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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/29/2026 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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 5 and 7 of USPGPub 2025/0152843, notice of allowance dated 06/09/2026, hereinafter Patent ‘843, in view of Gillespie (USPGPub 2004/0054327) and Markussen (USPGPub 2010/0280460).
Re Claim 2, Claim 1 of Patent ‘843 discloses an auto-injector comprising: a housing comprising at least one viewing window, wherein at least a portion of the housing is cylindrical and defines a longitudinal axis of the auto-injector; a syringe carrier disposed in the housing, the syringe carrier configured to hold a syringe within the housing, the syringe containing a medicament and having a needle configured to dispense the medicament; a sleeve configured to move relative to the housing from a first position to a second position by a direct touch of a user; a trigger button located at a distal end of the housing, the auto-injector configured such that (i) a proximal movement of the trigger button relative to the housing is limited when the sleeve is in the first position, and (ii) the proximal movement of the trigger button is allowed when the sleeve is in the second position, the trigger button comprising a proximally-extending portion; a plunger comprising a non-cylindrical portion centered on the longitudinal axis of the plunger and configured to prevent a rotation of the plunger relative to the housing throughout operation of the auto-injector, wherein the non-cylindrical portion of the plunger extends along a portion of an axial length of the plunger, the portion of the axial length being less than an entire axial length of the plunger; a torsion spring configured to apply a rotational biasing force to the second part to rotate the second part relative to the housing after at least the portion of the medicament has been dispensed from the syringe; and a cap removably attached to a proximal end of the housing such that removal of the cap from the housing removes a protective needle shield from the needle while the plunger remains in the distal position within the housing.
The claims of Patent ‘843 fail to disclose a first part disposed within a housing; the plunger comprising a lip defined by a distal end of the plunger, the lip configured to releasably engage the first part to releasably hold the plunger in a distal position within the housing until a proximally-extending portion of the trigger button releases the lip from being engaged to the first part by a radial deflection; a proximal end configured to (i) proximally advance a stopper relative to the housing for needle insertion and then (ii) proximally advance the stopper within a syringe for medicament delivery; and an axial portion connecting the lip of the plunger to the proximal end of the plunger, the axial portion being substantially centered on the longitudinal axis of the auto-injector.
Gillespie teaches an auto-injector (Gillespie Figs. 2A-4) comprising a first part (267) disposed within a housing (110, 115, 120); the plunger (305) comprising a lip (330) defined by a distal end of the plunger (305), the lip (330) configured to releasably engage the first part (267) to releasably hold the plunger (305) in a distal position within the housing (110, 115, 120) until a proximally-extending portion (210) of the trigger button (205) releases the lip (330) from being engaged to the first part (267) by a radial deflection (Gillespie ¶ 0020, 0025-0027, 0041); a proximal end (310) configured to (i) proximally advance a stopper (515) relative to the housing (110, 115, 120) for needle insertion and then (ii) proximally advance the stopper (515) within a syringe (400) for medicament delivery (Gillespie Fig. 5; ¶ 0043-0047, 0053); and an axial portion (portion distal to groove 335) connecting the lip (330) of the plunger (305) to the proximal end of the plunger (305), the axial portion being substantially centered on the longitudinal axis of the auto-injector (Gillespie Fig. 2A), the configuration for preventing inadvertent medicament expulsion (Gillespie Claim 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the housing and plunger of Patent ‘843 to comprise a first part disposed within a housing; the plunger comprising a lip defined by a distal end of the plunger, the lip configured to releasably engage the first part to releasably hold the plunger in a distal position within the housing until a proximally-extending portion of the trigger button releases the lip from being engaged to the first part by a radial deflection; a proximal end configured to (i) proximally advance a stopper relative to the housing for needle insertion and then (ii) proximally advance the stopper within a syringe for medicament delivery; and an axial portion connecting the lip of the plunger to the proximal end of the plunger, the axial portion being substantially centered on the longitudinal axis of the auto-injector, the configuration as disclosed by Gillespie for preventing inadvertent medicament expulsion (Gillespie Claim 12).
The claims of Patent ‘843 also fail to disclose a second part configured to rotate relative to the housing about the longitudinal axis of the housing after at least a portion of the medicament has been dispensed from the syringe. Markussen teaches an auto-injector (100) (Markussen Figs. 1a-1g) comprising a housing (122) and a syringe (104), a second part (128) configured to rotate relative to the housing (122) about a longitudinal axis of the housing (122) after at least a portion of the medicament has been dispensed from the syringe (104) (Markussen ¶ 0053), the second part (128) for withdrawing and shielding a needle (112) (Markussen ¶ 0053). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included with the auto-injector of Patent ‘843 a second part configured to rotate relative to the housing about the longitudinal axis of the housing after at least a portion of the medicament has been dispensed from the syringe as disclosed by Markussen for withdrawing and shielding the needle (Markussen ¶ 0053).
Re Claim 3, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. Claims in Patent ‘843 fail to disclose wherein the lip extends radially outward from the plunger and a proximally-facing surface of the lip is engaged to a distally-facing surface of the first part of the auto-injector to hold the plunger in the distal position within the auto-injector prior to the lip radially deflecting out of engagement with the first part of the auto-injector. Gillespie teaches wherein the lip (330) extends radially inward from the plunger (305) and a proximally-facing surface of the lip (330) is engaged to a distally- facing surface of the first part (267) of the auto-injector to hold the plunger (305) in the distal position within the auto-injector prior to the lip (330) radially deflecting out of engagement with the first part (267) of the auto-injector (as seen in Gillespie Figs. 2A-4), the configuration for preventing inadvertent medicament expulsion (Gillespie Claim 12). Gillespie fails to teach the lip extending radially outward. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the lip of Gillespie extend radially outward, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167; see also MPEP 2144 (VI- A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the lip and plunger of Patent ‘843 in view of Gillespie and Markussen such that the lip extends radially outward from the plunger and a proximally-facing surface of the lip is engaged to a distally-facing surface of the first part of the auto-injector to hold the plunger in the distal position within the auto-injector prior to the lip radially deflecting out of engagement with the first part of the auto-injector, a similar configuration as disclosed by Gillespie for preventing inadvertent medicament expulsion (Gillespie Claim 12).
Re Claim 4, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. Claim 1 of Patent ‘843 disclose 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 5, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. Claim 1 of Patent ‘843 disclose wherein the auto-injector is configured to dispense the medicament from the syringe within 10 seconds.
Re Claims 6 and 7, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. Claims in Patent ‘843 fail to disclose wherein the non-cylindrical portion of the plunger has a rectangular shape defined by one or more axially-extending planar surfaces; and wherein the non-cylindrical portion of the plunger is configured to slidably engage an axial guide during the proximal movement of the plunger within the housing. Markussen teaches a non-cylindrical portion (216) of the plunger (234) (Markussen embodiment of Figs. 8 and 9a) has a rectangular shape (wherein a cross-section of the groove 236 is rectangular, as seen in Markussen Fig. 8) defined by one or more axially-extending planar surfaces (walls of groove 236); and wherein the non-cylindrical portion (216) of the plunger (234) is configured to slidably engage an axial guide (238) during the proximal movement of the plunger (234) within the housing (222), the configuration for safely guiding the syringe and needle through the housing during an injection (Markussen ¶ 0064-0070).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the non-cylindrical portion of the plunger of Patent ‘843 in view of Gillespie and Markussen have a rectangular shape defined by one or more axially-extending planar surfaces; and wherein the non-cylindrical portion of the plunger is configured to slidably engage an axial guide during the proximal movement of the plunger within the housing as disclosed by Markussen, the configuration for safely guiding the syringe and needle through the housing during an injection (Markussen ¶ 0064-0070).
Re Claim 8, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. Claim 5 of Patent ‘843 discloses wherein the sleeve moves axially between the first position and the second position.
Re Claim 9, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. In the device of Patent ‘843 in view of Gillespie and Markussen, the second part would be proximal to the first part.
Re Claim 10, Patent ‘843 in view of Gillespie and Markussen teach all of the limitations of Claim 2. Claim 7 of Patent ‘843 discloses wherein the medicament in the syringe is a GLP-1 class drug.
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a nonstatutory double patenting rejection over a reference patent (37 CFR 1.321(b) and (c)). 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. 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/PatentForms. The filing date of the application will determine what form 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/TerminalDisclaimer.
Response to Arguments
Applicant’s arguments with respect to drawing objections have been fully considered and are persuasive. Applicant’s arguments on Pages 10-11 of the response are sufficient to resolve any issues regarding the first part and the second part.
Applicant’s arguments with respect to Claims 2-10 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
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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