DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Applicant is advised that should Claim 1 be found allowable, Claim 22 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 16, 18, 22 and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 2 of USPN 8,808,250, hereinafter Patent ‘250. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims use different language for the same structures, word the claims differently, and order elements in a different manner.
Re Claim 16, Claim 1 of Patent ‘250 discloses an auto-injector for administering a dose of a liquid medicament, the auto-injector comprising: a housing configured to contain a medicament container that contains the medicament, a plunger, a torsion spring having a proximal end and a distal end, a releasing trigger operable to release the torsion spring from a biased state, and a gear arrangement configured to convert torque from the distal end of the torsion spring into an administration movement of the plunger in a proximal direction from an initial position to a proximal end position in order to administer the dose, and the plunger is rotationally fixed in relation to the housing, wherein torque provided by the torsion spring is converted into movement of the plunger during an entire movement of the plunger from the initial position into the proximal end position, wherein the administration movement of the plunger comprises movement of the plunger in the proximal direction relative to the housing, and wherein the initial position of the plunger is the position of the plunger relative to the housing before the releasing trigger is operated. In the present case, the limitation “wherein the auto-injector can be operated only once and only for administering one dose of medicament” is being determined an implicit function of the auto-injector of the present case.
Re Claim 18, Claim 1 of Patent ‘250 discloses wherein the torsion spring is in the biased state before the auto-injector is manipulated by a user for a first time.
Re Claim 22, Claim 1 of Patent ‘250 discloses wherein the plunger is rotationally fixed to the housing.
Re Claim 26, Claim 1 of Patent ‘250 discloses wherein the gear arrangement comprises a first gear member coupled to the distal end of the torsion spring, wherein the plunger is driven in the proximal direction by rotation of the first gear member through the torque of the torsion spring.
Re Claim 27, Claim 2 of Patent ‘250 discloses wherein the first gear member at least partially surrounds the plunger.
Re Claim 28, Claim 1 of Patent ‘250 discloses wherein the medicament container is contained in the housing.
Re Claim 29, Claim 1 of Patent ‘250 discloses wherein the medicament container is a syringe.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of USPN 8,808,250 in view of Markussen (USPGPub 2010/0280460).
Re Claim 17, Claim 1 of Patent ‘250 discloses all of the limitations of Claim 16. However, the claims of Patent ‘250 fail to disclose wherein the one dose is a fixed dose. Markussen teaches wherein the one dose is a fixed dose for consistent dosing (Markussen 6. Abstract; Figs. 1a-1g). 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 dose of medicament in Patent ‘250 to be a fixed dose as disclosed by Markussen for the purpose of consistent dosing (Markussen 6. Abstract; Figs. 1a-1g).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of USPN 8,808,250 in view of Cowe (Int. Pat. App. WO2011/048422A2).
Re Claim 19, Claim 1 of Patent ‘250 discloses all of the limitations of Claim 16. However, the claims of Patent ‘250 fail to disclose the auto-injector comprising a safety-mechanism including a beam element, the safety-mechanism configured to prevent further administration of the medicament when the auto-injector is removed from an injection site during administration of the dose. Cowe teaches an auto-injector (as seen in Cowe Fig. 1) comprising a safety-mechanism including a beam element (proximal part of chassis clip 48 in Cowe Fig. 1), the safety-mechanism configured to prevent further administration of the medicament when the auto-injector is removed from an injection site during administration of the dose for the purpose of preventing accidental triggering of the auto-injector (Cowe Pg. 3 Lines 1-3 and Claim 6).
Therefore, it would have been obvious to one or ordinary skill in the art at the time of the invention to have included with the auto-injector of Markussen a safety-mechanism including a beam element, the safety-mechanism configured to prevent further administration of the medicament when the auto-injector is removed from an injection site during administration of the dose as disclosed by Cowe for the purpose of preventing accidental triggering of the auto-injector (Cowe Pg. 3 Lines 1-3 and Claim 6).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of USPN 8,808,250 in view of Cowe (Int. Pat. App. WO2011/048422A2) as applied to Claim 19 above, and further in view of Cowe691 (USPGPub 2008/0269691).
Re Claim 20, Claim 1 of Patent ‘250 in view of Cowe teach all of the limitations of Claim 19. However, the claims of Patent ‘250 in view of Cowe fail to teach a needle shroud, which is arranged in the housing and translatable in a longitudinal direction, wherein the needle shroud is configured to activate the safety-mechanism when the needle shroud is moved in the proximal direction. Cowe691 teaches an auto-injector (as seen in Cowe691 Figs. 3 and 4) wherein a needle shroud (18) is arranged in a housing (Cowe691 Figs. 5a and 5b) and translatable in a longitudinal direction and a flexible beam element (32) arranged on the needle shroud (18) in a manner to deflect a flexible first beam element (42) out of the path of a trigger button (54) on proximal movement of the needle shroud (18) for the purpose of retracting the shroud and permitting the needle to penetrate the skin (Cowe691 ¶ 0034-0039).
Therefore, it would have been obvious to one or ordinary skill in the art at the time of the invention to have included with the auto-injector of Patent ‘250 in view of Cowe, a needle shroud, which is arranged in the housing and translatable in a longitudinal direction, wherein the needle shroud is configured to activate the safety-mechanism when the needle shroud is moved in the proximal direction as disclosed by Cowe691 for the purpose of retracting the shroud and permitting the needle to penetrate the skin (Cowe691 ¶ 0034-0039).
Claims 21 and 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of USPN 8,808,250 in view of Kohlbrenner et al. (USPGPub 2008/0051713).
Re Claim 21, Claim 1 of Patent ‘250 discloses all of the limitations of Claim 16. However, the claims of Patent ‘250 fail to disclose the auto-injector comprising a needle shroud arranged in the housing and translatable in a longitudinal direction, wherein: the needle shroud is configured to be in an initial position protruding from a proximal end of the housing in an initial state for preventing release of the torsion spring, the needle shroud is arranged to be translated distally into the housing into a distal position against a load of a shroud spring when the needle shroud is pushed against an injection site for allowing release of the torsion spring, and the needle shroud is rotationally fixed to the housing.
Kohlbrenner teaches an auto-injector for administering a dose of a liquid medicament (Kohlbrenner Figs. 19-22), the auto-injector comprising: a housing (4, 38) configured to contain a medicament container (2), a plunger (15), and a torsion spring (25); and a needle shroud (39), wherein the needle shroud (39) is arranged in the housing (4, 38) and translatable in a longitudinal direction, wherein: the needle shroud (39) is configured to be in an initial position protruding from a proximal end of the housing (4, 38) in an initial state for preventing release of the torsion spring (25) (wherein prior to the needle protection 39 being retracted, the drive member cannot function where the needle cannot reach the dermis - Kohlbrenner ¶ 0114- 0115), the needle shroud (39) is arranged to be translated distally into the housing (4, 38) into a distal position against a load of a shroud spring (restoring spring as described in Kohlbrenner ¶ 0098) when the needle shroud (39) is pushed against an injection site for allowing release of the torsion spring (25), and the needle shroud (39) is rotationally fixed to the housing (4, 38), the configuration for preventing needle sticks after an injection (Kohlbrenner ¶ 0114; Fig. 19).
Therefore, it would have been obvious to one or ordinary skill in the art at the time of the invention to have modified Patent ‘250 to include a needle shroud arranged in the housing and translatable in a longitudinal direction, wherein: the needle shroud is configured to be in an initial position protruding from a proximal end of the housing in an initial state for preventing release of the torsion spring, the needle shroud is arranged to be translated distally into the housing into a distal position against a load of a shroud spring when the needle shroud is pushed against an injection site for allowing release of the torsion spring, and the needle shroud is rotationally fixed to the housing as disclosed by Kohlbrenner for preventing needle sticks after an injection (Kohlbrenner ¶ 0114; Fig. 19).
Re Claim 23, Claim 1 of Patent ‘250 discloses all of the limitations of Claim 16. However, the claims of Patent ‘250 fail to disclose an audible feedback mechanism associated with the plunger and configured to communicate to a user an audible feedback indicative of the movement of the plunger. Kohlbrenner teaches an auto-injector for administering a dose of a liquid medicament (Kohlbrenner Figs. 19-22), the auto-injector comprising: a housing (4, 38) configured to contain a medicament container (2), a plunger (15), and a torsion spring (25); and an audible feedback mechanism (Kohlbrenner ¶ 0101) associated with the plunger (15) and configured to communicate to a user audible feedback indicative of the movement of the plunger (15) thus preventing rotational movement in the opposite direction (Kohlbrenner ¶ 0101-0106). Therefore, it would have been obvious to one or ordinary skill in the art at the time of the invention to have modified Patent ‘250 to include an audible feedback mechanism associated with the plunger and configured to communicate to a user an audible feedback indicative of the movement of the plunger as disclosed by Kohlbrenner for preventing rotational movement in the opposite direction (Kohlbrenner ¶ 0101-0106).
Re Claim 24, Claim 1 of Patent ‘250 in view of Kohlbrenner teach all of the limitations of Claim 23. The claims of Patent ‘250 fail to teach wherein the audible feedback mechanism comprises a ratchet. Kohlbrenner teaches wherein the audible feedback mechanism comprises an audible ratchet, the ratchet for preventing rotational movement in the opposite direction (ratchet as described in Kohlbrenner ¶ 0101 describing interaction of blocking elements 24 and 34). Therefore, it would have been obvious to one or ordinary skill in the art at the time of the invention to have modified the audible feedback mechanism of Patent ‘250 in view of Kohlbrenner to comprise a ratchet as disclosed by Kohlbrenner for preventing rotational movement in the opposite direction (Kohlbrenner ¶ 0101-0106).
Re Claim 25, Patent ‘250 in view of Kohlbrenner teach all of the limitations of Claim 24. The claims of Patent ‘250 fail to teach wherein the ratchet operates in response to the movement of the plunger. Kohlbrenner teaches wherein the ratchet operates in response to the movement of the plunger (15) for preventing rotational movement in the opposite direction (Kohlbrenner ¶ 0101-0106). Therefore, it would have been obvious to one or ordinary skill in the art at the time of the invention to have modified the ratchet of Patent ‘250 in view of Kohlbrenner such that the ratchet operates in response to the movement of the plunger as disclosed by Kohlbrenner for preventing rotational movement in the opposite direction (Kohlbrenner ¶ 0101-0106).
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of USPN 12,514,989, hereinafter Patent ‘989. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims use different language for the same structures, word the claims differently, and order elements in a different manner.
Re Claim 30, Claim 1 of Patent ‘989 discloses a method of administering a dose of a liquid medicament using an auto-injector, the method comprising: activating a releasing trigger of the auto-injector, the auto-injector comprising a housing, a medicament container disposed in the housing and containing the medicament, a plunger, a torsion spring, and a gear arrangement, wherein the releasing trigger is operable to release the torsion spring from a biased state; releasing the torsion spring from the biased state; and converting torque, by the gear arrangement, from a distal end of the torsion spring into an administration movement of the plunger in a proximal direction from an initial position to a proximal end position to administer the dose, wherein the plunger is rotationally fixed in relation to the housing, and wherein torque provided by the torsion spring is converted into movement of the plunger during an entire movement of the plunger from the initial position into the proximal end position, and wherein the administration movement of the plunger comprises movement of the plunger in the proximal direction relative to the housing and the initial position of the plunger is the position of the plunger relative to the housing before the releasing trigger is operated. In the present case, the limitation “wherein the auto-injector can be operated only once and only for administering one dose of medicament” is being determined an implicit function of the auto-injector of the present case.
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 16-30 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