DETAILED CORRESPONDENCE
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This office action is in response to the Patent Application filed on 16 January 2025. This is a non-final first office action on merits. Claim 1 is cancelled. Claims 2-21 are pending and considered below.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. The instant application claims priority to U.S. application Ser. No. 18/390, 664 now U.S. Patent 12,293,812 which was filed on Dec. 20, 2023, which claims priority to U.S. application Ser. No. 17/856, 384 now U.S. Patent 11,894,115 which was filed on Jul. 1, 2022, which claims priority to U.S. application Ser. No. 15/569,629, which was filed on Oct. 26, 2017, which claims priority to PCT/US2016/029324 filed on Apr. 26, 2016, which claims priority to Provisional Application No. 62/153,100 filed on Apr. 27, 2015 and Provisional Application No. 62/258,855, filed on Nov. 23, 2015.
Examiner acknowledges priority date of the instant invention to be 27 April 2015.
Claim Rejections - 35 USC § 101
As a result of analyzing the instant invention with respect to the requirement of the 2019 PEG Revised Step 2A Prongs One and Two and as well the requirements of MPEP 2106 Examiner concludes the instant invention is directed to a judicial exception and further directed to a practical application or processing improvement. Therefore the instant invention is determined to not be subject to a rejection under the statute.
As a result of evaluation with respect to the requirements of the 2019 PEG Revised Step 2A Prong One and requirements of MPEP 2106 Examiner concludes that the instant invention is directed to a judicial exception related to managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
As a result of evaluation with respect to the requirements of the 2019 PEG Revised Step 2A Prong Two and requirements of MPEP 2106 Examiner concludes that the instant invention is directed to a practical application related to the implementation of a sponge counting system implemented to maintain an inventory of medical or surgical procedural articles for the use and implementation of a wide range of procedures which include the tracking of sponges with RFID tags, the implementation of event loggers wherein each logger is specifically executed by a processor and memory, and the individual tracking of sponge related data. Examiner’s conclusion is guided by the specific technical details disclosed at paragraphs [35]-[55]. Therefore the Examiner determines the instant invention is directed to a practical application and therefore eligible under the requirements of the statute.
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 instant application 19/024891, claims 1-20 of U.S. Patent No. 12,293,812, claims 1-20 of U.S. Patent No. 11,894,115. Although the claims at issue are not identical, they are not patentably distinct from each other because as indicated in BOLD below the instant invention is subject to a rejection under nonstatutory double patenting.
Instant Invention 19/024891
A sponge reconciliation system for maintaining records of a plurality of sponges used during a procedure to ensure proper removal of surgical sponges following the procedure, the sponge reconciliation system comprising:
the plurality of sponges, each including an RFID tag or a bar code, the RFID tag or the bar code each including a unique identifier;
a server;
a plurality of event loggers, each of the plurality of event loggers including a processor and a memory, each of the plurality of the plurality of event loggers being configured to read the RFID tag or the bar code, wherein each processor is configured to:
download data from a first article record for a first sponge of the plurality of sponges that has been partially reconciled to the memory of the event logger from the server, the downloaded data being from a prior procedure associated with a patient;
generate a second article record identifying a second sponge of the plurality of sponges scanned into a current procedure,
store data from the second article record on the memory of the event logger;
transmit data from the second article record to the server; and
wherein at least one event logger is configured to:
display text associated with the first article record for the first sponge that has been partially reconciled; and
display text associated with the second article record for the second sponge.
Issued Patent 12,293,812
A sponge reconciliation system for maintaining records of a plurality of sponges used during a procedure to ensure proper removal of the plurality of sponges following the procedure, the sponge reconciliation system including:
the plurality of sponges, each including an RFID tag or a bar code, the RFID tag or the bar code each including a unique identifier;
a server;
a plurality of tablets, each of the plurality of tablets including a processor, a memory, and a transceiver, and each of the plurality of the plurality of tablets being configured to read the RFID tag or the bar code, wherein each processor is configured to:
generate a first article record identifying a first sponge of the plurality of sponges scanned into a current procedure, generate a first procedure event record that identifies a current procedure and a patient with whom the current procedure is to be identified;
store data from the first article record on the memory of the tablet;
transmit data from the first procedure event record and the first article record to the server;
download data from a second article record for a second sponge of the plurality of sponges that has been partially reconciled to the memory of the tablet from the server, the downloaded data being from a prior procedure associated with the patient with which the tablet is currently associated for the current procedure;
wherein the server is configured to:
store data received from the first article record and the first procedure event record;
determine whether the first article event record received is a record indicating that the partially reconciled second sponge should now be considered scanned out; and wherein the system is configured to:
display text associated with a sponge that has not yet been scanned out in a first color; and
display text associated with a sponge that has been partially reconciled in a second color.
Issued Patent 11,894,115
A sponge reconciliation system for maintaining records of sponges used during a procedure to ensure proper removal of surgical sponges following the procedure, the sponge reconciliation system including:
a server;
a plurality of tablets, each of the plurality of tablets including a processor, a memory, and a transceiver, and wherein each processor is configured to:
generate a first article record identifying a first sponge scanned into a current procedure, wherein the first article record corresponds to a sponge that is to be considered partially reconciled;
generate a first procedure event record that identifies a current procedure, a user operating the tablet, and a patient with whom the current procedure is to be identified;
store data from the first article record on the memory of the tablet, wherein the scanner memory does not contain data that specifically identifies the patients with which the procedure event record and article event record is associated with;
transmit data from the first procedure event record and the first article record to the server;
download data from a second article record for a second sponge that has been partially reconciled to the memory of the tablet from the server, the downloaded data being from a prior procedure associated with the patient with which the tablet is currently associated for the current procedure;
wherein the server is configured to:
store data received from the first article record and the first procedure event record;
determine whether the first article event record received is a record indicating that the partially reconciled first sponge should now be considered scanned out;
based on the step of determining, remove the first sponge from a file of partially reconciled articles; and
wherein the system is configured to:
display text associated with a sponge that has been fully counted out in a first color;
display text associated with a sponge that has not yet been scanned out in a second color; and
display text associated with a sponge that has been partially reconciled in a third color.
Determination of Allowability of the instant invention
As previously determined with respect to examination of the previously filed inventions the combination of Reppas (20100179822) and Nguyen (20160371574) do not disclose the collection of sponge based RFID tag data for the purpose of processing events as they occur with respect to the tracking of the tags and does not disclose processing and display of text related information with respect to the tracking of the sponges and as well does not disclose the detection and display of sponges left inside patients. Therefore the instant invention is determined to allowable over the combination of cited to art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Please see attached References Cited form 892.
See Augustine (20150216610) for disclosures related to the implementation of a sponge tracking system related to the counting and detection of surgical sponges implemented with RFID sensors to detect entry and exit of the sponges. See at least paras. [37]-[57].
See Pollock et al (20140262553) for disclosures related to a surgical sponge and fluid monitoring system with respect to the detection of RFID communication systems implemented within container support rings. See at least paras [22]-[55].
See Rivera et al., Assist – Automated System for Surgical instrument and Sponge Tracking, 2008 IEEE International Conference of RFID, Las Vegas, April 16-17 2008; for disclosures related to automated tracking of surgical instruments and sponges.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Stoltenberg whose telephone number is (571) 270-3472.
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/DAVID J STOLTENBERG/Primary Examiner, Art Unit 3685
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