Notice of 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 .
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.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,127,861.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,127,861.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,127,861.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12,127,861.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No. 12,127,861.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,127,861.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,127,861.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,127,861.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,127,861.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,127,861.
Claim 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 12,127,861.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,127,861.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,127,861.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,127,861.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,127,861.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,127,861.
Although the claims at issue are not identical, they are not patentably distinct from each other because all the elements of instant claims 1-11,14-18 are recited in patented claims 1-8, and 12 as shown in the table below.
Claims USPN 12,127,861
Claims instant application
Claim 1. A system for packaging instruments for sterilization, comprising: an input for receiving instrument identification data; an instrument processor coupled to the input, the instrument processor including a database and an instrument analyzer, wherein the database is configured to store instrument type data, instrument packaging data, and package labeling data;
the instrument analyzer is configured to identify an instrument based on the received instrument identification data to determine an instrument packaging type based on the identified instrument, and to determine a labeling associated with the identified instrument using data stored in the database;
wherein the instrument analyzer is further configured to determine instrument handling instructions, packaging instructions, and labeling instructions based on the determined instrument packaging type;
and an output coupled to the instrument processor, wherein the output is configured for sending the handling instructions, packaging instructions, and labeling instructions to at least one external device, the at least one external device including a packager configured to, for each identified instrument, automatically customize a variably sized package cut from bulk packaging material based on the received instrument identification data for the identified instrument, in response to packaging instructions received from the instrument processor, such that a plurality of variably sized packages are automatically produced.
Claim 1. A system for packaging instruments, comprising: an input for receiving instrument identification data; an instrument processor coupled to the input, the instrument processor including a database and an instrument analyzer, the database to store instrument type data, instrument packaging data and package labeling data,
the instrument analyzer to identify instrument type and to determine instrument packaging and labeling using data stored in the database,
the instrument analyzer further to determine instrument handling, packaging and labeling instructions;
and an output coupled to the instrument processor, the output for sending the handling, packaging and labeling instructions to at least one packager and labeling instructions to a labeler, wherein the packager is configured to select a package from a plurality of variably sized packages based on the packaging instructions, and the labeler is configured to produce a label to be affixed to the package based on the labeling instructions.
(The Labeler as written is equivalent to the external device with the ability to have labeling instructions based on instrument type)
Claim 2. The system of claim 1 wherein the at least one external device further comprises a labeler.
Claim 2. The system of claim 1 wherein the at least one external device further comprises a labeler.
Claim 1 “the at least one external device including a packager”
Claim 3. The system of claim 1 wherein the at least one external device further comprises a packager.
Claim 3. The system of claim 1 wherein the packager is a packaging turret holding a plurality of instrument pouches.
Claim 4. The system of claim 3 wherein the packager is a packaging turret holding a plurality of instrument pouches.
Claim 4. The system of claim 1, wherein the packager is a unit that holds a roll of packaging tubing and cuts and forms the customized packages.
Claim 5. The system of claim 3 wherein the packager is a unit that holds a roll of packaging tubing and cuts and forms a package in response to instructions received from the instrument processor.
Claim 5. The system of claim 1 wherein the at least one external device further comprises a transfer device for transferring the instrument from an instrument identification platform to a package element.
Claim 6. The system of claim 1 wherein the at least one external device further comprises a transfer device for transferring the instrument from an instrument identification platform to a package element.
Claim 6. The system of claim 5 wherein the transfer device further comprises a catch and release mechanism.
Claim 7. The system of claim 6 wherein the transfer device further comprises a catch and release mechanism.
Claim 7. The system of claim 5 wherein the transfer device further comprises a robotic arm.
Claim 8. The system of claim 6 wherein the transfer device further comprises a robotic arm.
Claim 8. The system of claim 5 wherein the package element is a peel pouch.
Claim 9. The system of claim 6 wherein the package element is a peel pouch.
Claim 1. “A system for packaging instruments for sterilization” interpreted as a sterilization device
Claim 10. The system of claim 1, wherein the system further comprises a sterilization device
Claim 5. The system of claim 1 wherein the at least one external device further comprises a transfer device for transferring the instrument from an instrument identification platform to a package element.
Claim 11. The system of claim 6, wherein the system further comprises a sterilization device,
wherein the transfer device transfers the package containing the one or more instruments to the
sterilization device.
Claim 1. “an output coupled to the instrument processor, wherein the output is configured for sending the handling instructions, packaging instructions, and labeling instructions”
Claim 14. The system of claim 1, wherein the instrument processor is configured to generate
pouch label content based on instrument type and packaging parameters.
Claim 1. “to determine a labeling associated with the identified instrument using data stored in the database”
Claim 15. wherein the system is configured to send instrument data to a log. (a log is interpreted as a database)
Claim 12. A method for packaging instruments for sterilization, the method comprising steps of: receiving at an input information relating to instrument identification data; identifying an instrument using the received instrument identification data and stored instrument data; determining and selecting an instrument packaging based on the received instrument identification data, the received instrument identification data including instrument size data associated with the identified instrument; determining label information for the packaging; and creating packaging instructions and labelling instructions to prepare the instrument and packaging based on the determined and selected instrument packaging, the instructions being configured to be provided to at least one packaging device configured to, for each identified instrument, automatically customize a variably sized package cut from bulk packaging material based on the received instrument identification data for the identified instrument, in response to packaging instructions received, such that a plurality of variably sized packages are automatically produced.
Claim 16. A method for packaging medical instruments with an instrument packaging and
labeling system, comprising:
identifying one or more instruments via an instrument processor, the instrument processor
including a database and an instrument analyzer, wherein the database contains instrument type
data, instrument packaging data, and package labeling data,
the instrument analyzer further configured to determine instrument packaging and labeling
using data stored in the database based on the identified one or more instruments, the instrument
analyzer further configured to:
determine instrument packaging and labeling instructions; and
provide an output with instrument packaging instructions and labeling instructions to a
packager and a labeler, wherein the packager selects a package from a plurality of variably sized packages based on the packaging instructions,
Claim 12. “determining label information for the packaging; and creating packaging instructions and labelling instructions to prepare the instrument and packaging based on the determined and selected instrument packaging”
Claim 17. The method of claim 16, wherein the instrument processor is configured to generate
label content based on instrument type and packaging parameters stored in the database.
Claim 12. “identifying an instrument using the received instrument identification data and stored instrument data; determining and selecting an instrument packaging based on the received instrument identification data”
Claim 18 The method of claim 16, wherein the instrument packaging and labeling system
sends instrument data to a log.
Allowable Subject Matter
Claims 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 1/02/2026 have been fully considered but they are not persuasive. Although amended to include the allowable subject matter of the parent case 15/068,420, no terminal disclaimer has been filed, the amendments to the claims do not overcome the non-statutory double patenting as recited herein, additionally new claims 14-18 are also now rejected as being unpatentable of non-statutory double patenting, claims 12-13 are new to prosecution and are not rejected under non-statutory double patenting, but are objected to as being dependent from rejected claim 1.
Regarding the arguments related to the prior art rejection, after the latest amendment, claims 1-11 and 14-18 are currently free from prior art. However, a subsequent prior art rejection may be made in view of Applicant’s amendments submitted to overcome the double patenting rejection
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 MARY C HIBBERT-COPELAND whose telephone number is (571)270-0601. The examiner can normally be reached M-TH 9am -5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at 5712701926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY C HIBBERT-COPELAND/Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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