DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4 of USPGPub 2025/0152843, notice of allowance dated 06/09/2026, hereinafter Patent ‘843, in view of Gillespie (USPGPub 2004/0054327).
Re Claim 2, Claims 1-4 of Patent ‘843 discloses an auto-injector comprising: a housing comprising at least one viewing window and a cylindrical portion defining a longitudinal axis of the auto-injector; a first part disposed within the housing; a button disposed at a distal end of the housing; a plunger disposed in the housing, the plunger comprising a non-cylindrical portion (i) centered on the longitudinal axis of the auto-injector and (ii) extending axially along an axial portion of the plunger that is less than an entire axial length of the plunger, wherein an axially sliding engagement between the non-cylindrical portion of the plunger and the first part prevents a rotation of the plunger relative to the housing during all movements of the plunger within the housing and wherein the non-cylindrical portion of the plunger comprises a non-circular shape; and wherein the auto-injector is configured such that, after the two distally-extending resilient clips have radially deflected to release the plunger from being held in a distal position within the housing, the drive spring proximally drives the plunger relative to the housing such that the non-cylindrical portion of the plunger proximally slides on the first part and the plunger dispenses a medicament from a syringe, and wherein the auto-injector is configured such that the plunger remains in the distal position within the housing as a cap covering a needle of the syringe is removed from a proximal end of the housing.
However, the drive spring disposed proximally of two distally-extending resilient clips and radially outward of the two distally-extending resilient clips. Gillespie teaches an auto-injector (Gillespie Fig. 1) comprising: a housing (100); a plunger (300) disposed in the housing (100) and comprising a non-cylindrical portion (315) (Gillespie Fig. 7; ¶ 0025); and a drive spring (500) disposed proximally of two distally-extending resilient clips (325) and radially outward of the two distally-extending resilient clips (325) (as seen in Gillespie Fig. 1), the configuration for preventing inadvertent movement of the plunger to expel a dose (Gillespie Claim 12). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the auto-injector of Patent ‘843 to include the drive spring disposed proximally of two distally-extending resilient clips and radially outward of the two distally-extending resilient clips as disclosed by Gillespie for preventing inadvertent movement of the plunger to expel a dose (Gillespie Claim 12).
Re Claim 3, Patent ‘843 in view of Gillespie teach all of the limitations of Claim 2. Claim 1 of Patent ‘843 discloses wherein the auto-injector is configured to produce an audible indication when the medicament has been dispensed from the syringe to indicate that an injection is substantially complete.
Re Claim 4, Patent ‘843 in view of Gillespie teach all of the limitations of Claim 2. Claim 1 of Patent ‘843 discloses wherein the auto-injector is configured to dispense the medicament from the syringe within approximately 10 seconds.
Re Claim 5, Patent ‘843 in view of Gillespie teach all of the limitations of Claim 2. The claims of Patent ‘843 fail to disclose wherein each of the two distally-extending resilient clips comprise a ramped portion for producing a radial deflection of the two distally-extending resilient clips when the two distally-extending resilient clips are engaged in a proximal direction. Gillespie further teaches wherein each of the two distally-extending resilient clips (325) comprise a ramped portion (as seen in Gillespie Fig. 2A) for producing a radial deflection of the two distally-extending resilient clips (325) when the two distally-extending resilient clips (325) are engaged in a proximal direction (Gillespie ¶ 0025), wherein the configuration of the two distally-extending resilient clips prevents inadvertent movement of the plunger to expel a dose (Gillespie Claim 12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the two distally-extending resilient clips of Patent ‘843 in view of Gillespie wherein each of the two distally-extending resilient clips comprise a ramped portion for producing a radial deflection of the two distally-extending resilient clips when the two distally-extending resilient clips are engaged in a proximal direction as disclosed by Gillespie wherein the configuration of the two distally-extending resilient clips prevents inadvertent movement of the plunger to expel a dose (Gillespie Claim 12).
Claims 6-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4 of USPGPub 2025/0152843, notice of allowance dated 06/09/2026, hereinafter Patent ‘843, in view of Gillespie (USPGPub 2004/0054327) as applied to Claim 2 above, and further in view of Markussen (USPGPub 2010/0280460).
Re Claim 6, Patent ‘843 in view of Gillespie teach all of the limitations of Claim 2. The claims of Patent ‘843 and prior art Gillespie fail to teach a second part surrounding at least a portion of the plunger, wherein the plunger proximally slides relative to the second part when the plunger dispenses the medicament from the syringe. Markussen teaches the auto-injector (Markussen Figs. 1a-1g) comprising a second part (116) surrounding at least a portion of a plunger (114), wherein the plunger (114) proximally slides relative to the second part (116) when the plunger (114) dispenses the medicament from the syringe (104) wherein the second part acts to shield a needle of the syringe after medicament delivery (Markussen ¶ 0053).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the auto-injector of Patent ‘843 in view of Gillespie comprise a second part surrounding at least a portion of the plunger, wherein the plunger proximally slides relative to the second part when the plunger dispenses the medicament from the syringe as disclosed by Markussen wherein the second part acts to shield a needle of the syringe after medicament delivery (Markussen ¶ 0053).
Re Claim 7, Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen teach all of the limitations of Claim 6. Patent ‘843 fails to teach the auto-injector comprising a third part configured to rotate about the longitudinal axis of the auto-injector, wherein the plunger proximally slides relative to the third part when the plunger dispenses the medicament from the syringe. Markussen teaches the auto-injector (Markussen Figs. 1a-1g) comprising a third part (128) configured to rotate about the longitudinal axis of the auto-injector (Markussen ¶ 0053), wherein the plunger proximally slides relative to the third part (128) when the plunger (114) dispenses the medicament from the syringe (104), the third part of Markussen configured for shielding the syringe needle after medicament delivery (Markussen ¶ 0053).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the auto-injector of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen comprise a third part configured to rotate about the longitudinal axis of the auto-injector, wherein the plunger proximally slides relative to the third part when the plunger dispenses the medicament from the syringe, the third part of Markussen configured for shielding the syringe needle after medicament delivery (Markussen ¶ 0053).
Re Claim 8, Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen teach all of the limitations of Claim 7. Patent ‘843 fails to teach wherein the auto-injector comprises a first state in which the plunger is engaged to the second part while (i) the two distally-extending resilient clips limit a proximal movement of the plunger relative to the housing, (ii) the non-cylindrical portion of the plunger is slidably engaged to the first part, and (iii) a rotation of the third part relative to the housing is limited. Gillespie teaches (i) the two distally-extending resilient clips (325) limit a proximal movement of the plunger (300) relative to the housing (100) (Gillespie ¶ 0025), (ii) the non-cylindrical portion (315) of the plunger (300) is slidably engaged to the first part (340) (Gillespie ¶ 0025, 0027), wherein the configuration of the two distally-extending resilient clips prevents inadvertent movement of the plunger to expel a dose (Gillespie Claim 12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the two distally-extending resilient clips of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen such that the two distally-extending resilient clips limit a proximal movement of the plunger relative to the housing as disclosed by Gillespie, wherein the configuration of the two distally-extending resilient clips prevents inadvertent movement of the plunger to expel a dose (Gillespie Claim 12). Markussen teaches wherein the auto-injector comprises a first state (Markussen Figs. 1a-1e) in which the plunger (114) is engaged to the second part (116) for locking the first part for rotation relative to the plunger (Markussen ¶ 0049). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the auto-injector of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen comprise a first state in which the plunger is engaged to the second part as disclosed by Markussen for locking the first part for rotation relative to the plunger (Markussen ¶ 0049).
Re Claim 9, Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen teach all of the limitations of Claim 8. Patent ‘843 fails to teach wherein the auto-injector comprises a second state in which the two distally-extending resilient clips have radially deflected to release the plunger from being held in the distal position within the housing and allow the plunger to move proximally relative to the housing by the drive spring such that the plunger proximally advances the syringe relative to the housing until the needle of the syringe reaches an injection depth while the rotation of the third part relative to the housing remains limited.
Gillespie further teaches wherein the auto-injector comprises a second state (state as seen in Gillespie Fig. 4) in which the two distally-extending resilient clips (325) have radially deflected to release the plunger (300) from being held in the distal position within the housing (100) and allow the plunger (300) to move proximally relative to the housing (100) by the drive spring (500) such that the plunger (300) proximally advances the syringe (400) relative to the housing (100) until the needle (540) of the syringe (400) reaches an injection depth (Gillespie ¶ 0024-0025, 0044), wherein the configuration of the two distally-extending resilient clips prevents inadvertent movement of the plunger to expel a dose (Gillespie Claim 12).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the auto-injector of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen to comprise a second state in which the two distally-extending resilient clips have radially deflected to release the plunger from being held in the distal position within the housing and allow the plunger to move proximally relative to the housing by the drive spring such that the plunger proximally advances the syringe relative to the housing until the needle of the syringe reaches an injection depth, wherein the configuration of the two distally-extending resilient clips prevents inadvertent movement of the plunger to expel a dose (Gillespie Claim 12).
Markussen teaches wherein rotation of the third part (128) relative to a housing (122) remains limited during injection wherein rotation occurs to sheath the needle after an injection, not before, thus preventing inadvertent needle sticks after injection (Markussen ¶ 0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the third part of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen wherein rotation of the third part relative to a housing remains limited during injection as disclosed by Markussen wherein rotation occurs to sheath the needle after an injection, not before, thus preventing inadvertent needle sticks after injection (Markussen ¶ 0053).
Re Claim 10, Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen teach all of the limitations of Claim 9. The claims of Patent ‘843 fail to teach wherein the auto-injector comprises a third state in which the drive spring continues to proximally drive the plunger relative to the housing to proximally drive a stopper of the syringe to dispense the medicament from the syringe while the non-cylindrical portion of the plunger slides relative to the first part. Gillespie teaches wherein the auto-injector comprises a third state in which the drive spring (500) continues to proximally drive the plunger (300) relative to the housing (100) to proximally drive a stopper (515) of the syringe (400) to dispense the medicament from the syringe (400) while the non-cylindrical portion (315) of the plunger (300) slides relative to the first part (340) for dispending the contents of the syringe (Gillespie ¶ 0024-0025, 0044).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have the auto-injector of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen to comprise a third state in which the drive spring continues to proximally drive the plunger relative to the housing to proximally drive a stopper of the syringe to dispense the medicament from the syringe while the non-cylindrical portion of the plunger slides relative to the first part as disclosed by Gillespie for dispending the contents of the syringe (Gillespie ¶ 0024-0025, 0044).
Re Claim 11, Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen teach all of the limitations of Claim 10. The claims of Patent ‘843 fail to teach wherein the auto-injector is configured such that after at least a portion of the medicament has been dispensed from the syringe, the third part is released for rotation within the housing. Markussen teaches wherein the auto-injector is configured such that after at least a portion of the medicament has been dispensed from the syringe (104), the third part (128) is released for rotation within the housing (122) for sheathing the needle after an injection and preventing inadvertent needle stick (Markussen ¶ 0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the third part of Patent ‘843 in view of Gillespie as applied to Claim 2 above, and further in view of Markussen wherein after at least a portion of the medicament has been dispensed from the syringe, the third part is released for rotation within the housing as disclosed by Markussen for sheathing the needle after an injection and preventing inadvertent needle stick (Markussen ¶ 0053).
Response to Arguments
Applicant’s arguments filed 12/17/2025 with respect to drawing objections have been fully considered and are persuasive. Applicant’s arguments on Pages 9-10 of the response are sufficient to resolve any issues regarding the first part and the second part.
Applicant’s arguments with respect to Claims 1-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights