DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/26/26 has been entered.
Response to Arguments
Regarding amended claims 15 and 29, Applicant further requires "the activation
member is attached to the movable cap". The added limitation does not appear to overcome the current 102 rejection to Yang. Yang teaches the activation member 40 which includes spring lever 42 having a rotatable coupling 47 that engages an extension 36 of the cap assembly 30. See Col 19, In. 55 to Col 20 In. 17. As such, Yang teaches "the activation member is attached to the movable cap".
Examiner notes the cancellation of claim 28 obviates the 112(f) interpretation and corresponding 112(b) rejection in the prior office action.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 15-27 and 29-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (US 20180318526), hereinafter: “Yang”.
In Regard to Claim 15
Yang teaches:
A medicament delivery system comprising:
a drug delivery device(10) comprising a medicament container(112; P[0078]) positioned within a housing(11; P[0078]), a dose delivery outlet(distal end 118 of needle; P[0049]-P[0050]) accessible through a terminal end of the housing(P[0049]) and a needle shield(122, 30) acting as a sterile barrier(P[0080]-P[0081]), coupled to a needle shield remover(18; Fig 9A; 122,30 is inherently coupled to the needle shield remover 18; P[0080]-P[0081]);
a supplemental device(33) comprising a battery module(35, power supply is a battery, P[0063]), an activation member(40) and a communication module(152);
a movable cap(30) coupled to the needle shield remover(Fig 8-10; P[0101]) wherein a cap movement(cap coupling/removal sequence illustrated in Fig 9A-10) creates a gap(see annotated fig below) between the cap and the housing of the medicament delivery device, wherein the creation of the gap creates a space(see annotated figure below) for the activation member to enter after passing a proximal end of the housing(activation member 40 enters the gap/space during the cap removal sequence; see annotated figure below) of the medicament delivery device as the activation member moves in a proximal direction(see annotated figure below), and wherein the activation member entering the space triggers the supplemental device (visually apparent from Fig 10, the activation member 40 enters the space and triggers (activates) the supplemental device by engaging the switch 41; P[0097]-P[0103]); and
wherein the activation member is attached to the movable cap(the activation member 40 which includes spring lever 42 having a rotatable coupling 47 that engages an extension 36 of the cap assembly 30. See Col 19, In. 55 to Col 20 In. 17), and
wherein the supplemental device is configured to determine if the cap has moved relative to the needle shield(P[0100]-P[0105]) and wherein the communication module is configured to transmit data to an external device where the data comprises information directly related to the status of the activation member and/or the movement of the movable cap(communication module 152 transmits “data representative of at least one of a condition and an operational state of the drug delivery device”, i.e. the data comprises information directly related to the activation status of 40 and/or the position of the removable cap; P[0062], P[0065], P[0079]).
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In Regard to Claim 16
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the cap when coupled to the needle shield remover is configured to be movable in an axial direction and wherein an initial motion sequence of the cap activates the supplemental device but does not move the needle shield remover(Fig 9A-11B; the arrows indicate the cap being movable in the axial direction, and as described at P[0089-P[0104] the cap can be moved axially between a 1st, 2nd and 3rd positions, wherein when the cap is moved to the 3rd position, represented by Fig 10, an initial motion sequence of the cap moving in the axial direction activates the supplemental device but does not move the needle shield remover 18; this sequence is explicitly described in P[0103]).
In Regard to Claim 17
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the dose delivery outlet is prevented from being accessible unless the cap is fully removed from the medicament delivery device(the dose delivery outlet is shielded unless the cap is fully removed from the drug delivery device), wherein a continued moving sequence of the cap subsequently to the initial moving sequence of the cap is required to remove of needle shield from the dose delivery outlet(as described in P[0101], the needle shield remover 18 is removed from the device 10 with a continued moving sequence of the cap 30 to ready the device for administering the drug, as such the needle shield remover also removes the needle shield from the dose delivery outlet simultaneously during the continued moving sequence; P[0080]).
In Regard to Claim 18
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the battery module or the communication module comprises one or more sensors(164) configured to detect a motion of at least one of the components of the medicament delivery device(P[0062], P[0079]).
In Regard to Claim 19
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the system further comprises a sensor module(160,162,164,165) connectable to any other module(controller module 150, communication module 152) and wherein said sensor module comprises one or more sensors configured to detect a motion of at least one of the components of the medicament delivery device(P[0062]-P[0071]).
In Regard to Claim 20
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the activation member is a switch(40 is a switch; P[0079]).
In Regard to Claim 21
Yang teaches:
The medicament delivery system of claim 20(see rejection of claim 20 above), wherein the switch is initially in a first state(deactivated/first position; P[0041], P[0096]) where the communication module is prevented to receive power from the battery(P[0096]) and where movement of the cap relative to the proximal end of the medicament delivery device changes the switch to a second state(activated/third position; P[0041], P[0096]) where the battery provides power to the communication module(P[0096]).
In Regard to Claim 22
Yang teaches:
The medicament delivery system of claim 21(see rejection of claim 21 above), wherein the activation member is configured to activate the supplemental device only once(the switch 40 activates the supplemental device only once during the cap removal sequence; P[0041], P[0096]), and wherein the switch being in the second state, indicates a potential breach of the sterile barrier of the medicament delivery device(the switch being in being in the second state, or activated state indicates the sterile barrier has been removed along with the cap).
In Regard to Claim 23
Yang teaches:
The medicament delivery system of claim 23(see rejection of claim 23 above), wherein the supplemental device comprises a recorder(172; P[0079]) configured to obtain and store data information about the medicament delivery device(P[0063]-P[0064]).
In Regard to Claim 24
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the data transmission by the communication module starts when the recorder receives power from the battery(data transmission by communication module 152 starts when the battery 35 provides power to the electronic component 33 which includes the recorder 172; P[0079]).
In Regard to Claim 25
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein any of the modules is removable from the housing and is reusable(each of the battery module and the communication module are contained within the cap and are thus removable from the housing and reusable; P[0071]).
In Regard to Claim 26
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the system further comprises a logging module(172) connectable to any other module or included as part of any other module(172 is connected to the battery module which provided its power and may be included as part of any other module; P[0079]), and wherein the logging module is configured to start tracking motion of the medicament delivery device when the cap is removed(motion tracking by the logging module 172 starts when the battery 35 provides power to the electronic component 33 which includes the recorder 172; P[0079]).
In Regard to Claim 27
Yang teaches:
The medicament delivery system of claim 15(see rejection of claim 15 above), wherein the system further comprises a memory module(172) connectable to any other module or included as part of any other module(172 is connected to the battery module which provided its power and may be included as part of any other module; P[0079]), and wherein the memory module is configured to store the data(P[0063]-P[0064]) and the communication module is configured to transmit the data wirelessly to the external device(P[0065]).
In Regard to Claim 29
Yang teaches:
A medicament delivery system comprising:
a medicament delivery device(10) having a medicament container(112; P[0078]) positioned within a housing(11; P[0078]), a dose delivery outlet(distal end 118 of needle; P[0049]-P[0050]) accessible through a terminal end of the housing(P[0049]) and a needle shield(122,30) surrounding the dose delivery outlet to provide a sterile barrier(P[0080]-P[0081]), where the needle shield is operatively associated with a needle shield remover(18; Fig 9A; 122,30 is inherently coupled to the needle shield remover 18; P[0080]-P[0081]);
a supplemental device(33) comprising a battery module(35, power supply is a battery, P[0063]), an activation member(40) and a communication module(152); and
a removable cap(30) is operatively associated with the needle shield remover (Fig 8-10; P[0101]), where an initial movement of the cap creates a gap(see annotated fig above) between the cap and the housing of the medicament delivery device, wherein the creation of the gap creates a space(see annotated figure above) for the activation member to enter after passing a proximal end of the housing(activation member 40 enters the gap/space during the cap removal sequence; see annotated figure above) of the medicament delivery device as the activation member moves in a proximal direction(see annotated figure above), and wherein the activation member entering the space causes the activation member to activate the supplemental device(see annotated figures above; the cap being movable in the proximal direction, and as described at P[0089-P[0104] the cap can be moved axially between a 1st, 2nd and 3rd positions, wherein when the cap is moved to the 3rd position, represented by Fig 10, an initial motion sequence of the cap moving in the axial direction activates the supplemental device; this sequence is explicitly described in P[0103]) and where subsequent movement of the cap causes the needle shield to be removed from the dose delivery outlet(as described in P[0101], the needle shield remover 18 is removed from the device 10 with a continued moving sequence of the cap 30 to ready the device for administering the drug, as such the needle shield remover also removes the needle shield from the dose delivery outlet simultaneously during the continued moving sequence; P[0080]),
wherein the supplemental device is configured to determine if the cap has moved relative to the needle shield(P[0100]-P[0105]), wherein the activation member is attached to the removable cap(the activation member 40 which includes spring lever 42 having a rotatable coupling 47 that engages an extension 36 of the cap assembly 30. See Col 19, In. 55 to Col 20 In. 17), and
wherein the communication module is configured to transmit data to an external device where the data comprises information directly related to the status of the activation member or the movement of the removable cap(communication module 152 transmits “data representative of at least one of a condition and an operational state of the drug delivery device”, i.e. the data comprises information directly related to the activation status of 40 and/or the position of the removable cap; P[0062], P[0065], P[0079]).
In Regard to Claim 30
Yang teaches:
The medicament delivery system of claim 29(see rejection of claim 29 above), further comprising a sensor module(160,162,164,165) containing a sensor that detects a motion of the cap relative to the housing(P[0062]-P[0071]).
In Regard to Claim 31
Yang teaches:
The medicament delivery system of claim 29(see rejection of claim 29 above), wherein the activation member comprises a switch(40 is a switch; P[0079]).
In Regard to Claim 32
Yang teaches:
The medicament delivery system of claim 29(see rejection of claim 29 above), wherein the activation member comprises a switch(40 is a switch; P[0079]) that is initially in a first state(deactivated/first position; P[0041], P[0096]) that prevents a battery from energizing the communication module(P[0096]) and where movement of the cap relative to the terminal end of the housing moves the switch to a second state(activated/third position; P[0041], P[0096]) where the battery provides power to the communication module(P[0096]).
In Regard to Claim 33
Yang teaches:
The medicament delivery system of claim 29(see rejection of claim 29 above), wherein the cap can move axially relative to the needle shield remover a first distance that will activate the activation member, where further axial movement of the cap will cause axial movement of the needle shield remover which in turn will cause axial movement of the needle shield relative to the dose delivery outlet(Fig 9A-11B; the arrows indicate the cap being movable in the proximal/axial direction, and as described at P[0089-P[0104] the cap can be moved axially between a 1st, 2nd and 3rd positions, wherein when the cap is moved to the 3rd position, represented by Fig 10, an initial motion sequence of the cap moving in the axial direction activates the supplemental device but does not move the needle shield remover 18; this sequence is explicitly described in P[0103}, and as described in P[0101], the needle shield remover 18 is removed from the device 10 with a continued moving sequence of the cap 30 to ready the device for administering the drug, as such the needle shield remover also removes the needle shield from the dose delivery outlet simultaneously during the continued moving sequence; P[0080]).
In Regard to Claim 34
Yang teaches:
The medicament delivery system of claim 29(see rejection of claim 29 above), wherein the supplemental device is removable from the medicament delivery device and is attachable to and reusable with a second medicament delivery device(each of the battery module and the communication module are contained within the cap and are thus removable from the housing and reusable with a second drug delivery device; P[0071]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN P WOLCOTT whose telephone number is (571)272-9837. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at 571-270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN P WOLCOTT/Primary Examiner, Art Unit 3711
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