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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/31/2025 has been entered.
Acknowledgment
Claims 1, 6, 8, 10, 17, are amended and filed on 10/31/2025.
Claim 16 is canceled.
Claim Rejections - 35 USC § 102
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) 1, 6, 17-27 is/are rejected under 35 U.S.C. 102 (a)1) as being anticipated by Byerly et al. (WO 2019/040313A1) (“Byerly”).
Re claim 1, Byerly discloses a medication delivery device (the general delivery is in Fig. 2 and switch in Fig. 10-13) comprising: a housing (12, 212); an outlet (close to 24, Fig. 2); a dose button (256, Fig. 10, ¶0093) to activate a dose dispensing mode in which medication is dispensed out of the outlet (¶0093); a printed circuit board (325, Fig. 12, ¶0095); a protruded dose element (232, include 301, 302 ) that is rotatable relative to the printed circuit board during a dose dispensing event (¶0095); a switch (320) mounted to the printed circuit board (Fig. 12), the switch comprising a conductive pad (base of 32 and/or330) coupled to the printed circuit board (Fig. 12) and a cantilevered arm (344), the cantilevered arm having a first curved portion extending from the printed circuit board (a portion close to 340) and a second curved portion (a portion close to 348) that, in the dose dispensing event (¶0102), is configured to move toward and contact the conductive pad to change the switch to a first state (wherein 346 is slide on top of 301 and 348 contact 332, ¶0102) when an arm portion of the cantilevered arm is in slidable contact with the protruded dose element (at least 342 is slidable on 301, Fig. 13 as 348 contacts 332, ¶0102), and configured to move away and be spaced from the conductive pad to change the switch to a second state (Fig. 13 as 348 not contacting 332 and 346 is between 301s ); a protrusion extending from the printed circuit board (324), the protrusion being flanked by the first curved portion and the second curved portion when the second curved portion is in contact with the conductive pad (¶0102); and a controller configured to receive a signal from the switch (¶0062, ¶0095).
Re claim 6, Byerly discloses wherein said arm portion of the cantilevered arm defines a third curved portion of the cantilevered arm (346), wherein the third curved portion comprises a U-shape connecting the first curved portion to the second curved portion (Fig. 12, ¶0102), and wherein a curvature of the third curved portion transitions the cantilevered arm from pointing in a distal direction to pointing proximally toward the printed circuit board (Fig. 12, ¶0102).
Re claim 17, Byerly discloses wherein the protrusion prohibits the second curved portion from further movement toward the first curved portion while the cantilevered arm is moved toward a closed position when the switch is in the first state (when the 326 slide om 301, 348 is pressed and contact 332, so that 324 prohibits the second curved portion from further movement, ¶0102).
Re claim 18, Byerly discloses wherein the protruded dose element includes a series of teeth (301, 302, Fig. 13) that are spaced from one another (Fig. 13), the protruded dose element being positioned to permit the teeth to slide against the arm portion of the cantilevered arm to move the cantilevered arm between a closed position when the switch is in the first state and an open position when the switch is in the second state as the protruded dose element is rotated (¶0102, Fig. 12-13).
Re claim 19, Byerly discloses wherein sliding contact between the teeth and the cantilevered arm causes the first curved portion to move toward a straightened configuration in which the cantilevered arm is in the closed position and in which the switch is in the first state (as 342 is pressed by the teeth 301, first curve will be close to straightened configuration, ¶0102, Fig.13).
Re claim 20, Byerly discloses wherein the protruded dose element is rotatable with the dose button in
Re claim 21, Byerly discloses wherein the switch is configured to sense data indicative of an angular displacement of the protruded dose element relative to the dose button during the dose dispensing mode (¶0055).
Re claim 22, Byerly discloses wherein the printed circuit board is fixed to the dose button (Fig. 10).
Re claim 23, Byerly discloses wherein the cantilevered arm is a single monolithic component (Fig. 13, 240 is a single piece).
Re claim 24, Byerly discloses wherein the switch comprises a base (320 or a portion of 340 that inside 320 ) connected to the cantilevered arm, the base being mounted to the printed circuit board (Fig. 13).
Re claim 25, Byerly discloses wherein the cantilevered arm and the base together form a single monolithic component (portion of 326 inside 320 is the base portion Fig. 13).
Re claim 26, Byerly discloses wherein the cantilevered arm and the base comprise a stamped metal component (Metal, ¶0102).
Re claim 27, Byerly discloses herein the housing includes a reservoir having a medication (20, Fig. 1, ¶0047).
Claim(s) 10, 15 is/are rejected under 35 U.S.C. 102 (a)1) as being anticipated by Biederman et al. (US 20200078527 A1, the Provisional date is 9/6/2018).
Re claim 10, Biederman et al. discloses a medication delivery device (Fig. 1-3c) comprising: a housing (104); an outlet (close to 103); a dose button (150) to activate a dose dispensing mode in which medication is dispensed out of the outlet (¶0021); a printed circuit board (300); a protruded dose element (330) that is rotatable relative to the printed circuit board during a dose dispensing event (¶0033); a switch (305) mounted to the printed circuit board (Fig. 3c), the switch comprising a conductive pad coupled to the printed circuit board (45. ¶0031) and a cantilevered arm, (320, 310, Fig. 3b-c) the cantilevered arm having a first branch defining a first curved portion extending from the printed circuit board (310, 355) and a second branch (320) coupled to the first branch at a branching location ( connection between 320 and 355), wherein said branching location on the first branch is connected to the printed circuit board by the first curved portion (Fig. 3b-c), the second branch being configured to move toward and contact the conductive pad in the dose dispensing event to change the switch to a first state ( Fig. 3b) when an arm portion of the cantilevered arm is in slidable contact with the protruded dose element (as 320 slide over 325, Fig. 3b, ¶0032), and configured to move away and be spaced from the conductive pad to change the switch to a second state (Fig. 3b, as 320 release to the valley between 325) ; and a controller configured to receive a signal from the switch (¶0023).
Re claim 15, Biederman et al. discloses wherein the second branch forms a C-shape (Fig. 3b).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly in view of Yang et al. (US. 20180318526A1) (“Yang”).
Re claim 7, Byerly fails to disclose wherein a width of at least a segment of the second curved portion is less than a width of the first curved portion.
However, Yang discloses a drug delivery device (Fig. 1-12b) and wherein a width of at least a segment of the second curved portion (width at 46) is less than a width of the first curved portion (width at 47)
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 width of the a segment of a second curved portion of Byerly so that a width of at least a segment of the second curved portion is less than a width of the first curved portion as taught by Yang for the purpose of providing different resilient portion and solid portion (Yang, ¶0099).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byerly in view of Badelt et al. (WO 2017120178 A1) (“Badelt”).
Re claim 8, Byerly discloses a medication delivery device (the general delivery is in Fig. 2 and switch in Fig. 10-13) comprising: a housing (12, 212); an outlet (close to 24, Fig. 2); a dose button (256, Fig. 10, ¶0093) to activate a dose dispensing mode in which medication is dispensed out of the outlet (¶0093); a printed circuit board (325, Fig. 12, ¶0095); a protruded dose element (232, include 301, 302 ) that is rotatable relative to the printed circuit board during a dose dispensing event (¶0095); a switch (320) mounted to the printed circuit board (Fig. 12), the switch comprising a conductive pad (base of 32 and/or330) coupled to the printed circuit board (Fig. 12) and a cantilevered arm (344), the cantilevered arm having a first curved portion extending from the printed circuit board (a portion close to 340) and a second curved portion (a portion close to 348) that, in the dose dispensing event (¶0102), is configured to move toward and contact the conductive pad to change the switch to a first state (wherein 346 is slide on top of 301 and 348 contact 332, ¶0102) when an third portion (346) of the cantilevered arm is in slidable contact with the protruded dose element (at least 346 on slidable on 301, Fig. 13 as 348 contacts 332, ¶0102), and is configured to move away and be spaced from the conductive pad to change the switch to a second state (Fig. 13 as 348 not contacting 332 and 346 is between 301s) when the third curved portion is not in slidable contact with the protruded dose element ( in between 301s in Fig. 13 or in Fig. 12), and a controller configured to receive a signal from the switch (¶0062, ¶0095), but it fails to discloses that the second curved portion connects the first curved portion to the third curved portion, and wherein the third curved portion of the cantilevered arm is connected with the second curved portion by a straight portion so that only the third curved portion is contactable by the protruded dose element.
However, Badelt discloses a pen injector (Fig. 1-6) and wherein circuit (616) comprising an arm (622), a protrusion (618) and wherein the arm comprises a first curved portion (26, 27, Fig. 5), a second curved portion (23) and a third curved portion (24) and wherein the second curved portion connects the first curved portion to the third curved portion (Fig. 5), and wherein the third curved portion of the cantilevered arm is connected with the second curved portion by a straight portion ( Fig. 5, portion between 23 and 24) so that only the third curved portion is contactable by the protruded dose element (12).
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 the cantilevered arm of Byerly so that the second curved portion connects the first curved portion to the third curved portion, and wherein the third curved portion of the cantilevered arm is connected with the second curved portion by a straight portion so that only the third curved portion is contactable by the protruded dose element as taught by Badelt for the purpose of accommodating the force of changing the arm between the positions without do the actuation with insufficient force (Badelt, ¶0073, wherein the arm of Byerly is replaced with the one of Badelt such as only third portion is connected the protruding dose element ).
Re claim 9, Byerly discloses wherein , a curvature of the first curved portion extends the cantilevered arm distally away from the printed circuit board (Fig. 13).
Response to Arguments
Applicant’s arguments filed 10/31/2025 with respect to the rejection(s) of claim(s) 1, 8, 10 under 102/103 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 Byerly o for claim 1, 8 and Biederman et al. for claim 10.
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