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 .
Claims 16-30 are examined in this 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.
Claim(s) 16-24 and 26-30 are rejected under 35 U.S.C. 102(1) as being anticipated by Krulevitch et al. (WO 2021095003 A1).
Regarding claim 16, Kurlevitch discloses a supplemental device (sensing module 310, Fig. 13) attached to a removable cap (cap 308, Fig. 12) of a medicament delivery device (device 312, Fig. 12), the supplemental device comprising:
a housing (bottom housing portion 322, top housing portion 327, Fig. 13) attachable to the removable cap (cap 308, Fig. 13) wherein the housing is configured to accommodate:
- a battery module (power source 330, Fig. 13) ("… a power source 230 in the form of a coin cell battery …" - Para [00127]),
- an activation clip (switch contact pads 334, Fig. 13) connected to the battery module (See interpretation below),
- a switch (switch 336, Fig. 14) having a first surface (See annotated Fig. 13) connected to the battery module (See interpretation below) and a second surface (See annotated Fig. 13) which is connectable to the activation clip ("… the switch is allowed to engage the switch contact pads 334 …" - Para [00132]) and when connected creates a contact area (See annotated Fig. 14); and
- and a communication module (communication interface 332, Fig. 14) connectable to the battery module or included as part of the battery module (See interpretation below), and configured to transmit data to an external device ("… a communication interface configured to transmit data to an external source …" - Para [00154]), where the data comprises information directly related to a status of the switch (“The sensor 26 being configured to gather motion data may allow for detecting when the drug delivery process has begun …” – Para [00116],”… the tab 306 acts as an insulator to prevent the switch 336 from engaging the switch contact pads 334 (FIG. 14), thereby creating an open circuit that prevents the power source 330 from providing power to electronic components of the sensing module 310. " - Para [00132]),
the supplemental device further comprises an insulation strip (tab 306, Fig. 13) ("The tab 306 is made from an insulating material, such as Mylar® or non-conductive, insulating material, to allow the tab 306 to act as an insulator." - [00132]), having a first portion (See annotated Fig. 13) which has a predetermined area that is larger than the contact area between the switch and the activation clip ("The second portion of the tab 306 is positioned so as to prevent the switch 336 from engaging the switch contact pads 334." - Para [00133]), and a second portion which is attachable to a housing of the medicament delivery device ("… the tab 306 has a first, lower portion located outside of the sensing module 310 and attached to the cap 308, such as by being adhered thereto with adhesive or other attachment mechanism." - Para [00133], See annotated Fig. 13) which extends along a longitudinal axis between a proximal and distal end (See annotated Fig. 11),
wherein the supplemental device is initially in a first state when the first portion of the insulation strip is slidably arranged between switch and the activation clip such that the communication module is prevented to receive power from the battery module ("With the tab 306 in the first position, as shown in FIGS. 10-12, the tab 306 acts as an insulator to prevent the switch 336 from engaging the switch contact pads 334 (FIG. 14), thereby creating an open circuit that prevents the power source 330 from providing power to electronic components of the sensing module 310. " - Para [00132]) and where the removable cap is removed by a first and/or second movement towards the proximal end relative to the housing of the medicament delivery device (“… when the cap 308 is pulled off the housing 318, the tab 306 is pulled out of the sensing module 310 to move from the first position to the second position." - Para [00134], See annotated Fig. 11), the removal of the removable cap changes the supplemental device to a second state when the first portion of the insulation strip is removed from the contact area between the switch and the activation clip thereafter the battery module provides power to the communication module ("With the tab 306 in the second position, the switch 336 is allowed to engage the switch contact pads 334, thereby creating a closed circuit that allows the power source 330 to provide power to electronic components of the sensing module 310. " - Para [00132]).
PNG
media_image1.png
438
612
media_image1.png
Greyscale
PNG
media_image2.png
238
582
media_image2.png
Greyscale
PNG
media_image3.png
396
652
media_image3.png
Greyscale
Examiner interprets the power source to be connected to each of the parts on the PCB 324 (also called the electronic components of the of the sensing module), which includes the processor 326, the memory 328, the communication interface 332, the switch contact pads 34, and the switch 336.
Regarding claim 17, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the insulating strip (tab 306, Fig. 12), is flexible or adaptable to a shape of an outer and/or inner surface of the medicament delivery device, or the insulating strip comprises a shape that matches the outer and/or inner surface of the medicament delivery device (Fig. 12).
Examiner interprets the shape of the insulating strip in Fig. 12 to be a shape that matches the shape of the cap of the medicament delivery device.
Regarding claim 18, , Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the insulating strip (tab 306, Fig. 12) extends along the longitudinal axis (See annotated Fig. 11 above), wherein the first portion is arranged within the housing of the supplemental device ("The tab 306 has a second, upper portion extending from the first portion and extending into the sensing module 310 …" - Para [00133]) and the second portion extends towards the distal end of the housing of the supplemental device (...the tab 306 has a first, lower portion located outside of the sensing module 310 …" - Para [00133]).
Regarding claim 19, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the first movement is a linear movement of the removable cap in relation to the housing of the medicament delivery device and towards the proximal end ("… when the cap 308 is pulled off the housing 318, the tab 306 is pulled out of the sensing module 310 to move from the first position to the second position." - Para [00134]. See annotated Fig. 11 above).
Regarding claim 20, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the insulating strip (tab 306, Fig. 12) extends in a circumferential direction around the housing (housing 318, Fig. 12) of the medicament delivery device (device 312, Fig. 12), wherein the first portion is arranged within the housing of the supplemental device ("The tab 306 has a second, upper portion extending from the first portion and extending into the sensing module 310 …" - Para [00133]) and the second portion extends in circumferential direction out of the housing of the supplemental device (...the tab 306 has a first, lower portion located outside of the sensing module 310 …" - Para [00133]).
Regarding claim 21, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the second movement is first a rotational movement and then a linear movement or vice-versa or a helical movement or a linear movement of the removable cap in relation to the housing of the medicament delivery device and towards the proximal end. ("… when the cap 308 is pulled off the housing 318, the tab 306 is pulled out of the sensing module 310 to move from the first position to the second position." - Para [00134]. See annotated Fig. 11 above).
Regarding claim 22, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the supplemental device further comprises an adhesive pad ("… the tab 306 has a first, lower portion located outside of the sensing module 310 and attached to the cap 308, such as by being adhered thereto with adhesive or other attachment mechanism." - Para [00133]) configured to securely attach and hold the supplemental device to the removable cap.
Examiner interprets "adhesive or other attachment mechanisms" to be inclusive of an adhesive pad.
Regarding claim 23, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the battery module or the communication module comprises one or more sensors ("The PCB 324 includes … one or more sensors." - Para [00131]) configured to detect a motion or a status of at least one of the components of the medicament delivery device ("… the sensor 26 can be configured to sense any one or more of a variety of parameters such as … motion …", "the sensor 26 can include one sensor configured to sense all of the parameter(s) being sensed by the sensing module 10 …" - Para [00111]).
Regarding claim 24, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the supplemental device (sensing module 310, Fig. 10), further comprises a sensor module ("The sensing module 310 is attached non-removably to an outer surface of the device 312, although as mentioned above the sensing module 310 can instead be removably attached to the device 312." - Para [00125]) connectable to any other module (device 312, Fig. 12) and wherein said sensor module comprises one or more sensors configured to detect a motion or status of at least one of the components of the medicament delivery device ("… the sensor 26 can include two or more sensors each configured to sense one or more of the parameters being sensed by the sensing module 10." - Para [00111]).
Regarding claim 26, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the battery module or the communication module (sensing module 10, Fig. 3) comprises a recorder (sensor 26, memory 28, Fig. 3) configured to obtain and store data information about the medicament delivery device ("… a sensor 26 configured to gather data regarding one or more parameters and transmit the gathered data to the processor 24, a memory 28 configured to store instructions …" - Para [0093]).
Regarding claim 27, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the data transmission by the communication module ("… data is transmitted from the communication interface 30 to the external source …" - Para [00108]) starts when the recorder receives power from the battery ("With the tab 306 in the second position, the switch 336 is allowed to engage the switch contact pads 334, thereby creating a closed circuit that allows the power source 330 to provide power to electronic components of the sensing module 310. The tab 306 is thus configured to “wake up” the sensing module 310 by moving from the first position to the second position. " - Para [00132]).
Examiner interprets the sensing module to include the communication interface 332 which "wakes up' when the sensing module 310 "wakes up".
Regarding claim 28, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the supplemental device further comprises a logging module (sensor 26, Fig. 3) connectable to any other module or included as part of any other module (device 312, Fig. 12), and wherein the logging module is configured to start tracking motion of the medicament delivery device when the removable cap is removed ("… the tab 806 of FIGS. 36 and 37 can include a sensor configured to detect motion of the trigger 820, which may allow for detecting when drug delivery has begun." - Para [00154]) ("The tab 306 is thus configured to “wake up” the sensing module 310 by moving from the first position to the second position. " - Para [00132]).
Examiner interprets that the sensors are powered off when the removable cap is attached and wakes up only when the removable cap is removed. Thus, the sensors are only able to begin tracking motion once the cap has been removed.
Regarding claim 29, Krulevitch discloses the supplemental device (sensing module 310, Fig. 13) as recited above, wherein
the supplemental device further comprises a memory module (memory 28, Fig. 3) connectable to any other module or included as part of any other module (device 312, Fig. 12), and wherein the memory module is configured to store the data ("… a sensor 26 configured to gather data regarding one or more parameters and transmit the gathered data to the processor 24, a memory 28 configured to store instructions …" - Para [0093]) and the communication module is configured to transmit the data wirelessly to the external device (“The sensing module also includes a communication interface located on the base and configured to wirelessly transmit data to an external source …” – Para [0010]).
Regarding claim 30, Krulevitch discloses a medicament delivery device (device 312, Fig. 12), comprising:
a housing (housing 318, Fig. 12);
a medicament container positioned within the housing (container 16, Fig. 1);
a dose delivery outlet accessible through a terminal end of the housing ("The drug delivery device 12 in this illustrated embodiment is an autoinjector configured to inject the drug 14 … out of a needle (obscured in FIG. 1 by a needle shield 20) …" - Para [0090]);
a removable cap attached to the housing such that the dose delivery outlet is prevented from being accessible unless the removable cap is fully removed from the medicament delivery device (cap 308, Fig. 10) ("The drug delivery device 312 also includes a removable cap 308 configured to be removed from a remainder of the device 312 by a user to expose the needle shield 320." - Para [00129]); and
the supplemental device of claim 16 (sensing module 310, Fig. 10).
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) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch et al. WO 2021095003 A1) in view of McCullough et al. (US Patent No. 10,695,492 B2).
Regarding claim 25, Krulevitch in view of McCullough discloses the supplemental device (Krulevitch, sensing module 310, Fig. 13) as recited above, wherein
Krulevitch does not expressly disclose that any of the modules is removable from the housing and is reusable.
McCullough teaches that any of the modules is removable from the housing and is reusable ("Either autoinjectors or on-body injectors may have assemblies or sub-assemblies that are reusable, in that the assemblies may be used and re-used by refilling the reservoir, by removing an empty reservoir and replacing it with a filled reservoir, or by replacing the cannula, for example." - Col. 8 Lines 40-45).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the supplemental device of Krulevitch to include that any of the modules is removable from the housing and is reusable as taught by McCullough so that the autoinjectors may be multi-use devices (McCullough, Col. 8 Line 36).
Conclusion
.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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, Chelsea Stinson can be reached at (571) 270-1744. 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.
/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights