DETAILED ACTION
Notice of Pre-AIA or AIA Status
In the present application, filed on or after March 16, 2013, claims 1-20 have been considered and examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/03/2025 is in compliance with the provision of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by Examiner.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this 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 §§ 706.02(1)(1) - 706.02(1)(3) 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 1.32l(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. 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 tohttp ://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-20 are rejected on the ground of nonstatutory double patenting over claims 1-20 of patent US 12,383,373 B2 since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
The subject matter claimed in the instant application is fully disclosed in the patent US 12,383,373 B2, as follows:
Claim
US 19/284,021
Claim
US 1121,383,373 B2
1
A surgical article system for managing removal of surgical articles following a surgical procedure, the surgical articles each including an identification tag comprising identification information identifying the corresponding surgical article, the system comprising:
1
A surgical article system for managing removal of surgical articles following a surgical procedure, the surgical articles each including an identification tag comprising identification information identifying the corresponding surgical article, the system comprising:
1
a hand-held reader operable to read the identification information from the identification tags;
1
a hand-held reader operable to read the identification information from the identification tags;
1
a cradle, the cradle adapted to receive the hand-held reader wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle;
1
a cradle, the cradle adapted to receive the hand-held reader;
1
1
wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle, wherein the system enables an operation of the hand-held reader in the second count-out mode based on the presence of the hand-held reader received in the cradle,
1
a display device including a graphical user interface for receiving a user selection to operate the hand-held reader;
5
wherein the hand-held reader further comprises a display device and an input device, and wherein the set of instructions when executed by the at least one processor further causes the system to display on the display device a status of the hand-held reader selectively operated in the first count-in mode or the second count-out mode.
1
at least one processor; and a non-transitory computer readable memory storing a set of instructions that that when executed by the at least one processor causes the system to:
1
at least one processor; and a non-transitory computer readable memory storing a set of instructions that when executed by the at least one processor causes the system to:
1
selectively operate the hand-held reader in a first count-in mode wherein the system identifies the surgical articles as counted-in for use in the surgical procedure based on the identification information;
1
selectively operate the hand-held reader in a first count-in mode wherein the system stores information, based on the identification information, identifying the surgical articles as counted-in for use in the surgical procedure; and
1
selectively operate the hand-held reader in a second count-out mode wherein the system identifies the surgical articles as counted-out and removed from the surgical procedure based on the identification information; and
1
selectively operate the hand-held reader in a second count-out mode wherein the system stores information, based on the identification information, identifying the surgical articles as counted-out and removed from the surgical procedure,
1
responsive to the graphical user interface receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader has been removed from the cradle, trigger an alert on the graphical user interface
1
responsive to the user interface receiving the user selection to operate the hand-held reader in the second count-out mode when the hand-held reader is not present in the cradle, trigger an alert without triggering the hand-held reader to operate in the second count-out mode; and responsive to the user interface receiving a user selection of an override option after the alert is triggered, trigger an operation of the hand-held reader in the second count-out mode
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method executed by at least one processor for managing removal of surgical articles following a surgical procedure, the surgical articles each including an identification tag comprising identification information identifying the corresponding surgical article, the method comprising: operating a hand-held reader in a first count-in mode including identifying the surgical articles as counted-in for use in the surgical procedure based on the identification information; operating the hand-held reader in a second count-out mode including identifying the surgical articles as counted-out and removed from the surgical procedure based on the identification information; determining a presence or absence of the hand-held reader in a cradle; receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and responsive to receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader is not present in the cradle, triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader.
The limitations of operating a hand-held reader in a first count-in mode; operating the hand-held reader in a second count-out mode; determining a presence or absence of the hand-held reader in a cradle; receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader, as drafted, is a process performed by at least one processor that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “by at least one processor,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “by at least one processor” language, “operating a hand-held reader in a first count-in mode; operating the hand-held reader in a second count-out mode; determining a presence or absence of the hand-held reader in a cradle; receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader” in the context of this claim encompasses the user manually select an operation mode to receive information from response devices.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform the above steps. The processor in the steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of the above steps) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the above steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 10-11, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Quintini et al. (WO 2018/132527 A1) in view of Fletcher (Fletcher – US 8,186,597 B1) and Nguyen et al. (Nguyen – US 2016/0371574 A1).
As to claim 1, Quintini discloses a surgical article system for managing removal of surgical articles following a surgical procedure, the surgical articles each including an identification tag comprising identification information identifying the corresponding surgical article, the system comprising:
a hand-held reader (Quintini: [0025], [0044], FIG. 1 , and FIG. 6 the single entry/exit scanner 662: The entry and exit scanners 102, 104 may be formed as a single entry and exit scanner 664 that provides the same functionality as both the entry and exit scanners 102, 104. At least one of the entry scanner 102, the exit scanner 104, and the single entry and exit scanner 664 may be stationary on the stationary unit 662. Alternatively, only one of the entry and exit scanners 102, 104 may be stationary on the stationary unit 662 while the other of the entry and exit scanners 102, 104 may be a handheld device) operable to read the identification information from the identification tags (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: the surgical object identifier 1 10 may be a label 1 14 on a surgical object package 1 16 readable by at least one of the entry and exit scanners 102, 104. The label 114 may contain data pertaining to at least one of the total number of surgical objects 112 within the surgical object package 1 16, the types of each surgical object 112 within the surgical object package 1 16, and the number of each type of surgical objects 112 within the surgical object package 116. The label 1 14 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 1 12 may have an attached discardable material 1 18. The discardable material 1 18 may be excess suture threading or any other appropriate material that is attached to a surgical object 1 12 and discarded at any desired time during and/or after a medical procedure);
at least one processor; and a non-transitory computer readable memory storing a set of instructions that that when executed by the at least one processor (Quintini: FIG.1 and FIG. 6 the monitoring system 106) causes the system to:
selectively operate the hand-held reader in a first count-in mode wherein the system identifies the surgical articles as counted-in for use in the surgical procedure based on the identification information (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the entry count 128: the monitoring system 106 has a surgical object recognition module 122. The surgical object recognition module 122 has a processor 124 and a database of preexisting surgical object identifier data 126. The surgical object recognition module 122 may identify at least one of the number of surgical objects 1 12, the type of surgical objects 1 12, and the number of each type of surgical objects 1 12 from the first set of image data by comparing the first set of image data with the pre-existing surgical object identifier data to produce at least one of a surgical object entry count 128 and a surgical object type entry count 130); and
selectively operate the hand-held reader in a second count-out mode wherein the system identifies the surgical articles as counted-out and removed from the surgical procedure based on the identification information (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the exit count 132: the surgical object recognition module 122 may identify at least one of the number of surgical objects 1 12, the type of surgical objects 1 12, and the number of each type of surgical objects 1 12 from the second set of image data by comparing the second set of image data with the pre-existing surgical object identifier data to produce at least one of a surgical object exit count 132 and a surgical object type exit count 134).
Quintini does not explicitly disclose a cradle, the cradle adapted to receive the hand-held reader wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle;
a display device including a graphical user interface for receiving a user selection to operate the hand-held reader;
responsive to the graphical user interface receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader has been removed from the cradle, trigger an alert on the graphical user interface.
However, it has been known in the art of reading devices to implement a cradle, the cradle adapted to receive the hand-held reader wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle; and
a display device including a graphical user interface for receiving a user selection to operate the hand-held reader, as suggested by Fletcher, which discloses
a cradle (Fletcher: Abstract, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510), the cradle adapted to receive the hand-held reader (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: a cradle having a first magnetic attachment device disposed in the cradle arm for removably holding the indicia reader; a second attachment device disposed on the indicia reader to removably attach the indicia reader to the first magnetic attachment device) wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle); and
a display device including a graphical user interface for receiving a user selection to operate the hand-held reader (Fletcher: column 2 lines 65-column 3 lines 23, column 5 lines 29-50, FIG. 2 the display 116 and the trigger or button 115: An operator may aim a hand-held indicia reader 112 at a target containing an IBI, dataform, text, or other data to be collected and actuate a button or trigger 115 on the indicia reader to control full or partial operation of the reader, such as to activate scanning of an IBI. An IBI or dataform may be an originally machine generated symbology that is also machine readable, such as a 1-D barcode, a 2-D barcode, a 1-D stacked barcode, a logo, glyphs, color-codes, and the like).
Therefore, in view of teachings by Quintini and Fletcher, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini to include a cradle, the cradle adapted to receive the hand-held reader wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle; and
a display device including a graphical user interface for receiving a user selection to operate the hand-held reader, as suggested by Fletcher. The motivation for this is to implement a known alternative device for receiving information of surgical objects.
While the combination of Quintini and Fletcher discloses a determination the hand-held reader has been removed from the cradle indicative of scanning objects (Fletcher: Abstract, column 8 lines 49-67, and FIG. 1: The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode), the combination of Quintini and Fletcher does not explicitly disclose responsive to the graphical user interface receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader has been removed from the cradle, trigger an alert on the graphical user interface.
However, it has been known in the art of obtaining information from tagged objects to implement responsive to the graphical user interface receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader has been removed from the cradle, trigger an alert on the graphical user interface, as suggested by Nguyen, which discloses responsive to the graphical user interface receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader has been removed from the cradle, trigger an alert on the graphical user interface (Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: Further, the system GUI 170 may include certain status indicators. For example, the system GUI 170 provides a “Count Cleared” indicator and a “Count Error” indicator. The system GUI 170 may also use color to convey certain status or meaning).
Therefore, in view of teachings by Quintini, Fletcher, and Nguyen, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini and Fletcher to include responsive to the graphical user interface receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader has been removed from the cradle, trigger an alert on the graphical user interface, as suggested by Nguyen. The motivation for this is to provide information of surgical objects to a user.
As to claim 2, Quintini, Fletcher, and Nguyen disclose the limitations of claim 1 further comprising the system of claim 1, wherein the hand-held reader comprises an RFID reader (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: The label 114 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 112 may have an attached discardable material 118. The discardable material 118 may be excess suture threading or any other appropriate material that is attached to a surgical object 112 and discarded at any desired time during and/or after a medical procedure and Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle) and wherein each identification tag comprises an RFID tag (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: the surgical object identifier 1 10 may be a label 1 14 on a surgical object package 1 16 readable by at least one of the entry and exit scanners 102, 104. The label 114 may contain data pertaining to at least one of the total number of surgical objects 112 within the surgical object package 1 16, the types of each surgical object 112 within the surgical object package 1 16, and the number of each type of surgical objects 112 within the surgical object package 116. The label 1 14 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 1 12 may have an attached discardable material 1 18. The discardable material 1 18 may be excess suture threading or any other appropriate material that is attached to a surgical object 1 12 and discarded at any desired time during and/or after a medical procedure and Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1 tagged objects 110 having RFID tags 115, and FIG. 3-7: a radio-frequency identification (RFID)-based system for automatically tracking objects used in surgical procedures, and methods of use thereof, are disclosed. More particularly, an objects monitoring system is provided that includes a set of RFID tagged-objects (e.g., RFID tagged-surgical instruments), an RFID reader, an RFID reader antenna installed in a disposable wearable article, a computing device, and optionally a centralized server).
As to claim 3, Quintini, Fletcher, and Nguyen disclose the limitations of claim 1 further comprising the system of claim 1, wherein the hand-held reader comprises the at least one processor and the non-transitory computer readable memory storing the set of instructions, and wherein the set of instructions when executed by the at least one processor (Quintini: FIG.1 and FIG. 6 the monitoring system 106 and Fletcher: column 4 lines 25-42, column 4 lines 54-column 5 lines 19, column 5 lines 51-64, and FIG. 2 the local processor 170 and the local memory 172: Exemplary indicia readers may use memory or firmware to store certain reader settings or reader configuration settings. Exemplary configuration settings may be selection of scanning distance, trigger functionality, pre-defined bar code output data based on the scan input, continuous scanning mode, discontinuous scanning mode or routine, decoding mode or routine, I/O configurations, symbology enablement, output interface functionality, min/max symbology character lengths, scan engine selection, illumination functionality, settings that affect the functional operation of the processor(s), which codes are enabled for processing, aimer operation, engine orientation, illumination, photosensor functionality, software control, sales tracking or warranty tracking, reader capabilities, etc) further causes the system to display on the display device a status of the hand-held reader selectively operated in the first count-in mode or the second count-out mode (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: the surgical object identifier 1 10 may be a label 1 14 on a surgical object package 1 16 readable by at least one of the entry and exit scanners 102, 104. The label 114 may contain data pertaining to at least one of the total number of surgical objects 112 within the surgical object package 1 16, the types of each surgical object 112 within the surgical object package 1 16, and the number of each type of surgical objects 112 within the surgical object package 116. The label 1 14 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 1 12 may have an attached discardable material 1 18. The discardable material 1 18 may be excess suture threading or any other appropriate material that is attached to a surgical object 1 12 and discarded at any desired time during and/or after a medical procedure and Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: Further, the system GUI 170 may include certain status indicators. For example, the system GUI 170 provides a “Count Cleared” indicator and a “Count Error” indicator. The system GUI 170 may also use color to convey certain status or meaning).
As to claim 4, Quintini, Fletcher, and Nguyen disclose the limitations of claim 3 further comprising the system of claim 3, wherein the set of instructions when executed by the at least one processor further causes the system to display information selected from among the identification information of the surgical articles, a count of surgical articles identified as counted-in (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the entry count 128: At least one of the surgical object entry count 128 and the surgical object type entry count 130 is electrically transferred 460 from the monitoring system 106 to the display screen 108. At least one of the surgical object entry count 128 and the surgical object type entry count 130 is displayed in a user-perceptible manner and Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: In the “check out” mode of operation, as the tagged objects 110 enter the surgical field, the tagged objects 110 are detected by the RFID reader 120 and added to a list in the main viewing area of the system GUI 170, which is the contents of the checked out list 150 generated by the objects monitoring software 145), a count of surgical articles identified as counted-out (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the exit count 132: The display screen 108 may display, in a user-perceptible format, at least one of the surgical object entry count 128, the surgical object exit count 132, the surgical object type entry count 130, the surgical object type exit count 134, the difference between the surgical object entry count 128 and the surgical object exit count 132, and the difference between the surgical object type entry count 130 and the surgical object type exit count 134 and Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: In the “check in” mode of operation, the “Check Out” pushbutton is grayed out to indicate that it is inactive. In the “check in” mode of operation, as tagged objects 110 exit the surgical field, the tagged objects 110 are detected by the RFID reader 120 and the checked in list 155 is generated by objects monitoring software 145. Since the contents of the checked in list 155 is to be reconciled with the contents of the checked out list 150, such reconciliation can be indicated using color to indicate the status of each tagged object 110 that is displayed in the system GUI 170. For example, as each tagged object 110 is detected exiting the surgical field, the line displaying the detected tagged object 110 turns, for example, from black text to green text. When all tagged objects 110 exiting the surgical field match all tagged objects 110 that entered the surgical field, that is when the contents of the checked out list 150 matches the contents of the checked in list 155, all line items are changed from black text to green text, the total count line turns from black text to green text, and the “Count Cleared” indicator is activated. Namely, the objects monitoring software 145 uses the “Count Cleared” indicator and the color green to indicate a successful reconciliation between the checked out list 150 and the checked in list 155), and combinations thereof.
As to claim 5, Quintini, Fletcher, and Nguyen disclose the limitations of claim 1 further comprising the system of claim 1, wherein the display device is positioned on the hand-held reader (Fletcher: column 2 lines 65-column 3 lines 23, column 5 lines 29-50, FIG. 2 the display 116 and the trigger or button 115: An operator may aim a hand-held indicia reader 112 at a target containing an IBI, dataform, text, or other data to be collected and actuate a button or trigger 115 on the indicia reader to control full or partial operation of the reader, such as to activate scanning of an IBI. An IBI or dataform may be an originally machine generated symbology that is also machine readable, such as a 1-D barcode, a 2-D barcode, a 1-D stacked barcode, a logo, glyphs, color-codes, and the like and Nguyen: Abstract, [0020]-[0023], [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: The RFID reader 120 processes signals from the RFID tags 115 and converts them to unique identification numbers. In one example, RFID reader 120 is a portable, battery-powered RFID reader that may be clipped onto the wardrobe (e.g., the surgical gown) of the participant who is wearing the wearable sleeve 130).
As to claim 6, Quintini, Fletcher, and Nguyen discloses the limitations of claim 1 further comprising the system of claim 1, wherein the display device is positioned on a base unit in electronic communication with the hand-held reader (Quintini: [0038]-[0039], [0042]-[0044], and FIG. 2-6: The stationary unit 662 may have at least one of the entry scanner 102, the exit scanner 104, the monitoring system 106, the display screen 108, the containment surface 238, the disposal recess 240, the disposal container 246, the electromagnet 242, any other feature of the system for monitoring surgical objects 100 previously described, or any combination thereof. The entry and exit scanners 102, 104 may be formed as a single entry and exit scanner 664 that provides the same functionality as both the entry and exit scanners 102, 104. At least one of the entry scanner 102, the exit scanner 104, and the single entry and exit scanner 664 may be stationary on the stationary unit 662. Alternatively, only one of the entry and exit scanners 102, 104 may be stationary on the stationary unit 662 while the other of the entry and exit scanners 102, 104 may be a handheld device ), the base unit (Quintini: FIG. 1 and FIG. 6 the monitoring system 106) comprising the at least one processor (Quintini: FIG. 1 the processor 124), the non-transitory memory storing the set of instructions (Fletcher: column 4 lines 25-42, column 4 lines 54-column 5 lines 19, column 5 lines 51-64, and FIG. 2 the local processor 170 and the local memory 172: Exemplary indicia readers may use memory or firmware to store certain reader settings or reader configuration settings. Exemplary configuration settings may be selection of scanning distance, trigger functionality, pre-defined bar code output data based on the scan input, continuous scanning mode, discontinuous scanning mode or routine, decoding mode or routine, I/O configurations, symbology enablement, output interface functionality, min/max symbology character lengths, scan engine selection, illumination functionality, settings that affect the functional operation of the processor(s), which codes are enabled for processing, aimer operation, engine orientation, illumination, photosensor functionality, software control, sales tracking or warranty tracking, reader capabilities, etc and Nguyen: [0022] and FIG. 1 the objects monitoring software 145: For example, the computing device 140 may be a microcontroller device, a microprocessor device, or any computing device, such as a mobile phone, a handheld computing device, a tablet device, a laptop computer, a desktop computer, a centralized server, and the like. A certain amount of data storage (e.g., a memory device, not shown) may be associated with the computing device 140).
As to claim 7, Quintini, Fletcher, and Nguyen discloses the limitations of claim 6 further comprising the system of claim 6, wherein the set of instructions when executed by the at least one processor further causes the system to display information selected from among the identification information of the surgical articles, a count of surgical articles identified as counted-in (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the entry count 128: At least one of the surgical object entry count 128 and the surgical object type entry count 130 is electrically transferred 460 from the monitoring system 106 to the display screen 108. At least one of the surgical object entry count 128 and the surgical object type entry count 130 is displayed in a user-perceptible manner and Steward: [0077]-[0078], [0081]-[0084], [0092], [0101], and FIG. 8-9: the interface can be used to put software into count IN mode (to add more sponges to the procedure if necessary), count OUT mode (to count out sponges removed from the patient) or FIND mode (to find missing sponges)), a count of surgical articles identified as counted-out (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the exit count 132: The display screen 108 may display, in a user-perceptible format, at least one of the surgical object entry count 128, the surgical object exit count 132, the surgical object type entry count 130, the surgical object type exit count 134, the difference between the surgical object entry count 128 and the surgical object exit count 132, and the difference between the surgical object type entry count 130 and the surgical object type exit count 134 and Steward: [0077]-[0078], [0081]-[0084], [0092], [0101], and FIG. 8-9: the interface can be used to put software into count IN mode (to add more sponges to the procedure if necessary), count OUT mode (to count out sponges removed from the patient) or FIND mode (to find missing sponges)), and combinations thereof (Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: Further, the system GUI 170 may include certain status indicators. For example, the system GUI 170 provides a “Count Cleared” indicator and a “Count Error” indicator. The system GUI 170 may also use color to convey certain status or meaning).
As to claim 8, Quintini, Fletcher, and Nguyen discloses the limitations of claim 6 further comprising the system of claim 6, wherein the base unit is a tablet computing device and the graphical user interface is a touchscreen of the tablet computing device (Nguyen: [0022], [0037], [0044], [0048]-[0054], FIG. 1, and FIG. 3-7: FIG. 2 also shows an example of computing device 140. In this example, computing device 140 is a portable tablet device, such as, but not limited to, an Apple® iPad® or a Samsung Galaxy® Tab. The tablet device is non-sterile and non-disposable. Accordingly, the tablet device must be kept clear of the surgical field. In this example, the tablet device is connected wirelessly to both the RFID reader 120 and the server 160. The objects monitoring software 145 provides a user interface. For example, a system graphical user interface (GUI) 170 is displayed on the tablet device, which is the computing device 140. More details of an example of the system GUI 170 are shown and described with reference to FIG. 3, FIG. 4, and FIG. 5).
As to claim 10, Quintini, Fletcher, and Nguyen disclose the limitations of claim 6 except for the claimed limitations of the system of claim 6, wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle via near field communication between the cradle and hand-held reader (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
As to claim 11, Quintini, Fletcher, and Nguyen disclose the limitations of claim 10 further comprising the system of claim 10, wherein the near field communication between the cradle and the hand-held reader requires a proximity between the cradle and hand-held reader present only when the reader is received in the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
As to claim 15, Quintini, Fletcher, and Nguyen disclose the limitations of claim 1 further comprising the system of claim 1, wherein the cradle is operable to determine a presence of the hand-held reader repeatedly while the system is selectively operating the hand-held reader in the second count-out mode (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
As to claim 16, Quintini, Fletcher, and Nguyen disclose the limitations of claim 1 further comprising the system of claim 1, wherein the set of instructions when executed by the at least one processor further causes the system to terminate operation of the hand-held reader in the second count-out mode based on the determination that the hand-held reader has been removed from the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
As to claim 17, Quintini discloses a method executed by at least one processor for managing removal of surgical articles following a surgical procedure, the surgical articles each including an identification tag comprising identification information identifying the corresponding surgical article, the method comprising:
operating a hand-held reader (Quintini: [0025], [0044], FIG. 1 , and FIG. 6 the single entry/exit scanner 662: The entry and exit scanners 102, 104 may be formed as a single entry and exit scanner 664 that provides the same functionality as both the entry and exit scanners 102, 104. At least one of the entry scanner 102, the exit scanner 104, and the single entry and exit scanner 664 may be stationary on the stationary unit 662. Alternatively, only one of the entry and exit scanners 102, 104 may be stationary on the stationary unit 662 while the other of the entry and exit scanners 102, 104 may be a handheld device) in a first count-in mode (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: the surgical object identifier 1 10 may be a label 1 14 on a surgical object package 1 16 readable by at least one of the entry and exit scanners 102, 104. The label 114 may contain data pertaining to at least one of the total number of surgical objects 112 within the surgical object package 1 16, the types of each surgical object 112 within the surgical object package 1 16, and the number of each type of surgical objects 112 within the surgical object package 116. The label 1 14 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 1 12 may have an attached discardable material 1 18. The discardable material 1 18 may be excess suture threading or any other appropriate material that is attached to a surgical object 1 12 and discarded at any desired time during and/or after a medical procedure) including identifying the surgical articles as counted-in for use in the surgical procedure based on the identification information (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: the surgical object identifier 1 10 may be a label 1 14 on a surgical object package 1 16 readable by at least one of the entry and exit scanners 102, 104. The label 114 may contain data pertaining to at least one of the total number of surgical objects 112 within the surgical object package 1 16, the types of each surgical object 112 within the surgical object package 1 16, and the number of each type of surgical objects 112 within the surgical object package 116. The label 1 14 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 1 12 may have an attached discardable material 1 18. The discardable material 1 18 may be excess suture threading or any other appropriate material that is attached to a surgical object 1 12 and discarded at any desired time during and/or after a medical procedure);
operating the hand-held reader in a second count-out mode including identifying the surgical articles as counted-out and removed from the surgical procedure based on the identification information (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the exit count 132: the surgical object recognition module 122 may identify at least one of the number of surgical objects 1 12, the type of surgical objects 1 12, and the number of each type of surgical objects 1 12 from the second set of image data by comparing the second set of image data with the pre-existing surgical object identifier data to produce at least one of a surgical object exit count 132 and a surgical object type exit count 134).
Quintini does not explicitly disclose
determining a presence or absence of the hand-held reader in a cradle;
receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and
responsive to receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader is not present in the cradle, triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader.
However, it has been known in the art of reading devices to implement determining a presence or absence of the hand-held reader in a cradle, as suggested by Fletcher, which discloses determining a presence or absence of the hand-held reader in a cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
Therefore, in view of teachings by Quintini and Fletcher, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini to include determining a presence or absence of the hand-held reader in a cradle, as suggested by Fletcher. The motivation for this is to implement a known alternative device for receiving information of surgical objects.
While the combination of Quintini and Fletcher discloses a determination the hand-held reader has been removed from the cradle indicative of scanning objects (Fletcher: Abstract, column 8 lines 49-67, and FIG. 1: The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode), the combination of Quintini and Fletcher does not explicitly disclose receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and
responsive to receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader is not present in the cradle, triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader.
However, it has been known in the art of obtaining information from tagged objects to implement receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and
responsive to receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader is not present in the cradle, triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader, as suggested by Nguyen, which discloses receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode (Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1 tagged objects 110 having RFID tags 115, and FIG. 3-7: In the “check in” mode of operation, the “Check Out” pushbutton is grayed out to indicate that it is inactive. In the “check in” mode of operation, as tagged objects 110 exit the surgical field, the tagged objects 110 are detected by the RFID reader 120 and the checked in list 155 is generated by objects monitoring software 145. Since the contents of the checked in list 155 is to be reconciled with the contents of the checked out list 150, such reconciliation can be indicated using color to indicate the status of each tagged object 110 that is displayed in the system GUI 170. For example, as each tagged object 110 is detected exiting the surgical field, the line displaying the detected tagged object 110 turns, for example, from black text to green text. When all tagged objects 110 exiting the surgical field match all tagged objects 110 that entered the surgical field, that is when the contents of the checked out list 150 matches the contents of the checked in list 155, all line items are changed from black text to green text, the total count line turns from black text to green text, and the “Count Cleared” indicator is activated. Namely, the objects monitoring software 145 uses the “Count Cleared” indicator and the color green to indicate a successful reconciliation between the checked out list 150 and the checked in list 155); and
responsive to receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader is not present in the cradle, triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader (Nguyen: Abstract, [0025]-0027], [0037]-[0044], FIG. 1, and FIG. 3-7: Further, the system GUI 170 may include certain status indicators. For example, the system GUI 170 provides a “Count Cleared” indicator and a “Count Error” indicator. The system GUI 170 may also use color to convey certain status or meaning).
Therefore, in view of teachings by Quintini, Fletcher, and Nguyen, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini and Fletcher to include receiving via a user interface a user selection to operate the hand-held reader in the second count-out mode; and
responsive to receiving the user selection to operate the hand-held reader in the second count-out mode and a determination the hand-held reader is not present in the cradle, triggering an alert on a graphical user interface of a display device for receiving a user selection to operate the hand-held reader, as suggested by Nguyen. The motivation for this is to provide information of surgical objects to a user.
As to claim 18, Quintini, Fletcher, and Nguyen disclose the limitations of claim 17 further comprising the method of claim 17, further comprising: determining the hand-held reader has been removed from the cradle; and terminating operation of the hand-held reader in the second count-out mode based on the determination that the hand-held reader has been removed from the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Quintini et al. (WO 2018/132527 A1) in view of Fletcher (Fletcher – US 8,186,597 B1) and Nguyen et al. (Nguyen – US 2016/0371574 A1) and further in view of Stewart et al. (Stewart – US 2018/0285704 A1) and Peterson (Peterson – US 2019/0087544 A1).
As to claim 9, Quintini, Fletcher, and Nguyen discloses the limitations of claim 8 except for the claimed limitations of the system of claim 8, further comprising a mobile pedestal stand having a pole, the base unit and the cradle supported on the pole; and the pedestal stand arranged to be disposed outside a sterile field of the surgical procedure.
However, it has been known in the art of reading devices to implement a mobile pedestal stand having a pole, the base unit and the cradle supported on the pole, as suggested by Stewart, which discloses a mobile pedestal stand having a pole, the base unit and the cradle supported on the pole (Steward: [0077]-[0078], and FIG. 8: Means are provided for attaching the mobile computer and UHF reader to a stable, mobile stand (likely an IV pole) in a fashion where both can be easily attached, removed, and reattached. The processor be programmed or uploaded with a user application which typically provides at least four functionalities. A first functionality provides for real-time counting and finding of the sponges or other surgical articles during the surgical procedure. A second functionality aggregates the data and information captured during a specific case (e.g. to allow producing a Procedure Report)).
Therefore, in view of teachings by Quintini, Fletcher, Nguyen, and Stewart it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini, Fletcher, and Nguyen to include a mobile pedestal stand having a pole, the base unit and the cradle supported on the pole, as suggested by Stewart. The motivation for this is to implement a known alternative device for receiving information of surgical objects.
The combination of Quintini, Fletcher, Nguyen, and Stewart does not explicitly disclose the pedestal stand arranged to be disposed outside a sterile field of the surgical procedure.
However, it has been known in the art of medical operating system to implement the pedestal stand arranged to be disposed outside a sterile field of the surgical procedure, as suggested by Peterson, which discloses the pedestal stand arranged to be disposed outside a sterile field of the surgical procedure (Peterson: Abstract, [0054], and FIG. 5: The example environment 500 also includes one or more additional tables 506, 508, stands 510, 512, 514, light box 516, intravenous (IV) fluid poles 516, 518, etc., inside and/or outside the sterile field 502. The example environment 500 can also include one or more machines such as an anesthesia machine and monitor 520).
Therefore, in view of teachings by Quintini, Fletcher, Nguyen, Stewart, and Peterson it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini, Fletcher, Nguyen, and Stewart to include the pedestal stand arranged to be disposed outside a sterile field of the surgical procedure, as suggested by Peterson. The motivation for this is to selectively choose an appropriate location for arranging medical devices in an operating room.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Quintini et al. (WO 2018/132527 A1) in view of Fletcher (Fletcher – US 8,186,597 B1) and Nguyen et al. (Nguyen – US 2016/0371574 A1) and further in view of Liu et al. (Liu – US 2016/0188925 A1).
As to claim 12, Quintini, Fletcher, and Nguyen disclose the limitations of claim 11 except for the claimed limitations of the system of claim 11, wherein a Bluetooth pairing is made between the base unit and the hand-held reader based on information communicated via the near field communication between the hand-held reader and the cradle.
However, it has been known in the art of communication system to implement wherein a Bluetooth pairing is made between the base unit and the hand-held reader based on information communicated via the near field communication between the hand-held reader and the cradle, as suggested by Liu, which discloses wherein a Bluetooth pairing is made between the base unit and the hand-held reader based on information communicated via the near field communication between the hand-held reader and the cradle (Liu: Abstract, [0006], [0049], and FIG. 1-2: in the situation that the Bluetooth headset is equipped with the controlled NFC tag provided in the present invention, if the Bluetooth headset is in the state of power-on, then the enabling signal (such as Vcc) is exerted upon the input terminal of the electronic switch control circuit of the controlled NFC tag, so that the electronic switch of the controlled NFC tag is off. At this moment, when the electronic equipment (such as NFC mobile phone) equipped with the NFC card reader is close to the Bluetooth headset, the electronic equipment can read the headset pairing information such as Bluetooth address stored in the NFC tag chip of the Bluetooth headset so as to pair with the Bluetooth headset. If the Bluetooth headset is in the state of power-off, then the disabling signal (such as 0V) is exerted upon the input terminal of the electronic switch control circuit of the controlled NFC tag, so that the electronic switch of the controlled NFC tag is on (closes)).
Therefore, in view of teachings by Quintini, Fletcher, Nguyen, and Liu it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini, Fletcher, and Nguyen to include wherein a Bluetooth pairing is made between the base unit and the hand-held reader based on information communicated via the near field communication between the hand-held reader and the cradle, as suggested by Liu. The motivation for this is to selectively choose an appropriate method for providing pairing information between electronic devices.
As to claim 13, Quintini, Fletcher, Nguyen, and Liu disclose the limitations of claim 12 further comprising the system of claim 12, wherein the hand-held reader comprises a passive NFC tag encoded with a Bluetooth address corresponding to the hand-held reader (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: a cradle having a first magnetic attachment device disposed in the cradle arm for removably holding the indicia reader; a second attachment device disposed on the indicia reader to removably attach the indicia reader to the first magnetic attachment device and Liu: Abstract and FIG. 1), wherein the cradle comprises an NFC reader operable to read the Bluetooth address, and wherein the Bluetooth pairing is made between the base unit and the hand-held reader based on the Bluetooth address (Liu: Abstract, [0006], [0049], and FIG. 1-2: in the situation that the Bluetooth headset is equipped with the controlled NFC tag provided in the present invention, if the Bluetooth headset is in the state of power-on, then the enabling signal (such as Vcc) is exerted upon the input terminal of the electronic switch control circuit of the controlled NFC tag, so that the electronic switch of the controlled NFC tag is off. At this moment, when the electronic equipment (such as NFC mobile phone) equipped with the NFC card reader is close to the Bluetooth headset, the electronic equipment can read the headset pairing information such as Bluetooth address stored in the NFC tag chip of the Bluetooth headset so as to pair with the Bluetooth headset. If the Bluetooth headset is in the state of power-off, then the disabling signal (such as 0V) is exerted upon the input terminal of the electronic switch control circuit of the controlled NFC tag, so that the electronic switch of the controlled NFC tag is on (closes)).
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Quintini et al. (WO 2018/132527 A1) in view of Fletcher (Fletcher – US 8,186,597 B1), Nguyen et al. (Nguyen – US 2016/0371574 A1) and Liu et al. (Liu – US 2016/0188925 A1), and further in view of Talyansky et al. (Talyansky – US 2018/0247151 A1).
As to claim 14, Quintini, Fletcher, Nguyen, and Liu disclose the limitations of claim 13 further comprising the system of claim 13, wherein the set of instructions when executed by the at least one processor further causes the system to:
receive a cradle Bluetooth address from the NFC reader of the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: a cradle having a first magnetic attachment device disposed in the cradle arm for removably holding the indicia reader; a second attachment device disposed on the indicia reader to removably attach the indicia reader to the first magnetic attachment device and Liu: Abstract and FIG. 1), except for the claimed limitations of
compare the cradle Bluetooth address from the NFC reader with an active connection Bluetooth address; and
responsive to the cradle Bluetooth address not matching the active connection Bluetooth address, initiate an alert.
However, it has been known in the art of communication system to implement compare the cradle Bluetooth address from the NFC reader with an active connection Bluetooth address; and responsive to the cradle Bluetooth address not matching the active connection Bluetooth address, initiate an alert, as suggested by Talyansky, which discloses compare the cradle Bluetooth address from the NFC reader with an active connection Bluetooth address; and responsive to the cradle Bluetooth address not matching the active connection Bluetooth address, initiate an alert (Talyansky: Abstract, [0034]-[0039], FIG. 1, and FIG. 3: After the example smartphone 112 detects the light pattern emitted by the example optical emitter 106, the example smartphone controller 118 decodes the pattern to discern the device ID encoded into the received light pattern and compares it to the device ID previously received via the Bluetooth connection (block 312). If the two device IDs do not match then control passes to block 313. If the two device IDs match then control passes to block 314… If the example smartphone controller 118 determines that the device ID received via the Bluetooth connection does not match the device ID encoded in the received light pattern (block 312), then the smartphone controller 118 indicates that an error has occurred to the user of the smartphone 112 (block 313). This verification of the device ID prevents nefarious users from fooling the system by using multiple detection devices or otherwise attempting to defeat the security of the verification system).
Therefore, in view of teachings by Quintini, Fletcher, Nguyen, Liu, and Talyansky it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini, Fletcher, Nguyen, and Liu to include compare the cradle Bluetooth address from the NFC reader with an active connection Bluetooth address; and responsive to the cradle Bluetooth address not matching the active connection Bluetooth address, initiate an alert, as suggested by Talyansky. The motivation for this is to verify pairing information between electronic devices.
As to claim 19, Quintini, Fletcher, Nguyen, Liu, and Talyansky disclose the limitations of claim 17 including the claimed limitations considered in the above rejection of claim 14, and the details are as followings the method of claim 17, wherein the display device is positioned on a base unit in electronic communication with the hand-held reader (Quintini: [0038]-[0039], [0042]-[0044], and FIG. 2-6: The stationary unit 662 may have at least one of the entry scanner 102, the exit scanner 104, the monitoring system 106, the display screen 108, the containment surface 238, the disposal recess 240, the disposal container 246, the electromagnet 242, any other feature of the system for monitoring surgical objects 100 previously described, or any combination thereof. The entry and exit scanners 102, 104 may be formed as a single entry and exit scanner 664 that provides the same functionality as both the entry and exit scanners 102, 104. At least one of the entry scanner 102, the exit scanner 104, and the single entry and exit scanner 664 may be stationary on the stationary unit 662. Alternatively, only one of the entry and exit scanners 102, 104 may be stationary on the stationary unit 662 while the other of the entry and exit scanners 102, 104 may be a handheld device ), the hand-held reader comprises a passive NFC tag encoded with a Bluetooth address corresponding to the hand-held reader (Liu: Abstract, [0006], [0049], and FIG. 1-2: in the situation that the Bluetooth headset is equipped with the controlled NFC tag provided in the present invention, if the Bluetooth headset is in the state of power-on, then the enabling signal (such as Vcc) is exerted upon the input terminal of the electronic switch control circuit of the controlled NFC tag, so that the electronic switch of the controlled NFC tag is off. At this moment, when the electronic equipment (such as NFC mobile phone) equipped with the NFC card reader is close to the Bluetooth headset, the electronic equipment can read the headset pairing information such as Bluetooth address stored in the NFC tag chip of the Bluetooth headset so as to pair with the Bluetooth headset. If the Bluetooth headset is in the state of power-off, then the disabling signal (such as 0V) is exerted upon the input terminal of the electronic switch control circuit of the controlled NFC tag, so that the electronic switch of the controlled NFC tag is on (closes)), and the cradle comprises an NFC reader, the method further comprising: receiving the hand-held reader within the cradle; receiving a cradle Bluetooth address from the NFC reader of the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: a cradle having a first magnetic attachment device disposed in the cradle arm for removably holding the indicia reader; a second attachment device disposed on the indicia reader to removably attach the indicia reader to the first magnetic attachment device and Liu: Abstract and FIG. 1);
compare the cradle Bluetooth address from the NFC reader with an active connection Bluetooth address; and responsive to the Bluetooth address not matching the active connection Bluetooth address, initiating an alert (Talyansky: Abstract, [0034]-[0039], FIG. 1, and FIG. 3: After the example smartphone 112 detects the light pattern emitted by the example optical emitter 106, the example smartphone controller 118 decodes the pattern to discern the device ID encoded into the received light pattern and compares it to the device ID previously received via the Bluetooth connection (block 312). If the two device IDs do not match then control passes to block 313. If the two device IDs match then control passes to block 314… If the example smartphone controller 118 determines that the device ID received via the Bluetooth connection does not match the device ID encoded in the received light pattern (block 312), then the smartphone controller 118 indicates that an error has occurred to the user of the smartphone 112 (block 313). This verification of the device ID prevents nefarious users from fooling the system by using multiple detection devices or otherwise attempting to defeat the security of the verification system).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Quintini et al. (WO 2018/132527 A1) in view of Fletcher (Fletcher – US 8,186,597 B1).
As to claim 20, Quintini discloses a surgical article system for managing removal of surgical articles following a surgical procedure, the surgical articles each including an identification tag comprising identification information identifying the corresponding surgical article, the system comprising:
a hand-held reader (Quintini: [0025], [0044], FIG. 1 , and FIG. 6 the single entry/exit scanner 662: The entry and exit scanners 102, 104 may be formed as a single entry and exit scanner 664 that provides the same functionality as both the entry and exit scanners 102, 104. At least one of the entry scanner 102, the exit scanner 104, and the single entry and exit scanner 664 may be stationary on the stationary unit 662. Alternatively, only one of the entry and exit scanners 102, 104 may be stationary on the stationary unit 662 while the other of the entry and exit scanners 102, 104 may be a handheld device) operable to read the identification information from the identification tags (Quintini: Abstract, [0004]-[0005], [0025]-[0028], [0044], FIG. 1 , and FIG. 6: the surgical object identifier 1 10 may be a label 1 14 on a surgical object package 1 16 readable by at least one of the entry and exit scanners 102, 104. The label 114 may contain data pertaining to at least one of the total number of surgical objects 112 within the surgical object package 1 16, the types of each surgical object 112 within the surgical object package 1 16, and the number of each type of surgical objects 112 within the surgical object package 116. The label 1 14 may be at least one of a UPC barcode, an RFID tag, an EAN barcode, any other barcode, a QR code, any alpha-numeric-based label, or any other scanner- perceptible marking. The surgical object 1 12 may have an attached discardable material 1 18. The discardable material 1 18 may be excess suture threading or any other appropriate material that is attached to a surgical object 1 12 and discarded at any desired time during and/or after a medical procedure);
at least one processor; and a non-transitory computer readable memory storing a set of instructions that that when executed by the at least one processor (Quintini: FIG.1 and FIG. 6 the monitoring system 106) causes the system to:
selectively operate the hand-held reader in a first count-in mode wherein the system stores information, based on the identification information, identifying the surgical articles as counted-in for use in the surgical procedure (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the entry count 128: the monitoring system 106 has a surgical object recognition module 122. The surgical object recognition module 122 has a processor 124 and a database of preexisting surgical object identifier data 126. The surgical object recognition module 122 may identify at least one of the number of surgical objects 1 12, the type of surgical objects 1 12, and the number of each type of surgical objects 1 12 from the first set of image data by comparing the first set of image data with the pre-existing surgical object identifier data to produce at least one of a surgical object entry count 128 and a surgical object type entry count 130); and
selectively operate the hand-held reader in a second count-out mode wherein the system stores information, based on the identification information, identifying the surgical articles as counted-out and removed from the surgical procedure (Quintini: [0028]-[0032], [0038]-[0039], [0052]-[0053], and FIG. 1 the exit count 132: the surgical object recognition module 122 may identify at least one of the number of surgical objects 1 12, the type of surgical objects 1 12, and the number of each type of surgical objects 1 12 from the second set of image data by comparing the second set of image data with the pre-existing surgical object identifier data to produce at least one of a surgical object exit count 132 and a surgical object type exit count 134).
Quintini does not explicitly disclose
a cradle, the cradle adapted to receive the hand-held reader, wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle; and terminating operation of the hand-held reader in the second count-out mode based on a determination that the hand-held reader has been removed from the cradle.
However, it has been known in the art of reading devices to implement a cradle, the cradle adapted to receive the hand-held reader, wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle; and terminating operation of the hand-held reader in the second count-out mode based on a determination that the hand-held reader has been removed from the cradle, as suggested by Fletcher, which discloses
a cradle (Fletcher: Abstract, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510), the cradle adapted to receive the hand-held reader (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: a cradle having a first magnetic attachment device disposed in the cradle arm for removably holding the indicia reader; a second attachment device disposed on the indicia reader to removably attach the indicia reader to the first magnetic attachment device) wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle); and terminating operation of the hand-held reader in the second count-out mode based on a determination that the hand-held reader has been removed from the cradle (Fletcher: Abstract, column 3 lines 24-30, column 7 lines 23 – column 8 lines 24, column 8 lines 49-column 9 lines 62, FIG. 1 the cradle 138 and FIG. 3-4 the cradle 510: the cradle may have a reading instrument or detector 550, such as an RFID reader and associated circuitry/connectivity for making RF payments or for article detection. The cradle may also have a proximity reader 554 for detecting or reading information from items placed in proximity to the cradle. A proximity detector may be utilized to trigger the reader for such things as activating illumination, activating an aimer, changing decoding algorithms, changing decoding modes, operating modes, operating characteristics, etc. The reader may be configured to sense that it is in the cradle and thereby change the operating mode when it is either cradled in the cradle or removed from the cradle rather than rely upon a trigger pull to change the operating mode. An exemplary configuration may be a mechanical switch or microswitch that is activated when the reader is placed in the cradle. It may also be a microswitch that is activated by a mechanical feature in the scanner cradle. It may also be a magnetically actuated read relay that responds to a permanent magnet on or in the scanner cradle).
Therefore, in view of teachings by Quintini and Fletcher, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to implement in the monitoring system of Quintini to include a cradle, the cradle adapted to receive the hand-held reader, wherein the cradle is operable to determine a presence of the hand-held reader received in the cradle; and terminating operation of the hand-held reader in the second count-out mode based on a determination that the hand-held reader has been removed from the cradle, as suggested by Fletcher. The motivation for this is to implement a known alternative device for receiving information of surgical objects.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Learmonth, US 2021/0390811 A1, discloses physical access control system and method.
Yavari et al., US 2021/0085428 A1, discloses a surgical article and method for managing surgical articles during a surgical procedure.
Fuerst et al, US 2021/0068907 A1, discloses handheld user interface device for surgical robot.
Conclusion
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/QUANG PHAM/Primary Examiner, Art Unit 2685
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