informalities:
Regarding claim 10, “the threaded interior” should be corrected to “a threaded interior” for claim language consistency.
Regarding claim 13, “a drug” should be corrected to “the drug” for claim language consistency.
Regarding claim 18, the second recitation of “at least a portion of the plunger assembly” should be corrected to “at least the portion of the plunger assembly” for claim language consistency.
Regarding claim 24, “the threaded interior” should be corrected to “a threaded interior” and “at least a portion of the plunger assembly” should be corrected to “at least the portion of the plunger assembly” for claim language consistency.
Appropriate correction is required.
Applicant is advised that should claim 2 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 17 be found allowable, claim 24 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 19 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
Applicant is advised that should claim 20 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-2, 6-20, and 24-25 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 claims 1 and 16-20, the limitation of “at least one component of the drive mechanism” renders the claim unclear. Based on the claim language, it is unclear what structures constitute a “component of the drive mechanism” as the components of the drive mechanism are not defined by the claim.
The Examiner is unsure if the components of the drive mechanism constitute a stopper, a plunger assembly, a biasing member, and an annular member or if the drive mechanism constitutes the listed components and any other additional components that may be interpreted as part of the drive mechanism. For purposes of examination, a “component of the drive mechanism” is being interpreted as a stopper, a plunger assembly, a biasing member, an annular member, and any other structure that may be interpreted as part of a driving mechanism of a drug delivery device.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 6-8, 10-12, 17-18, 20, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (U.S. 5,112,317) in view of Hourmand (U.S. 2013/0317448).
Regarding claim 1, Michel teaches a drug delivery device (Figures 1 – 5) comprising:
a housing (housing members 1 and 2, abstract & Fig. 1-5);
a drug container (pre-filled syringe 3, abstract & Fig. 1) disposed within the housing and including a proximal end and a distal end as shown in Figure 1;
a drive mechanism activatable to expel a drug from the drug container, the drive mechanism comprising: a stopper (plunger 5, abstract and & Fig. 1) movably disposed within the drug container;
a plunger assembly (sleeve 29 and drive stem 39, Fig. 1) configured to translate in a distal direction (element 39 is configured to translate in a distal direction, col 3 lines 27-33), at least a portion of the plunger assembly being configured to rotate relative to the housing (element 29 is configured to rotate); Examiner notes that the plunger as taught by Michel is made up of drive stem 39 and drive sleeve 29 since Michel discloses that “drive stem 39 lying in the axis 36 of the injection device is attached in the lower part of the intermediate member 31 and carries at its opposite end a disk 41... The drive stem 39 travels, with clearance fitting, in its upper part in a cylindrical driving sleeve 29 and in its lower part in a threaded sleeve 42” in Col. 3, lines 27 – 32; Element 39 of the plunger as taught by Michel is configured to translate in a distal direction relative to the housing during dose dispensing since Michel discloses that the disk 41 of the drive stem 39, moved along with the intermediate member 31, abuts against the plunger 5 and urges the latter into the ampoule to such an extent that a small amount of liquid exits from the injection needle (Col. 4, lines 11 – 14); Element 29 of the plunger as taught by Michel is configured to rotate relative to the housing during dose setting since Michel discloses that “the revolution of the push button 11 is transmitted via its longitudinal splines 30 and the grooves in the collar 32 to the intermediate member 31 and, from the latter (cf. FIG. 2) via its longitudinal splines 35 and the longitudinal grooves 44, to the driving sleeve 29 as well as the threaded sleeve 42 fixedly joined to the latter” as discussed in Col. 4, lines 31 – 37;
a biasing member (spring 49, abstract & Fig. 1) operably coupled to the plunger assembly as shown in Figure 1 and discussed in Col. 3, lines 39 – 43;
an annular member (annular shoulder 6) disposed within the housing (Figure 1 shows annular shoulder 6 is located within sleeve 17 of the housing of the device 1) and operably coupled to the plunger assembly (element 6 is operably coupled to the plunger (29 and 39) via the interaction between the threaded interior surface of element 6 and the threaded outer surface of thread sleeve 42 as discussed in Col. 4, lines 37 – 41),
However, Michel does not specify a dampening mechanism disposed within the housing and operably coupled to the drive mechanism, wherein, upon activation of the drive mechanism, the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component, wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component.
Hourmand teaches a drug delivery device (Injector 1, Figure 1) similar to Michel and the current application, further including a dampening mechanism (engagement between rotary damper 28 and syringe holder 22 as discussed in paragraph [0072]) disposed within the housing (housing of injector 1, Figures 1A and 1B) and operably coupled to the drive mechanism (damper 28 is splined engaged to plunger 9 as discussed in paragraph [0072]), wherein, upon activation of the drive mechanism (when auto-injector is pressed against the injection site as discussed in paragraph [0065]), the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component (A rotary damper 28 is arranged around the plunger 9 and engaged to the plunger 9 by a spline 29 or thread on the plunger 9. “, [0064] & Fig. 1A-1B; “Due to the splined engagement of the rotary damper 28 with the plunger 9 the drive spring force on the plunger 9 causes the rotary damper 28 to rotate. Thus, the force of the drive spring 8 is shared between the stopper 9 translation and the rotation of the rotary damper 28. The rotary damper 28 allows for rapid needle insertion since its is not yet engaged with the syringe holder 22 at that point in the injection cycle. Rapid needle insertion is thought to be less painful for the patient. The engagement of the rotary damper 28 with the syringe holder 22 during the actual injection allows for adapting the dispense characteristics of the auto-injector 1 so as to inject the medicament slowly into the injection site.”, [0072]; damper 28 frictionally engages plunger 9, which is being interpreted as a component of the drive mechanism; damper 28 is configured to reduce the rotational velocity of plunger 9, slowing the speed of injection),
wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component (see discussion of the force of the drive spring 8 is shared between the plunger 9 and damper 28 due to the splined engagement of the damper 28 and plunger 9 in order to inject the medicament slowly into the injection site in paragraph [0072]; the output rotational velocity to drive plunger 9 in the distal direction is partly made up by the dampened rotational velocity induced by damper 28).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Regarding claim 6, Michel teaches that wherein at least the portion of the plunger assembly has a threaded exterior surface (driving sleeve 29 and threaded sleeve 42 constitute a fixed joined unit as disclosed in Col. 3, lines 58 – 61, therefore the portion of the plunger assembly 29/42 has a threaded exterior surface).
Regarding claim 7, Michel teaches that the plunger assembly comprises a telescoping plunger assembly (since drive stem 39 move in and out of elements 29 and in and out of connection with stopper 5 as discussed in Col. 4, lines 11 – 14).
Regarding claim 8, Michel teaches that the biasing member comprises a coil spring (Col. 3, lines 39 – 40).
Regarding claim 10, Michel teaches that wherein the drive mechanism comprises an elongate member (threaded sleeve 42) having a threaded external surface (threaded external surface 50) threadingly engaged with the threaded interior surface of the annular member as discussed in Col. 4, lines 37 – 41, and wherein the drug delivery device further comprises a coupler (coupling between driving sleeve 29 and threaded sleeve 42, which are made up of two parts merely for assembly reasons and constitute a fixedly joined unit as discussed in Col. 3, lines 58 – 61) configured to receive a first rotational velocity from the elongate member and deliver a second rotational velocity to the plunger assembly; Examiner notes that the driving sleeve 29 and the threaded sleeve 42 are made up of two parts merely for assembly reasons and constitute a fixedly joined unit as discussed in Col. 3, lines 58 – 61 and therefore when elongate member 42 rotates, the plunger assembly (29 and 39, Figure 1) also rotate at the same rotational velocity. Examiner further notes that the claim does not require the first rotational velocity and the second rotational velocity to be the same or different. Therefore, the disclosure of Michel reads on the current claim.
Regarding claim 11, Michel teaches an activation device (11) operably coupled to the drive mechanism to control activation thereof (drive stem 39 connected to push button 11 for operation as discussed in Col. 4, lines 8 – 14).
Regarding claim 12, Michel teaches a drug delivery member (injection needle) in fluid communication with the distal end of the drug container as shown in Figure 1 and discussed in Col. 2 lines 36 – 37.
Regarding claim 17, Michel teaches a drug delivery device (Figures 1 – 5) comprising:
a housing (housing members 1 and 2, abstract & Fig. 1-5);
a drug container (pre-filled syringe 3, abstract & Fig. 1) disposed within the housing and including a proximal end and a distal end as shown in Figure 1;
a drive mechanism activatable to expel a drug from the drug container, the drive mechanism comprising: a stopper (plunger 5, abstract and & Fig. 1) movably disposed within the drug container;
a plunger assembly (sleeve 29 and drive stem 39, Fig. 1) configured to translate in a distal direction (element 39 is configured to translate in a distal direction, col 3 lines 27-33), at least a portion of the plunger assembly being configured to rotate relative to the housing (element 29 is configured to rotate); Examiner notes that the plunger as taught by Michel is made up of drive stem 39 and drive sleeve 29 since Michel discloses that “drive stem 39 lying in the axis 36 of the injection device is attached in the lower part of the intermediate member 31 and carries at its opposite end a disk 41... The drive stem 39 travels, with clearance fitting, in its upper part in a cylindrical driving sleeve 29 and in its lower part in a threaded sleeve 42” in Col. 3, lines 27 – 32; Element 39 of the plunger as taught by Michel is configured to translate in a distal direction relative to the housing during dose dispensing since Michel discloses that the disk 41 of the drive stem 39, moved along with the intermediate member 31, abuts against the plunger 5 and urges the latter into the ampoule to such an extent that a small amount of liquid exits from the injection needle (Col. 4, lines 11 – 14); Element 29 of the plunger as taught by Michel is configured to rotate relative to the housing during dose setting since Michel discloses that “the revolution of the push button 11 is transmitted via its longitudinal splines 30 and the grooves in the collar 32 to the intermediate member 31 and, from the latter (cf. FIG. 2) via its longitudinal splines 35 and the longitudinal grooves 44, to the driving sleeve 29 as well as the threaded sleeve 42 fixedly joined to the latter” as discussed in Col. 4, lines 31 – 37;
a biasing member (spring 49, abstract & Fig. 1) operably coupled to the plunger assembly as shown in Figure 1 and discussed in Col. 3, lines 39 – 43;
an annular member (annular shoulder 6) disposed within the housing (Figure 1 shows annular shoulder 6 is located within sleeve 17 of the housing of the device 1), rotationally fixed relative to the housing, and operably coupled to the plunger assembly (element 6 is operably coupled to the plunger (29 and 39) via the interaction between the threaded interior surface of element 6 and the threaded outer surface of thread sleeve 42 as discussed in Col. 4, lines 37 – 41; should 6 is rotationally fixed to housing members 1 and 2, Fig. 1),
the annular member has a threaded interior surface (annular shoulder 6 has an internal thread 9 as discussed in lines 40 and 41 and shown in Figure 1),
an elongate member (42 with external thread 50 as discussed in Col. 4, lines 37 - 42) having a threaded external surface threadingly engaged with the threaded interior surface of the annular member (annular member 6 with internal thread 9 as discussed in Col. 2, lines 40 – 41);
wherein the elongate member (threaded sleeve 42, Fig. 1) is directly coupled to the plunger assembly to drive rotation of at least a portion of the plunger assembly, such that the relative rotation of the elongate member and at least the portion of the plunger assembly are the same (Examiner notes that the driving sleeve 29 and the threaded sleeve 42 are made up of two parts merely for assembly reasons and constitute a fixedly joined unit as discussed in Col. 3, lines 58 – 61 and therefore when elongate member 42 rotates, the plunger assembly (29 and 39, Figure 1) also rotate at the same rotational velocity).
However, Michel does not specify a dampening mechanism disposed within the housing and operably coupled to the drive mechanism, wherein, upon activation of the drive mechanism, the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component, wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component.
Hourmand teaches a drug delivery device (Injector 1, Figure 1) similar to Michel and the current application, further including a dampening mechanism (engagement between rotary damper 28 and syringe holder 22 as discussed in paragraph [0072]) disposed within the housing (housing of injector 1, Figures 1A and 1B) and operably coupled to the drive mechanism (damper 28 is splined engaged to plunger 9 as discussed in paragraph [0072]), wherein, upon activation of the drive mechanism (when auto-injector is pressed against the injection site as discussed in paragraph [0065]), the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component (A rotary damper 28 is arranged around the plunger 9 and engaged to the plunger 9 by a spline 29 or thread on the plunger 9. “, [0064] & Fig. 1A-1B; “Due to the splined engagement of the rotary damper 28 with the plunger 9 the drive spring force on the plunger 9 causes the rotary damper 28 to rotate. Thus, the force of the drive spring 8 is shared between the stopper 9 translation and the rotation of the rotary damper 28. The rotary damper 28 allows for rapid needle insertion since its is not yet engaged with the syringe holder 22 at that point in the injection cycle. Rapid needle insertion is thought to be less painful for the patient. The engagement of the rotary damper 28 with the syringe holder 22 during the actual injection allows for adapting the dispense characteristics of the auto-injector 1 so as to inject the medicament slowly into the injection site.”, [0072]; damper 28 frictionally engages plunger 9, which is being interpreted as a component of the drive mechanism; damper 28 is configured to reduce the rotational velocity of plunger 9, slowing the speed of injection),
wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component (see discussion of the force of the drive spring 8 is shared between the plunger 9 and damper 28 due to the splined engagement of the damper 28 and plunger 9 in order to inject the medicament slowly into the injection site in paragraph [0072]; the output rotational velocity to drive plunger 9 in the distal direction is partly made up by the dampened rotational velocity induced by damper 28).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Regarding claim 18, Michel teaches a drug delivery device (Figures 1 – 5) comprising:
a housing (housing members 1 and 2, abstract & Fig. 1-5);
a drug container (pre-filled syringe 3, abstract & Fig. 1) disposed within the housing and including a proximal end and a distal end as shown in Figure 1;
a drive mechanism activatable to expel a drug from the drug container, the drive mechanism comprising: a stopper (plunger 5, abstract and & Fig. 1) movably disposed within the drug container;
a plunger assembly (sleeve 29 and drive stem 39, Fig. 1) configured to translate in a distal direction (element 39 is configured to translate in a distal direction, col 3 lines 27-33), at least a portion of the plunger assembly being configured to rotate relative to the housing (element 29 is configured to rotate relative to the housing); Examiner notes that the plunger as taught by Michel is made up of drive stem 39 and drive sleeve 29 since Michel discloses that “drive stem 39 lying in the axis 36 of the injection device is attached in the lower part of the intermediate member 31 and carries at its opposite end a disk 41. The drive stem 39 travels, with clearance fitting, in its upper part in a cylindrical driving sleeve 29 and in its lower part in a threaded sleeve 42” in Col. 3, lines 27 – 32. Element 39 of the plunger as taught by Michel is configured to translate in a distal direction relative to the housing during dose dispensing since Michel discloses that the disk 41 of the drive stem 39, moved along with the intermediate member 31, abuts against the plunger 5 and urges the latter into the ampoule to such an extent that a small amount of liquid exits from the injection needle (Col. 4, lines 11 – 14). Element 29 of the plunger as taught by Michel is configured to rotate relative to the housing during dose setting since Michel discloses that “the revolution of the push button 11 is transmitted via its longitudinal splines 30 and the grooves in the collar 32 to the intermediate member 31 and, from the latter (cf. FIG. 2) via its longitudinal splines 35 and the longitudinal grooves 44, to the driving sleeve 29 as well as the threaded sleeve 42 fixedly joined to the latter” as discussed in Col. 4, lines 31 – 37;
wherein at least a portion of the plunger assembly has a threaded exterior surface (threaded outer surface of thread sleeve 42 as discussed in Col. 4, lines 37 – 41);
a biasing member (spring 49, abstract & Fig. 1) operably coupled to the plunger assembly as shown in Figure 1 and discussed in Col. 3, lines 39 – 43; and
an annular member (annular shoulder 6) disposed within the housing (Figure 1 shows annular shoulder 6 is located within sleeve 17 of the housing of the device 1) and rotationally fixed relative to the housing (since annular shoulder 6 is provided as part of housing part 2 as shown in Figure 1),
the annular member being operably coupled to the plunger assembly (element 6 is operably coupled to the plunger (29 and 39) via the interaction between the threaded interior surface of element 6 and the threaded outer surface of thread sleeve 42 as discussed in Col. 4, lines 37 – 41),
and having a threaded interior surface (annular shoulder 6 has an internal thread 9 as discussed in lines 40 and 41 and shown in Figure 1),
However, Michel does not specify a dampening mechanism disposed within the housing and operably coupled to the drive mechanism, wherein, upon activation of the drive mechanism, the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component, wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component.
Hourmand teaches a drug delivery device (Injector 1, Figure 1) similar to Michel and the current application, further including a dampening mechanism (engagement between rotary damper 28 and syringe holder 22 as discussed in paragraph [0072]) disposed within the housing (housing of injector 1, Figures 1A and 1B) and operably coupled to the drive mechanism (damper 28 is splined engaged to plunger 9 as discussed in paragraph [0072]), wherein, upon activation of the drive mechanism (when auto-injector is pressed against the injection site as discussed in paragraph [0065]), the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component (A rotary damper 28 is arranged around the plunger 9 and engaged to the plunger 9 by a spline 29 or thread on the plunger 9. “, [0064] & Fig. 1A-1B; “Due to the splined engagement of the rotary damper 28 with the plunger 9 the drive spring force on the plunger 9 causes the rotary damper 28 to rotate. Thus, the force of the drive spring 8 is shared between the stopper 9 translation and the rotation of the rotary damper 28. The rotary damper 28 allows for rapid needle insertion since its is not yet engaged with the syringe holder 22 at that point in the injection cycle. Rapid needle insertion is thought to be less painful for the patient. The engagement of the rotary damper 28 with the syringe holder 22 during the actual injection allows for adapting the dispense characteristics of the auto-injector 1 so as to inject the medicament slowly into the injection site.”, [0072]; damper 28 frictionally engages plunger 9, which is being interpreted as a component of the drive mechanism; damper 28 is configured to reduce the rotational velocity of plunger 9, slowing the speed of injection),
wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component (see discussion of the force of the drive spring 8 is shared between the plunger 9 and damper 28 due to the splined engagement of the damper 28 and plunger 9 in order to inject the medicament slowly into the injection site in paragraph [0072]; the output rotational velocity to drive plunger 9 in the distal direction is partly made up by the dampened rotational velocity induced by damper 28).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Regarding claim 20, Michel teaches a drug delivery device (Figures 1 – 5) comprising:
a housing (housing members 1 and 2, abstract & Fig. 1-5);
a drug container (pre-filled syringe 3, abstract & Fig. 1) disposed within the housing and including a proximal end and a distal end as shown in Figure 1;
a drive mechanism activatable to expel a drug from the drug container, the drive mechanism comprising: a stopper (plunger 5, abstract and & Fig. 1) movably disposed within the drug container;
a plunger assembly (sleeve 29 and drive stem 39, Fig. 1) configured to translate in a distal direction (element 39 is configured to translate in a distal direction, col 3 lines 27-33), at least a portion of the plunger assembly being configured to rotate relative to the housing (element 29 is configured to rotate relative to the housing); Examiner notes that the plunger as taught by Michel is made up of drive stem 39 and drive sleeve 29 since Michel discloses that “drive stem 39 lying in the axis 36 of the injection device is attached in the lower part of the intermediate member 31 and carries at its opposite end a disk 41. The drive stem 39 travels, with clearance fitting, in its upper part in a cylindrical driving sleeve 29 and in its lower part in a threaded sleeve 42” in Col. 3, lines 27 – 32. Element 39 of the plunger as taught by Michel is configured to translate in a distal direction relative to the housing during dose dispensing since Michel discloses that the disk 41 of the drive stem 39, moved along with the intermediate member 31, abuts against the plunger 5 and urges the latter into the ampoule to such an extent that a small amount of liquid exits from the injection needle (Col. 4, lines 11 – 14). Element 29 of the plunger as taught by Michel is configured to rotate relative to the housing during dose setting since Michel discloses that “the revolution of the push button 11 is transmitted via its longitudinal splines 30 and the grooves in the collar 32 to the intermediate member 31 and, from the latter (cf. FIG. 2) via its longitudinal splines 35 and the longitudinal grooves 44, to the driving sleeve 29 as well as the threaded sleeve 42 fixedly joined to the latter” as discussed in Col. 4, lines 31 – 37;
a biasing member (spring 49, abstract & Figure 1) operably coupled to the plunger assembly as shown in Figure 1 and discussed in Col. 3, lines 39 – 43;
an annular member (annular shoulder 6) disposed within the housing (Figure 1 shows annular shoulder 6 is located within sleeve 17 of the housing of the device 1) and rotationally fixed relative to the housing (since annular shoulder 6 is provided as part of housing part 2 as shown in Figure 1),
the annular member being operably coupled to the plunger assembly (element 6 is operably coupled to the plunger (29 and 39) via the interaction between the threaded interior surface of element 6 and the threaded outer surface of thread sleeve 42 as discussed in Col. 4, lines 37 – 41),
and has a threaded interior surface (annular shoulder 6 has an internal thread 9 as discussed in lines 40 and 41 and shown in Figure 1),
an elongate member (threaded sleeve 42, Fig. 1) having a threaded external surface (threaded external surface 50, Fig. 1) threadingly engaged with the threaded interior surface of the annular member as discussed in Col. 4, lines 37 – 41;
and a coupler (coupling between driving sleeve 29 and threaded sleeve 42, which are made of two parts and fixedly joined as discussed in Col. 3, lines 58 -61) configured to receive a first rotational velocity from the elongate member and deliver a second rotational velocity to the plunger assembly; Examiner notes that the driving sleeve 29 and the threaded sleeve 42 are made up of two parts merely for assembly reasons and constitute a fixedly joined unit as discussed in Col. 3, lines 58 – 61 and therefore when elongate member 42 rotates, the plunger assembly also rotate at the same rotational velocity; Examiner further notes that the claim does not require the first rotational velocity and the second rotational velocity to be the same or different. Therefore, the disclosure of Michel reads on the current claim.
However, Michel does not specify a dampening mechanism disposed within the housing and operably coupled to the drive mechanism, wherein, upon activation of the drive mechanism, the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component, wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component.
Hourmand teaches a drug delivery device (Injector 1, Figure 1) similar to Michel and the current application, further including a dampening mechanism (engagement between rotary damper 28 and syringe holder 22 as discussed in paragraph [0072]) disposed within the housing (housing of injector 1, Figures 1A and 1B) and operably coupled to the drive mechanism (damper 28 is splined engaged to plunger 9 as discussed in paragraph [0072]), wherein, upon activation of the drive mechanism (when auto-injector is pressed against the injection site as discussed in paragraph [0065]), the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component (A rotary damper 28 is arranged around the plunger 9 and engaged to the plunger 9 by a spline 29 or thread on the plunger 9. “, [0064] & Fig. 1A-1B; “Due to the splined engagement of the rotary damper 28 with the plunger 9 the drive spring force on the plunger 9 causes the rotary damper 28 to rotate. Thus, the force of the drive spring 8 is shared between the stopper 9 translation and the rotation of the rotary damper 28. The rotary damper 28 allows for rapid needle insertion since its is not yet engaged with the syringe holder 22 at that point in the injection cycle. Rapid needle insertion is thought to be less painful for the patient. The engagement of the rotary damper 28 with the syringe holder 22 during the actual injection allows for adapting the dispense characteristics of the auto-injector 1 so as to inject the medicament slowly into the injection site.”, [0072]; damper 28 frictionally engages plunger 9, which is being interpreted as a component of the drive mechanism; damper 28 is configured to reduce the rotational velocity of plunger 9, slowing the speed of injection),
wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component (see discussion of the force of the drive spring 8 is shared between the plunger 9 and damper 28 due to the splined engagement of the damper 28 and plunger 9 in order to inject the medicament slowly into the injection site in paragraph [0072]; the output rotational velocity to drive plunger 9 in the distal direction is partly made up by the dampened rotational velocity induced by damper 28).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Regarding claim 24, Michel teaches that the drive mechanism comprises an elongate member (threaded sleeve 42) having a threaded external surface (threaded external surface 50) threadingly engaged with the threaded interior surface of the annular member as discussed in Col. 4, lines 37 – 41, and wherein the elongate member (42) is directly coupled to the plunger assembly (driving sleeve 29 is fixedly joined to threaded sleeve 42) to drive rotation of the portion of the plunger assembly (when button 11 is rotated as discussed in Col. 4, lines 31 – 42) such that the relative rotation of the elongate member and the portion of the plunger assembly are the same (since threaded sleeve 42 is fixedly joined to drive sleeve 29).
Regarding claim 25, Michel and Hourmand teach claim 1 as seen above.
However, Michel does not specify that wherein the rotational velocity of the at least one component is converted to an output rotational velocity to drive the plunger assembly in the distal direction.
Hourmand teaches a drug delivery device similar to Michel and the current application, further including that the rotational velocity of the at least one component is converted to an output rotational velocity to drive the plunger assembly in the distal direction (since plunger 9 is being interpreted as the at least one component, the rotational velocity of plunger 9 is directly related to an output rotational velocity to drive plunger 9, [0072] & Fig. 1A1-B).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Claim(s) 2, 9, 14 – 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (U.S. 5,112,317) in view of Hourmand (U.S. 2013/0317448), and in view of Beek (U.S. 2015/0265776).
Regarding claim 2, Michel and Hourmand teach claim 1 as seen above.
However, Michel and Hourmand do not specify that wherein the biasing member, via the drive mechanism, is configured to rotate the portion of the plunger assembly.
Beek teaches a drug delivery device similar to Michel, Hourmand, and the current application, further including that the biasing member, via the drive mechanism, is configured to rotate the portion of the plunger assembly (paragraph [0024]), specifically a spring drive arrangement which is rotated by the torsion spring to rotate the rotatable drive member to move the piston rod forward in the housing.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Beek as discussed above with the combined system of Michel and Hourmand in order to drive the piston rod forward in the housing (paragraph [0019]).
Regarding claim 9, Michel and Hourmand teach claim 1 as seen above.
However, Michel and Hourmand do not specify that the drive mechanism converts rotational motion into linear motion on the plunger assembly.
Beek teaches a drug delivery device similar to Michel, Hourmand, and the current application, further including that the drive mechanism converts rotational motion into linear motion on the plunger assembly (paragraph [0019]), specifically a spring drive arrangement which is rotated by the torsion spring to rotate the rotatable drive member to move the piston rod forward in the housing.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Beek as discussed above with combined system of Michel and Hourmand in order to drive the piston rod forward in the housing (Beek, paragraph [0019]).
Regarding claim 14, Michel and Hourmand teach claim 1 as seen above.
However, Michel and Hourmand do not specify that wherein the biasing member causes the portion of the plunger assembly to rotate when the biasing member is released.
Beek teaches a drug delivery device similar to Michel, Hourmand, and the current application, further including that the biasing member causes the portion of the plunger assembly to rotate when the biasing member is released (paragraph [0024]), specifically a spring drive arrangement which is rotated by the torsion spring to rotate the rotatable drive member to move the piston rod forward in the housing.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Beek as discussed above with the combined system of Michel and Hourmand in order to drive the piston rod forward in the housing (Beek, paragraph [0019]).
Regarding claim 15, Michel and Hourmand teach claim 1 as seen above.
However, Michel and Hourmand do not specify that wherein the portion of the plunger assembly is configured to rotate relative to the housing while translating in the distal direction.
Beek teaches a drug delivery device similar to Michel, Hourmand, and the current application, further including that the portion of the plunger assembly is configured to rotate relative to the housing while translating in the distal direction (paragraph [0024]), specifically a spring drive arrangement which is rotated by the torsion spring to rotate the rotatable drive member to move the piston rod forward in the housing.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Beek as discussed above with the combined system of Michel and Hourmand in order to drive the piston rod forward in the housing (Beek, paragraph [0019]).
Regarding claim 16, Michel teaches a drug delivery device (Figures 1 – 5) comprising:
a housing (housing members 1 and 2, abstract & Fig. 1-5);
a drug container (pre-filled syringe 3, abstract & Fig. 1) disposed within the housing and including a proximal end and a distal end as shown in Figure 1;
a drive mechanism activatable to expel a drug from the drug container, the drive mechanism comprising: a stopper (plunger 5, abstract and & Fig. 1) movably disposed within the drug container;
a plunger assembly (sleeve 29 and drive stem 39, Fig. 1) configured to translate in a distal direction (element 39 is configured to translate in a distal direction, col 3 lines 27-33), at least a portion of the plunger assembly being configured to rotate relative to the housing (element 29 is configured to rotate); Examiner notes that the plunger as taught by Michel is made up of drive stem 39 and drive sleeve 29 since Michel discloses that “drive stem 39 lying in the axis 36 of the injection device is attached in the lower part of the intermediate member 31 and carries at its opposite end a disk 41... The drive stem 39 travels, with clearance fitting, in its upper part in a cylindrical driving sleeve 29 and in its lower part in a threaded sleeve 42” in Col. 3, lines 27 – 32; Element 39 of the plunger as taught by Michel is configured to translate in a distal direction relative to the housing during dose dispensing since Michel discloses that the disk 41 of the drive stem 39, moved along with the intermediate member 31, abuts against the plunger 5 and urges the latter into the ampoule to such an extent that a small amount of liquid exits from the injection needle (Col. 4, lines 11 – 14); Element 29 of the plunger as taught by Michel is configured to rotate relative to the housing during dose setting since Michel discloses that “the revolution of the push button 11 is transmitted via its longitudinal splines 30 and the grooves in the collar 32 to the intermediate member 31 and, from the latter (cf. FIG. 2) via its longitudinal splines 35 and the longitudinal grooves 44, to the driving sleeve 29 as well as the threaded sleeve 42 fixedly joined to the latter” as discussed in Col. 4, lines 31 – 37;
a biasing member (spring 49, abstract & Fig. 1) operably coupled to the plunger assembly as shown in Figure 1 and discussed in Col. 3, lines 39 – 43;
However, Michel does not specify that the biasing member, via the drive mechanism, is configured to rotate the portion of the plunger assembly, and a dampening mechanism disposed within the housing and operably coupled to the drive mechanism, wherein, upon activation of the drive mechanism, the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component, wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component.
Hourmand teaches a drug delivery device (Injector 1, Figure 1) similar to Michel and the current application, further including a dampening mechanism (engagement between rotary damper 28 and syringe holder 22 as discussed in paragraph [0072]) disposed within the housing (housing of injector 1, Figures 1A and 1B) and operably coupled to the drive mechanism (damper 28 is splined engaged to plunger 9 as discussed in paragraph [0072]), wherein, upon activation of the drive mechanism (when auto-injector is pressed against the injection site as discussed in paragraph [0065]), the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component (A rotary damper 28 is arranged around the plunger 9 and engaged to the plunger 9 by a spline 29 or thread on the plunger 9. “, [0064] & Fig. 1A-1B; “Due to the splined engagement of the rotary damper 28 with the plunger 9 the drive spring force on the plunger 9 causes the rotary damper 28 to rotate. Thus, the force of the drive spring 8 is shared between the stopper 9 translation and the rotation of the rotary damper 28. The rotary damper 28 allows for rapid needle insertion since its is not yet engaged with the syringe holder 22 at that point in the injection cycle. Rapid needle insertion is thought to be less painful for the patient. The engagement of the rotary damper 28 with the syringe holder 22 during the actual injection allows for adapting the dispense characteristics of the auto-injector 1 so as to inject the medicament slowly into the injection site.”, [0072]; damper 28 frictionally engages plunger 9, which is being interpreted as a component of the drive mechanism; damper 28 is configured to reduce the rotational velocity of plunger 9, slowing the speed of injection),
wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component (see discussion of the force of the drive spring 8 is shared between the plunger 9 and damper 28 due to the splined engagement of the damper 28 and plunger 9 in order to inject the medicament slowly into the injection site in paragraph [0072]; the output rotational velocity to drive plunger 9 in the distal direction is partly made up by the dampened rotational velocity induced by damper 28).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Further, Beek teaches a drug delivery device similar to Michel, Hourmand, and the current application, further including that the biasing member, via the drive mechanism, is configured to rotate the portion of the plunger assembly (paragraph [0024]), specifically a spring drive arrangement which is rotated by the torsion spring to rotate the rotatable drive member to move the piston rod forward in the housing.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Beek as discussed above with the combined system of Michel and Kemp in order to drive the piston rod forward in the housing (Beek, paragraph [0019]).
Regarding claim 19, Michel teaches a drug delivery device (Figures 1 – 5) comprising:
a housing (housing members 1 and 2, abstract & Fig. 1-5);
a drug container (pre-filled syringe 3, abstract & Fig. 1) disposed within the housing and including a proximal end and a distal end as shown in Figure 1;
a drive mechanism activatable to expel a drug from the drug container, the drive mechanism comprising: a stopper (plunger 5, abstract and & Fig. 1) movably disposed within the drug container;
a plunger assembly (sleeve 29 and drive stem 39, Fig. 1) configured to translate in a distal direction (element 39 is configured to translate in a distal direction, col 3 lines 27-33), at least a portion of the plunger assembly being configured to rotate relative to the housing (element 29 is configured to rotate); Examiner notes that the plunger as taught by Michel is made up of drive stem 39 and drive sleeve 29 since Michel discloses that “drive stem 39 lying in the axis 36 of the injection device is attached in the lower part of the intermediate member 31 and carries at its opposite end a disk 41... The drive stem 39 travels, with clearance fitting, in its upper part in a cylindrical driving sleeve 29 and in its lower part in a threaded sleeve 42” in Col. 3, lines 27 – 32; Element 39 of the plunger as taught by Michel is configured to translate in a distal direction relative to the housing during dose dispensing since Michel discloses that the disk 41 of the drive stem 39, moved along with the intermediate member 31, abuts against the plunger 5 and urges the latter into the ampoule to such an extent that a small amount of liquid exits from the injection needle (Col. 4, lines 11 – 14); Element 29 of the plunger as taught by Michel is configured to rotate relative to the housing during dose setting since Michel discloses that “the revolution of the push button 11 is transmitted via its longitudinal splines 30 and the grooves in the collar 32 to the intermediate member 31 and, from the latter (cf. FIG. 2) via its longitudinal splines 35 and the longitudinal grooves 44, to the driving sleeve 29 as well as the threaded sleeve 42 fixedly joined to the latter” as discussed in Col. 4, lines 31 – 37;
a biasing member (spring 49, abstract & Fig. 1) operably coupled to the plunger assembly as shown in Figure 1 and discussed in Col. 3, lines 39 – 43;
an annular member (annular shoulder 6) disposed within the housing (Figure 1 shows annular shoulder 6 is located within sleeve 17 of the housing of the device 1) rotationally fixed relative to the housing (annular shoulder 6 is provided as part of housing part 2 as shown in Figure 1), and operably coupled to the plunger assembly (element 6 is operably coupled to the plunger (29 and 39) via the interaction between the threaded interior surface of element 6 and the threaded outer surface of thread sleeve 42 as discussed in Col. 4, lines 37 – 41),
However, Michel does not specify a dampening mechanism disposed within the housing and operably coupled to the drive mechanism, wherein, upon activation of the drive mechanism, the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component, wherein an output velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component, wherein the drive mechanism converts rotational motion into linear motion of the plunger assembly.
Hourmand teaches a drug delivery device (Injector 1, Figure 1) similar to Michel and the current application, further including a dampening mechanism (engagement between rotary damper 28 and syringe holder 22 as discussed in paragraph [0072]) disposed within the housing (housing of injector 1, Figures 1A and 1B) and operably coupled to the drive mechanism (damper 28 is splined engaged to plunger 9 as discussed in paragraph [0072]), wherein, upon activation of the drive mechanism (when auto-injector is pressed against the injection site as discussed in paragraph [0065]), the dampening mechanism is configured to exert a frictional force on at least one component of the drive mechanism to reduce a rotational velocity of the at least one component (A rotary damper 28 is arranged around the plunger 9 and engaged to the plunger 9 by a spline 29 or thread on the plunger 9. “, [0064] & Fig. 1A-1B; “Due to the splined engagement of the rotary damper 28 with the plunger 9 the drive spring force on the plunger 9 causes the rotary damper 28 to rotate. Thus, the force of the drive spring 8 is shared between the stopper 9 translation and the rotation of the rotary damper 28. The rotary damper 28 allows for rapid needle insertion since its is not yet engaged with the syringe holder 22 at that point in the injection cycle. Rapid needle insertion is thought to be less painful for the patient. The engagement of the rotary damper 28 with the syringe holder 22 during the actual injection allows for adapting the dispense characteristics of the auto-injector 1 so as to inject the medicament slowly into the injection site.”, [0072]; damper 28 frictionally engages plunger 9, which is being interpreted as a component of the drive mechanism; damper 28 is configured to reduce the rotational velocity of plunger 9, slowing the speed of injection),
wherein an output rotational velocity to drive the plunger assembly in the distal direction depends at least partially on the rotational velocity of the at least one component (see discussion of the force of the drive spring 8 is shared between the plunger 9 and damper 28 due to the splined engagement of the damper 28 and plunger 9 in order to inject the medicament slowly into the injection site in paragraph [0072]; the output rotational velocity to drive plunger 9 in the distal direction is partly made up by the dampened rotational velocity induced by damper 28).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Hourmand as discussed with the device of Michel in order to inject the medicament slowly into the injection site (Hourmand, paragraph [0072]).
Further, Beek teaches a drug delivery device similar to Michel, Hourmand, and the current application, further including that the drive mechanism converts rotational motion into linear motion on the plunger assembly (paragraph [0019]), specifically a spring drive arrangement which is rotated by the torsion spring to rotate the rotatable drive member to move the piston rod forward in the housing.
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Beek as discussed above with the combined system of Michel and Hourmand in order to drive the piston rod forward in the housing (Beek, paragraph [0019]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (U.S. 5,112,317) in view of Hourmand (U.S 2013/0317448), and in view of Clube (U.S. 2015/0166677).
Regarding claim 13, Michel teaches that the drug container is filled or pre-filled with a drug (Col. 2, lines 31 – 32 discussed prefilled),
However, Michel and Hourmand do not specify that the drug comprises evolocumab.
Clube teaches a device similar to Michel, Hourmand, and the current application, further including that the drug comprises evolocumab (paragraph [0139] discloses administer evolocumab to the patient).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Clube with the combined system of Michel and Hourmand in order to enable tailored medicines that address individual patient genotypes (paragraph [0010]).
Response to Arguments
Applicant’s arguments, see pages 9-12, filed 4/6/2026, with respect to the rejection(s) of claim(s) 1, 6-8, 10-12, 17-18, 20, and 24-25 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternate interpretation of Hourmand.
Conclusion
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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