DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive. Applicant argues that Murakami fails to teach “providing a prompt to said user to perform opening of said pivot mount element” and the latch operating “in response to operation of said user facility” because applicant asserts that Murakami teaches away from this limitation, based on ¶0011,0073, 0170 of Murakami. However, the controller of Murakami is further disclosed as “telling the user to open the cartridge holder 7” in ¶0153, which is a prompt to a user to perform opening of the pivot mount element (7), even if there are specific conditions that need to be fulfilled to cause this prompt. The claim limitation does not exclude extra requirements being part of this prompt. In addition, the limitation “said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility” is a broad functional limitation. The user uses the user input facility (6) to set a dose before injecting the dose which then ultimately opens the latch after delivery of the set dose. This means that ultimately the motor is fully capable of opening the mechanical latch in response to operating the user input facility, which thereby anticipates the broad limitation of the claim. As such, the rejections are maintained as detailed below.
Examiner further notes that the terminal disclaimer filed by the applicant was disapproved in the decision sent to the applicant 31 December 2025. As such, the non-statutory double patenting rejections are maintained as detailed below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, 8-9, 12-14, 17-18, 33, 35, 38, 43-44, and 76-79 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murakami et al (US 2015/0328404).
Regarding claim 1, Murakami discloses:
A computer-controlled injector (Fig. 1) for use with a medicament cartridge (9; Fig. 2) and comprising: a housing (1) including a medicament cartridge receiving volume (¶0055) and a medicament cartridge insertion and removal opening (8) communicating with said medicament cartridge receiving volume; a pivot mount element (7) mounted onto said housing (1) for selectably enabling access to said medicament cartridge receiving volume via said opening (8) (¶0046); a mechanical latch (19; Fig. 4B) selectably locking said pivot mount element (7) in a closed operative orientation (Fig. 1); a computer interactive user interface (25; Fig. 8; ¶0068) including a display (5) and user input facility (6), said computer interactive user interface (25) providing a prompt to said user to perform opening of said pivot mount element (7) (S15; Fig. 16; ¶0153) and an injection drive mechanism (100; Fig. 3) including a computer-controlled motor (13) for driving a piston (sealing element within cartridge 9), forming part of said medicament cartridge (9), for injecting a medicament (¶0050), said computer-controlled motor (13) also being operative for operating said mechanical latch (19) in response to operation of said user input facility (Fig. 16 – user input causes the medicament to be delivered, which then initiates the operation for replacing the cartridge 9 and therefore controlling the latch 19).
Regarding claim 2, Murakami discloses:
A computer-controlled injector (Fig. 1) for use with a medicament cartridge (9; Fig. 2) and comprising: a housing (1) including a medicament cartridge receiving volume (¶0055) and a medicament cartridge insertion and removal opening (8) communicating with said medicament cartridge receiving volume; a pivot mount element (7) mounted onto said housing (1) for selectably enabling access to said medicament cartridge receiving volume via said opening (8) (¶0046); a computer interactive user interface (25; Fig. 8; ¶0068) including a display (5) and user input facility (6), said computer interactive user interface (25) providing a prompt to said user to perform opening of said pivot mount element (7) (S15; Fig. 16; ¶0153); and an injection drive mechanism (100; Fig. 3) including a computer-controlled motor (13) for driving a piston (sealing element within cartridge 9), forming part of said medicament cartridge (9), for injecting a medicament (¶0050), said computer-controlled motor (13) also being operative for enabling opening of said pivot mount element (7) in response to operation of said user input facility (Fig. 16 – user input causes the medicament to be delivered, which then initiates the operation for replacing the cartridge 9 and therefore controlling the latch 19).
Regarding claim 4, Murakami discloses:
The computer-controlled injector according to claim 1 and also comprising a moveable subassembly (10, 11), which is linearly displaceable by said computer-controlled motor (13) for linearly displacing said piston (¶0051-0052), said moveable subassembly (10, 11) including a mechanical latch engagement portion (20) which engages said mechanical latch (19) when said moveable subassembly (10, 11) is at a predetermined linear position with respect to said medicament cartridge (9) (¶0062 – unless the rod 10 is fully retracted, engagement portion 20 engages latch 19 to keep the pivot mount element 7 closed).
Regarding claim 5, Murakami discloses:
The computer-controlled injector according to claim 4 and wherein said mechanical latch engagement portion (20) unlatches said mechanical latch (19), thereby allowing opening of said pivot mount element (7), only when said moveable subassembly (10, 11) is entirely retracted from said medicament cartridge (9) (¶0156-0157).
Regarding claim 8, Murakami discloses:
The computer-controlled injector according to claim 1 and also comprising a biasing element (18) operative to open said pivot mount element (7) except when said pivot mount element (7) is locked in said closed operative orientation (Fig. 3) by said mechanical latch (19) (¶0057-0060).
Regarding claim 9, Murakami discloses:
The computer-controlled injector according to claim 1 and wherein said pivot mount element (7) is pivotably mounted onto said housing (1) (Fig. 1 to Fig. 2).
Regarding claim 12, Murakami discloses:
The computer-controlled injector according to claim 1 and wherein said pivot mount element (7) comprises a threaded portion (14) for mounting of a needle assembly (16) thereon (¶0055).
Regarding claim 13, Murakami discloses:
The computer-controlled injector according to claim 1 and also comprising a needle presence responsive element (15; Fig. 7), configured to be coupled to said pivot mount element (7), and being axially displaceable (Fig. 7a to Fig. 7c), thereby indicating mounting of a needle assembly (16) to said pivot mount element (7).
Regarding claim 14, Murakami discloses:
The computer-controlled injector according to claim 1 and wherein said mechanical latch (19) is biased to be positioned in a locked operative orientation (Fig. 4B) by the biasing force of a biasing element (21) (¶0066).
Regarding claim 17, Murakami discloses:
The computer-controlled injector according to claim 1 and also comprising a PCB assembly (Fig. 8) including at least one of: a cartridge sensor, which is configured to indicate whether said medicament cartridge is inserted into said medicament cartridge receiving volume, a needle sensor (15), which is configured to indicate whether a needle assembly (16) is mounted to said pivot mount element (7) (¶0077), and a cartridge enclosure assembly state sensor (24), which is configured to indicate whether said pivot mount element (7) is disposed in an open or a closed operative orientation (¶0075).
Regarding claim 18, Murakami discloses:
The computer-controlled injector according to claim 4 and wherein when said moveable subassembly (10, 11) is disposed in a forward operative orientation (Fig. 5), said mechanical latch (19) is latched and urges said pivot mount element (7) to assume said closed operative orientation (Fig. 5); when said moveable subassembly (10, 11) is disposed in a rearward operative orientation (Fig. 3), said mechanical latch (19) is unlatched and urges said pivot mount element to assume an open operative orientation (Fig. 2) (¶0128) and when said moveable subassembly (10, 11) is disposed in an intermediate operative orientation (Fig. 14), said mechanical latch (19) urges said pivot mount element (7) to assume a snapped operative orientation (¶0134 – the snapped operative orientation has latch engagement portion 20 in a lowered position, as seen in Fig. 15B, to be ready to snap the latch 19 closed).
Regarding claim 33, Murakami discloses:
A computer-controlled injection method for use with a medicament cartridge (9; Fig. 2) and an injector (Fig. 1) including: a housing (1)
including a medicament cartridge receiving volume (¶0055) and a medicament cartridge insertion and removal opening (8) communicating with said medicament cartridge receiving volume; a pivot mount element (7) mounted onto said housing (1) for selectably enabling access to said medicament cartridge receiving volume via said opening (8) (¶0046), said pivot mount element (7) being normally open unless latched closed (¶0059); a computer interactive user interface (25; Fig. 8; ¶0068) including a display (5) and user input facility (6), said computer interactive user interface (25) providing a prompt to said user to perform opening of said pivot mount element (7) (S15; Fig. 16; ¶0153); and an injection drive mechanism (100; Fig. 3) including a computer-controlled motor (13) for driving a piston (sealing element within cartridge 9), forming part of said medicament cartridge (9), for injecting a medicament (¶0050), the method comprising: operating said computer-controlled motor (13) for permitting said pivot mount element (7) to assume a biased open operational orientation (Fig. 2) to permit insertion of said medicament cartridge (9) into said medicament cartridge receiving volume (¶0196-0200 – user activates the cartridge holder (7), which causes motor 13 to retract the rod 10 and open the latch 19); thereafter, manually pushing the pivot mount element (7) to a closed position (Fig. 1) (¶0064); thereafter, automatically operating said computer-controlled motor (13) to lock said pivot mount element (7) in said closed position (¶0066 – the motor 13 automatically moves rod 10 to place locking element 20 into its locking position, which automatically causes the mount element 7 to stay locked in the closed position), thereby preventing opening of said pivot mount element (7); thereafter, operating said computer-controlled motor (13) for driving said piston (¶0070); thereafter, operating said user input facility (25) to enable opening of said pivot mount element (7) by said computer-controlled motor (13) (Fig. 16).
Regarding claim 35, Murakami discloses:
The computer-controlled injection method according to claim 33 and wherein operating said computer-controlled motor (13) comprises positioning of a mechanical latch (19) in an unlocked operative orientation (Fig. 13B) for permitting said pivot mount element (7) to assume said biased open operational orientation (Fig. 2).
Regarding claim 38, Murakami discloses:
The computer-controlled injection method according to claim 35 and also comprising employing a biasing element (18) operative to open said pivot mount element (7) except when said pivot mount element (7) is locked in said closed operative orientation (Fig. 1) by said mechanical latch (19).
Regarding claim 43, Murakami discloses:
The computer-controlled injection method according to claim 33 and also comprising a needle presence responsive element (15; Fig. 7), configured to be coupled to said pivot mount element (7), and being axially displaceable (Fig. 7a to Fig. 7c), thereby indicating mounting of a needle assembly (16) to said pivot mount element (7) (¶0077).
Regarding claim 44, Murakami discloses:
The computer-controlled injection method according to claim 33 and also comprising a PCB assembly (Fig. 8) including at least one of a cartridge sensor, which is configured to indicate whether said medicament cartridge is inserted into said medicament cartridge receiving volume, a needle sensor (15), which is configured to indicate whether a needle assembly (16) is mounted to said pivot mount element (7) (¶0077), and a cartridge enclosure assembly state sensor (24), which is configured to indicate whether said pivot mount element (7) is disposed in an open or a closed operative orientation (¶0075).
Regarding claim 76, Murakami discloses:
The computer-controlled injector according to claim 2 and also comprising a moveable subassembly (10, 11), which is linearly displaceable by said computer-controlled motor (13) for linearly displacing said piston (¶0051-0052), said moveable subassembly (10, 11) including a mechanical latch engagement portion (20) which engages said mechanical latch (19) when said moveable subassembly (10, 11) is at a predetermined linear position with respect to said medicament cartridge (9) (¶0062 – unless the rod 10 is fully retracted, engagement portion 20 engages latch 19 to keep the pivot mount element 7 closed).
Regarding claim 77, Murakami discloses:
The computer-controlled injector according to claim 2 and also comprising a biasing element (18) operative to open said pivot mount element (7) except when said pivot mount element (7) is locked in said closed operative orientation (Fig. 1) by said mechanical latch (19).
Regarding claim 78, Murakami discloses:
The computer-controlled injector according to claim 2 and also comprising a needle presence responsive element (15; Fig. 7), configured to be coupled to said pivot mount element (7), and being axially displaceable (Fig. 7a to Fig. 7c), thereby indicating mounting of a needle assembly (16) to said pivot mount element (7) (¶0077).
Regarding claim 79, Murakami discloses:
The computer-controlled injector according to claim 2 and wherein said mechanical latch (19) is biased to be positioned in a locked operative orientation (Fig. 4B) by the biasing force of a biasing element (21) (¶0066).
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 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,571,516. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as follows:
Instant
Patent
1. A computer-controlled injector for use with a medicament cartridge and comprising:
a housing including a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume;
a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening;
a mechanical latch selectably locking said pivot mount element in a closed operative orientation;
a computer interactive user interface including a display and user input facility,
said computer interactive user interface providing a prompt to said user to perform opening of said pivot mount element and
an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament,
said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility.
1. A computer-controlled injector for use with a medicament cartridge and comprising:
a housing including a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume;
a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening;
a mechanical latch selectably locking said pivot mount element in a closed operative orientation;
a computer interactive user interface including a display and user input facility,
said computer interactive user interface providing a prompt to said user to perform a priming function and requiring a confirmatory indication, indicating carrying out of at least part of said priming function before permitting injection to take place; and
said computer interactive user interface providing a prompt to said user to perform opening of said pivot mount element,
an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament,
said injection drive mechanism being responsive to operation of said user input facility for performing said priming function,
said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility.
2. A computer-controlled injector for use with a medicament cartridge and comprising:
a housing including a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume;
a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening;
a computer interactive user interface including a display and user input facility,
said computer interactive user interface providing a prompt to said user to perform opening of said pivot mount element; and
an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament,
said computer-controlled motor also being operative for enabling opening of said pivot mount element in response to operation of said user input facility.
1. A computer-controlled injector for use with a medicament cartridge and comprising:
a housing including a medicament cartridge receiving volume and a medicament cartridge insertion and removal opening communicating with said medicament cartridge receiving volume;
a pivot mount element mounted onto said housing for selectably enabling access to said medicament cartridge receiving volume via said opening;
a mechanical latch selectably locking said pivot mount element in a closed operative orientation;
a computer interactive user interface including a display and user input facility,
said computer interactive user interface providing a prompt to said user to perform a priming function and requiring a confirmatory indication, indicating carrying out of at least part of said priming function before permitting injection to take place; and
said computer interactive user interface providing a prompt to said user to perform opening of said pivot mount element,
an injection drive mechanism including a computer-controlled motor for driving a piston, forming part of said medicament cartridge, for injecting a medicament,
said injection drive mechanism being responsive to operation of said user input facility for performing said priming function,
said computer-controlled motor also being operative for operating said mechanical latch in response to operation of said user input facility.
Conclusion
THIS ACTION IS MADE FINAL. 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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783