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 § 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hostettler et al. (EP 3260151).
Regarding claim 1, Hostettler discloses a pumping and inserting mechanism comprising:
a pumping assembly (“The gear wheel (14) is directly coupled, e.g. axially and rotationally fixed coupled to a threaded rod (15) having an external threading (18). The threaded rod drives the piston rod which ensures that medication is expelled from the reservoir. The threaded coupling between the gear wheel (14) and the first part (1) is permanent, thus a rotation of the gear wheel will always result in a rotation of the first part (1), but also in a rotation of the threaded rod (15).” [0073], see also all of [0102-0104]) comprising an input portion (gear wheel 14) and an output portion (first part 1);
a driving assembly (electromotor 83, gearing 84 and worm wheel 85) coupled to the input portion of the pumping assembly (Figures 8-9) and configured to drive a rotating movement of the input portion of the pumping assembly to drive a rotating movement of the output portion of the pumping assembly (“A rotation of the gear wheel (14), preferably by a drive mechanism comprising the motor and a worm wheel, results in a rotation of the first part.” [0075]); and
an inserting assembly (needle control element 41 and third part 3) comprising a triggering component (third part 3) and an inserting component (cannula 36), the triggering component being driven to rotate to trigger an inserting movement of the inserting component in response to the rotating movement of the output portion of the pumping assembly (“Once the toothings of the second and third part (11,12) are in a form fit after closing the coupling by the axial shift of the second part (2) towards the third part (3), the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity…The first rotation direction for closing the coupling is preferably accompanied with a needle insertion and/or needle retraction…The coupling of the second part (2) to the third part (3) in a rotationally locked configuration ensures that the cams (13) which are on the end surface (22) of the third part, also rotate a needle control element (41) over a defined angle.” [0077-0078]).
Regarding claim 2, Hostettler discloses the pumping and inserting mechanism of claim 1, wherein the driving assembly comprises a driving component (electromotor 83) and an adaptor (gearing 84 and worm wheel 85), and the adaptor is mounted between the driving component and the input portion of the pumping assembly and detachable from the input portion of the pumping assembly (“A rotation of the gear wheel (14), preferably by a drive mechanism comprising the motor and a worm wheel” [0075]; “The threaded rod (15) is rotated by an electromotor (83) which drives the threaded rod via a gearing (84) in combination with a worm wheel (85).” [0102]; Figure 41).
Regarding claim 3, Hostettler discloses the pumping and inserting mechanism of claim 1, further comprising an engaging component (second part 2) coupled to the output portion (first part 1) of the pumping assembly and configured to move from a disengaged state to an engaged state in response to the rotating movement of the input portion of the pumping assembly, the engaging component being disengaged from the triggering component (third part 3) for not driving the triggering component to rotate when the engaging component is not in the engaged state, and the engaging component being engaged with the triggering component for driving the triggering component to rotate when the engaging component is in the engaged state (“Once the toothings of the second and third part (11,12) are in a form fit after closing the coupling by the axial shift of the second part (2) towards the third part (3), the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity. Reversing the rotation direction opens, or decouples the coupling (11,12) between the second part and the third part, e.g., the toothings (11,12) move out of engagement, the third part (3) will stop co-rotating with the first (1) and second (2) part.” [0077]; “The coupling of the second part (2) to the third part (3) in a rotationally locked configuration ensures that the cams (13) which are on the end surface (22) of the third part, also rotate a needle control element (41) over a defined angle.” [0078]).
Regarding claim 4, Hostettler discloses the pumping and inserting mechanism of claim 3, wherein the engaging component is a rotatable component (“the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity” [0077]).
Regarding claim 5, Hostettler discloses the pumping and inserting mechanism of claim 4, wherein the engaging component (second part 2) is rotatable relative to the inserting assembly (“A rotation of the gear wheel (14)…results in a rotation of the first part. Due to the threaded engagement between the first (1) and second (2) part in combination with the higher friction on the outside of the second part, which axially and rotationally temporarily holds or fixates the second part (2) with respect to the housing, this ensures that the second part (2) axially shifts away from the flange (7) of the first part (1) without rotation or at least rotates less, e.g. at a lower angular velocity than the first part.” [0075]), the engaging component comprises a first cooperating structure (toothing 11), the inserting assembly comprises a second cooperating structure (toothing 12) configured to cooperate with the first cooperating structure to drive the engaging component to move from the disengaged state to the engaged state when the engaging component is driven to rotate in response to the rotating movement of the output portion of the pumping assembly (“Once the toothings of the second and third part (11,12) are in a form fit after closing the coupling by the axial shift of the second part (2) towards the third part (3), the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity.” [0077]; “The coupling of the second part (2) to the third part (3) in a rotationally locked configuration ensures that the cams (13) which are on the end surface (22) of the third part, also rotate a needle control element (41) over a defined angle.” [0078]).
Regarding claim 6, Hostettler discloses the pumping and inserting mechanism of claim 3, wherein the output portion of the pumping assembly (first part 1) is disposed through the triggering component (third part 3; Figures 10-11 and 13, via the connection of the second part 2) and at least partially inserted into the engaging component (second part 2; Figure 13 showing at least the body of first part 1 are partially inserted at least through the arms of second part 2), and the engaging component (second part 2) is movable along an extending direction of the output portion of the pumping assembly when the engaging component rotates (see all of 0075-0078]).
Regarding claim 7, Hostettler discloses the pumping and inserting mechanism of claim 6, wherein the triggering component (third part 3) comprises a first engaging structure (inner surface of third part 3 having toothing 12; Figure 13), the output portion of the pumping assembly (first part 1) is disposed through the first engaging structure (Figures 10-11 and 13, via the connection of the second part 2), and the engaging component (second part 2) comprises a second engaging structure (toothing 11) configured to engage with the first engaging structure (“The second part has an end surface (23) with an toothing (11), preferably an asymmetric toothing circumferentially arranged that matches or complements the toothing (12), preferably an asymmetric toothing present on the end surface (22) of the third part (3).” [0077]).
Regarding claim 8, Hostettler discloses the pumping and inserting mechanism of claim 3, wherein a rotating axis of the triggering component is coincided with a rotating axis of the output portion of the pumping assembly, a rotating axis of the input portion of the pumping assembly and a rotating axis of the engaging component (Figures 10-11; “The gear wheel (14) is directly coupled, e.g. axially and rotationally fixed coupled to a threaded rod (15) having an external threading (18). The threaded rod drives the piston rod which ensures that medication is expelled from the reservoir. The threaded coupling between the gear wheel (14) and the first part (1) is permanent, thus a rotation of the gear wheel will always result in a rotation of the first part (1), but also in a rotation of the threaded rod (15).” [0073] “the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity.” [0077]; wherein each of the rotating axes cooperate and rotate together simultaneously, and are therefore coincided).
Regarding claim 9, Hostettler discloses the pumping and inserting mechanism of claim 1, wherein the triggering component (third part 3) is coupled to the output portion (first part 1) of the pumping assembly (Figures 10-11, via second part 2).
Regarding claim 10, Hostettler discloses the pumping and inserting mechanism of claim 9, wherein a rotating axis of the triggering component is coincided with a rotating axis of the output portion of the pumping assembly and a rotating axis of the input portion of the pumping assembly (Figures 10-11; “The gear wheel (14) is directly coupled, e.g. axially and rotationally fixed coupled to a threaded rod (15) having an external threading (18). The threaded rod drives the piston rod which ensures that medication is expelled from the reservoir. The threaded coupling between the gear wheel (14) and the first part (1) is permanent, thus a rotation of the gear wheel will always result in a rotation of the first part (1), but also in a rotation of the threaded rod (15).” [0073] “the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity.” [0077]; wherein each of the rotating axes cooperate and rotate together simultaneously, and are therefore coincided).
Regarding claim 11, Hostettler discloses an automated injection system (Figure 1) comprising:
a case (housing 4);
a reservoir (reservoir 26)mounted on the case internally or externally, or separated from the case (Figure 8); and a pumping and inserting mechanism comprising:
a pumping assembly (“The gear wheel (14) is directly coupled, e.g. axially and rotationally fixed coupled to a threaded rod (15) having an external threading (18). The threaded rod drives the piston rod which ensures that medication is expelled from the reservoir. The threaded coupling between the gear wheel (14) and the first part (1) is permanent, thus a rotation of the gear wheel will always result in a rotation of the first part (1), but also in a rotation of the threaded rod (15).” [0073], see also all of [0102-0104]) at least partially mounted inside the case (Figure 8) and comprising an inlet (spike 31), an outlet (tubing 43), an input portion (gear wheel 14) and an output portion (first part 1), the inlet of the pumping assembly being communicated with the reservoir (“A tubing (43) connects the spike (31) to the canula holder (35) to create a fluid path between a canula (36) and the contents of the reservoir (26) once the spike (31) has been inserted.” [0084]);
a driving assembly (electromotor 83, gearing 84 and worm wheel 85) mounted one the case internally or externally (Figure 8) and coupled to the input portion of the pumping assembly (Figures 8-9) and configured to drive a rotating movement of the input portion of the pumping assembly to drive a rotating movement of the output portion of the pumping assembly (“A rotation of the gear wheel (14), preferably by a drive mechanism comprising the motor and a worm wheel, results in a rotation of the first part.” [0075]); and
an inserting assembly (needle control element 41 and third part 3) at least partially mounted in the case (Figure 8) and comprising a triggering component (third part 3) and an inserting component (cannula 36), the inserting component being communicated with the outlet of the pumping assembly (“A tubing (43) connects the spike (31) to the canula holder (35) to create a fluid path between a canula (36) and the contents of the reservoir (26) once the spike (31) has been inserted.” [0084]), the triggering component being driven to rotate to trigger an inserting movement of the inserting component in response to the rotating movement of the output portion of the pumping assembly (“Once the toothings of the second and third part (11,12) are in a form fit after closing the coupling by the axial shift of the second part (2) towards the third part (3), the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity…The first rotation direction for closing the coupling is preferably accompanied with a needle insertion and/or needle retraction…The coupling of the second part (2) to the third part (3) in a rotationally locked configuration ensures that the cams (13) which are on the end surface (22) of the third part, also rotate a needle control element (41) over a defined angle.” [0077-0078]).
Regarding claim 12, Hostettler discloses the automated injection system of claim 11, wherein the driving assembly comprises a driving component (electromotor 83) and an adaptor (gearing 84 and worm wheel 85), and the adaptor is mounted between the driving component and the input portion of the pumping assembly and detachable from the input portion of the pumping assembly (“A rotation of the gear wheel (14), preferably by a drive mechanism comprising the motor and a worm wheel” [0075]; “The threaded rod (15) is rotated by an electromotor (83) which drives the threaded rod via a gearing (84) in combination with a worm wheel (85).” [0102]; Figure 41).
Regarding claim 13, Hostettler discloses the automated injection system of claim 11, further comprising an engaging component (second part 2) coupled to the output portion (first part 1) of the pumping assembly and configured to move from a disengaged state to an engaged state in response to the rotating movement of the input portion of the pumping assembly, the engaging component being disengaged from the triggering component (third part 3) for not driving the triggering component to rotate when the engaging component is not in the engaged state, and the engaging component being engaged with the triggering component for driving the triggering component to rotate when the engaging component is in the engaged state (“Once the toothings of the second and third part (11,12) are in a form fit after closing the coupling by the axial shift of the second part (2) towards the third part (3), the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity. Reversing the rotation direction opens, or decouples the coupling (11,12) between the second part and the third part, e.g., the toothings (11,12) move out of engagement, the third part (3) will stop co-rotating with the first (1) and second (2) part.” [0077]; “The coupling of the second part (2) to the third part (3) in a rotationally locked configuration ensures that the cams (13) which are on the end surface (22) of the third part, also rotate a needle control element (41) over a defined angle.” [0078]).
Regarding claim 14, Hostettler discloses the automated injection system of claim 13, wherein the engaging component is a rotatable component (“the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity” [0077]).
Regarding claim 15, Hostettler discloses the automated injection system of claim 14, wherein the engaging component (second part 2) is rotatable relative to the inserting assembly (“A rotation of the gear wheel (14)…results in a rotation of the first part. Due to the threaded engagement between the first (1) and second (2) part in combination with the higher friction on the outside of the second part, which axially and rotationally temporarily holds or fixates the second part (2) with respect to the housing, this ensures that the second part (2) axially shifts away from the flange (7) of the first part (1) without rotation or at least rotates less, e.g. at a lower angular velocity than the first part.” [0075]), the engaging component comprises a first cooperating structure (toothing 11), the inserting assembly comprises a second cooperating structure (toothing 12) configured to cooperate with the first cooperating structure to drive the engaging component to move from the disengaged state to the engaged state when the engaging component is driven to rotate in response to the rotating movement of the output portion of the pumping assembly (“Once the toothings of the second and third part (11,12) are in a form fit after closing the coupling by the axial shift of the second part (2) towards the third part (3), the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity.” [0077]; “The coupling of the second part (2) to the third part (3) in a rotationally locked configuration ensures that the cams (13) which are on the end surface (22) of the third part, also rotate a needle control element (41) over a defined angle.” [0078]).
Regarding claim 16, Hostettler discloses the automated injection system of claim 13, wherein the output portion of the pumping assembly (first part 1) is disposed through the triggering component (third part 3; Figures 10-11 and 13, via the connection of the second part 2) and at least partially inserted into the engaging component (second part 2; Figure 13 showing at least the body of first part 1 are partially inserted at least through the arms of second part 2), and the engaging component (second part 2) is movable along an extending direction of the output portion of the pumping assembly when the engaging component rotates (see all of 0075-0078]).
Regarding claim 17, Hostettler discloses the automated injection system of claim 16, wherein the triggering component (third part 3) comprises a first engaging structure (inner surface of third part 3 having toothing 12; Figure 13), the output portion of the pumping assembly (first part 1) is disposed through the first engaging structure (Figures 10-11 and 13, via the connection of the second part 2), and the engaging component (second part 2) comprises a second engaging structure (toothing 11) configured to engage with the first engaging structure (“The second part has an end surface (23) with an toothing (11), preferably an asymmetric toothing circumferentially arranged that matches or complements the toothing (12), preferably an asymmetric toothing present on the end surface (22) of the third part (3).” [0077]).
Regarding claim 18, Hostettler discloses the automated injection system of claim 13, wherein a rotating axis of the triggering component is coincided with a rotating axis of the output portion of the pumping assembly, a rotating axis of the input portion of the pumping assembly and a rotating axis of the engaging component (Figures 10-11; “The gear wheel (14) is directly coupled, e.g. axially and rotationally fixed coupled to a threaded rod (15) having an external threading (18). The threaded rod drives the piston rod which ensures that medication is expelled from the reservoir. The threaded coupling between the gear wheel (14) and the first part (1) is permanent, thus a rotation of the gear wheel will always result in a rotation of the first part (1), but also in a rotation of the threaded rod (15).” [0073] “the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity.” [0077]; wherein each of the rotating axes cooperate and rotate together simultaneously, and are therefore coincided).
Regarding claim 19, Hostettler discloses the automated injection system of claim 11, wherein the triggering component (third part 3) is coupled to the output portion (first part 1) of the pumping assembly (Figures 10-11, via second part 2).
Regarding claim 20, Hostettler discloses the automated injection system of claim 19, wherein a rotating axis of the triggering component is coincided with a rotating axis of the output portion of the pumping assembly and a rotating axis of the input portion of the pumping assembly (Figures 10-11; “The gear wheel (14) is directly coupled, e.g. axially and rotationally fixed coupled to a threaded rod (15) having an external threading (18). The threaded rod drives the piston rod which ensures that medication is expelled from the reservoir. The threaded coupling between the gear wheel (14) and the first part (1) is permanent, thus a rotation of the gear wheel will always result in a rotation of the first part (1), but also in a rotation of the threaded rod (15).” [0073] “the first part, the second part and the third part co-rotate in one rotation direction at the same angular velocity.” [0077]; wherein each of the rotating axes cooperate and rotate together simultaneously, and are therefore coincided).
Conclusion
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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