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
Claims 17-18, 20-22, 25, 27-29, and 35-36 are objected to because of the following informalities:
Regarding claim 17, the phrase “the user interface member” in line 11, line 14, lines 15-16, and lines 16-17 should all read “the at least one user interface member” for proper antecedent basis,
Regarding claims 18, 20, 21, 22, 25, 27, 28, 35, and 36, all instances of “the user interface member” should read “the at least one user interface member”,
Regarding claim 29, the phrase “the activation“ in line 2 should read “the activation operation” for proper antecedent basis,
Regarding claim 36, the phrase “a manipulation the user interface” in line 6 should read “a manipulation of the user interface” for proper grammar,
Regarding claim 36, the phrase “generated in response a manipulation of the user interface member” in line 7 should read “generated in response to a manipulation of the user interface member” for proper grammar,
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 23-31 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 23, the phrase “wherein a separation between the first position and the second position is determined by a switching distance by which a first member of a dose setting and drive mechanism has to be moved relative to a second member of the dose setting and drive mechanism” in lines 1-4 renders the claim indefinite because it is unclear. From p.10, lines 5-10 of the specification, “the separation, e.g. the axial separation, between the first position and the second position is determined by, for example equal to, a switching distance, e.g. a clutch release distance. The switching distance may be the distance by which the second member of the dose setting and drive mechanism has to be moved relative to the first member of the dose setting and drive mechanism in order to switch the dose setting and drive mechanism from a dose setting configuration of the mechanism to a dose delivery configuration of the mechanism.” The specification defines the first member as a dial sleeve or number sleeve and the second member as a drive member or dose knob. Thus, it is unclear form the disclosed operation of the device in the specification how the first member would move relative to the second member the (axial) switching distance when it is described in the specification that the second member (axially) moves relative to the first member. Examiner suggests amending this limitation to be consistent with the specification “wherein a separation between the first position and the second position is determined by a switching distance by which a second member of a dose setting and drive mechanism has to be moved relative to a first member of the dose setting and drive mechanism,” and examiner will be interpreting the limitation as such. Examiner notes with this amendment, the limitations of dependent claims 24-26 would be definite as written.
Regarding claim 27, the phrase “the switch signal decreases” renders the claim indefinite because it is unclear. It is unclear what the scope of a signal decreasing would comprise of, i.e. the signal’s strength decreases, the signal’s frequency decreases, or if another characteristic of the signal decreases. Examiner notes, in light of the specification (e.g. p. 35), this limitation is being interpreted as the signal’s strength decreases which is a function of decreasing current.
Regarding claims 24-26 and 28-31, these claims are rejected due to their dependency upon claims 23 and 27, respectively.
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) 17-22 and 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer et al. (W.O Patent Pub. No. 2019077094 A1, “Helmer”) in view of Friedli (U.S Patent Pub. No. 20110270219 A1).
Regarding claim 17, Helmer discloses the limitations of (Claim 17)
an electronic system (13 in Fig. 5a-6) for a drug delivery device (1 in Fig. 1, see p.15, lines 7-8), the electronic system (13) comprising:
at least one user interface member (17, 25 in Fig. 5a) configured to be manipulated by a user for performing a dose setting operation to set a dose of drug to be delivered by the drug delivery device (1) and/or for performing a dose delivery operation for delivering a set dose (see p.8, lines 22-31 for attachment assembly 17 manipulated during dose setting, see p.15, lines 10-15 for switch 25 manipulated to initiate rotation of protrusions 11 and thus dose delivery), and is further configured to be manipulated for an activation operation (see p.15, lines 12-15 and lines 32-35 – the switch 25 may be used to operate the device as a wake-up switch i.e. to turn the device on or off in addition to initiating dose delivery);
an electronic control unit (22 in Fig. 6) configured to control operation of the electronic system (13, see Fig. 6 and p.15, lines 21-29), the electronic system (13) having a first state and a second state (see p.15, lines 32-35 – system 13 may have a first state as a powered-down state and a second state as a powered-up state), wherein the electronic system (13) has an electrical power consumption in the second state that is higher than an electrical power consumption of the electronic system in the first state (see p.15, lines 33-37);
an electrical signaling unit configured to provide at least one electrical signal indicating that the user interface member (17, 25) is manipulated (see p.16, lines 5-20 – switch 25 may be implemented as a sensor switch incorporating an electrical signaling unit that provides an electric signal indicating the switch 25 is manipulated by the user).
While Helmer discloses that the at least one user interface member (17, 25) may be configured to be manipulated for an activation operation and is disclosed as being actuated to perform a number of other functions such as a multi-function button (see p.15, lines 11-15), Helmer fails to disclose (Claim 17) a manipulation evaluation unit operatively connected to the electrical signaling unit and configured to evaluate the at least one electrical signal in order to determine whether a manipulation of the user interface member indicated by the at least one electrical signal of the electrical signaling unit qualifies as the activation operation, wherein a manipulation of the user interface member for the activation operation is different from a manipulation of the user interface member for the dose setting operation and for the dose delivery operation, wherein the electronic control unit is configured to switch the electronic system into the second state that has the higher electrical power consumption in response to the manipulation evaluation unit confirming that the manipulation qualifies as the activation operation.
Friedli discloses a drug administration device having a user interface member (18 in Fig. 2b) in the form of a button which may be manipulated by a user to input data, actuate a display, and initiate a dose delivery operation (see para. 0031-0033). Friedli further discloses an electronic signaling unit (20) in the form of a touch sensor which provides a signal indicating manipulation of the user interface member (18, see para. 0029) and an electronic control unit (14) in the form of a controller configured for controlling the electronic system (see para. 0033). Friedli teaches (Claim 17) a manipulation evaluation unit operatively connected to the electrical signaling unit (20) and configured to evaluate the at least one electrical signal in order to determine whether a manipulation of the user interface member (18) indicated by the at least one electrical signal of the electrical signaling unit (20) qualifies as the activation operation (see para. 0031, para. 0036, and para. 0048-0049 – controller 14 comprises a manipulation evaluation unit which evaluates the signal from touch sensor 20 if the user manipulation of button 18 was a particular code for activating the display or other functions of the device), wherein a manipulation of the user interface member (18) for the activation operation is different from a manipulation of the user interface member (18) for the dose delivery operation (see para. 0031 and 0048-0049 – the activation operation is pressing the button 18 with a particular code such as pressing the button two or three times in a row versus a singular touch for drug administration),
wherein the electronic control unit (14) is configured to switch the electronic system into the second state that has the higher electrical power consumption in response to the manipulation evaluation unit confirming that the manipulation qualifies as the activation operation (see para. 0036 and 0048-0049 – the controller may recognize the particular code for the activation operation which may activate the display which is a higher electrical power consumption state).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic system taught by Helmer to incorporate a manipulation evaluation unit operatively connected to the electrical signaling unit and configured to evaluate the at least one electrical signal in order to determine whether a manipulation of the user interface member indicated by the at least one electrical signal of the electrical signaling unit qualifies as the activation operation, wherein the activation operation is different from a manipulation of the user interface member for the dose setting operation and for the dose delivery operation, and wherein the electronic control unit is configured to switch the electronic system into the second state that has the higher electrical power consumption in response to the manipulation evaluation unit confirming that the manipulation qualifies as the activation operation as taught by Friedli. Friedli teaches that the activation operation being recognized by a particular “touch code” allows for additional user control over functions of the device, prevents unintentional administration of a dose, and allows for minimizing energy consumption (see para. 0031 and 0036).
In combination, the user interface member (25) and electronic system (13) of Helmer would be modified such that a user would manipulate the user interface member (25) with an activation operation such as entering a particular code as taught by Friedli wherein the electronic control unit would be able to recognize the particular code in order to perform the wake-up functions of Helmer.
Regarding claim 18, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Friedli discloses (Claim 18) wherein the manipulation that qualifies as the activation operation requires a sequence of different movements of the user interface member (18 in Fig. 2b, see para. 0031 and 0048).
Regarding claim 19, modified Helmer discloses the electronic system of claim 18. In modified Helmer, Friedli discloses (Claim 19) wherein the manipulation that qualifies as the activation operation requires the sequence of different movements to be completed within a predetermined time (see para. 0048).
Regarding claim 20, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Helmer discloses (Claim 20) wherein the manipulation that qualifies as the activation operation requires movement of the user interface member (17, 25) in opposite axial directions (see Fig. 5a and p.15, lines 13-15 – switch 25 may be depressed for activation such that it would move in opposite axial directions upon depression and return to its original position).
Examiner notes in modified Helmer, Friedli discloses the manipulation that qualifies as the activation operation of the user interface member (18) is depressing the push-button (18) with a particular code such as in repetition two or three times indicating required movement in opposite axial directions (see para. 0033 and 0048).
Regarding claim 21, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Friedli discloses (Claim 21) wherein the manipulation that qualifies as the activation operation requires a repetition of one particular sequence of movements of the user interface member (18, see para. 0048).
Regarding claim 22, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Helmer discloses (Claim 22) wherein the user interface member (17, 25) is movable from a first position to a second position relative to a housing (12, see Fig. 5a and p.15, lines 13-20 – switch 25 may be depressed such that it moves from a first, initial position to second, depressed position relative to housing 12).
In modified Helmer, Friedli discloses wherein the user interface member (18) is movable from a first position to a second position relative to a housing (22, see para. 0033 and 0048 – button 18 is a push-button and thus may move from its initial position to a depressed position relative to housing 22), and wherein the manipulation which qualifies as the activation operation requires a movement of the user interface (18) towards the first position (see para. 0048 – activation operation requires repeated depression of the button 18 indicating that it must move back towards its initial, first position before it can be depressed again).
Regarding claim 32, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Helmer discloses (Claim 32) further comprising: a motion sensing unit (18, 19, see Fig. 5a and p.9, lines 4-5), wherein the motion sensing unit (18, 19) is configured to generate electrical motion signals suitable to quantify a relative movement of a first member (10) relative to a second member (8, see Fig. 5a and p.9, lines 14-22 and p.12, lines 1-6 – light source 18 and optical sensor 19 generate motion signals to quantify relative rotation of drive sleeve 10 relative to dial 8), and wherein the motion sensing unit (18, 19) is not operational in the first state and is operational in the second state (see p. 15, lines 33-35 and p. 16, lines 15-17 – activation of switch 25 turns on device and may include powering the light source 18 and optical sensor 19).
Regarding claim 33, modified Helmer discloses the electronic system of claim 17, as discussed above.
However, modified Helmer fails to disclose (Claim 33) wherein the electronic system comprises a feedback unit configured to generate a feedback indicating whether the electronic system is in the second state, wherein the feedback is perceivable by the user of the electronic system.
Friedli teaches (Claim 33) wherein the electronic system comprises a feedback unit (26) configured to generate a feedback indicating whether the electronic system is in the second state, wherein the feedback is perceivable by the user of the electronic system (see para. 0027 and 0031 – controller 14 may output a feedback signal via a feedback unit 26 outputting a vibration, audio signal, or visual signal to the user indicating that the system received the activation operation and switched to the second state).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic system taught by Helmer to incorporate a feedback unit as taught by Friedli to provide visual, tactile, or acoustic feedback to the user that the activation operation was received by the device (see para. 0027 and 0031).
Regarding claim 34, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Helmer discloses (Claim 34) wherein the electronic system (13) is configured as an add-on module for the drug delivery device (1, see Fig. 1 and 5a and p.6, lines 31-33).
Regarding claim 35, Helmer discloses the limitations of (Claim 35) a drug delivery device (1 in Fig. 1) comprising:
a reservoir (3) including a drug (see Fig. 1 and p.4, lines 22-23);
and an electronic system (13) comprising (see Fig. 5a-6 and p.15, lines 7-8)
at least one user interface member (17, 25 in Fig. 5a) configured to be manipulated by a user for performing a dose setting operation to set a dose of drug to be delivered by the drug delivery device (1) and/or for performing a dose delivery operation for delivering a set dose (see p.8, lines 22-31 for attachment assembly 17 manipulated during dose setting, see p.15, lines 10-15 for switch 25 manipulated to initiate rotation of protrusions 11 and thus dose delivery), and is further configured to be manipulated for an activation operation (see p.15, lines 12-15 and lines 32-35 – the switch 25 may be used to operate the device as a wake-up switch i.e. to turn the device on or off in addition to initiating dose delivery);
an electronic control unit (22 in Fig. 6) configured to control operation of the electronic system (13, see Fig. 6 and p.15, lines 21-29), the electronic system (13) having a first state and a second state (see p.15, lines 32-35 – system 13 may have a first state as a powered-down state and a second state as a powered-up state), wherein the electronic system (13) has an electrical power consumption in the second state that is higher than an electrical power consumption of the electronic system in the first state (see p.15, lines 33-37);
an electrical signaling unit configured to provide at least one electrical signal indicating that the user interface member (17, 25) is manipulated (see p.16, lines 5-20 – switch 25 may be implemented as a sensor switch incorporating an electrical signaling unit that provides an electric signal indicating the switch 25 is manipulated by the user).
While Helmer discloses that the at least one user interface member (17, 25) may be configured to be manipulated for an activation operation and is disclosed as being actuated to perform a number of other functions such as a multi-function button (see p.15, lines 11-15), Helmer fails to disclose (Claim 35) a manipulation evaluation unit operatively connected to the electrical signaling unit and configured to evaluate the at least one electrical signal in order to determine whether a manipulation of the user interface member indicated by the at least one electrical signal of the electrical signaling unit qualifies as the activation operation, wherein a manipulation of the user interface member for the activation operation is different from a manipulation of the user interface member for the dose setting operation and for the dose delivery operation, wherein the electronic control unit is configured to switch the electronic system into the second state that has the higher electrical power consumption in response to the manipulation evaluation unit confirming that the manipulation qualifies as the activation operation.
Friedli discloses a drug administration device having a user interface member (18 in Fig. 2b) in the form of a button which may be manipulated by a user to input data, actuate a display, and initiate a dose delivery operation (see para. 0031-0033). Friedli further discloses an electronic signaling unit (20) in the form of a touch sensor which provides a signal indicating manipulation of the user interface member (18, see para. 0029) and an electronic control unit (14) in the form of a controller configured for controlling the electronic system (see para. 0033). Friedli teaches (Claim 35) a manipulation evaluation unit operatively connected to the electrical signaling unit (20) and configured to evaluate the at least one electrical signal in order to determine whether a manipulation of the user interface member (18) indicated by the at least one electrical signal of the electrical signaling unit (20) qualifies as the activation operation (see para. 0031, para. 0036, and para. 0048-0049 – controller 14 comprises a manipulation evaluation unit which evaluates the signal from touch sensor 20 if the user manipulation of button 18 was a particular code for activating the display or other functions of the device), wherein a manipulation of the user interface member (18) for the activation operation is different from a manipulation of the user interface member (18) for the dose delivery operation (see para. 0031 and 0048-0049 – the activation operation is pressing the button 18 with a particular code such as pressing the button two or three times in a row versus a singular touch for drug administration),
wherein the electronic control unit (14) is configured to switch the electronic system into the second state that has the higher electrical power consumption in response to the manipulation evaluation unit confirming that the manipulation qualifies as the activation operation (see para. 0036 and 0048-0049 – the controller may recognize the particular code for the activation operation which may activate the display which is a higher electrical power consumption state).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic system taught by Helmer to incorporate a manipulation evaluation unit operatively connected to the electrical signaling unit and configured to evaluate the at least one electrical signal in order to determine whether a manipulation of the user interface member indicated by the at least one electrical signal of the electrical signaling unit qualifies as the activation operation, wherein the activation operation is different from a manipulation of the user interface member for the dose setting operation and for the dose delivery operation, and wherein the electronic control unit is configured to switch the electronic system into the second state that has the higher electrical power consumption in response to the manipulation evaluation unit confirming that the manipulation qualifies as the activation operation as taught by Friedli. Friedli teaches that the activation operation being recognized by a particular “touch code” allows for additional user control over functions of the device, prevents unintentional administration of a dose, and allows for minimizing energy consumption (see para. 0031 and 0036).
In combination, the user interface member (25) and electronic system (13) of Helmer would be modified such that a user would manipulate the user interface member (25) with an activation operation such as entering a particular code as taught by Friedli wherein the electronic control unit would be able to recognize the particular code in order to perform the wake-up functions of Helmer.
Regarding claim 36, Helmer discloses the limitations of (Claim 36) a method of preparing an electronic system (13) for a dose delivery operation, the method comprising:
wherein the at least one electrical signal is generated in response to a manipulation the user interface member (17, 25, see p.15, lines 12-15 and lines 32-35 – the switch 25 may be used to operate the device as a wake-up switch i.e. to turn the device on or off in addition to initiating dose delivery), switching the electronic system (13) from a state of low power consumption to a state of high power consumption for the dose delivery operation (see p.15, lines 12-15 and lines 32-35), wherein the electronic system (13) consumes more power in the state of high power consumption than in the state of low power consumption (see p.15, lines 12-15 and lines 32-35).
While Helmer discloses that the at least one user interface member (17, 25) may be configured to be manipulated for an activation operation and is disclosed as being actuated to perform a number of other functions such as a multi-function button (see p.15, lines 11-15), Helmer fails to disclose the method of (Claim 36) evaluating at least one electrical signal generated by the electronic system to determine whether the at least one electrical signal indicates an activation operation of a user interface member of the electronic system, and wherein the at least one electrical signal generated in response a manipulation of the user interface member indicative for the activation operation is different from an electrical signal generated in response to a manipulation of the user interface member required for a dose setting operation and from an electrical signal generated in response to a manipulation required for the dose delivery operation; and in response to determining that the at least one electrical signal indicates the activation operation, switching the electronic system from a state of low power consumption to a state of high power consumption for the dose delivery operation.
Friedli discloses a drug administration device having a user interface member (18 in Fig. 2b) in the form of a button which may be manipulated by a user to input data, actuate a display, and initiate a dose delivery operation (see para. 0031-0033). Friedli further discloses an electronic signaling unit (20) in the form of a touch sensor which provides a signal indicating manipulation of the user interface member (18, see para. 0029) and an electronic control unit (14) in the form of a controller configured for controlling the electronic system (see para. 0033). Friedli teaches (Claim 36) evaluating at least one electrical signal generated by the electronic system to determine whether the at least one electrical signal indicates an activation operation of a user interface member (18) of the electronic system (see para. 0031, para. 0036, and para. 0048-0049 – controller 14 comprises a manipulation evaluation unit which evaluates the signal from touch sensor 20 if the user manipulation of button 18 was a particular code for activating the display or other functions of the device), and wherein the at least one electrical signal generated in response a manipulation of the user interface member (18) indicative for the activation operation is different from an electrical signal generated in response to a manipulation of the user interface member (18) required for the dose delivery operation (see para. 0031 and 0048-0049 – the activation operation is pressing the button 18 with a particular code such as pressing the button two or three times in a row versus a singular touch for drug administration), and in response to determining that the at least one electrical signal indicates the activation operation, switching the electronic system from a state of low power consumption to a state of high power consumption for the dose delivery operation (see para. 0036 and 0048-0049 – the controller may recognize the particular code for the activation operation which may activate the display which is a higher electrical power consumption state).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of preparing an electronic system taught by Helmer to incorporate evaluating at least one electrical signal generated by the electronic system to determine whether the at least one electrical signal indicates an activation operation of a user interface member of the electronic system, and wherein the at least one electrical signal generated in response a manipulation of the user interface member indicative for the activation operation is different from an electrical signal generated in response to a manipulation of the user interface member required for a dose setting operation and from an electrical signal generated in response to a manipulation required for the dose delivery operation; and in response to determining that the at least one electrical signal indicates the activation operation, switching the electronic system from a state of low power consumption to a state of high power consumption for the dose delivery operation as taught by Friedli. Friedli teaches that the activation operation being recognized by a particular “touch code” allows for additional user control over functions of the device, prevents unintentional administration of a dose, and allows for minimizing energy consumption (see para. 0031 and 0036).
In combination, the user interface member (25) and electronic system (13) of Helmer would be modified such that a user would manipulate the user interface member (25) with an activation operation such as entering a particular code as taught by Friedli wherein the electronic control unit would be able to recognize the particular code in order to perform the wake-up functions of Helmer.
Claim(s) 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Friedli as applied to claim 22 above, and further in view of Byerly et al. (W.O Patent Pub. No. 2019040313 A1, “Byerly”).
Regarding claim 23, modified Helmer discloses the electronic system of claim 22, as discussed above.
While modified Helmer discloses the user interface member (25) movable between the first position and the second position as it is depressed (see Fig. 5a), modified Helmer fails to disclose (Claim 23) wherein a separation between the first position and the second position is determined by a switching distance by which a first member of a dose setting and drive mechanism has to be moved relative to a second member of the dose setting and drive mechanism in order to switch the dose setting and drive mechanism from a dose setting configuration of the dose setting and drive mechanism to a dose delivery configuration of the dose setting and drive mechanism.
Byerly discloses a medication delivery device (10) having an add-on sensing module (82 in Fig. 3-4 and para. 0062), wherein Byerly teaches (Claim 23) wherein a separation between the first position and the second position is determined by a switching distance by which a second member (56) of a dose setting and drive mechanism has to be moved relative to a first member (30) of the dose setting and drive mechanism in order to switch the dose setting and drive mechanism from a dose setting configuration of the dose setting and drive mechanism to a dose delivery configuration of the dose setting and drive mechanism (examiner notes this limitation is interpreted in light of the 112b rejection above as the second member moves relative to the first member, see Fig. 2-3 and para. 0063 and 0066 – module 82 is attached to the dose button 56 of the delivery device 10 such that moving the module 82 from a first, initial position to a second, depressed position actuates dose delivery, see para. 0045-0046 – the axial depression of module 82 is determined by a distance separating dose button 56 and dose setting member 30 specifically its flange 38, wherein when the dose button 56 moves relative to flange 38 to close the axial separation, the device is switched from dose setting to dose delivery, see para. 0038 – dose setting member 30 comprises flange 38 and are considered as a single structure as they are rotationally and axially fixed together).
Since Helmer discloses that the second member (dial 8) must be disengaged from the first member (dial sleeve 10) for dose delivery (see p.7, lines 25-29), and Byerly explicitly discloses that in order to disengage the second member (dose button 56) from the first member (dose setting member 30 including dial sleeve 32), the second member (dose button 56) must move axially relative to the first member (dose setting member 30 including dial sleeve 32) to close the separation between two, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first position and second position of the user interface member and the first member and second member taught by modified Helmer to explicitly have a separation between the first position and the second position which is determined by a switching distance by which a second member of a dose setting and drive mechanism has to be moved relative to a first member of the dose setting and drive mechanism in order to switch the dose setting and drive mechanism from a dose setting configuration of the dose setting and drive mechanism to a dose delivery configuration of the dose setting and drive mechanism as taught by Byerly according to known methods to yield predictable results. The dose setting and drive mechanisms of Helmer and Byerly operate in a similar manner with a dose button (dial 8 in Helmer and dose button 56 in Byerly) which is depressed to disengage said dose button from a dial sleeve (10 in Helmer and 30 in Byerly) to initiate the drug delivery operation. Helmer is silent to the explicit disclosure of the dose button (8 in Helmer) moving axial a switching distance, and Byerly explicitly discloses this axial movement. Thus, one of ordinary skill in the art would have recognized that the combination of these elements as claimed by known methods would yield results with each element performing the same function as they do separately and as would be predictable.
Regarding claim 24, modified Helmer discloses the electronic system of claim 23, as discussed above. In modified Helmer, Helmer discloses (Claim 24) wherein, in the first position, the first member (10) and the second member (8) are rotationally locked to one another (see p.7, lines 15-23 – dial 8 and dial sleeve 10 are rotationally locked to one another during dose setting before the switch 25 has been depressed to initiate dose delivery), and in the second position, the first member (10) is rotatable relative to the second member (8, see p.7, lines 25-29 – when switch 25 has been depressed to initiate dose delivery, dial sleeve 10 rotates relative to dial 8).
Regarding claim 25, modified Helmer discloses the electronic system of claim 23, as discussed above. In modified Helmer, Helmer discloses (Claim 25) wherein the first position is an initial position of the user interface member (25) relative to the housing (12) before the dose setting operation and/or the dose delivery operation is commenced (see Fig. 5a and p.15, lines 13-15 – first position of switch 25 is its initial, undepressed position relative to the housing 12 as seen in Fig. 5a which the switch 25 is in before dose setting and before dose delivery).
Regarding claim 26, modified Helmer discloses the electronic system of claim 23, as discussed above. In modified Helmer, Byerly discloses (Claim 26) wherein the separation between the first position and the second position is equal to the switching distance (see Fig. 2-3 and para. 0045-0046, 0063 and 0066 – the separation between the module’s 82 initial position and its second, depressed position is equal to the distance that dose button 56 moves relative to dose setting member 30 specifical flange 38 as the dose button 56 is mounted within module 82 and moves therewith).
Claim(s) 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Friedli as applied to claim 22 above, and further in view of Beckwith et al (U.S Patent Pub. No. 20060214778 A1, “Beckwith”).
Regarding claim 27, modified Helmer discloses the electronic system of claim 22, as discussed above. In modified Helmer, Friedli discloses the limitations of (Claim 27) the electrical signaling unit (20) configured to be triggered to generate an electrical signal when the user interface member (18) moves from the first position to the second position (see para. 0031 and 0033).
However, modified Helmer fails to explicitly disclose (Claim 27) the electrical signaling unit comprising an electrical switch configured to be triggered to generate a switch signal, as part of the at least one electrical signal, when the user interface member moves from the first position to the second position, and wherein the switch signal decreases when the user interface member moves towards the first position from the second position.
Beckwith discloses a programmable push button comprising user interface member (9 in Fig. 1) as a push button cap which can be moved from a first, initial position to a second, depressed position (see para. 0022), wherein Beckwith teaches (Claim 27) the electrical signaling unit (50, 52, 54 in Fig. 5) comprising an electrical switch (50) in the form of a piezoelectric disc which triggers generation of a switch signal by microcontroller (66), as part of the least one electrical signal, when the user interface member (9) moves from the first position to the second position (examiner notes a switch signal is being interpreted as an electrical signal generated by the switch, see Fig. 5 and para. 0029 – when push button cap 9 is depressed multiple times in sequence to the second position, the piezoelectric disc 50 outputs voltages which are converted into digital pulses sent to the microcontroller 66 for evaluation, the digital pulses being interpreted as the switch signal which is an electrical signal generated by the switch), and wherein the switch signal decreases when the user interface member (9) moves towards the first position from the second position (see para. 0029 – when push button cap 9 returns to its original position, piezoelectric disc 50 does not output a voltage and thus the sequence of digital pulses received by the microcontroller 66 would have alternating decreased signals in between the digital pulses when the user interface member is in the second position).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the electrical signaling unit taught by modified Helmer with the electrical signaling unit of Beckwith having an electrical switch configured to be triggered to generate a switch signal as taught by Beckwith as Beckwith teaches that it is preferable to utilize a force responsive piezoelectric disc as a switch which outputs a voltage representative of an applied force such that the microcontroller can easily determine a series of depressions on the push button cap through a series of pulses output by the piezoelectric disc (see para. 0022 and 0027).
In combination, the user interface member (17, 25) of Helmer modified to have the electrical signaling unit (20) of Friedli would be substituted with the electrical signaling unit (50, 52, 54) of Beckwith such that multiple depressions of the user interface member (25) of Helmer would flex the electrical switch (50) of Beckwith to trigger generation of a switch signal to close a circuit as taught by Beckwith.
Regarding claim 28, modified Helmer discloses the electronic system of claim 27, as discussed above. In modified Helmer, Beckwith discloses (Claim 28) wherein the switch signal has a signal portion that indicates a movement of the user interface member (9) from the second position to the first position (see para. 0027-0029 – when push button cap 9 returns to its original position, piezoelectric disc 50 does not output a voltage and thus the sequence of digital pulses received by the microcontroller 66 would have alternating decreased signals in between the digital pulses when the user interface member is in the second position), wherein the manipulation evaluation unit is configured to qualify the manipulation as the activation operation only when the manipulation evaluation unit recognizes the signal portion (see para. 0027-0029 – microcontroller 66 comprises manipulation evaluation unit that qualifies the received sequence of digital pulses as an activation operation only when the portions of decreased voltage are recognized to indicate that a sequence of depressions of the user interface member 9 was made).
Regarding claim 29, modified Helmer discloses the electronic system of claim 28, as discussed above. In modified Helmer, Beckwith discloses (Claim 29) wherein the manipulation evaluation unit is configured to qualify the manipulation as the activation solely by recognizing the signal portion (see para. 0027-0029 – microcontroller 66 comprises manipulation evaluation unit that qualifies the received sequence of digital pulses as an activation operation only when the portions of decreased voltage are recognized to indicate that a sequence of depressions of the user interface member 9 was made, thus the manipulation evaluation unit is capable of being configured to qualify the activation operation based solely on recognizing the decreased voltage digital pulses).
Regarding claim 30, modified Helmer discloses the electronic system of claim 28, as discussed above. In modified Helmer, Beckwith discloses (Claim 30) wherein the signal portion indicates opening the switch (see para. 0029 – the increased digital pulses indicate closing the piezoelectric disc switch and thus the periods of decreased or zero voltage in the sequences of digital pulses would indicate opening of the switch).
Regarding claim 31, modified Helmer discloses the electronic system of claim 27, as discussed above. In modified Helmer, Beckwith discloses (Claim 31) wherein the manipulation evaluation unit is configured to qualify the manipulation as the activation operation only when the manipulation evaluation unit recognizes a predetermined number of multiple successive switch signals within a predetermined time (see para. 0027-0029 – the manipulation evaluation unit of microcontroller 66 qualifies the activation operation by recognizing a predetermined number of multiple successive digital pulses in a predetermined time).
Conclusion
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783
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