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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Claim Objections
Claims 11-14 are objected to because of the following informalities: Claims 11-14 are listed as withdrawn. However, claims 11-14 comprise no content. Examiner is treating Claims 11-14 as cancelled. Examiner requests that applicant list Claims 11-14 as cancelled as opposed to withdrawn.
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 and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. Patent No. 8,517,983, hereinafter Kakiuchi, in view of Hommann et al. (USPGPub 2006/0111666).
Re Claim 1, Kakiuchi Claim 1 discloses a dual chamber prefillable syringe comprising: a cylinder which has a cylindrical shape with an axis line as a center and has a bypass portion formed due to bulging of a part of an inner circumferential surface to an outside; a hub luer- lock which is provided at a front end of the cylinder; a finger grip which is provided at a rear end of the cylinder; a front stopper which is fitted on a front end side of the bypass portion in the cylinder; a middle stopper which is fitted on a rear end side of the bypass portion in the cylinder to seal a preparation together with the front stopper; an end stopper which is fitted into a portion of the cylinder which is on a rear end side of the middle stopper to seal a solvent together with the middle stopper; a plunger rod which is connected to the end stopper from a rear end side of the end stopper through the finger grip; a female screw portion which is formed to be screwed around the axis line onto an inner circumferential surface of the finger grip; and a male screw portion which is formed to be able to be screwed to the female screw portion, male screw portion being formed on an outer circumferential surface of the plunger rod between a first position and a second position that are different positions in an axial direction along the axis line (the last limitation involving a first position and a second position is implicitly disclosed by Kakiuchi Claim 1 limitation “an outer peripheral surface of the plunger rod is formed with a first male screw portion” wherein having a male screw portion implies male screw portion being formed on an outer circumferential surface of the plunger rod between a first position and a second position that are different positions in an axial direction along the axis line).
Kakiuchi Claim 1 further discloses a guide groove which is formed in the female screw portion and extends parallel to the axis line; and a guide plate which is formed on a rear end side of the male screw portion on the outer circumferential surface of the plunger rod and is guided in accordance with the guide groove; a first protrusion which is formed at a rear end of the finger grip and with which the guide plate is brought into contact so as to be able to surmount the first protrusion when at least a part of the middle stopper which is advanced by rotating the plunger rod in accordance with the female screw portion and the male screw portion moves out of the bypass portion; and a second protrusion which is formed at the rear end of the finger grip and with which the guide plate having surmounted the first protrusion is brought into contact at a position in which the guide plate can be fitted to the guide groove, wherein a front end of the male screw portion is disposed on the plunger rod such that the front end of the male screw portion reaches a rear end of the female screw portion and can be screwed thereto when a front end of the male screw portion reaches a rear end of the female screw portion and can be screwed thereto when a front end of the middle stopper which is advanced by pressing the plunger rod enters the bypass portion or before the front end of the middle stopper reaches a rear end of the bypass portion, a rear end of the male screw portion is disposed on the plunger rod such that a screwing between the male screw portion and the female screw portion is released when the guide plate is positioned between the first protrusion and the second protrusion.
However, the claims of Kakiuchi fail to teach the male screw portion is formed at an equal pitch on the entire range between the first position and the second position of the plunger rod, the front end of the male screw portion is disposed at the first position, and the rear end of the male screw portion is disposed at the second position. In the instant case, this limitation is being considered as implicitly disclosed by the claims of Kakiuchi wherein the make screw portion would have to be formed at an equal pitch on the entire range between the first position and the second position of the plunger rod, the front end of the male screw portion is disposed at the first position, and the rear end of the male screw portion is disposed at the second position for the device to function properly. Regardless, this limitation is well known in the prior art.
Hommann teaches a dual chamber prefillable syringe (Hommann Figs. 1-3) comprising: a cylinder (1) with a bypass portion (3); a plunger rod (11), a male screw portion (20); and a female screw portion (21), wherein the male screw portion (20) is formed at an equal pitch on the entire range between a first position (Hommann Figs. 1-3) and a second position (Hommann Figs. 1-3) of the plunger rod (11), the front end of the male screw portion (20) is disposed at the first position, and the rear end of the male screw portion (20) is disposed at the second position (Hommann ¶ 0036-0037), thus making it possible to set the axial path of stoppers within the cylinder during rotation of the male screw portion in relation to the female screw portion (Hommann ¶ 0013 and 0025).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the male screw portion of Kakiuchi to be formed at an equal pitch on the entire range between the first position and the second position of the plunger rod, the front end of the male screw portion is disposed at the first position, and the rear end of the male screw portion is disposed at the second position as disclosed by Hommann, thus making it possible to set the axial path of stoppers within the cylinder during rotation of the male screw portion in relation to the female screw portion (Hommann ¶ 0013 and 0025).
Re Claim 9, Kakiuchi Claim 1 in view of Hommann teach all of the limitations of Claim 1. The claims of Kakiuchi fail to teach wherein the plunger rod and the end stopper advance in accordance with pitches of the male screw portion and the female screw portion by rotating the plunger rod around the axis line in a state where the male screw portion is screwed to the female screw portion, and the pitches of the male screw portion and the female screw portion are set such that the middle stopper stays in the bypass portion while the solvent flows from a rear side to a front side of the bypass portion in accordance with an advance of the end stopper. Hommann teaches wherein the plunger rod (11) and an end stopper (4) advance in accordance with pitches of the male screw portion (20) and the female screw portion (21) by rotating the plunger rod (11) around the axis line in a state where the male screw portion (20) is screwed to the female screw portion (21), and the pitches of the male screw portion (20) and the female screw portion (21) are set such that a middle stopper (5) stays in the bypass portion (3) while a solvent (8) flows from a rear side to a front side of the bypass portion (3) in accordance with an advance of the end stopper (4) (Hommann ¶ 0036-0037), thus making it possible to set the axial path of stoppers within the cylinder during rotation of the male screw portion in relation to the female screw portion (Hommann ¶ 0013 and 0025).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the plunger rod and the end stopper of Kakiuchi Claim 1 in view of Hommann in accordance with pitches of the male screw portion and the female screw portion by rotating the plunger rod around the axis line in a state where the male screw portion is screwed to the female screw portion, and the pitches of the male screw portion and the female screw portion are set such that the middle stopper stays in the bypass portion while the solvent flows from a rear side to a front side of the bypass portion in accordance with an advance of the end stopper as disclosed by Hommann, thus making it possible to set the axial path of stoppers within the cylinder during rotation of the male screw portion in relation to the female screw portion (Hommann ¶ 0013 and 0025).
Re Claim 10, Kakiuchi Claim 1 in view of Hommann teach all of the limitations of Claim 1. Claim 2 of Kakiuchi teaches wherein an area other than an area between the first position and the second position on the outer circumferential surface of the plunger rod is provided with no male screw portion.
Claims 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of U.S. Patent No. 8,517,983, hereinafter Kakiuchi, in view of Hommann et al. (USPGPub 2006/0111666) above, and further in view of Williams (USPGPub 2006/0079846).
Re Claim 7, Kakiuchi Claim 1 in view of Hommann disclose all of the limitations of Claim 1 in the present case. However, prior patent Kakiuchi in view of Hommann fail to disclose wherein the preparation includes aripiprazole. Williams teaches prefilled syringes containing preparations such as aripiprazole (Williams ¶ 0010) for the purpose of reducing the danger involved in administering an antipsychotic drug such as aripiprazole to a violent/dangerous patient (Williams ¶ 0002-0006). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the dual chamber prefillable syringe of Kakiuchi in view of Hommann to include a prefilled preparation of aripiprazole as taught by Williams for the purpose of reducing the danger involved in administering an antipsychotic drug such as aripiprazole to a violent/dangerous patient (Williams ¶ 0002-0006).
Re Claim 8, Kakiuchi Claim 1 discloses a dual chamber prefillable syringe comprising: a cylinder which has a cylindrical shape with an axis line as a center and has a bypass portion formed due to bulging of a part of an inner circumferential surface to an outside; a hub luer- lock which is provided at a front end of the cylinder; a finger grip which is provided at a rear end of the cylinder; a front stopper which is fitted on a front end side of the bypass portion in the cylinder; a middle stopper which is fitted on a rear end side of the bypass portion in the cylinder to seal a preparation together with the front stopper; an end stopper which is fitted into a portion of the cylinder which is on a rear end side of the middle stopper to seal a solvent together with the middle stopper; a plunger rod which is connected to the end stopper from a rear end side of the end stopper through the finger grip; a female screw portion which is formed to be screwed around the axis line onto an inner circumferential surface of the finger grip; and a male screw portion which is formed to be able to be screwed to the female screw portion, male screw portion being formed on an outer circumferential surface of the plunger rod between a first position and a second position that are different positions in an axial direction along the axis line (the last limitation involving a first position and a second position is implicitly disclosed by Kakiuchi Claim 1 limitation “an outer peripheral surface of the plunger rod is formed with a first male screw portion” wherein having a male screw portion implies male screw portion being formed on an outer circumferential surface of the plunger rod between a first position and a second position that are different positions in an axial direction along the axis line).
Kakiuchi Claim 1 further discloses a guide groove which is formed in the female screw portion and extends parallel to the axis line; and a guide plate which is formed on a rear end side of the male screw portion on the outer circumferential surface of the plunger rod and is guided in accordance with the guide groove; a first protrusion which is formed at a rear end of the finger grip and with which the guide plate is brought into contact so as to be able to surmount the first protrusion when at least a part of the middle stopper which is advanced by rotating the plunger rod in accordance with the female screw portion and the male screw portion moves out of the bypass portion; and a second protrusion which is formed at the rear end of the finger grip and with which the guide plate having surmounted the first protrusion is brought into contact at a position in which the guide plate can be fitted to the guide groove, wherein a front end of the male screw portion is disposed on the plunger rod such that the front end of the male screw portion reaches a rear end of the female screw portion and can be screwed thereto when a front end of the male screw portion reaches a rear end of the female screw portion and can be screwed thereto when a front end of the middle stopper which is advanced by pressing the plunger rod enters the bypass portion or before the front end of the middle stopper reaches a rear end of the bypass portion, a rear end of the male screw portion is disposed on the plunger rod such that a screwing between the male screw portion and the female screw portion is released when the guide plate is positioned between the first protrusion and the second protrusion.
However, prior patent Kakiuchi in view of Hommann fail to disclose wherein the syringe comprising aripiprazole. Williams teaches prefilled syringes containing preparations such as aripiprazole (Williams ¶ 0010) for the purpose of reducing the danger involved in administering an antipsychotic drug such as aripiprazole to a violent/dangerous patient (Williams ¶ 0002-0006). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the syringe of Kakiuchi to include a prefilled preparation of aripiprazole as taught by Williams for the purpose of reducing the danger involved in administering an antipsychotic drug such as aripiprazole to a violent/dangerous patient (Williams ¶ 0002-0006).
The claims of Kakiuchi also fail to teach the male screw portion is formed at an equal pitch on the entire range between the first position and the second position of the plunger rod, the front end of the male screw portion is disposed at the first position, and the rear end of the male screw portion is disposed at the second position. In the instant case, this limitation is being considered as implicitly disclosed by the claims of Kakiuchi wherein the make screw portion would have to be formed at an equal pitch on the entire range between the first position and the second position of the plunger rod, the front end of the male screw portion is disposed at the first position, and the rear end of the male screw portion is disposed at the second position for the device to function properly. Regardless, this limitation is well known in the prior art.
Hommann teaches a dual chamber prefillable syringe (Hommann Figs. 1-3) comprising: a cylinder (1) with a bypass portion (3); a plunger rod (11), a male screw portion (20); and a female screw portion (21), wherein the male screw portion (20) is formed at an equal pitch on the entire range between a first position (Hommann Figs. 1-3) and a second position (Hommann Figs. 1-3) of the plunger rod (11), the front end of the male screw portion (20) is disposed at the first position, and the rear end of the male screw portion (20) is disposed at the second position (Hommann ¶ 0036-0037), thus making it possible to set the axial path of stoppers within the cylinder during rotation of the male screw portion in relation to the female screw portion (Hommann ¶ 0013 and 0025). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the male screw portion of Kakiuchi to be formed at an equal pitch on the entire range between the first position and the second position of the plunger rod, the front end of the male screw portion is disposed at the first position, and the rear end of the male screw portion is disposed at the second position as disclosed by Hommann, thus making it possible to set the axial path of stoppers within the cylinder during rotation of the male screw portion in relation to the female screw portion (Hommann ¶ 0013 and 0025).
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 filed 09/17/2025 have been fully considered but they are not persuasive. At the bottom of Page 9 of the response, applicant argues the limitation "the male screw portion is screwed to the female screw portion when the entire middle stopper is disposed inside the bypass portion," an amendment made to independent Claims 1 and 8, was not properly addressed in the final action dated 06/17/2025. However, this limitation is taught by Hommann Figs. 1-3. Applicant goes on to argue Kakiuchi requires "before the middle stopper completely enters the bypass portion by further moving the middle stopper forward by rotating the plunger rod with respect to the finger grip, the screwing of the first male screw portion into the female screw portion is released." Examiner is available for interview should applicant like to discuss the present case to determine avenues for allowance.
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.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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