CTNF 18/685,330 CTNF 101820 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Roe (US 20210046247; hereinafter “Roe”) . Regarding claim 1, Roe discloses a plunger device (p. 11, col 2, [0146], lines 11-15, syringe stopper rod as shown in Fig. 7) for a drug delivery device (Fig. 23 drug delivery system). Roe does not explicitly mention or show the embodiment of the plunger device of Fig. 7 being used by the drug delivery device (Fig. 23 drug delivery system) and just shows a possible slight variation of the embodiment of the plunger device (Fig. 7) used as a plunger device (Fig. 23 actuation component) for the drug delivery system (Fig. 23). However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plunger device of Fig. 23 (actuation component) with the plunger device of Fig. 7 in the drug delivery system (Fig. 23) because Roe discloses the plunger device of Fig. 7 being used with a drug delivery device that is a syringe when Roe describes in p. 11, col 2, [0146], lines 15-17, when a delivery stroke is completed, the syringe stopper rod is fully inserted into the syringe barrel,…). Additionally, Fig. 23 shows a plunger device (actuation component) used with the drug delivery device of Fig. 23 which is described in one example as a syringe, see p. 18, col 1, [0205], line 5, e.g., onto a pre-filled syringe. Roe discloses plunger device (p. 11, col 2, [0146], lines 11-15, syringe stopper rod as shown in Fig. 7) for a drug delivery device (Fig. 23) comprising: a plunger rod (Fig. 7) having a proximal end (see ‘Modified Fig. 7’ below, proximal end) and a distal end (see ‘Modified Fig. 7’ below, distal end) configured to be attached to a stopper. PNG media_image1.png 675 516 media_image1.png Greyscale Roe does not explicitly mention the specific embodiment of the plunger rod of Fig. 7 configured to be attached to a stopper. However, an embodiment of a plunger rod (described in p. 14, col 2, [0179], lines 11-14, syringe stopper rod) is configured to be attached to a stopper (p. 14, col 2, [0179], lines 11-14, the threaded coupler is configured to screw into a proximal end of a syringe stopper to physically couple the syringe stopper rod to the syringe stopper). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the plunger rod embodiment as described in ([0179]) to be configured with the stopper ([0179]) in Roe with the teachings of the plunger rod of Fig. 7 in Roe to configure the plunger rod of Fig. 7 with a stopper, because plunger rods of various embodiments being configured with stoppers is taught in Roe on multiple occasions. One occasion in Roe teaches plunger rods being configured with stoppers as described in p. 14, col 2, [0179], lines 11-14, the threaded coupler is configured to screw into a proximal end of a syringe stopper to physically couple the syringe stopper rod to the syringe stopper. Another occasion in Roe teaches plunger rods being configured with stoppers as described in p. 8, col 2, [0126], lines 8-9, the amount of force that is applied to a syringe stopper by a syringe stopper rod). Roe discloses a first switch (see ‘Modified Fig. 7’ above, dome switch) and a second switch (see ‘Modified Fig. 7’ above, second switch) arranged at the proximal end (see ‘Modified Fig. 7’ above, proximal end); at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8) in communication with the first switch (see ‘Modified Fig. 7’ above, dome switch) and the second switch (see ‘Modified Fig. 7’ above, second switch); and at least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9), wherein the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8) is programmed or configured to: receive a first signal (a delivery signature from the first switch (see ‘Modified Fig. 7’ above, dome switch) from the p. 13, [0169], col 2, lines 1-7, plurality of trigger switches) when the first switch (see ‘Modified Fig. 7’ above, dome switch) is activated; generate first time data (a variety of first time data can be generated from the first delivery signature such as p.13, col 2, [0169], lines 5-8, data relating to a deflection order of the trigger switches); transmit, with the at least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9), the first timestamp (p.19, col 1, [0212], lines 1-4, a time stamp for the drug dose administration); receive a second signal (a delivery signature from a second switch from the p. 13, col 2, [0169], lines 1-7, plurality of trigger switches) when the second switch (see ‘Modified Fig. 7’ above, second switch) is activated; generate a second time data (a variety of second time data can be generated from a second delivery signature such as p. 13, col 2, [0169], lines 5-9, a deflection duration of each trigger switch); and transmit, with the at least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9), the second time data (a variety of second time data can be generated from a second delivery signature such as p. 13, col 2, [0169], lines 5-9, a deflection duration of each trigger switch). Regarding claim 2, Roe discloses a plunger rod (p. 11, col 2, [0146], lines 11-15, syringe stopper rod as shown in Fig. 7) is configured to be used with a manual syringe. Roe does not explicitly mention or show the embodiment of the plunger rod of Fig. 7 being used by the manual syringe (Fig. 23 drug delivery system) and just shows a possible slight variation of the embodiment of the plunger rod (Fig. 7) used as a plunger rod (Fig. 23 actuation component) for the manual syringe (Fig. 23). However, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plunger rod of Fig. 23 with the plunger rod of Fig. 7 in the manual syringe (Fig. 23) because Roe discloses the plunger rod of Fig. 7 being used with a drug delivery device that is a syringe when Roe describes in p. 11, col 2, [0146], lines 15-17, when a delivery stroke is completed, the syringe stopper rod is fully inserted into the syringe barrel,…). Additionally, Fig. 23 shows a plunger rod (actuation component) used with the drug delivery device of Fig. 23 which is described in one example as a syringe, see p. 18, col 1, [0205], line 5, e.g., onto a pre-filled syringe. Regarding claim 3, Roe discloses the proximal end of the plunger rod (as shown in ‘Modified Fig. 7’ above, proximal end) comprises a housing (see ‘Modified Fig. 7’ above, housing) comprising a proximal end (see ‘Modified Fig. 7’ above, proximal end housing proximal end) configured to be contacted by a user's thumb during drug delivery, a distal end attached to the proximal end of the plunger rod (see ‘Modified Fig. 7’ above, proximal end housing distal end), and a sidewall therebetween defining an interior (see ‘Modified Fig. 7’ above, sidewall). Regarding claim 4, Roe, in the embodiment of the plunger device of Fig. 7 discloses the proximal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing proximal end) is displaceable relative to the distal end of the housing (see dome switch (see ‘Modified Fig. 7’ above, dome switch) right under the proximal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing proximal end) which would cause the proximal end of the housing to displace during actuation relative to the distal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing distal end)) when a distally-directed force is applied by a user during drug delivery (p. 10, col 2, [0141], lines 15-16, end of dose delivery position). Regarding claim 5, Roe discloses the first switch (see ‘Modified Fig. 7’ above, dome switch), the second switch (see ‘Modified Fig. 7’ above, second switch), the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8), and at the least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9) are arranged in the interior of the housing (see within the housing of Fig. 7). Regarding claim 6, Roe discloses the first switch (see ‘Modified Fig. 7’ above, dome switch) and the second switch (see ‘Modified Fig. 7’ above, second switch) are mechanical switches (these triggers are mechanical switches which are physically triggered as described in p. 11, col 2, [0146], lines 15-18, when a delivery stroke is completed, the syringe stopper rod is fully inserted into the syringe barrel, causing each of the three trigger switches in the assembly to radially deflect in an inward direction). Regarding claim 7, Roe, in the embodiment of the plunger device of Fig. 7, discloses the first switch (see Modified Fig. 7’ above, dome switch) is arranged in the housing (see Modified Fig. 7’ above, proximal end housing) such that the proximal end of the housing (see Modified Fig. 7’ above, proximal end housing), when displaced during drug delivery (see dome switch (see ‘Modified Fig. 7’ above, dome switch) right under the proximal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing proximal end) which would cause the proximal end of the housing to displace during actuation relative to the distal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing distal end) during drug delivery as described in p. 10, col 2, [0141], lines 15-16, end of dose delivery position), activates the first switch (see Modified Fig. 7’ above, dome switch). Regarding claim 8, Roe discloses the second switch (see ‘Modified Fig. 7’ above, second switch) is arranged in the housing (see ‘Modified Fig. 7’ above, housing) such that the second switch (see ‘Modified Fig. 7’ above, second switch) is activated upon completion of drug delivery (p. 11, col 2, [0146], lines 15-16, when a delivery stroke is completed). Regarding claim 9, Roe discloses the distal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing distal end) comprises a displaceable element (Fig. 7 trigger switches light pipe) configured to move proximally (the trigger switches light pipe directly in line with the three switches as seen in Fig. 7 would move proximally ([0146], causing each of the three trigger switches to radially deflect in an inward direction), and activate the second switch ([0146], causing each of the three trigger switches (which includes the second switch) to radially deflect in an inward direction) upon completion of drug delivery (p. 11, col 2, [0146], lines 15-16, when a delivery stroke is completed). Regarding claim 10, Roe discloses the communication interface is a BLUETOOTH transmitter (p. 9, col 2, [0134], line 17, Bluetooth). Regarding claim 11, Roe discloses a drug delivery device (Fig. 23 drug delivery device) comprising: a proximal end (see ‘Modified Fig. 23’ below, proximal end); a distal end (see ‘Modified Fig. 23’ below, distal end); and a barrel (Fig. 23 housing) therebetween defining an interior configured to receive a medicament (Fig. 23 drug reservoir), and the plunger device of claim 1 (Fig. 23 actuation component) received at least partially within the interior. PNG media_image2.png 497 631 media_image2.png Greyscale Regarding claim 12, Roe discloses the drug delivery device (Fig. 23 drug delivery device) comprises, at the proximal end (see ‘Modified Fig. 23’ above, proximal end), one or more finger flanges extending radially outward (Fig. 23 finger flange component). Regarding claim 13, Roe discloses the displaceable element (Fig. 7 trigger switches light pipe) arranged at the distal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing distal end) is configured to move proximally (the trigger switches light pipe directly in line with the three switches as seen in Fig. 7 would move proximally ([0146], causing each of the three trigger switches to radially deflect in an inward direction) by contacting the flange. Roe, in the plunger device embodiment of Fig. 7, does not explicitly disclose it is used with a drug delivery system with a flange that the plunger device embodiment of Fig. 7 would come into contact with. However, a plunger device embodiment that comes into contact with a flange in a drug delivery system can be seen in Fig. 23. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace the plunger device embodiment of Fig. 7 with the plunger device embodiment of Fig. 23 (actuation component) as a plunger device is a well-known and predictable mechanism for applying force to a stopper in order to deliver medicament from a container in a drug delivery device. Regarding claim 14, Roe discloses a method of monitoring timing of medicament delivery (p.19, col 1, [0212], lines 1-4, a time stamp for the drug dose administration), comprising: providing a syringe (Fig. 23 drug delivery system), comprising: a syringe proximal end (see ‘Modified Fig. 23’ above, proximal end) having one or more finger flanges extending radially outward (Fig. 23 finger flange component); a syringe distal end (see ‘Modified Fig. 23’ below, distal end); a syringe sidewall therebetween defining a syringe interior configured to receive a medicament (Fig. 23 housing); and a plunger device (Fig. 23 actuation component) received at least partially within the syringe interior (see Fig. 23, where actuation component is partially within syringe interior), the plunger device comprising: a proximal end (see ‘Modified Fig. 23’ above, actuation component proximal end); a distal end (see ‘Modified Fig. 23’ above, actuation component distal end) configured to be attached to or to be in contact with a stopper. Roe does not explicitly mention the specific embodiment of the plunger device of Fig. 23 configured to be attached to or to be in contact with a stopper. However, Roe, in an embodiment of a plunger device (described in p. 14, col 2, [0179], lines 11-14, syringe stopper rod) is configured to be attached to or to be in contact with a stopper (p. 14, col 2, [0179], lines 11-14, the threaded coupler is configured to screw into a proximal end of a syringe stopper to physically couple the syringe stopper rod to the syringe stopper). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to replace the plunger device of Fig. 23 with the plunger device embodiment described in ([0179]) to be configured with the stopper ([0179]) because a plunger rod configured with a stopper is a well-known and predictable mechanism for delivering medicament and controlling fluid displacement. Roe, in the plunger device embodiment of Fig. 23, does not explicitly disclose a housing arranged at the proximal end of the plunger device, comprising a displaceable proximal end. However, Roe, in the embodiment of the plunger device of Fig. 7, discloses a housing (see ‘Modified Fig. 7’ above, proximal end housing) arranged at the proximal end of the plunger device (see ‘Modified Fig. 7’ above, proximal end), comprising a displaceable proximal end (see dome switch (see ‘Modified Fig. 7’ above, dome switch) right under the proximal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing proximal end) which would cause the proximal end of the housing to displace during actuation relative to the distal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing distal end) during drug delivery as described in p. 10, col 2, [0141], lines 15-16, end of dose delivery position). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plunger device of Fig. 23 (actuation component) with the plunger device of Fig. 7 in the drug delivery system (Fig. 23) because Roe discloses the plunger device of Fig. 7 being used with a drug delivery device that is a syringe when Roe describes in p. 11, col 2, [0146], lines 15-17, when a delivery stroke is completed, the syringe stopper rod is fully inserted into the syringe barrel,…). Additionally, Fig. 23 shows a plunger device (actuation component) used with the drug delivery device of Fig. 23 which is described in one example as a syringe, see p. 18, col 1, [0205], line 5, e.g., onto a pre-filled syringe. Roe, in the plunger device embodiment of Fig. 23 (actuation component), does not explicitly disclose a housing distal end comprising a displaceable element, and a housing sidewall therebetween defining a housing interior; a first switch and a second switch arranged in the housing interior; at least one processor arranged in the housing interior and in communication with the first switch and the second switch; and at least one communication interface arrange in the housing interior and in communication with the at least one processor; receiving, with the at least one processor, a first signal indicating that the first switch has been activated; generating, with the at least one processor, first time data; transmitting, with the at least one communication interface, the first time data; receiving, with the at least one processor a second signal indicating that the second switch has been activated; generating, with the at least one processor, second time data; and transmitting, with the at least one communication interface, the second time data. However, Roe, in the embodiment of the plunger device of Fig. 7, discloses a housing distal end (see ‘Modified Fig. 7’ above, proximal end housing distal end) comprising a displaceable element (Fig. 7 trigger switches light pipe), and a housing sidewall (see ‘Modified Fig. 7’ above, housing) therebetween defining a housing interior (see everything within the housing of ‘Modified Fig. 7’ above); a first switch (see ‘Modified Fig. 7’ above, dome switch) and a second switch (see ‘Modified Fig. 7’ above, second switch) arranged in the housing interior (see everything within the housing of ‘Modified Fig. 7’ above); at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8) arranged in the housing interior (see everything within the housing of ‘Modified Fig. 7’ above) and in communication with the first switch (see ‘Modified Fig 7’ above, dome switch) and the second switch (see ‘Modified Fig 7’ above, second switch); and at least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9), the first time data (a variety of first time data can be generated from the first delivery signature such as p.13, col 2, [0169], lines 5-8, data relating to a deflection order of the trigger switches) arrange in the housing interior (see everything within the housing of ‘Modified Fig. 7’ above) and in communication with the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8); receiving, with the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8), a first signal (a delivery signature from a first switch (see ‘Modified Fig. 7’ above, dome switch) from the p. 13, col 2, [0169], lines 1-7, plurality of trigger switches) indicating that the first switch (see ‘Modified Fig. 7’ above, first switch) has been activated; generating, with the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8), first time data; transmitting, with the at least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9), the first time data (a variety of first time data can be generated from the first delivery signature such as p.13, col 2, [0169], lines 5-8, data relating to a deflection order of the trigger switches); receiving, with the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8) a second signal (a delivery signature from a second switch from the p. 13, col 2, [0169], lines 1-7, plurality of trigger switches) indicating that the second switch (see ‘Modified Fig. 7’ above, second switch) has been activated; generating, with the at least one processor (sensor component described in p. 8, col 1, [0121], lines 3-8), second time data (a variety of second time data can be generated from a second delivery signature such as p. 13, col 2, [0169], lines 5-9, a deflection duration of each trigger switch); and transmitting, with the at least one communication interface (wireless transmitter module as described in p. 22, col 2, [0268], lines 6-9), the second time data (a variety of second time data can be generated from a second delivery signature such as p. 13, col 2, [0169], lines 5-9, a deflection duration of each trigger switch). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plunger device of Fig. 23 (actuation component) with the plunger device of Fig. 7 in the drug delivery system (Fig. 23) because Roe discloses the plunger device of Fig. 7 being used with a drug delivery device that is a syringe when Roe describes in p. 11, col 2, [0146], lines 15-17, when a delivery stroke is completed, the syringe stopper rod is fully inserted into the syringe barrel,…). Additionally, Fig. 23 shows a plunger device (actuation component) used with the drug delivery device of Fig. 23 which is described in one example as a syringe, see p. 18, col 1, [0205], line 5, e.g., onto a pre-filled syringe. Regarding claim 15, Roe in the plunger device embodiment of Fig. 23, does not explicitly disclose the first switch is activated by displacement of the proximal end of the housing and the second switch is activated by displacement of the displaceable element. However, Roe, in the embodiment of the plunger device of Fig. 7, discloses the first switch (see ‘Modified Fig. 7’ above, dome switch) is activated by displacement of the proximal end of the housing (see dome switch (see ‘Modified Fig. 7’ above, dome switch) right under the proximal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing proximal end) which would cause the proximal end of the housing to displace during actuation relative to the distal end of the housing (see ‘Modified Fig. 7’ above, proximal end housing distal end) during drug delivery as described in p. 10, col 2, [0141], lines 15-16, end of dose delivery position) and the second switch (see ‘Modified Fig. 7’ above, second switch) is activated by displacement of the displaceable element (Fig. 7 trigger switches light pipe, which is directly in line with the three switches as seen in Fig. 7 and would move proximally ([0146], causing each of the three trigger switches to radially deflect in an inward direction). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plunger device of Fig. 23 (actuation component) with the plunger device of Fig. 7 in the drug delivery system (Fig. 23) because Roe discloses the plunger device of Fig. 7 being used with a drug delivery device that is a syringe when Roe describes in p. 11, col 2, [0146], lines 15-17, when a delivery stroke is completed, the syringe stopper rod is fully inserted into the syringe barrel,…). Additionally, Fig. 23 shows a plunger device (actuation component) used with the drug delivery device of Fig. 23 which is described in one example as a syringe, see p. 18, col 1, [0205], line 5, e.g., onto a pre-filled syringe . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Corbett et al. (US 2017/0049947 A1) is considered relevant prior art where it also demonstrates using two or more suture holes per suture pad as claimed . Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISSA J GHANNOUM whose telephone number is (571) 272-8591. The examiner can normally be reached Monday through Friday 8:30 AM to 5:00 PM. 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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/685,330 Page 2 Art Unit: 3783 Application/Control Number: 18/685,330 Page 3 Art Unit: 3783 Application/Control Number: 18/685,330 Page 4 Art Unit: 3783 Application/Control Number: 18/685,330 Page 5 Art Unit: 3783 Application/Control Number: 18/685,330 Page 6 Art Unit: 3783 Application/Control Number: 18/685,330 Page 7 Art Unit: 3783 Application/Control Number: 18/685,330 Page 8 Art Unit: 3783 Application/Control Number: 18/685,330 Page 9 Art Unit: 3783 Application/Control Number: 18/685,330 Page 10 Art Unit: 3783 Application/Control Number: 18/685,330 Page 11 Art Unit: 3783 Application/Control Number: 18/685,330 Page 12 Art Unit: 3783 Application/Control Number: 18/685,330 Page 13 Art Unit: 3783 Application/Control Number: 18/685,330 Page 14 Art Unit: 3783 Application/Control Number: 18/685,330 Page 15 Art Unit: 3783
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