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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/6/2026 has been entered.
Acknowledgment
Claims 1, 17 are amended and field on 7/6/2026.
Claims 14 and 30 are cancelled.
The amendment to claims overcome the objection in the action mailed on 4/8/2026.
Claim Rejections - 35 USC § 103
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) 1-5, 13- 21, 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Säll (US 20190083708A1) in view of Keller (WO-2018069150-A1).
Re Claim 1, Säll discloses an end-of-dose indicator device (100, Fig, 6a-9f) for a medical injection device (1, ¶0104, ¶0106), comprising: a housing ( housing of 100 include 102) comprising a proximal end (upper end, Fig. 9a), a distal end (lower end), and a sidewall (sidewall) therebetween defining an interior (chamber for the electronic, ¶01026, Fig. 9e), the housing configured to be secured to a proximal end of a medical injection device (Fig,9a-f, ¶0126); a switch (122,¶0105, Fig. 9e) arranged within the housing interior and having an open position and a closed position (in and off position, ¶0123); a circuit (150, ¶0126); and one or more indicators in electrical communication with the circuit, wherein the switch, when in the closed position, triggers the circuit to activate (140, ¶0129), but it fails to disclose that the circuit including one or more capacitors configured with the circuit and wherein the switch, when in the closed position, triggers the circuit to supply power to the one or more indicators after a delay produced by the one or more capacitors, such that the activation of the one or more indicators is delayed following closure of the switch.
However, Keller discloses an injector (Fig. 1-4) and wherein the housing has a light indicator (12, ¶0041), a circuit (controller 11, ¶0037, Fig. 5) and one or more capacitors. (Fig. 2, C1, ¶0030) and wherein the switch ( activating the delivery phase, ¶0041), when in the closed position, triggers the circuit to supply power to the one or more indicators after a delay produced by the one or more capacitors, such that the activation of the one or more indicators is delayed following closure of the switch (LED 12 will have different color to indicate the completion of the medication after delay time is passed, ¶0014, ¶0035, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify circuit to include one or more capacitors so that the circuit including one or more capacitors configured with the circuit and wherein the switch, when in the closed position, triggers the circuit to supply power to the one or more indicators after a delay produced by the one or more capacitors, such that the activation of the one or more indicators is delayed following closure of the switch as taught by Keller for the purpose of providing a customizable indication after predetermined time of injection (Keller, ¶0015-¶0017, ¶0035).
Re Claim 2, Säll discloses wherein the housing comprises a cylinder ( Fig. 9a) with a flared proximal end (top 102).
Re Claim 3, Säll discloses wherein the flared proximal end comprises a proximal-facing outer surface (top surface of 102) configured to receive a user's thumb (the user capable to press top surface of 102 by a thumb, ¶0101).
Re Claim 4, Säll discloses wherein the one or more indicators are one or more visual indicators (141, ¶0132).
Re Claim 5, Säll discloses wherein the one or more visual indicators are one or more light-emitting diodes (141, ¶0132).
Re Claim 13, Säll discloses wherein a shape of the housing matches a shape of the proximal end of the medical injection device (shape of house of 100 matches the shape of end of 1, Fig. 6a , Fig. 9f).
Re Claim 15, Säll discloses wherein activation of the indicator is delayed at least 2 seconds (such as 5 second , ¶0130).
Re Claim 16, Säll discloses wherein activation of the indicator is delayed at least 5 seconds (such as 5 second , ¶0130).
Re Claim 17, Säll discloses a medical injection system (Fig. 1-9f), comprising: a medical injection device (1, Fig. 1) comprising: an injection device housing (24 is housing of 1) having a proximal end (lower end of 24, note, the directions of the art is opposite to the current application see ¶0062 of the current application, needle is close to the distal end), a distal end ( upper end of 24, Fig. 1), and a sidewall therebetween defining an injection device interior (Fig. 1) ; a syringe (16) received within the injection device interior (Fig. 1), the syringe comprising a proximal end comprising a piston (stopper close to the tip of plunger 60, ¶0096), a distal end comprising a needle (18), and a sidewall therebetween defining a syringe interior configured to receive a medicament (sidewall of 16, ¶0087); a plunger rod (60) received within the injection device interior and configured to displace the piston distally to cause the medicament to be expelled through the needle (¶0098); a drive assembly configured to displace the plunger rod distally (spring, resilient member 64, ¶0096); a plunger rod follower (121) comprising a distal end operatively coupled to the plunger rod and a proximal end (it is coupled by lower end of 120, see 11 and 21 in Fig. 8a-c); and an end-of-dose indicator device (100 including 102), comprising: an indicator housing (housing of 100, Fig. 9a-e) comprising a proximal end (upper end), a distal end ( lower end), and a sidewall therebetween defining an indicator interior (sidewall around the chamber for the electronic, ¶01026, Fig. 9e), the indicator housing configured to be secured to the proximal end of the medical injection device (Fig. 9a-f); a switch (122) arranged within the indicator housing interior (Fig. 9e) and having an open position and a closed position (in and off positions, ¶0129); a circuit (150, ¶0126); and one or more indicators in electrical communication with the circuit (140, ¶0129), wherein when the plunger rod is displaced distally ( moved to push the medication out, ¶0098), the proximal end of the plunger rod follower moves proximally (121 is moved from 131 to 132, Fig. 8c, ¶0106) to contact the switch, and moves the switch from the open position to the closed position which triggers the circuit (Fig. 8c, 140, ¶0129), but it fails to disclose that the circuit including one or more capacitors configured with the circuit and wherein the switch, when in the closed position, triggers the circuit to supply power to the one or more indicators after a delay produced by the one or more capacitors, such that the activation of the one or more indicators is delayed following closure of the switch.
However, Keller discloses an injector (Fig. 1-4) and wherein the housing has a light indicator (12, ¶0041), a circuit (controller 11, ¶0037, Fig. 5) and one or more capacitors. (Fig. 2, C1, ¶0030) and wherein the switch ( activating the delivery phase, ¶0041), when in the closed position, triggers the circuit to supply power to the one or more indicators after a delay produced by the one or more capacitors, such that the activation of the one or more indicators is delayed following closure of the switch (LED 12 will have different color to indicate the completion of the medication after delay time is passed, ¶0014, ¶0035, ¶0041).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify circuit to include one or more capacitors so that the circuit including one or more capacitors configured with the circuit and wherein the switch, when in the closed position, triggers the circuit to supply power to the one or more indicators after a delay produced by the one or more capacitors, such that the activation of the one or more indicators is delayed following closure of the switch as taught by Keller for the purpose of providing a customizable indication after predetermined time of injection (Keller, ¶0015-¶0017, ¶0035).
Re Claim 18, Säll discloses wherein the housing comprises a cylinder ( Fig. 9a) with a flared proximal end (top 102).
Re Claim 19, Säll discloses wherein the flared proximal end comprises a proximal-facing outer surface (top surface of 102) configured to receive a user's thumb (the user capable to press top surface of 102 by a thumb, ¶0101
Re Claim 20, Säll discloses wherein the one or more indicators are one or more visual indicators (141, ¶0132).
Re Claim 21, Säll discloses wherein the one or more visual indicators are one or more light-emitting diodes (141, ¶0132).
Re Claim 31, Säll discloses wherein activation of the indicator is delayed at least 2 seconds (such as 5 second , ¶0130).
Re Claim 32, Säll discloses wherein activation of the indicator is delayed at least 5 seconds (such as 5 second , ¶0130).
Claim(s) 6, 8-9.12, 22. 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Säll in view of Keller and further in view of Jorgensen et al. (US 20110270214 A1) (“Jorgensen”).
Re Claim 6, Säll discloses the one or more visual indicators to be seen outside of the housing (the light can be seen visually, ¶0049, ¶0056), but it fails to disclose wherein the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) comprises one or more windows (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified housing to include one or more windows so that the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Re Claim 8, Säll fails to disclose wherein the one or more windows are arranged at the proximal end of the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) comprises one or more windows are arranged at the proximal end of the housing (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that one or more windows are arranged at the proximal end of the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Re Claim 9, Säll fails to disclose wherein the one or more windows are arranged circumferentially around the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) comprises one or more windows are arranged circumferentially around the housing (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the one or more windows are arranged circumferentially around the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Re Claim 12, Säll fails to disclose wherein the one or more windows are arranged on a proximal-facing surface of the proximal end of the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) the one or more windows are arranged on a proximal-facing surface of the proximal end of the housing (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified housing to include one or more windows so that the one or more windows are arranged on a proximal-facing surface of the proximal end of the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Re Claim 22, Säll discloses the one or more visual indicators to be seen outside of the housing (the light can be seen visually, ¶0049, ¶0056), but it fails to disclose wherein the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) comprises one or more windows (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Re Claim 24, Säll fails to disclose wherein the one or more windows are arranged at the proximal end of the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) comprises one or more windows are arranged at the proximal end of the housing (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that one or more windows are arranged at the proximal end of the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Re Claim 25, Säll fails to disclose wherein the one or more windows are arranged circumferentially around the housing.
However, Jorgensen discloses a pen injector (Fig. 1-10) and wherein the housing (260 house for electronic 271, 272) comprises one or more windows are arranged circumferentially around the housing (276, ¶0108, Fig. 9) configured to allow the one or more visual indicators to be seen outside of the housing (¶0108).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the one or more windows are arranged circumferentially around the housing as taught by Jorgensen for the purpose of viewing the information related to the injection (Jorgensen, ¶0094).
Claim(s) 6-7, 11, 22-23, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Säll in view of Keller and further in view of Fabien et al. (US 20180161507 A1) (“Fabien”).
Re Claim 6, Säll discloses the one or more visual indicators to be seen outside of the housing (the light can be seen visually, ¶0049, ¶0056), but it fails to disclose wherein the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) configured to allow the one or more visual indicators to be seen outside of the housing (¶077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Re Claim 7, Säll fails to disclose wherein the one or more windows are arranged at the distal end of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) are arranged at the distal end of the housing (at least the lower one are close to distal end ( below end, ¶0077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified housing to include one or more windows so that the one or more windows are arranged at the distal end of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Re Claim 11, Säll fails to disclose wherein the one or more windows are arranged along a longitudinal axis of the housing between the proximal end of the housing and the distal end of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) the one or more windows are arranged along a longitudinal axis of the housing between the proximal end of the housing and the distal end of the housing (¶077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the one or more windows are arranged along a longitudinal axis of the housing between the proximal end of the housing and the distal end of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Re Claim 22, Säll discloses the one or more visual indicators to be seen outside of the housing (the light can be seen visually, ¶0049, ¶0056), but it fails to disclose wherein the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) configured to allow the one or more visual indicators to be seen outside of the housing (¶077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the housing further comprises one or more windows configured to allow the one or more visual indicators to be seen outside of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Re Claim 23, Säll fails to disclose wherein the one or more windows are arranged at the distal end of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) are arranged at the distal end of the housing (at least the lower one are close to distal end, lower end, ¶0077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified housing to include one or more windows so that the one or more windows are arranged at the distal end of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Re Claim 27, Säll fails to disclose wherein the one or more windows are arranged along a longitudinal axis of the housing between the proximal end of the housing and the distal end of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) the one or more windows are arranged along a longitudinal axis of the housing between the proximal end of the housing and the distal end of the housing (¶0077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the one or more windows are arranged along a longitudinal axis of the housing between the proximal end of the housing and the distal end of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Claim(s) 10, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Säll in view of Keller and Jorgensen and further in view of Fabien.
Re Claim 10, Säll fails to disclose wherein the one or more windows are arranged circumferentially around the distal end of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) are arranged at the distal end of the housing (at least the lower one are close to distal end, below end, ¶0077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the one or more windows are circumferentially around the distal end of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Re Claim 26, Säll fails to disclose wherein the one or more windows are arranged circumferentially around the distal end of the housing.
However, Fabien discloses a pen injector (Fig. 1a-6) and wherein the housing (1c) comprises one or more windows (11, ¶0077) are arranged at the distal end of the housing (at least the lower one are close to distal end, lower end, ¶0077).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify housing to include one or more windows so that the one or more windows are arranged circumferentially around the distal end of the housing as taught by Fabien for the purpose of viewing the information related to the injection (Fabien, ¶0077).
Response to Arguments
Applicant’s arguments, see remark, filed 3/9/2026, with respect to the rejection(s) of claim(s) 1, 17 under 103 rejection over Sall in view of Mirov and with regards to the new added limitation have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Sall in view of Keller.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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