DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 2-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3 of patented application, USPGPub 2025/0152842, hereinafter Patent ‘842, in view of Larsen et al. (USPGPub 2002/0095120).
Re Claim 2, the claims of Patent ‘842, in particular Claim 1, discloses a method comprising: while holding the proximal end of the auto-injector against the injection site, depressing, by the user, a trigger button to allow a plunger to move in a proximal direction towards a stopper within the syringe while preventing a rotation of the plunger using a non-cylindrical axially-extending rod, wherein the non-cylindrical axially-extending rod prevents the rotation of the plunger during the entire movement of the plunger, such that (i) the plunger pushes on the stopper to drive the syringe in the proximal direction to insert the needle into the injection site, then (ii) once an injection depth of the needle has been reached, at least a portion of the medicament within the syringe is injected into the injection site by continued proximal movement of the plunger within the syringe, and then (iii) once at least a portion of the medicament has been injected into the injection site, the auto-injector produces an audible indication to indicate that at least a portion of the medicament has been injected into the injection site; and after the audible indication has been produced, removing the auto-injector from the injection site, wherein the auto-injector is configured such that after at least a portion of the medicament has been dispensed from the syringe a torsion spring rotates a part within the auto-injector to allow the needle to become circumferentially covered within the auto-injector to protect the user from accidental needle stick injuries after the auto-injector has been removed from the injection site. Claims 2 and 3 of Patent ‘842 teach substantially all of the medicament being dispensed while holding the proximal end of the auto-injector against the injection site for approximately 10 seconds.
However, the claims of Patent ‘842 fail to disclose removing, by a user, a cap from a proximal end of an auto-injector to remove a protective needle shield from a needle of a syringe disposed within the auto-injector while the needle remains a safe distance from the proximal end of the auto-injector; after removing the protective needle shield from the needle, placing, by the user, the proximal end of the auto-injector against an injection site on the user. Larsen teaches an auto-injector (Larsen Fig. 1) comprising a cap (8) removably attached to a proximal end of a housing (1) (as seen in Larsen Fig. 1) such that removal of the cap (8) from the housing (1) removes a protective needle shield (23) from a needle (9) of a syringe (4) while the syringe (4) remains stationary within the housing (1) when the syringe (4) is disposed in the auto-injector for simultaneous removal of both the cap and protective shield while preventing needle sticks (Larsen Fig. 1; ¶ 0028). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the housing of Patent ‘842 to include 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 syringe remains stationary within the housing when the syringe is disposed in the auto-injector as disclosed by Larsen for simultaneous removal of both the cap and protective shield while preventing needle sticks (Larsen Fig. 1; ¶ 0028).
Re Claim 3, Claims 1-3 of Patent ‘842 in view of Larsen teach all of the limitations of Claim 2 of the present case. Claim 1 of Patent ‘842 further discloses wherein the auto-injector is configured to allow the auto-injector to be removed from the injection site prior to injecting substantially all of the medicament from the syringe.
Re Claim 4, Claims 1-3 of Patent ‘842 in view of Larsen teach all of the limitations of Claim 2 of the present case. The claims of Patent ‘842 fail to disclose wherein the auto-injector is configured for single-use. Larsen teaches wherein the auto-injector is configured for single-use where it is sometimes necessary to administer a single pre-measured quantity of medicine to a person (Larsen ¶ 0002). 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 ‘842 in view of Larsen to be configured for single-use as disclosed by Larsen where it is sometimes necessary to administer a single pre-measured quantity of medicine to a person (Larsen ¶ 0002).
Claims 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-3 of patented application, USPGPub 2025/0152842, hereinafter Patent ‘842, in view of Larsen et al. (USPGPub 2002/0095120) as applied to Claim 2 above, and further in view of Markussen (USPGPub 2010/0280460).
Re Claims 5 and 6, Claims 1-3 of Patent ‘842 in view of Larsen teach all of the limitations of Claim 2 of the present case. The claims of Patent ‘842 in view of Larsen fail to teach wherein the non-cylindrical axially-extending rod has two or more flat surfaces that slidably engage an opening defined by two or more correspondingly-shaped flat surfaces; and wherein the non-cylindrical axially-extending rod has a rectangularly-shaped cross-section. Markussen teaches wherein the housing has two or more flat surfaces (surfaces of protrusion 238) that slidably engage an opening defined by two or more correspondingly-shaped flat surfaces (walls of groove 236); and wherein the non-cylindrical axially-extending rod (216) has a rectangularly-shaped cross-section (wherein a cross-section of the groove 236 is rectangular) (Markussen Figs. 8 and 9a). It would have been obvious to one of ordinary skill in the art at the time of the present invention to have had the two or more flat surfaces on the non-cylindrical axially-extending rod and the opening defined by two or more correspondingly-shaped flat surfaces on the housing, 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; Markussen Figs. 8 and 9a).
Re Claim 7, Claims 1-3 of Patent ‘842 in view of Larsen teach all of the limitations of Claim 2 of the present case. The claims of Patent ‘842 in view of Larsen fail to teach wherein the non-cylindrical axially-extending rod is distinct from the plunger. Markussen teaches wherein the non-cylindrical axially-extending rod (216) is distinct from the plunger (214) the configuration for preventing interference with dispelling of a dose (Markussen Figs. 9a-9e). 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 ‘842 in view of Larsen such that the non-cylindrical axially-extending rod is distinct from the plunger as disclosed by Larsen for preventing interference with dispelling of a dose (Markussen Figs. 9a-9e).
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 Claims 2-7 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
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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