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 .
Status of Claims
This office action is responsive to the amendment filed 16 December 2025.
Claims 1-3, 5, 10, 11, 13-15, and 17 are amended
Claims 1-20 are presently pending in this application.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grygus et al. (US Patent Publication No. 20200086051 A1), of hereinafter Grygus, in view of Russo (US Patent No. 11383026 B2) in further view of Cabiri et al. (US Patent No. 10646643 B2), hereinafter Cabiri.
Regarding claim 1, Grygus discloses an injection device (Grygus: Fig. 1, auto-injector 2), comprising: a housing (Fig. 1, housing 3); a container (Fig. 4B, container 1302) disposed within the housing (3), the container (1302) enclosing a fluid (vial 1302 contains fluid drugs; para. 0041) and having a first end (Fig. 13, first end 1304) and a second end (Fig. 13, second end 1306); a conduit (Fig. 5, fluid conduit 300) movable relative to the container (1302), wherein the conduit (300) is not in fluid communication with the fluid enclosed by the container (1302) while in a first position (Fig. 13, needle 308 of the conduit 300 is not in fluid communication with container 1302 while in the first position; para. 0065), and is in fluid communication with the fluid enclosed by the container (1302) and configured to deliver the fluid from the container (1302) to a patient while in a second position (Fig. 14, conduit 300 is in fluid communication with container 1302 while in the second position, delivering fluid to a patient; para. 0041 and 0058).
Grygus does not expressly disclose a lock that is removable from the housing, the lock having a cover portion and a curved protrusion, wherein: in a first configuration where the lock is coupled to the housing, the cover portion of the lock is disposed exterior of the housing, and the curved protrusion extends from the cover portion into of the lock is disposed within the housing such that the curved protrusion is disposed between the container and the conduit; in the first configuration, the conduit is prevented from moving into fluid communication with the fluid enclosed by the container by the curved protrusion of the lock; and in a second configuration where the lock is removed from the injection device, the conduit is able to move into fluid communication with the fluid enclosed by the container.
Russo teaches a lock (Russo: Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) that is removable from a housing (Fig. 2 and 4A, housing 110), the lock (230 and 234) having a cover portion (Fig. 8A, portion of tab 230 outside of housing 110) and a curved protrusion (Fig. 8A, area of tab 230 inside housing 110, which curves at its apex), wherein: in a first configuration (Fig. 9B, tab 230 and stop 234 are coupled to the housing 110) where the lock (230 and 234) is coupled to the housing (110), the cover portion (Fig. 8A, portion of tab 230 outside of housing 110) is disposed exterior of the housing (Fig. 8A, portion of tab 230 outside of housing 110), wherein the housing (110) comprises a tissue-engaging surface (Fig. 1, tissue-engaging surface 4), and the curved protrusion (Fig. 8A, area of tab 230 inside housing 110) extends from the cover portion (Fig. 8A, portion of tab 230 outside of housing 110) into the housing (110) of such that the curved protrusion (Fig. 8A, area of tab 230 inside housing 110) is disposed between a container (Fig. 2, container 222) and a conduit (Fig. 9B, tab 230 rests between needle 284 and container 222); in the first configuration (Fig. 9B), the conduit (Fig. 5, flow path sub-assembly FSA 260) is prevented from moving into fluid communication with the fluid (Fig. 4B, drug 290) enclosed by the container (Fig. 2, container 222) by the curved protrusion of the lock (Fig. 9B, area of tab 230 inside the housing 110 prevents contact between the container 222 and needle 284; col 15, ln 19-33); and in a second configuration (Fig. 7A and 8B) where the lock (Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) is removed from the injection device (Fig. 8B, tab 230 is removed from injector 100), the conduit (Fig. 5, flow path sub-assembly FSA 260) is able to move into fluid communication with the fluid (Fig. 4B, drug 290) enclosed by the container (when tab 230 is removed, needle 284 pierces septum 224 of container 222, creating fluid path from container 222 to needle 278; col 15, ln 34-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of the Grygus such that it includes a lock that is removable from the housing, the lock having a cover portion and a curved protrusion, wherein: in a first configuration where the lock is coupled to the housing, the cover portion of the lock is disposed exterior of the housing, and the curved protrusion extends from the cover portion into of the lock is disposed within the housing such that the curved protrusion is disposed between the container and the conduit; in the first configuration, the conduit is prevented from moving into fluid communication with the fluid enclosed by the container by the curved protrusion of the lock; and in a second configuration where the lock is removed from the injection device, the conduit is able to move into fluid communication with the fluid enclosed by the container as taught by Russo in order to maintain sterility of the container surface during storage, and allow for easy removal at the time of use and allow a mechanism to establish fluid connection (Russo: col 9, ln 31-57).
Grygus in view of Russo does not expressly disclose that the cover portion conforms to the tissue-engaging surface of the housing.
Cabiri teaches a cover portion (Cabiri: Fig. 5A, liner 534) that conforms to a tissue-engaging surface (Fig. 5A, contact surface 507) of a housing (Fig. 5A, base 502).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus in view of Russo such that the cover portion conforms to a tissue-engaging surface of the housing as taught by Cabiri in order to cover contact surfaces before use (Cabiri: col 19, ln 53-65).
Regarding claim 2, Grygus in view of Russo and Cabiri discloses the injection device above, further including: an adhesive (Grygus: Fig. 4, adhesive patch 12) disposed exterior of the housing (Fig. 1 and 2, patch 12 is disposed exterior of the housing 3).
Grygus does not expressly disclose that, when the lock is coupled to the housing in the first configuration, the cover portion is disposed over the adhesive and the cover portion is removable from the injection device to expose the adhesive.
Cabiri teaches, when a lock (Cabiri: Fig. 5A, comprising handle 532 and liner 534) is coupled to a housing (502) in a first configuration (Fig. 5A, prior to removal of handle 532 and liner 534), a cover portion (534) is disposed over an adhesive (Fig. 5A, adhesive 540) and the cover portion (534) is removable from an injection device (Fig. 5A) to expose the adhesive (the liner 534 is removed, peeling off the liner 534 from the adhesive; col 19, ln 38-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus in view of Russo such that, when the lock is coupled to the housing in the first configuration, the cover portion is disposed over the adhesive and the cover portion is removable from the injection device to expose the adhesive as taught by Cabiri in order to allow the device to be stuck to a skin surface (Cabiri: col 19, ln 38-52).
Regarding claim 3 Grygus in view of Russo and Cabiri discloses the injection device above, further comprising a controller (Fig. 4A, controller 1408) and a skin sensor (Grygus: Fig. 4A, sensor 1410) coupled to the controller (touch sensor 1410 and controller 1408 are coupled to an electronics board 1402; para. 0078), the skin sensor (Fig. 4A, sensor 1410) being adjacent to the tissue-engaging surface (Fig. 1 and 2, sensor 1410 is adjacent to tissue engaging surface 4), wherein; the skin sensor (Fig. 4A, sensor 1410) is configured to detect when skin is in contact with the tissue-engaging surface (sensor 1410 determines if skin is in contact with surface 4; para. 0036); the controller (Fig. 4A, controller 1408) is configured to cause the conduit (Fig. 5, fluid conduit 300) to move into fluid communication with the fluid enclosed by the container (needle 308 is moved to penetrate and allow fluid communication with vial 1302 by the controller 1408; para. 0008 and 0041).
Grygus does not expressly disclose that, when the lock is coupled to the housing in the first configuration, the first portion of the lock is configured to prevent skin from contacting the outer surface of the housing adjacent to the skin sensor.
Cabiri teaches an injection device (Cabiri: shown in Fig. 5A), wherein when a lock (Fig. 5A, comprising handle 532 and liner 534) is coupled to a housing (Fig. 5A, base 502) in a first configuration (Fig. 5A), a cover portion (Fig. 5A, liner 534) of the lock (Fig. 5A, comprising handle 532 and liner 534) is configured to prevent skin from contacting a tissue engaging surface (Fig. 5A, liner 534 prevents contact of the contact surface 505 to skin until removed; col 20, ln 9-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the lock of Grygus in view of Russo such that, when the lock is coupled to the housing in the first configuration, the cover portion of the lock is configured to prevent skin from contacting the outer surface of the housing adjacent to the skin sensor as taught by Cabiri in order to cover contact surfaces before use (Cabiri: col 19, ln 53-65).
Regarding claim 4, Grygus in view of Russo and Cabiri discloses the injection device above.
Grygus does not expressly disclose that, while in the first configuration, the lock is configured to prevent inadvertent activation of the injection device when the injection device is dropped or subject to vibration.
Russo teaches, while in a first configuration (Fig. 9B), a lock (Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) is configured to prevent inadvertent activation of an injection device when the injection device is dropped or subject to vibration (Fig. 2 and 4A, tab 230 and stop 234 prevent needle 284 from piercing container 222 and prevents the establishment of fluid connection between FSA 260 and container 222. Without fluid connection, the injector 100 is unable to fully activate and, thus, would not dispense fluid. Tab 230 is not designed to be removed prior to use; col 9, ln 31-57 and col 15, ln 34-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus in view of Cabiri such that, while in the first configuration, the lock is configured to prevent inadvertent activation of the injection device when the injection device is dropped or subject to vibration as taught by Russo in order to maintain the sterility of the container surface during storage (Russo: col 9, ln 31-57).
Regarding claim 5, Grygus in view of Russo and Cabiri discloses the injection device above, further comprising a plunger (Fig. 8, needle 306) coupled to the housing (Fig. 5, needle mechanism 20 is coupled to carrier 202, which is slidably coupled to housing 3; para. 0040) and movable relative to the housing (Fig. 5, needle mechanism 20 is coupled to carrier 202, which is slidably coupled to housing 3; para. 0040); and one or more electronics components (Fig. 4A, controller 1408 is coupled to the board 1402) used during an injection performed by the injection device (injection procedure controller by controller 1408; para. 0078), the one or more electronics components (Fig. 4A, controller 1408 is coupled to the board 1402) being formed within an electrical circuit (Fig. 4 and 4A, electronic board 1402), wherein: in a first configuration (Fig. 8), a first portion (Fig. 8, distal section of needle 308) of the plunger (Fig. 8, needle 306) is disposed within the housing (Fig. 8, distal section of needle 308 is retracted within carrier 202), the electrical circuit (Fig. 4 and 4A, electronic board 1402) is open (circuit is open when needle is retracted; para. 0009), and the one or more electronics components (Fig. 4A, controller 1408 is coupled to the board 1402) are in a low-power sleep mode (controller 1408 starts in sleep mode; para. 0082 and 0091); in a second configuration (Fig. 8 and 10), the plunger (Fig. 8, needle 306) moves outward relative to the housing (Fig. 10, needle 308 begins to be projected out of carrier 202 and out of housing 3 during injection procedure), and the first portion (Fig. 8, distal section of needle 308) of the plunger (Fig. 8, needle 306) extends exterior of the housing (Fig. 8 and 10, needle 308 begins to be projected out of carrier 202 and out of housing 3 during injection procedure); and in the second configuration (Fig. 8 and 10), the electrical circuit (Fig. 4 and 4A, electronic board 1402) is closed (circuit is closed when needle is deployed; para. 0009), and the one or more electronics components (Fig. 4A, controller 1408 is coupled to the board 1402) are transitioned from the low-power sleep mode (controller 1408 starts in sleep mode; para. 0082 and 0091), to an active mode (para. 0091).
Regarding claim 6, Grygus in view of Russo and Cabiri discloses the injection device above, further comprising a biasing member (Fig. 5 and 9, spring 370) movable from a resting position (Fig. 10, spring 370 is at rest state; para. 0049-0050) to a stressed position (Fig. 8, spring 370 is in stressed state; para 0046), wherein: in the first configuration (Fig. 8), the biasing member (Fig. 5 and 9, spring 370) is in the stressed position (para. 0046); and in the second configuration (Fig. 8 and 10), the biasing member (Fig. 5 and 9, spring 370) is in the resting position (Fig. 10, spring 370 reaches a rest state; para. 0049-0050).
Regarding claim 7, Grygus in view of Russo and Cabiri discloses the injection device above, further comprising a stop (Fig. 7, comprising impediment 600 and needle shield 2400) configured to maintain the biasing member (Fig. 5, spring 370) in the stressed position (Fig. 6 and 8, impediment 600 prevents movement to the second position; para. 0046-0047) and the plunger (Fig. 8, needle 308) in the first configuration (Fig. 8, needle is maintained in place by impediment 600; para. 0046-0047) when the stop (Fig. 7, comprising impediment 600 and needle shield 2400) is in a blocking position (Fig. 6), wherein movement of the stop (Fig. 7, comprising impediment 600 and needle shield 2400) from the blocking position (Fig. 6 to 7, stop is moved relative to carrier 202, thus no longer blocking movement; para. 0046-0047) allows the biasing member (Fig. 5 and 9, spring 370) to move to the resting position (Fig. 10, spring 370 is at rest state; para. 0049-0050) and the plunger (Fig. 10, needle 308) to move to the second configuration (Fig. 8 and 10, needle 308 is moved towards a deployed position).
Regarding claim 8, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the stop (Fig. 7, comprising impediment 600 and needle shield 2400) includes a packaging of the injection device (Fig. 7, needle shield 2400 is adhered to packaging, which is removed upon withdrawal of the injector 2 from the packaging, allowing normal operation of the injector 2; para. 0075).
Regarding claim 9, Grygus in view of Russo and Cabiri discloses the injection device above, wherein one or more electronics components (Fig. 4A, activating switch 1409 is coupled to the board 1402) include a switch (Fig. 4A, switch 1409), and transition of the plunger (Fig. 8, needle 306) from the first configuration (Fig. 8) to the second configuration (Fig. 8 and 10) moves the switch (Fig. 4A, switch 1409) to close the electrical circuit (upon activation of switch 1409, the electrical circuit is closed, activating the injector 2 and deploying the needle; para. 0091-0092).
Regarding claim 10, Grygus in view of Russo and Cabiri discloses the injection device above, wherein: the plunger (Fig. 10, needle 308) is movable from the second configuration (Fig. 8 and 10) toward the housing (Fig. 1, housing 3) to a third configuration (Fig. 10, needle 308 is deployed); and the injection device (Fig. 1, injector 2) is configured to initiate the injection by the injection device (Fig. 1, injector 2) only after the plunger (Fig. 10, needle 308) is moved to the third configuration (Fig. 10) and the one or more electronics components (Fig. 4A, controller 1408) are in the active mode (Fig. 10 and 16, drug is dispensed into user at step 2008 at third configuration; para. 0093-0094).
Regarding claim 11, Grygus in view of Russo and Cabiri discloses the injection device above, wherein: the one or more electronics components (Fig. 4A, touch sensor 1410 is coupled to board 1402) include a skin sensor (Fig. 4A, touch sensor 1410) adjacent to the tissue-engaging surface (Fig. 1 and 2, sensor 1410 is adjacent to tissue engaging surface 4) and the injection device (Fig. 1, injector 2) further includes a controller (Fig. 4A, controller 1408) configured to initiate the injection by the injection device (controller 1408 controls needle insertion procedure; para. 0078); the skin sensor (Fig. 4A, touch sensor 1410) is configured to detect a presence of skin in contact with the tissue-engaging surface (sensor 1410 senses skin contact with tissue-engaging surface 4; para. 0092) only after the plunger (Fig. 8, needle 306) has moved to the third configuration (sensor 1410 may determine if skin contact is broken and can stop the injection procedure; para. 0092) ; and the controller (Fig. 4A, controller 1408) is configured to initiate the injection only after detection of skin by the skin sensor (controller initiates injection procedure once skin contact is detected; para. 0092).
Regarding claim 12, Grygus in view of Russo and Cabiri discloses the injection device above, further including a motor (Fig. 4, translation mechanism 1466 may include a motor; para. 0059) configured to dispense medicament from the injection device (Fig. 1, injector 2) during the injection (mechanism 1366 initiates and controls dispensing of medicament; para. 0078 and 0093), wherein: during the injection, the plunger Fig. 8, needle 306) is movable from the third configuration (Fig. 10), away from the housing (Fig. 1, housing 3), to a fourth configuration (Fig. 11, needle 308 is retracted); and the controller (Fig. 4A, controller 1408) is configured to cease operation of the motor (controller 1408 can determine if injection is complete or interrupted and stop the mechanism 1366; para. 0092) while the motor (Fig. 4, mechanism 1366) is operating (controller 1408 can determine if injection is complete or interrupted and stop the mechanism 1366 during operation; para. 0092) and the controller (Fig. 4A, controller 1408) senses the plunger (Fig. 8, needle 306) has moved from the third configuration (Fig. 10) to the fourth configuration (controller 1408 retracts needle 306).
Regarding claim 13, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the controller (Fig. 4A, controller 1408) is configured to: determine that skin has remained in contact with the tissue-engaging surface (controller 1408 determines if tissue-engaging surface 4 is still in contact with skin; para. 0092) adjacent to the skin sensor (Fig. 4A, sensor 1410), while the plunger (Fig. 11, needle 306) is in the fourth configuration (controller 1408 retracts the needle 306 upon detecting broken skin contact, thus resuming the injection procedure when skin contact is detected; para. 0092); and resume operation of the motor (Fig. 4, mechanism 1366) when the plunger (Fig. 8, needle 306) moves from the fourth configuration (controller 1408 retracts needle 306) to the third configuration (Fig. 10), after the controller (Fig. 4A, controller 1408) determines that skin has remained in contact with the tissue-engaging surface (Fig. 1 tissue engaging surface 4) while the plunger (Fig. 8, needle 306) was in the fourth configuration (controller 1408 retracts the needle 306 upon detecting broken skin contact, thus resuming the injection procedure when skin contact is detected; para. 0092).
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Regarding claim 14, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the tissue-engaging surface (Fig. 1, surface 4) is concave when viewed from a point external to the housing (Fig. 1, housing 3) that is closer to a bottom surface of the housing than a top surface of the housing (Fig. 3, surface 4 is concave when viewed from below), and wherein the injection device further comprises: a circuit board (Fig. 4 and 4A, electronic board 1402) positioned adjacent to the tissue-engaging surface (Fig. 4, board 1402 is adjacent to surface 4), wherein the circuit board (Fig. 4 and 4A, electronic board 1402) includes a skin sensor (Fig. 4A, skin sensor 1410 is a part of board 1402) configured to sense a presence of skin in contact with the tissue-engaging surface (para. 0036 and 0083); and a controller (Fig. 4A, controller 1408) coupled to the circuit board (Fig. 4A, controller 1408 is coupled to the board 1402), wherein the controller (Fig. 4A, controller 1408) is configured to initiate an injection by the injection device (controller 1408 configured to control and initiate needle insertion; para. 0078) only after the skin sensor (Fig. 4A, sensor 1410) senses the presence of skin in contact with the tissue-engaging surface (Fig. 16, step 2004 to 2008, sensor 1410 sends a signal upon sensed skin contact with the surface 4 to controller 1408 to initiate injection).
Regarding claim 15, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the skin sensor (Fig. 4A, sensor 1410) is configured to sense the presence of skin in contact with the tissue-engaging surface (Fig. 16, step 2004 to 2008, sensor 1410 sends a signal upon sensed skin contact with the surface 4 to controller 1408 to initiate injection) without skin directly contacting the skin sensor (contact portions of housing 3 or adhesive patch 12 can trigger electrode sensing of sensor 1410; para. 0083).
Regarding claim 16, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the skin sensor (Fig. 4A, sensor 1410) is a capacitance sensor (sensor is capacitive sensor; para. 0083).
Regarding claim 17, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the housing (Fig. 1, housing 3) further includes an opening (Fig. 2, opening 6) in the tissue-engaging surface (Fig. 2, opening 6 is disposed on surface 4); a portion of the conduit (needle 306 may be deployed through opening 6; para. 0036) is extendable out of the housing (needle 306 deploys through opening 6 out of housing 3; para. 0036) through the opening (Fig. 2, opening 6); and the skin sensor (Fig. 2, sensor 1410) is positioned adjacent to the opening (Fig. 2, sensor 1410 is adjacent to opening 6).
Regarding claim 18, Grygus in view of Russo and Cabiri discloses the injection device above, wherein the circuit board (Fig. 4, electronic board 1402) is the only circuit board disposed within the housing (Fig. 4, board 1402 is the only circuit board disposed within housing 3).
Regarding claim 19, Grygus discloses an injection device (Grygus: Fig. 1, auto-injector 2), comprising: a housing (Fig. 1, housing 3); a container (Fig. 4B, container 1302) disposed within the housing (3), the container (1302) enclosing a medicament (vial 1302 contains fluid drugs; para. 0041); a needle (Fig. 5, fluid conduit 300) movable relative to the container (1302), wherein the needle (300) is not in fluid communication with the fluid enclosed by the container (1302) while in a first position (Fig. 13, needle 308 of the conduit 300 is not in fluid communication with container 1302 while in the first position; para. 0065), and is in fluid communication with the fluid enclosed by the container (1302) and configured to deliver the fluid from the container (1302) to a patient while in a second position (Fig. 14, conduit 300 is in fluid communication with container 1302 while in the second position, delivering fluid to a patient; para. 0041 and 0058); the housing (Fig. 1, housing 3) comprising a tissue-engaging surface (Fig. 1, surface 4).
Grygus does not expressly disclose a removable lock coupled to the housing, the removable lock having a cover and a curved portion extending from the cover, wherein: in a first configuration where the removable lock is coupled to the housing, the curved portion protrudes into the housing between the container and the needle; in the first configuration, the needle is prevented from moving into fluid communication with the medicament enclosed by the container by the curved portion; and upon removal of the lock from the injection device, the needle is able to move into fluid communication with the medicament enclosed by the container.
Russo teaches a removable lock (Russo: Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) coupled to a housing (Fig. 2 and 4A, housing 110), the removable lock (230 and 234) having a cover (Fig. 8A, portion of tab 230 outside of housing 110) and a curved portion (Fig. 8A, area of tab 230 inside housing 110, which curves at its apex) extending from the cover (Fig. 8A, portion of tab 230 outside of housing 110), wherein: in a first configuration (Fig. 9B, tab 230 and stop 234 are coupled to the housing 110) where the removable lock (230 and 234) is coupled to the housing (110), and the curved portion (Fig. 8A, area of tab 230 inside housing 110) protrudes into the housing (110) between a container and a needle (Fig. 9B, tab 230 rests between needle 284 and container 222); in the first configuration (Fig. 9B, tab 230 and stop 234 are coupled to the housing 110), the needle (Fig. 5, flow path sub-assembly FSA 260) is prevented from moving into fluid communication with a medicament fluid (Fig. 4B, drug 290) enclosed by the container (Fig. 2, container 222) by the curved portion (Fig. 9B, area of tab 230 inside the housing 110 prevents contact between the container 222 and needle 284; col 15, ln 19-33); and upon removal of the lock (Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) from the injection device (Fig. 8B, tab 230 is removed from injector 100), the needle (Fig. 5, flow path sub-assembly FSA 260) is able to move into fluid communication with the medicament (Fig. 4B, drug 290) enclosed by the container (when tab 230 is removed, needle 284 pierces septum 224 of container 222, creating fluid path from container 222 to needle 278; col 15, ln 34-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus such that a removable lock is coupled to the housing, the removable lock having a cover and a curved portion extending from the cover, wherein: in a first configuration where the removable lock is coupled to the housing, the curved portion protrudes into the housing between the container and the needle; in the first configuration, the needle is prevented from moving into fluid communication with the medicament enclosed by the container by the curved portion; and upon removal of the lock from the injection device, the needle is able to move into fluid communication with the medicament enclosed by the container as taught by Russo in order to maintain sterility of the container surface during storage, and allow for easy removal at the time of use and allow a mechanism to establish fluid connection (Russo: col 9, ln 31-57).
Grygus in view of Russo does not expressly disclose that the cover extends along and conforms to a tissue-engaging surface of the housing.
Cabiri teaches a cover portion (Cabiri: Fig. 5A, liner 534) that conforms to a tissue-engaging surface (Fig. 5A, contact surface 507) of a housing (Fig. 5A, base 502).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus in view of Russo such that the cover portion conforms to a tissue-engaging surface of the housing as taught by Cabiri in order to cover contact surfaces before use (Cabiri: col 19, ln 53-65).
Regarding claim 20, Grygus discloses an injection device (Grygus: Fig. 1, auto-injector 2), comprising: a housing (Fig. 1, housing 3) including a tissue-engaging surface (Fig. 1, surface 4) adjacent to a skin sensor (Fig. 1 and 2, sensor 1410 is adjacent to tissue engaging surface 4); a primary container (Fig. 4B, container 1302) disposed within the housing (3), the primary container (1302) enclosing a fluid (vial 1302 contains fluid drugs; para. 0041) and having a first end (Fig. 13, first end 1304) and a second end (Fig. 13, second end 1306); a conduit (Fig. 5, fluid conduit 300) movable relative to the container (1302), wherein the conduit (300) is not in fluid communication with the fluid enclosed by the container (1302) while in a first position (Fig. 13, needle 308 of the conduit 300 is not in fluid communication with container 1302 while in the first position; para. 0065), and is in fluid communication with the fluid enclosed by the container (1302) and configured to deliver the fluid from the container (1302) to a patient while in a second position (Fig. 14, conduit 300 is in fluid communication with container 1302 while in the second position, delivering fluid to a patient; para. 0041 and 0058).
Grygus does not expressly disclose a lock coupled to the housing, the lock having a cover portion and a curved portion, wherein: in a first configuration where the lock is coupled to the housing, the curved portion extends into the housing between the primary container and the conduit and prevents the conduit from moving from the first position to the second position; in the first configuration, the conduit is prevented from moving into fluid communication with the fluid enclosed by the primary container by the curved portion and the skin sensor is prevented from detecting a presence of skin by the cover; and in a second configuration where the lock is removed from the injection device, the conduit is able to move into fluid communication with the fluid enclosed by the primary container and the skin sensor is able to detect contact of the tissue-engaging surface with skin.
Russo teaches a lock (Russo: Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) coupled to the housing (Fig. 2 and 4A, housing 110), the lock (230 and 234) having a cover portion (Fig. 8A, portion of tab 230 outside of housing 110) and a curved protrusion (Fig. 8A, area of tab 230 inside housing 110, which curves at its apex), wherein: in a first configuration (Fig. 9B, tab 230 and stop 234 are coupled to the housing 110) where the lock (230 and 234) is coupled to the housing (110), the curved protrusion (Fig. 8A, area of tab 230 inside housing 110) extends from the cover portion (Fig. 8A, portion of tab 230 outside of housing 110) into the housing (110) between the primary container (Fig. 2, container 222) and a conduit (Fig. 9B, tab 230 rests between needle 284 and container 222) and prevents the conduit (Fig. 5, flow path sub-assembly FSA 260) from moving from the first position to the second position (Fig. 9B, area of tab 230 inside the housing 110 prevents contact between the container 222 and needle 284; col 15, ln 19-33); in the first configuration (Fig. 9B, tab 230 and stop 234 are coupled to the housing 110), the conduit (Fig. 5, flow path sub-assembly FSA 260) is prevented from moving into fluid communication with the fluid (Fig. 4B, drug 290) enclosed by the primary container (Fig. 2, container 222) by the curved protrusion of the lock (Fig. 9B, area of tab 230 inside the housing 110 prevents contact between the container 222 and needle 284; col 15, ln 19-33); and in a second configuration (Fig. 7A and 8B) where the lock (Fig. 2 and 4A, comprising sterile barrier tab 230 and container stop 234) is removed from the injection device (Fig. 8B, tab 230 is removed from injector 100), the conduit (Fig. 5, flow path sub-assembly FSA 260) is able to move into fluid communication with the fluid (Fig. 4B, drug 290) enclosed by the primary container (when tab 230 is removed, needle 284 pierces septum 224 of container 222, creating fluid path from container 222 to needle 278; col 15, ln 34-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus such that
Grygus in view of Russo does not expressly disclose that the cover extends along and conforms to a tissue-engaging surface of the housing; in a first configuration, the skin sensor is prevented from detecting a presence of skin by the cover; and in a second configuration, the skin sensor is able to detect contact of the tissue-engaging surface with skin.
Cabiri teaches a cover portion (Cabiri: Fig. 5A, liner 534) that conforms to a tissue-engaging surface (Fig. 5A, contact surface 507) of a housing (Fig. 5A, base 502); in a first configuration (Fig. 5A), the skin sensor (skin sensor; col 20, ln 9-30) is prevented from detecting a presence of skin by the cover (skin sensor is inactive until the liner 534 has been pulled away; col 20, ln 9-30); and in a second configuration (when liner 534 is pulled away; col 20, ln 9-30), the skin sensor (col 20, ln 9-30) is able to detect contact of the tissue-engaging surface (Fig. 5A, surface 507) with skin (skin sensor is inactive until the liner 534 has been pulled away; col 20, ln 9-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Grygus in view of Russo such that the cover extends along and conforms to a tissue-engaging surface of the housing; in a first configuration, the skin sensor is prevented from detecting a presence of skin by the cover; and in a second configuration, the skin sensor is able to detect contact of the tissue-engaging surface with skin as taught by Cabiri in order to cover contact surfaces before use (Cabiri: col 19, ln 53-65).
Response to Arguments
Applicant’s arguments, see page 1-3, filed 16 December 2025, with respect to the rejections of claims 1-18 under 35 USC 102(a)(2) and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Grygus in view of Russo and Cabiri cited above.
Applicant argues that Russo does not expressly disclose a curved protrusion that extends into a housing.
The area of the tab 230 of Russo that extend into the housing 110 curves at its apex. The broadest reasonable interpretation of the word curved is a bend, whereas the interpretation of the word protrusion is something that projects outward. In both cases, Russo teaches that the area of the tab 230 that extends into the housing 110 is not only curved at its apex, but projects from the surface of 230 from that bend. Thus, Russo teaches a curved protrusion.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783