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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/11/26 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 8/31/26, with respect to the rejection(s) of claim(s) 15 and 29 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yang and Carlsson et al. (US 20180369488).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the activation member comprising an insulating pad and further comprising a switch as claimed in claims 20 and 31 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 20-22, 31, and 35-36 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.
Claims 20 and 31 recites the limitation, “the activation member further comprises a switch”. The specification, however, is silent regarding the activation member comprising both an insulating pad and a switch. P[0031] of Applicant’s specification states “The activation member is either a switch or an insulating pad”. There appears to be no evidence in the specification as originally filed to support a activation member comprising both a switch and an insulating pad as claimed. Therefore, it appears the specification does not sufficiently support the limitation. Furthermore, while the drawings may be relied upon for what they fairly teach, Fig 6A and 6B disclose the separate embodiments of the activation member being a switch or an insulating pad. There appears to be no evidence in the drawings as originally filed to support a activation member comprising both a switch and an insulating pad as claimed.
Therefore, the above amended limitations add new matter and fail to comply with the written description requirement, because there is no support in the disclosure as originally filed for the amended limitations. Claims 21-22 and 35-36 also contain new matter by virtue of their dependency on Claims 20 and/or 31.
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) 15, 17-19, 23-27, 29-30 and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20180318526), hereinafter: “Yang” in view of Carlsson et al. (US 20180369488), hereinafter: “Carlsson”.
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) wherein the activation member is a switch(40 is a switch; P[0079]), 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 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; and as shown in Fig 10, which depicts a portion of the cap removal sequence, the cap is moved relative to the needle shield remover to activate the supplemental device. In this initial activation sequence, the needle shield remover is not moved. As described in P[0103], the spring lever is rotated to engage switch 41, which activates the supplemental device. As shown in Fig 10, the cap is still coupled to the housing, thus the needle shield remover is not moved).
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]).
Examiner notes the limitation “wherein an initial motion sequence of the cap activates the supplemental device but does not move the needle shield remover” is a functional limitation that describes what the does, rather than what the device is. In short, the claimed invention does not differ from the prior art in any physical structural manner. It has been held that “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997); MPEP 2114 Additionally the limitations “that makes it compatible with standard tees having different ball resting diameters” are construed to be functional language not structurally distinguishable over the prior art because the limitation indicates a manner of operating the device or an intended result. Furthermore, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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Yang fails to teach:
wherein the activation member comprises an insulating pad
Carlsson teaches
An analogous medicament delivery device(1) having an activation member(rotation detection arrangement of Fig 4a-b, 5a-b) wherein the activation member comprises a switch(301; P[0086], P[0087]) or in an alternate embodiment, an insulating pad(501; P[0090], P[0091]).
It is obvious to substitute one known element for another to obtain predictable results. See MPEP 2143(B). The MPEP states the prior art must: (1) teach a device (method) which differs from the claimed device (method) by the substitution of some component or step with another component (step), (2) teach that the substituted components and their functions were known, and (3) show that one of ordinary skill could have substituted one known element for another to yield predictable results. See MPEP 2143(B).
In this case, Yang teaches an activation member that differs from the claimed activation member because it is a switch. The switch of Yang and the insulating pad of Carlsson both perform the function of activating the medicament device. One of ordinary skill could have replaced the switch of Yang with the insulating pad of Carlsson to achieve predictable results because both references deal with activation members that function in the same manner in the environment of a medicament delivery device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the activation member of Yang by replacing the switch with an insulating pad because the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
In Regard to Claim 17
Yang in view of Carlsson 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 in view of Carlsson 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 in view of Carlsson 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 23
Yang in view of Carlsson 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 in view of Carlsson 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 in view of Carlsson 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 in view of Carlsson 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 in view of Carlsson 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), wherein the activation member comprises a switch(40 is a switch; P[0079]) 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),
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; and as shown in Fig 10, which depicts a portion of the cap removal sequence, the cap is moved relative to the needle shield remover to activate the supplemental device. In this initial activation sequence, the needle shield remover is not moved. As described in P[0103], the spring lever is rotated to engage switch 41, which activates the supplemental device. As shown in Fig 10, the cap is still coupled to the housing, thus the needle shield remover is not moved).
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]), 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]).
Examiner notes the limitation “wherein an initial motion sequence of the cap activates the supplemental device but does not move the needle shield remover” is a functional limitation that describes what the does, rather than what the device is. In short, the claimed invention does not differ from the prior art in any physical structural manner. It has been held that “While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997); MPEP 2114 Additionally the limitations “that makes it compatible with standard tees having different ball resting diameters” are construed to be functional language not structurally distinguishable over the prior art because the limitation indicates a manner of operating the device or an intended result. Furthermore, a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Yang fails to teach:
wherein the activation member comprises an insulating pad
Carlsson teaches
An analogous medicament delivery device(1) having an activation member(rotation detection arrangement of Fig 4a-b, 5a-b) wherein the activation member comprises a switch(301; P[0086], P[0087]) or in an alternate embodiment, an insulating pad(501; P[0090], P[0091]).
It is obvious to substitute one known element for another to obtain predictable results. See MPEP 2143(B). The MPEP states the prior art must: (1) teach a device (method) which differs from the claimed device (method) by the substitution of some component or step with another component (step), (2) teach that the substituted components and their functions were known, and (3) show that one of ordinary skill could have substituted one known element for another to yield predictable results. See MPEP 2143(B).
In this case, Yang teaches an activation member that differs from the claimed activation member because it is a switch. The switch of Yang and the insulating pad of Carlsson both perform the function of activating the medicament device. One of ordinary skill could have replaced the switch of Yang with the insulating pad of Carlsson to achieve predictable results because both references deal with activation members that function in the same manner in the environment of a medicament delivery device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the activation member of Yang by replacing the switch with an insulating pad because the substitution of one known element for another yields predictable results to one of ordinary skill in the art.
In Regard to Claim 30
Yang in view of Carlsson 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 32
Yang in view of Carlsson 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 in view of Carlsson 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 in view of Carlsson 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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