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
This office action is responsive to the amendment filed on 02/17/2026. As directed by the amendment: claims 17, 19-23, 25, 27-29, and 35 have been amended, claims 18, 24, and 36 have been cancelled, and claims 37-39 have been added. Thus, claims 17, 19-23, 25-35, and 37-39 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Office Action mailed on 11/18/2025.
Response to Arguments
Applicant' s arguments, see p.11-13 of “Remarks”, filed 02/17/2026, with respect to the rejection(s) of claim(s) 17 under 103 have been fully considered and are persuasive, specifically in regards to Friedli not teaching or disclosing “wherein the manipulation that qualifies as the activation operation requires either a sequence of different movements of the at least one user interface member”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claim 38 is objected to because of the following informalities:
Regarding claim 38, the phrase “at least one at least one user interface member” in line 2 should read “at least one user interface member” to remove the typo.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 39 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 39, the phrase “a method of delivering a drug from a drug delivery device” in line 1 fails to comply with the written description requirement and is new matter. On p.1 of “Remarks” filed on 02/17/2026, applicant asserts “new claim 39 depends from claim 35 and find support in the specification at least on page, lines 32-37 and page 15, lines 1-7.” The examiner respectfully disagrees as these excerpts from the spec. only provide support for “the method of preparing an electronic system for a drug delivery device or a drug delivery device comprising an electronic system for a dose delivery operation.” A method of preparing an electronic system for a drug delivery operation of a drug delivery device does not provide support for a method of delivering a drug from a drug delivery device. Thus, this claim contains new matter.
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 37 is 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 37, the phrase “wherein the manipulation evaluation unit issues an activation prompt signal or a use signal such that further electrical or electronic components of the system are rendered operational, when it is determined that the activation operation has occurred” in lines 27-29 renders the claim indefinite because it is unclear. It is unclear in light of the limitation “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” in lines 19-21 of claim 37 whether the activation prompt signal or use signal of the manipulation evaluation unit is switching the electronic system into the second state or if it is performing a different operation for rendering components operational. In light of the specification, examiner is interpreting this limitation as the former situation where the activation prompt signal or use signal of the manipulation evaluation unit is switching the electronic system into the second state, and examiner suggests application amend to state “wherein the manipulation evaluation unit issues an activation prompt signal or a use signal such that electronic system is switched into the second state
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, 19-22, 27-35, and 39 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) in view of Beckwith et al (U.S Patent Pub. No. 20060214778 A1, “Beckwith”).
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 at least one 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 at least one 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 at least one user interface member for the activation operation is different from a manipulation of the at least one 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, and wherein the manipulation that qualifies as the activation operation requires either a sequence of different movements of the at least one user interface member, or a sequence of touching different surfaces of the at least one user interface member.
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 at least one 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 an activation signal), wherein a manipulation of the at least one user interface member (18) for the activation operation is different from a manipulation of the at least one 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.
Beckwith discloses a programmable push button comprising user interface member (9 in Fig. 1 and 3) as a push button cap which can be moved from a first, initial position to a second, depressed position (see para. 0022), wherein multiple, sequenced depressions of the user interface member (9) indicates an activation signal (see para. 0027). Beckwith teaches (Claim 17) wherein the manipulation that qualifies as the activation operation requires a sequence of different movements of the at least one user interface member (9, see Fig. 3 and para. 0020 – push button cap 9 is depressed such that it moves from an initial-at rest position seen in Fig. 3 to an axially depressed position and the activation operation is when push button cap 9 is depressed multiple times in sequence, such that the push button cap 9 would move from its initial position and axially to the depressed position and back to the initial position in a sequence and thus would require a sequence of different movements of the cap 9).
Since modified Helmer discloses the user interface member (17, 25) comprising the pushbutton (25) of Helmer modified to operate with the activation operation of actuating the button (18) of Friedli multiple times in a particular code, and Beckwith discloses an activation operation for a user interface member (9) comprising actuating the pushbutton (9) multiple times in a particular code such that the pushbutton (9) moves axially up and down repeatedly, 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 user interface member of modified Helmer to explicitly move axially up and down repeatedly such that the activation operation would require a sequence of different movements of the user interface member as taught by Beckwith according to known methods to yield predictable results. The push button of Helmer is disclosed as being depressed by the user to actuate the button (see p.18, lines 8-20), and as modified by Friedli would thus be depressed multiple times in a particular code for the activation signal. Beckwith discloses a similar mechanism with the button being depressed by a user multiple times in a particular code for the activation signal. Thus, one of ordinary skill in the art could have combined modified Helmer with Beckwith as claimed by known methods, and the results of said combination yielding a push button such as that in modified Helmer that explicitly moves axially up and down would have been predictable.
Regarding claim 19, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Friedli discloses (Claim 19) wherein the manipulation that qualifies as the activation operation requires the activation operation to be completed within a predetermined time (see para. 0048 – the activation operation is multiple touches on the button 18 in sequence and within a certain time interval).
In modified Helmer, Beckwith discloses (Claim 19) the activation operation requires the sequence of different movements to be completed within a predetermined time (see para. 0020 and 0027 – the series of pulses i.e. up and down movements on the push button 9 must be generated within a predetermine time period for the microcontroller 66 to respond to them as the activation operation).
Regarding claim 20, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Beckwith discloses (Claim 20) wherein the manipulation that qualifies as the activation operation requires movement of the at least one user interface member (9) in opposite axial directions (see para. 0020).
Regarding claim 21, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Beckwith discloses (Claim 21) wherein the manipulation that qualifies as the activation operation requires a repetition of one particular sequence of movements of the at least one user interface member (9, see para. 0020 and 0027).
Regarding claim 22, modified Helmer discloses the electronic system of claim 17. In modified Helmer, Beckwith discloses (Claim 22) wherein the user interface member (9) is movable from a first position to a second position relative to a housing (3, see para. 0020 – button 9 is movable from initial position to second axially, depressed position relative to main body 3), and wherein the manipulation which qualifies as the activation operation requires a movement of the user interface (9) towards the first position (see para. 0027 – the activation operation is a series of depressions of the button 9 in a particular code and thus requires movement of the button 9 back to its initial position to thus be depressed again).
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) is pushed (see para. 0031 and 0033).
In modified Helmer, Beckwith discloses that the user interface member (9) being pushed means movements of the user interface member (9) from the first position to the second position (see para. 0020)
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 at least one user interface member moves from the first position to the second position, and wherein the switch signal decreases when the at least one user interface member moves towards the first position from the second position.
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 at least one 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 a strength of the switch signal decreases when the at least one 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 strength 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 at least one 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 operation 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).
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, modified Helmer discloses (Claim 35) the electronic system according to claim 17, as discussed above.
In modified Helmer, 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).
Regarding claim 39, modified Helmer discloses the drug delivery device according to claim 35, as discussed above, and thus in modified Helmer, Helmer discloses (Claim 39) a method of delivering a drug from a drug delivery device (1) the method comprising using the drug delivery device (1, see Fig. 1 and p.4, lines 22-35).
Claim(s) 23 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Friedli in view of Beckwith 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 Beckwith in modified Helmer discloses the user interface member (9) movable between the first position and the second position as it is depressed (see para. 0020), 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 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.
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 (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 25, modified Helmer discloses the electronic system of claim 23, as discussed above. In modified Helmer, Beckwith discloses (Claim 25) wherein the first position is an initial position of the at least one user interface member (9) relative to the housing (3, see para. 0020)
In combination, the user interface member (17, 25) specifically the push button (25) would be modified to move from a first, initial position before the dose setting operation and/or dose delivery operation is commenced to a second, axially depressed position (see Fig. 5a and p.15, lines 13-15 – switch 25 is its initial position relative to the housing 12 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) 37 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Friedli in view of Malave et al. (U.S Patent Pub. No. 20050090808 A1, “Malave”).
Regarding claim 37, Helmer discloses the limitations of (Claim 37)
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 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 at least one 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 37) 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 at least one 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 at least one user interface member for the activation operation is different from a manipulation of the at least one 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, wherein the manipulation evaluation unit has two different states, a low power state and a higher power state, wherein, when the manipulation evaluation unit is in the low power state, a signal generated by the electrical signaling unit is used to switch the manipulation evaluation unit from the low power state to the higher power state, and wherein the manipulation evaluation unit issues an activation prompt signal or a use signal such that further electrical or electronic units of the system are rendered operational, when it is determined that the activation operation has occurred.
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 37) 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 at least one 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 an activation signal), wherein a manipulation of the at least one user interface member (18) for the activation operation is different from a manipulation of the at least one 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.
Malave discloses an infusion pump (10 in Fig. 4) comprising a main processing unit (150 in Fig. 6) which receives a signal from an electrical signaling unit (22 in Fig. 6) and evaluates it and an interlock processing unit (152 in Fig. 6) which receives a signal from the main processing unit (150, see para. 0051-0053 and 0056). wherein the main processing unit (150) functions as a manipulation evaluation unit as it has low power, sleep mode and a higher power, wake up mode (see para. 0051). Malave teaches (Claim 37) wherein the manipulation evaluation unit (150) has two different states, a low power state and a higher power state (see para. 0051 – sleep mode and wake up mode), wherein, when the manipulation evaluation unit (150) is in the low power state, a signal generated by the electrical signaling unit (22) is used to switch the manipulation evaluation unit (150) from the low power state to the higher power state (see para. 0051-0053 – signal generated by telemetry processing unit 22 wakes up main processing unit 150), and wherein the manipulation evaluation unit (150) issues an activation prompt signal or a use signal such that further electrical or electronic units (152) of the system are rendered operational, when it is determined that the activation operation has occurred (see para. 0053-0056 – manipulation evaluation unit 150 evaluates the received signal to determine if it has the signature/validation sequence and once confirmed it wakes up the interlock processing unit 152).
Since modified Helmer discloses a controller comprising manipulation evaluation unit functions for confirming if a received signal comprises the activation operation and then powering up other electronics, and Malave discloses a system where the manipulation evaluation unit must be woken up by the signal first, confirm the signal is the activation operation, and then power up other electronics, 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 have a manipulation evaluation unit with a lower power state and a higher power state and to function as claimed in claim 37 as taught by Malave. Malave teaches that a system having multiple processing components should implement low power and high power states, where the high power states can only be triggered based upon a signal evaluation as this conserves battery power and reduces power consumption (see para. 0051).
Claim(s) 38 is rejected under 35 U.S.C. 103 as being unpatentable over Helmer in view of Friedli in view of Byerly.
Regarding claim 38, Helmer discloses the limitations of (Claim 38)
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 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 at least one 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 38) 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 at least one 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 at least one user interface member for the activation operation is different from a manipulation of the at least one 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, and wherein the at least one user interface member is one integral member configured to be manipulated for the dose setting operation and 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 38) 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 at least one 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 an activation signal), wherein a manipulation of the at least one user interface member (18) for the activation operation is different from a manipulation of the at least one 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.
Byerly discloses a medication delivery device (10) having an add-on sensing module (82 in Fig. 3-4 and para. 0062), wherein body (88 in Fig. 5) of the add-on sensing module (82) constitutes the user interface member, wherein Byerly teaches (Claim 38) the at least one user interface member (88 in Fig. 4-5) is one integral member configured to be manipulated for the dose setting operation and for the dose delivery operation (see para. 0063 and 0074 – the body 88 of electronic system 82 is a one integral member as seen in Fig. 5 for both dose setting and dose delivery).
Since Helmer discloses the electronic system (13 in Fig. 2) mounted to the proximal end of a drug delivery device (1, see Fig. 2) such that the electronic system (13) is rotated for carrying out dose setting in the device (1) and axially depressed for carrying out dose delivery in the device (1), and Byerly discloses a similar electronic system (82 in Fig. 4-5) that mounts to the proximal end of a drug delivery device (10 in Fig. 4) such that the electronic system (82) is rotated for carrying out dose setting in the device (10) and axially depressed for carrying out dose delivery in the device (10), 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 user interface member of modified Helmer to be on integral member as taught by Byerly according to known methods to yield predictable results. Both electronic systems of Helmer and Byerly mount to the proximal ends of drug delivery devices having a dose button for drug delivery and dose dial for dose setting, and both electronic systems mount in such a way that upon user rotation or user axial depression of the electronic system, drug delivery or dose setting is carried out, respectively. Thus, one of ordinary skill in the art could have combined modified Helmer with Byerly as claimed by known methods, and the results of said combination yielding one integral user interface member would have been predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights