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 .
Election/Restrictions
Claims 34-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device and system, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/13/2025. Applicant’s election without traverse of Group I in the reply filed on 11/13/2025 is acknowledged.
Applicant’s election of Species A in the reply filed on 11/13/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examiner notes claim 28 is withdrawn as it is drawn towards nonelected Species B in at least Fig. 31A disclosing a switching feature 1810 that is pivotally mounted (see p.57).
Examiner notes claims 30-31 are withdrawn as they are drawn towards a nonelected Species C in at least Fig. 25A-25B disclosing a first and second switching feature 1810 (see p.48).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“electronic control unit” in claim 19,
“an electrical use detection unit” in claim 19,
“a motion sensing unit” in claim 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “an electronic control unit” in claim 19, 112(f) is invoked because: (i) it uses a generic placeholder (unit), (ii) it is coupled with functional language (electronic control), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P., lines 26-27 discloses “the electronic control unit e.g. comprising a microprocessor or microcontroller. Examiner is interpreting the limitation as a microprocessor, microcontroller, or equivalent structure.
Regarding “an electrical use detection unit” in claim 19, 112(f) is invoked because: (i) it uses a generic placeholder (unit), (ii) it is coupled with functional language (electrical use detection), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.8, lines 15-20 discloses for example, generating or triggering of generation of the use signal may be caused by changing the state of an electrical connection, e.g. from open to closed or vice versa, and/or to trigger an electrical switch. Examiner is interpreting the limitation as any structure that can generate a signal that corresponds to the movement of one structure relative to another, such as due to the changing of state of an electrical connection or triggering an electrical switch.
Regarding “a motion sensing unit” in claim 32, 112(f) is invoked because: (i) it uses a generic placeholder (unit), (ii) it is coupled with functional language (motion sensing), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.11, lines 34-37 – p.12, lines 1-11 and p.32, lines 35-37 – p.33, lines 1-5 discloses the motion sensing unit as an electrically operated sensor capable of measuring or detecting relative rotational movement between two movable members. Examiner is interpreting the limitation as this structure and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 19-27, 29, and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Byerly et al. (U.S Patent Pub. No. 20210146061 A1, “Byerly”).
Regarding claim 19, Byerly discloses (Claim 19) an electronic system (30, 50 and 80 in Fig. 4-8) for a drug delivery device (10 in Fig. 1-3, see para. 0041 and 0075 – the components of dose delivery detection system 80, actuator 50, and dose setting member 30 are interpreted as the electronic system for drug delivery device 10), the electronic system (30, 50, 80) comprising:
a dose setting and drive mechanism (88, 30, 50 in Fig. 4-5) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device (10) and a dose delivery operation for delivering the set dose (see para. 0041 and 0063-0065 – module body 88, dose setting member 30, and actuator 50 interact with one another’s components to set and deliver a dose),
wherein the dose setting and drive mechanism (88, 30, 50 in Fig. 4-5) comprises a first member (38 in Fig. 6) and a second member (56 in Fig. 8), wherein in the dose delivery operation, the first member (38 in Fig. 6) moves relative to the second member (56 in Fig. 8, see para. 0044 and 0047 – flange 38 of dial member 32 moves relative to the dose button 56 during dose dispensing);
an electronic control unit (“controller”) configured to control an operation of the electronic system (30, 50, 80, examiner notes the electronic control unit is being interpreted under 112(f) as a microprocessor, microcontroller, or equivalent structure, see para. 0056).
However, the embodiment of Fig. 5-9 of Byerly fails explicitly disclose the electronic system comprising an electrical use detection unit operatively connected to the electronic control unit, the electrical use detection unit being configured to generate a use signal in response to a relative movement between the first member and the second member, the use signal indicating that a user has commenced the dose setting operation or the dose delivery operation, wherein the electronic system has a first state and a second state, and is configured to be switched from the first state into the second state by the electronic control unit in response to the use signal, wherein the electronic system consumes more electrical power in the second state as compared to the first state.
The embodiment of Fig. 10-14 of Byerly discloses the drug delivery device (210) may include a single electronic system that can perform both dose detection sensing and wake-up activation (see para. 0120). The embodiment of Fig. 10-14 of Byerly teaches (Claim 19) an electrical use detection unit (286) operatively connected to the electronic control unit (“controller”, examiner notes the electrical use detection unit is being interpreted under 112(f) as any structure that can generate a signal that corresponds to the movement of one structure relative to another, such as due to the changing of state of an electrical connection or triggering an electrical switch, see para. 0095 and 0100 – the components of the rotational sensor 286 comprising electrical contacts 324 and 326 which are used for the wake-up activation are interpreted as the electrical use detection unit as these components generate a signal indicating use detection), the electrical use detection unit (286) being configured to generate a use signal in response to a relative movement between the first member (238 in Fig. 10-13) and the second member (325 in Fig.10-13, see para. 0096-0099 and 0120 – a use signal is generated by the components of the rotational sensor 286 in response to relative rotation of the flange 238 to circuit board 325 of dose button 256 causing closing of the circuit formed by contacts 326 and 324), the use signal indicating that a user has commenced the dose setting operation or the dose delivery operation (see para. 0099 and 0120 – the use signal is indicative of commencement of the dose delivery operation),
wherein the electronic system (80, 230, 250 in Fig. 10-13) has a first state and a second state (see para. 0099 and 0120), and is configured to be switched from the first state into the second state by the electronic control unit (“controller’) in response to the use signal (see para. 0099 and 0120), wherein the electronic system (80, 230, 250 in Fig. 10-13) consumes more electrical power in the second state as compared to the first state (see para. 0099 and 0120).
Since, the embodiment of Fig. 5-9 of Byerly discloses an electronic system (30, 50, 80) comprising a first member (38) that rotates relative to a second member (56) during dose delivery and a rotational sensor (128), and the embodiment of Fig. 10-14 of Byerly discloses a similar electronic system (80, 230, 250) comprising a first member (238) that rotates relative to a second member (325) during dose delivery and a rotational sensor (286), 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 of the embodiment of Fig. 5-9 of Byerly to incorporate the wake-up activation of the embodiment of Fig. 10-14 of Byerly. Byerly teaches that a single sensing system comprising both dose detection sensing and wake-up activation reduces the number of electronic components in the device, reduces manufacturing complexity with additional sensors, and minimizes inadvertent power loss or usage when a dose dispensing event is not occurring (see para. 0099 and 0120). In combination, the embodiment of Fig. 5-9 of Byerly especially that of Fig. 8 would incorporate the wake-up activation taught by the embodiment of Fig. 10-14 of Byerly such that the relative rotation of the first member (38 in Fig. 5) and the second member (56 in Fig. 8) during the dose delivery operation would cause the rotational sensor (128) to generate a use signal when initially sensed that the pin (104) falls into the following recess (110) between surface features (101, see Fig. 8 and para. 0085, 0099, and 0120).
Regarding claim 20, modified Byerly discloses the electronic system of claim 19, as discussed above. In modified Byerly, the rotational sensor (128 in Fig. 8) of the embodiment of Fig. 5-9 of Byerly is modified to generate the use signal for wake-up activation, and thus the modified embodiment of Fig. 5-9 of Byerly discloses (Claim 20) wherein the electrical use detection unit (128 in Fig. 8) is configured to generate the use signal in response to a relative rotational movement between the first member (38 in Fig. 5) and the second member (56 in Fig. 8) during the dose delivery operation (see Fig. 8 and para. 0085, 0098-0099, and 0120 – the components of the rotational sensor 128 generate the use signal in response to initial sensing of the pin 104 falling into the following recess 110 occurring due to the relative rotation between flange 38 and dose button 56 during dose delivery).
Regarding claim 21, modified Byerly discloses the electronic system of claim 19, as discussed above. In modified Byerly, the embodiment of Fig. 5-9 of Byerly discloses (Claim 21) wherein the dose setting and drive mechanism (88, 30, 50 in Fig. 4-5) comprises a dose member (38 in Fig. 5-6) that is rotatable relative to a housing (12 in Fig. 5) of the electronic system (30, 50, 80) in the dose setting operation in whole-number multiples of a unit setting increment (examiner notes the dose member is being interpreted as either the same structure as one of the first member or the second member or an additional structure, see para. 0043-0044 – flange 38 is interpreted as the dose member which is the same as the first member, flange 38 rotates relative to housing 12 during dose setting in increments that may be one unit of medication),
wherein at least one of the first member (38 in Fig. 5-6) and the second member (56 in Fig. 5) is different from the dose member (38, dose button 56 is different than flange 38).
Regarding claim 22, modified Byerly discloses the electronic system of claim 21, as discussed above. In modified Byerly, the rotational sensor (128 in Fig. 8) of the embodiment of Fig. 5-9 of Byerly is modified to generate the use signal for wake-up activation, and thus the modified embodiment of Fig. 5-9 of Byerly discloses (Claim 22) further comprising a use signal generation interface (101 in Fig. 7-8) configured to generate the use signal during the dose delivery operation (see para. 0085, 0098-0099), wherein the use signal generation interface (101 in Fig. 7-8) is an incremented interface with an increment that is adjusted to the unit setting increment (examiner notes the incremented interface being adjusted to the unit setting increment is being interpreted as the incremented interface is adjusted such that it corresponds in a desired proportion to the unit setting increment e.g. equal to or smaller than, see para. 0080 and 0085 – the repeating pattern of the surface features 101 are adjusted such that they can be used by the controller in a calculation to determine the corresponding unit setting increments).
Regarding claim 23, modified Byerly discloses the electronic system of claim 21, as discussed above. In modified Byerly, the rotational sensor (128 in Fig. 8) of the embodiment of Fig. 5-9 of Byerly is modified to generate the use signal for wake-up activation, and thus the modified embodiment of Fig. 5-9 of Byerly discloses (Claim 23) the electronic system (30, 50, 80) is configured such that the use signal is generated after a rotation of the first member (38 in Fig. 5) has been commenced and before the first member (38) has rotated relative to the second member (56 in Fig. 8) by more than one increment (see Fig. 8 and para. 0085 and 0099 - the use signal would be generated by the falling of the pin 104 into the following recess 110 wherein the recess 110 and its subsequent projection 102 would be interpreted as a single increment).
However, modified Byerly fails to explicitly disclose the incremented, repeating pattern of the surface features corresponds to the unit setting increment.
The embodiment of Fig.10-14 of Byerly teaches the incremented, repeating pattern of the surface features (301) corresponds to the unit setting increment (see para. 0117 – the repeating pattern created by the incremented, surface features 301 may correspond to the minimum increment of dose set).
Since, the embodiment of Fig. 5-9 of Byerly discloses an electronic system (30, 50, 80) comprising an incremented, repeating pattern of surface features (101 in Fig. 7-8), and the embodiment of Fig. 10-14 of Byerly discloses a similar electronic system (80, 230, 250) comprising an incremented, repeating pattern of surface features (301 in Fig. 12-13), 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 incremented, repeating pattern of surface features of the embodiment of Fig. 5-9 of Byerly to correspond to the unit setting increment as taught by the embodiment of Fig. 10-14 of Byerly. Byerly teaches having the incremented, surface features create a repeating pattern that corresponds to the minimum increment of dose that can be set with the medication delivery device is convenient for the sensor system for detecting the amount of angular movement and thus dose amount based upon the repeating pattern (see para. 0117).
Regarding claim 24, modified Byerly discloses the electronic system of claim 19, as discussed above. In modified Byerly, the embodiment of Fig. 5-9 of Byerly discloses (Claim 24) wherein the electronic system (30, 50, 80 in Fig. 5-9) further comprises a movable switching feature (104 in Fig. 8) that is operatively coupled to one or both of the first member (38) and the second member (56) such that a rotation of the first member (38) relative to the second member (56) causes a movement of the switching feature (104) relative to the first member (38) and/or relative to the second member (56, see Fig. 8 and para. 0077 – pin 104 is operatively coupled to both flange 38 and dose button 56 wherein rotation of flange 38 relative to dose button 56 causes movement of pin 104 relative to both flange 38 and dose button 56).
However, modified Byerly fails to disclose (Claim 24) wherein the electronic system is configured such that the movement of the switching feature is used to trigger generation of the use signal.
The embodiment of Fig. 10-14 of Byerly teaches (Claim 24) wherein the electronic system (80, 230, 250 in Fig. 10-14) is configured such that the movement of the switching feature (326) is used to trigger generation of the use signal (see Fig. 12-13 and para. 0099 and 0102).
Since the embodiment of Fig. 5-9 of Byerly discloses that movement of the switching feature (104) triggers a signal generation for the dose sensing system (see para. 0085), and the embodiment of Fig. 10-14 of Byerly discloses that movement of the switching feature (326) triggers both a signal generation for the dose sensing system and the use signal for the wake-up activation (see para. 0099 and 0102), 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 of the embodiment of Fig. 5-9 of Byerly to incorporate the wake-up activation of the embodiment of Fig. 10-14 of Byerly. Byerly teaches that a single sensing system comprising both dose detection sensing and wake-up activation reduces the number of electronic components in the device, reduces manufacturing complexity with additional sensors, and minimizes inadvertent power loss or usage when a dose dispensing event is not occurring (see para. 0099 and 0120). In combination, the embodiment of Fig. 5-9 of Byerly especially that of Fig. 8 would incorporate the wake-up activation taught by the embodiment of Fig. 10-14 of Byerly such that the movement of the switching feature (104) would be used by the components of the rotational sensor (128) to trigger generation of the use signal (see para. 0085).
Regarding claim 25, modified Byerly discloses the electronic system of claim 24, as discussed above. In modified Byerly, the rotational sensor (128 in Fig. 8) of the embodiment of Fig. 5-9 of Byerly is modified to generate the use signal for wake-up activation, and thus the modified embodiment of Fig. 5-9 of Byerly discloses (Claim 25)
the movable switching feature (104 in Fig. 8) is operatively coupled to the first member (38) and/or to the second member (56) such that the rotation of the first member (38) relative to the second member (56) is converted into the movement of the switching feature (104) to cause generation of the use signal (see Fig. 8 and para. 0077-0078 – rotation of flange 38 and thus ring 100 relative to dose button 56 is converted into the movement of the pin 104 upon ramps 102 and falling into recesses 110, wherein the falling of the pin 104 into the recess 110 causes generation of the use signal by rotational sensor 128).
Regarding claim 26, modified Byerly discloses the electronic system of claim 24, as discussed above. In modified Byerly, the rotational sensor (128 in Fig. 8) of the embodiment of Fig. 5-9 of Byerly is modified to generate the use signal for wake-up activation, and thus the modified embodiment of Fig. 5-9 of Byerly discloses (Claim 26) the movable switching feature (104 in Fig. 8) is resiliently biased into engagement with a block feature (102) before the first member (38) is rotated relative to the second member (56, see Fig. 8 and para. 0077-0078 – ramp-like projections 102 acts as block features in which pin 104 is resiliently biased into engagement with by spring 108 before rotation has occurred), and wherein, when the first member (38) is rotated relative to the second member (56), the block feature (102) is removed from the switching feature (104) such that the biasing force can drive the movement of the switching feature (104) to cause generation of the use signal (see para. 0078 and 0085 – when flange 28 rotates relative to dose button 56, pin 104 climbs the ramp-like projection 102 against the biasing force of spring 108 and upon removing the engagement of the projection 102, the biasing force of spring 108 drives movement of pin 104 into recess 110 which causes generation of the use signal by rotational sensor 128).
Regarding claim 27, modified Byerly discloses the electronic system of claim 24, as discussed above. In modified Byerly, the embodiment of Fig. 5-9 of Byerly discloses (Claim 27) wherein the switching feature (104) is linearly guided (see Fig. 8 and para. 0077-0078 – pin 104 moves linearly in the distal and proximal directions as guided by the button aperture 105 in dose button 56).
Regarding claim 29, modified Byerly discloses the electronic system of claim 24, as discussed above. In modified Byerly, the embodiment of Fig. 5-9 of Byerly discloses (Claim 29) wherein one of the first member (38) is provided with a ratchet (101 in Fig. 7-8) with circumferentially disposed ratchet teeth (102, Fig. 7-8 and para. 0077 – the flange 38 comprises surface features 101 in the form of circumferentially disposed ramp-like projections indicating that the projections are equivalent to inclined teeth constituting them as ratchet teeth and the surface features forming a ratchet), wherein the switching feature (104) is arranged to cooperate with the ratchet (101, see Fig. 8 and para. 0078).
Regarding claim 32, modified Byerly discloses the electronic system of claim 19, as discussed above. In modified Byerly, the rotational sensor (128 in Fig. 8) of the embodiment of Fig. 5-9 of Byerly is modified to generate the use signal for wake-up activation, and thus the modified embodiment of Fig. 5-9 of Byerly discloses (Claim 32) a motion sensing unit (128, examiner notes the motion sensing unit is being interpreted under 112(f) as an electrically operated sensor capable of measuring or detecting relative rotational movement between two movable members, see para. 0085 – the motion sensing unit is being interpreted as the components of rotational sensor 128 used for dose sensing).
However, modified Byerly fails to disclose further comprising a motion sensing unit that is operational in the second state of the electronic system, and is non-operational in the first state of the electronic system, wherein the electronic control unit is configured to issue a command to render the motion sensing unit operational in response to the use signal.
The embodiment of Fig. 10-14 of Byerly discloses (Claim 32) further comprising a motion sensing unit that is operational in the second state of the electronic system (80, 230, 250, examiner notes the motion sensing unit is being interpreted under 112(f) as an electrically operated sensor capable of measuring or detecting relative rotational movement between two movable members, see para. 0096 and 0099 – examiner is interpreting the motion sensing unit as the components of the rotational sensor 286 that are operational during dose sensing, these components of rotation sensor 286 are only operation after the use signal has been generated and the electronics for dose sensing are activated in the second state), and is non-operational in the first state of the electronic system (see para. 0099 – electronics components for dose sensing are not activated in the first state), wherein the electronic control unit (“controller”) is configured to issue a command to render the motion sensing unit operational in response to the use signal (see para. 0099).
Since the embodiment of Fig. 5-9 of Byerly discloses a rotational sensor (128) operational for dose sensing to detect relative rotational movement between two movable members during dose dispensing, and the embodiment of Fig. 10-14 of Byerly discloses a rotational sensor (286) fully powered on by the use signal to be operational for detecting relative rotational movement between two movable members during dose dispensing, 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 of the embodiment of Fig. 5-9 of Byerly to incorporate the wake-up activation of the motion sensing unit as taught by the embodiment of Fig. 10-14 of Byerly. Byerly teaches that a single sensing system comprising both dose detection sensing and wake-up activation reduces the number of electronic components in the device, reduces manufacturing complexity with additional sensors, and minimizes inadvertent power loss or usage when a dose dispensing event is not occurring (see para. 0099 and 0120). In combination, the embodiment of Fig. 5-9 of Byerly especially that of Fig. 8 would incorporate the wake-up activation of the motion sensing unit taught by the embodiment of Fig. 10-14 of Byerly such the components of the rotational sensor (128) for generating the use signal, interpreted as the electronic use detection unit, would generate the use signal to activate the components of the rotational sensor (128) used for dose sensing, interpreted as the motion sensing unit.
Regarding claim 33, modified Byerly discloses the electronic system of claim 19, as discussed above. In modified Byerly, the embodiment of Fig. 5-9 of Byerly disclose (Claim 33) wherein the first member (38 in Fig. 5) and the second member (56 in Fig. 5) are configured to move during the dose setting operation and/or during the dose delivery operation relative to a housing (12 in Fig. 5) of the drug delivery device (10, see para. 0043-0044 – dose button 56 and flange 38 rotate relative to the housing 12 during dose setting, see para. 0046 - flange 38 of dose setting member 30 rotates relative to the housing 12 during dose dispensing).
Double Patenting
Claim 19 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 17914480 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because instant application claim 19 is anticipated by copending reference application claim 16.
Copending, reference application claim 16 recites an electronic system for a drug delivery device (see claim 16, line 1), the electronic system comprising: a dose setting and drive mechanism configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device and a dose delivery operation for delivering the set dose (see claim 16, lines 3-5), wherein the dose setting and drive mechanism comprises a first member and a second member, wherein in the dose delivery operation and/or in the dose setting operation, the first member moves relative to the second member (see claim 16, lines 5-8); an electronic control unit configured to control an operation of the electronic system (see claim 16, line 10); and an electrical use detection unit operatively connected to the electronic control unit (see claim 16, line 11), the electrical use detection unit being configured to generate a use signal in response to a relative movement between the first member and the second member, the use signal indicating that a user has commenced the dose setting operation or the dose delivery operation (see claim 16, lines 12-13 – the generated signal is generated to indicate a start or commencement of relative movement between the first member and second member), wherein the electronic system has a first state and a second state (see claim 16, lines 14-15), and is configured to be switched from the first state into the second state by the electronic control unit in response to the use signal, wherein the electronic system consumes more electrical power in the second state as compared to the first state (see claim 16, lines 14-17 – the second state activates the communication unit which is within the scope of the electronic control unit controlling an operation of the electronic system and indicates the second state consumes more electrical power than the first state). Therefore, copending reference application claim 16 is in essence a “species” of the generic invention of the instant application claim 19. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/KAYLA M. TURKOWSKI/ /BHISMA MEHTA/
Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783