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 .
Acknowledgment
Claims 1-2, 4, 13-14, 35 are amended and filed on 12/15/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 13-19,35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "entering the chamber proximal to the piston to pass through the piston into the chamber distal to the piston" in the last two lines, It is unclear if it is referring to “chamber” in line 3 or it is referring to new limitation Note: for the purpose of examination, the examiner will interpret the limitation as "entering a proximal portion of the chamber proximal to the piston to pass through the piston into a distal portion of the chamber distal to the piston".
Claim 13 recites the limitation "entering the second chamber proximal to the plunger piston to pass through the plunger piston into the second chamber distal to the plunger piston" in the last two lines, It is unclear if it is referring to “second chamber” in line 3 or it is referring to new limitation Note: for the purpose of examination, the examiner will interpret the limitation as "entering a proximal portion of the second chamber proximal to the plunger piston to pass through the plunger piston into a distal portion of the second chamber distal to the plunger piston".
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, 3-11, 13-19, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auld et al. (US. 20190167906A1) (“Auld”) in view of Jaeger et al. (US 20050070848 A1) (“Jaeger”).
Re Claim 1, Auld discloses a drive module (10, Figs. 1-3b) for an injection device (60, Fig. 1) for delivering one or more agents into a subject's body (¶0045), comprising: an elongate drive housing (12 and/or 66) including a first end (top end) and a second end (lower end), and a chamber (26); a source of pressurized gas (inside 40, ¶0044) communicating with a passage into the chamber (clearance that allow gas flow, ¶0044); a plunger (50) slidably disposed within the chamber (Fig. 3a-3b, ¶0045) comprising a proximal end (52) including a piston (53, ¶0045) and a distal end (54), the plunger configured such that gas entering the chamber from the passage causes the plunger to move from an initial position (Fig. 3a) to an extended position ( Fig. 3b, ¶0045) wherein the distal end of the plunger extends from the second end of the drive housing for delivering one or more agents from an injector module (70, 58, 75, 80, Fig. 2b) based on movement of the plunger (¶0045), and further disclose the chamber proximal to the piston (a portion of 26 above 52) and the chamber distal to the piston (a portion of 26 below 52), and that agas entering the chamber proximal to the piston (Fig. 3b), but it fails to disclose that the piston comprises one or more passages configured to allow gas from the source of pressurized gas entering the chamber proximal to the piston to pass through the piston into the chamber distal to the piston around the plunger.
However, Jaeger discloses an injector (Fig. 1-5d) and wherein a drive module (Fig. 2) comprises a plunger (228) comprises a piston (top end of 272, Fig. 4) comprises one or more passages (120 and side opening around the 272, see Fig. 1, Fig. 5d) configured to allow gas from the gas source (the gas inside 222, Fig. 2) entering the chamber (chamber 284 ) to pass through the piston (228) into the chamber around the plunger ( Fig. 5d, Col. 7, lines 1-15).
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 piston of Auld to include one or more passages so that the piston comprises one or more passages configured to allow gas from the source of pressurized gas entering the chamber proximal to the piston to pass through the piston into the chamber distal to the piston around the plunger as taught by Jaeger for the purpose of controlling the passageway of the gas that enough to push the plunger (Jaeger, Col. 7, lines 1-15).
Re Claim 3, Auld discloses an actuator (32) for opening a path from the source of pressurized gas through the passage into the chamber (¶0065).
Re Claim 4, Auld discloses wherein the source of pressurized gas comprises: a puncture mechanism (30) comprising a pin holder (114, ¶0039) within the drive housing adjacent the first end including a puncture pin (34, ¶0039, Fig. 1); a canister (40) containing pressurized gas including a penetrable septum (46, ¶0039) disposed adjacent the puncture pin (¶0039), the pin holder movable from an inactive position (Fig. 3a) wherein the puncture pin is spaced away from the septum (Fig. 3a) and an active position (Fig. 3b) wherein the puncture pin penetrates the septum and causes the gas within the canister to flow through the passage into the chamber (chamber 26); and an actuator (32, 38) for directing the pin holder from the inactive position to active position (¶0041).
Re Claim 5, Auld discloses wherein the actuator comprises: one or more catches (36) on the drive housing adjacent the pin holder for restraining the pin holder in the inactive position (¶0040-¶0041); an actuation sleeve (32) slidably disposed over the drive housing and comprising a proximal end disposed distal to the one or more catches (Fig.2, Fig. 3a) such that, movement of the actuation sleeve proximally disengages the one or more catches, whereupon the pin holder automatically moves from the inactive position to the active position to activate the drive module. (Fig. 3, ¶0041).
Re Claim 6, the embodiment of Fig. 1 of Auld fails to disclose wherein the pin holder comprises a lead screw comprising threads that cooperate with the first end of the drive housing such that rotation of the lead screw causes the lead screw to move from the inactive position to the active position.
However, the embodiment of Fig. 5a of Auld disclose that the pin holder (230) comprises a lead screw (232, ¶0070) comprising threads that cooperate with the first end of the drive housing (Fig. 5a) such that rotation of the lead screw causes the lead screw to move from the inactive position to the active position (¶0070).
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 pin holder of embodiment of Fig. 1 of Auld to include a lead screw so that the pin holder comprises a lead screw comprising threads that cooperate with the first end of the drive housing such that rotation of the lead screw causes the lead screw to move from the inactive position to the active position. as taught by embodiment of Fig. 5a of Auld for the purpose of having an art recognized septum puncturing mechanism fixedly secure to the driving housing (Auld, ¶0070).
Re Claim 7, the embodiment of Fig. 1 of Auld fails to disclose wherein the actuator comprises a rotating handle mounted on the first end of the drive housing and coupled to the lead screw, the handle rotatable relative to the drive housing for directing the lead screw from the inactive position to the active position.
However, the embodiment of Fig,. 5a of Auld disclose that the pin holder (230) comprises a lead screw (232, ¶0070) comprising threads that cooperate with the first end of the drive housing (Fig. 5a) and the actuator comprises a rotating handle (¶0071) mounted on the first end of the drive housing and coupled to the lead screw, the handle rotatable relative to the drive housing for directing the lead screw from the inactive position to the active position (¶0071).
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 pin holder of embodiment of Fig. 1 of Auld to include a lead screw and a handle so that the actuator comprises a rotating handle mounted on the first end of the drive housing and coupled to the lead screw, the handle rotatable relative to the drive housing for directing the lead screw from the inactive position to the active position as taught by embodiment of Fig. 5a of Auld for the purpose of having an art recognized septum puncturing mechanism fixedly secure to the driving housing (Auld, ¶0070).
Re Claim 8, the embodiment of Fig. 1 of Auld fails to disclose wherein the actuator comprises a handle pivotally coupled to the drive housing and a linking bar coupled between the handle and the pin holder such that rotation of the handle about a pivot to cause the linking bar to direct the pin holder from the inactive position to the active position.
However, the embodiment of Fig. 6a of Auld disclose that the actuator comprises a handle (338a) pivotally coupled to the drive housing (314, ¶0077) and a linking bar (338b, ¶0077) coupled between the handle (Fig, 6a) and the pin holder such that rotation of the handle about a pivot (338c) to cause the linking bar to direct the pin holder from the inactive position to the active position (¶0078).
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 pin holder of embodiment of Fig. 1 of Auld to include a handle and a linking bar so that the actuator comprises a handle pivotally coupled to the drive housing and a linking bar coupled between the handle and the pin holder such that rotation of the handle about a pivot to cause the linking bar to direct the pin holder from the inactive position to the active position as taught by embodiment of Fig. 6a of Auld for the purpose of having an art recognized septum puncturing mechanism fixedly secure to the driving housing (Auld, ¶0070).
Re Claim 9, the embodiment of Fig. 1 of Auld fails to disclose wherein the actuator comprises an actuation button extending from the drive housing and coupled to the pin holder, the actuation button advanceable to direct the pin holder distally for sufficient distance to move the pin holder from the inactive position to the active position.
However, the embodiment of Fig. 7a of Auld disclose that the actuator comprises an actuation button (438) extending from the drive housing and coupled to the pin holder (432, ¶0080), the actuation button advanceable to direct the pin holder distally for sufficient distance to move the pin holder from the inactive position to the active position (¶0080).
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 pin holder of embodiment of Fig. 1 of Auld to include button so that the actuator comprises an actuation button extending from the drive housing and coupled to the pin holder, the actuation button advanceable to direct the pin holder distally for sufficient distance to move the pin holder from the inactive position to the active position as taught by embodiment of Fig. 7a of Auld for the purpose of having an art recognized septum puncturing mechanism fixedly secure to the driving housing (Auld, ¶0070).
Re Claim 10, the embodiment of Fig. 1 of Auld discloses wherein the septum of the canister is oriented proximally within the drive housing (Fig. 1), and the puncture mechanism is disposed proximal to the canister (Fig. 1) such that the puncture pin is oriented distally towards the septum such that distal movement of the pin holder causes the puncture pin to move distally to penetrate the septum (Fig. 3a to Fig. 3b).
Re Claim 11, the embodiment of Fig. 1 of Auld fails to disclose wherein the septum of the canister is oriented distally within the drive housing, and the puncture mechanism is disposed distal to the canister such that the puncture pin is oriented proximally towards the septum such that proximal movement of the pin holder causes the puncture pin to move proximally to penetrate the septum.
However, the embodiment of Fig. 10a of Auld disclose that the septum (46) of the canister is oriented distally (Fig. 10a) within the drive housing (610), and the puncture mechanism (630) is disposed distal to the canister such that the puncture pin is oriented proximally towards the septum such that proximal movement of the pin holder causes the puncture pin to move proximally to penetrate the septum (¶0091).
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 pin holder of embodiment of Fig. 1 of Auld so that the septum of the canister is oriented distally within the drive housing, and the puncture mechanism is disposed distal to the canister such that the puncture pin is oriented proximally towards the septum such that proximal movement of the pin holder causes the puncture pin to move proximally to penetrate the septum as taught by embodiment of Fig. 10a of Auld for the purpose of having an art recognized septum puncturing mechanism fixedly secure to the driving housing (Auld, ¶0070).
Re Claim 13, the embodiment of Fig. 1 of Auld discloses a device for delivering one or more agents into a patient's body (Figs. 1-3b), comprising: a) a drive module (10) comprising: an elongate drive housing (12 and or 66) including a first end (top end) and a second end ( lower end), a first chamber (22) adjacent the first end (Fig. 1) communicating with a second chamber (26) adjacent the second end via an intermediate passage (28, Fig. 3); a puncture mechanism (30) within the first chamber adjacent the first end including a puncture pin (34); a canister (40) containing pressurized gas including a penetrable septum (46, ¶0039) disposed adjacent the puncture pin (Fig. 3a); an actuator (32) configured to move one of the puncture mechanism and the canister to cause the puncture pin to penetrate the septum (Fig. 3a to Fig. 3b) and cause the gas within the canister to flow through the first chamber around the canister (¶0039), and into the second chamber (¶0042); and a plunger (50) slidably disposed within the second chamber (Fig. 3a-3b) comprising a proximal end (top end) including a plunger piston (52) and a distal end (lower end), the plunger configured such that gas entering from the first chamber causes the plunger to move from an initial position (Fig. 3a) to an extended position (Fig. 3b) wherein the distal end of the plunger extends from the second end of the drive housing (Fig. 3b) for delivering one or more agents from an injector module based on movement of the plunger (¶0039); and b) an injector module (60) comprising: an injector housing (62) coupled to the drive housing carrying an agent chamber (64) containing one or more agents (72, ¶0046); an injector piston (76) slidably disposed within the agent chamber and coupled to the distal end of the plunger (¶0047, Fig. 2a); and a needle (78) extending from the injector module opposite the drive housing (Fig. 2a) and communicating with the agent chamber for delivering the one or more agents from the agent chamber when the plunger moves from the retracted position to the extended position (¶0039, Fig, 2a), thereby advancing the injector piston within the agent chamber (¶0047), and further disclose the chamber proximal to the piston (a portion of 26 above 52) and the chamber distal to the piston (a portion of 26 below 52), and that agas entering the chamber proximal to the piston (Fig. 3b), but it fails to disclose the gas is entering the second chamber from the first chamber causes the plunger to move and wherein the plunger piston comprises one or more passages configured to allow gas from the canister entering the second chamber proximal to the plunger piston to pass through the plunger piston into the second chamber distal to the plunger piston around the plunger.
However, Jaeger discloses an injector (Fig. 1-5d) and wherein a drive module (Fig. 2) comprises a plunger (228) comprises a plunger piston (top end of 272, Fig. 4) comprises one or more passages (120 and side opening around the 272, see Fig. 1, Fig. 5d) configured to allow gas from the gas source (the gas inside 222, Fig. 2) entering the chamber (chamber 284 ) to pass through the piston (228) into the chamber around the plunger ( Fig. 5d, Col. 7, lines 1-15).
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 plunger piston of Auld to include one or more passages so that the gas is entering the second chamber from the first chamber causes the plunger to move and wherein the plunger piston comprises one or more passages configured to allow gas from the canister entering the second chamber proximal to the plunger piston to pass through the plunger piston into the second chamber distal to the plunger piston around the plunger as taught by Jaeger for the purpose of controlling the passageway of the gas that enough to push the plunger (Jaeger, Col. 7, lines 1-15).
Re Claim 15, Auld discloses wherein the injector further comprises a needle guard (80, ¶0051) movable from a guarded position (Fig. 2a) wherein the needle guard covers the needle (Fig. 2a, ¶0051) and a retracted position wherein the needle is exposed to perform an injection (¶0051), the needle guard coupled to the actuator and slidable along the drive housing such that the needle guard activates the actuator when directed to the retracted position (¶0051).
Re Claim 16, Auld discloses wherein the needle guard is biased to the guarded position (¶0054).
Re Claim 17, Auld discloses an actuation sleeve (84, ¶0054) slidably disposed over the drive housing and coupled to the needle guard (¶0054); and a spring (82) coupled between the actuation sleeve and drive housing to bias the needle guard to the guarded position (¶0054).
Re Claim 18, Auld discloses wherein the puncture mechanism comprises a pin sleeve (32, ¶0039) slidably disposed within the first chamber adjacent the first end and carrying the puncture pin (34, ¶0039), the pin sleeve movable from an inactive position (Fig. 3a) wherein the puncture pin is spaced apart from the septum (Fig. 3a) and an active position wherein the puncture pin penetrates the septum (Fig, 3b, ¶0039), the pin sleeve biased to the active position and restrained in the inactive position by the actuator (36).
Re Claim 19, Auld discloses wherein the actuator comprises one or more catches (36, ¶0041) on the drive housing restraining the pin sleeve in the inactive position (¶0040), the actuation sleeve (32) configured to disengage the one or more catches to allow the pin sleeve to automatically move from the inactive position to the active position (¶0041).
Re Claim 35, the modified Auld discloses a method for performing an injection, comprising: providing an injection device according to claim1 (see rejection of claim 1); inserting the needle through a patient's skin (¶0059); and activating an actuator to deliver pressurized gas from the canister through into the second chamber (¶0059, and see Jaeger’s chamber, Fig. 5d), thereby moving the plunger from the initial position to the extended position (Fig. 3b) and, consequently, advancing the piston within the agent chamber to deliver the one or more agents through the needle into the patient's body (¶0039, ¶0059).
Claim(s) 2, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auld et al. (US. 20190167906A1) (“Auld”) in view of Jaeger et al. (US 20050070848 A1) (“Jaeger”) and further in view of Willis et al. (US.6406455BA1) (“Willis”).
Re Claim 2, Auld fails to disclose wherein the plunger comprises a plunger chamber extending from an opening in the proximal end communicating with the chamber such that pressurized gas from the source of pressurized gas entering the chamber fills the plunger chamber, wherein the distal end of the plunger is closed to enclose the plunger chamber.
However, Willis discloses an injector (Fig. 1-4) and wherein a drive module (Figs. 1) comprises a plunger (10) comprises a plunger chamber (inner space of 10, Fig. 4) extending from an opening in the proximal end ( top opening of 10) communicating with the second (chamber of 11) such that pressurized gas from the canister entering the chamber fills the plunger chamber (Fig. 44), wherein the distal end of the plunger is closed to enclose the plunger chamber ( Fig. 4, Col. 7, lines 16).
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 plunger of Auld to include plunger chamber so that the plunger comprises a plunger chamber extending from an opening in the proximal end communicating with the chamber such that pressurized gas from the source of pressurized gas entering the chamber fills the plunger chamber, wherein the distal end of the plunger is closed to enclose the plunger chamber as taught by Willis for the purpose of optimizing the pressure profile to release the medication (Willis, Col. 7, lines 10-20).
Re Claim 14, Auld fails to disclose wherein the plunger comprises a plunger chamber extending from an opening in the proximal end communicating with the second chamber such that pressurized gas from the canister entering the chamber fills the plunger chamber and wherein the distal end of the plunger is closed to enclosed the plunger chamber.
However, Willis discloses an injector (Fig. 1-4) and wherein a drive module (Figs. 1) comprises a plunger (10) comprises a plunger chamber (inner space of 10, Fig. 4) extending from an opening in the proximal end ( top opening of 10) communicating with the second (chamber of 11) such that pressurized gas from the canister entering the chamber fills the plunger chamber (Fig. 44), wherein the distal end of the plunger is closed to enclose the plunger chamber ( Fig. 4, Col. 7, lines 16).
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 plunger of Auld to include plunger chamber so that the plunger comprises a plunger chamber extending from an opening in the proximal end communicating with the second chamber such that pressurized gas from the canister entering the chamber fills the plunger chamber and wherein the distal end of the plunger is closed to enclosed the plunger chamber as taught by Willis for the purpose of optimizing the pressure profile to release the medication (Willis, Col. 7, lines 10-20).
Response to Arguments
Applicant’s arguments, see remark, filed 12/15/2025 with respect to the rejection(s) of claim(s) 1, 13 under 103 using Auld in view of Kim and with regards to the chamber and piston and how the gas is moving through the piston 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 Auld in view of Jaeger et al. (US 20050070848 A1) (“Jaeger”).
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783