Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This action is responsive to applicant’s response of 11/26/2025. Claims 1-7, 12-13 and 15-20 are pending and rejected. Claims 8-11 and 14 are cancelled.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-7 and 12-13 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (WO2021059210) in view of Blair et al. (US20110004276) in further view of Bonny wherein Bakos et al. teaches:
(re: cl 1) A method of determining a disposal methodology of a surgical component of a surgical system, the method comprising:(a) determining a geographical location in which the surgical component system is being used (¶220-“can include information regarding proper disposal of the drug administration device”; ¶223-“proper disposal of the drug administration device can be provided based on a geographic location of the user”, “the drug administration device including a geographic sensor”) based on at least one of: (i) reading a device code or a serial number embedded in: (A) a memory of the instrument, or (B) a memory of a generator of the surgical system (¶ 224 geographic location in remote computer system;¶223-from user location; ¶224-location from a remote server, and generally ¶220-224),
(ii)reading an RFID tag, wherein the surgical instrument comprises the RFID tag or the generator comprises the RFID tag (¶228-RFID tag and reader for reading),
and (iii) receiving, after one of the disposal assistance device or a surgical hub of the surgical system connects to a network (¶223-geographic location from a remote computer system-para. ¶224, Cl1-item key in remote server ),
a regional code comprising the geographical location from a remote server (¶224 geographic location in remote computer system; from user location; ¶223-geographic location sensor with local disposal requirement from a remote computer system-¶224, Cl1-item key in remote server; and more generally ¶220-224);
(b) generating a location data set based on the geographical location in which the surgical component system is being used (¶223-“ device including a geographic sensor or, for another example, by the user’s mobile device including location sensing capability“; ¶224-“in a lookup table correlating each of a plurality of geographic locations with medical component disposal instructions specific to that geographic location”);
(c) sending the location data set to a resource device (¶224-“in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”
(d) receiving the disposal methodology from the resource device based on the location data set (¶225-“ disposal database also includes carbon footprint information regarding disposal of the drug administration device. Carbon footprint information can be correlated with each of the geographic locations, e.g., in a lookup table. The carbon footprint information can be provided with the drug administration device disposal instructions to help inform users of environmental factors associated with the drug administration device. Alternatively, the carbon footprint information can be calculated once the geographic location of a particular drug administration device is known based on the disposal requirements for that geographic location, e.g., based on the facility that will discard or recycle the drug administration device, and/or based on the geographic location itself,”¶228-“the drug administration device, smart container, or smart carton can have a label attached thereto (or otherwise part of the drug administration device, smart container, or smart carton) that is configured to be read electronically to provide information regarding proper drug administration device disposal for the drug administration device”; 224-device can be configured to access a digital database to provide disposal instructions; ¶243-devices sent for disposal, sterilization, reuse, and reconditioning);
and (e) displaying, on a display of the disposal assistance device or another display configured to be used with the surgical system, a set of instructions based on the disposal methodology received from the resource device (¶223-dispose items per geographic jurisdictional requirements; ¶220, ¶226- user interface identifying proper disposal instructions ; ¶229- displays notification on use ; ¶243-devices sent for disposal, sterilization, reuse, and reconditioning ; ¶228-administration device instructs on disposal of medical items ).
the set of instructions comprising instructions for disposal(¶243-devices sent for disposal, sterilization, reuse, and reconditioning; ¶220, ¶226- user interface identifying proper disposal instructions ).
Blair et al. teaches what Bakos et al. explicitly lacks of:
The surgical object-component is a surgical instrument (¶6-surgical instrument);
and instructions for reuse (¶7-track objects returned during surgery; ¶7-checklists to return objects during surgery; ¶93-sterilization for reuse or disposal).
It 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, to modify Bakos et al. with the teachings of Blair et al. in that the surgical object is a surgical instrument as taught by Blair et al. and to track all medical items as one of ordinary skill in the art would recognize.
It 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, to modify Bakos et al. with the teachings of Blair et al. to determine where to return surgical components in order to assure items are not left behind in the patient as taught by Blair et al. and to make sure surgical kit components are sent for proper cleaning and reuse and disposal reusing and sterilizing surgical equipment would save the expense of single time use and prevent cross contamination of infection between patients as one of ordinary skill in the art would recognize.
Bakos et al. further teaches:
(re: cl 2) wherein the resource device comprises a cloud storage system (#951 Fig. 9;
¶155-cloud computing device stores device information).
(re: cl 3) wherein the cloud storage system comprises a plurality of disposal methodologies each directed to a different geographical location (¶224-Disposal Instructions ; ¶233 displays functionality).
(re: cl 4) further comprising determining a list of medical products used in conjunction with the surgical kit (¶34-lists medicament and usage schedule ).
(re: cl 5) further comprising generating a medical product data set based on the list of medical products used in conjunction with the surgical kit (¶34-data on medicament and usage schedule).
(re: cl 6) further comprising providing the medical product data set to the resource device (¶34-data on medicament and usage schedule).
Blair et al. teaches what Bakos et al. explicitly lacks of:
(re: cl 7) further comprising receiving the disposal methodology from the resource device based on the medical product data set (¶7-track objects returned during surgery; ¶7-checklists to return objects during surgery).
It 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, to modify Bakos et al. with the teachings of. to receive the disposal methodology from the resource device based on the medical product data set in order to assure items are not left behind in the patient as taught by Blair et al and to make sure surgical kit components are sent for proper cleaning and reuse and disposal as one of ordinary skill in the art would recognize.
(re: cl 12) wherein determining the geographical location further comprises receiving a use input (¶111- location sensor and user input ; ¶124-- location and user input).
(re: cl 13) wherein determining the geographical location further comprises utilizing a network address (¶223-“ so basing the information regarding proper disposal of the drug administration device on the geographic location of the user can help ensure that local jurisdiction rules are followed. The geographic location of the user can be known, for example, by the drug administration device including a geographic sensor or, for another example, by the user’s mobile device including location sensing capability “; ¶128-“location from which the user is accessing the system).
(re: cl 15) wherein the surgical system comprises a battery (¶235-device contains battery).
(re: cl 16) wherein the surgical system comprises an ultrasonic transducer (¶93-ultrasonic atomizing).
Blair et al. teaches what Bakos et al. explicitly lacks of:
(re: cl 17) wherein the surgical system comprises a power cord (¶301-power cord).
It 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, to have the surgical kit include a power cord as taught by Blair et al. in order to provide power to the kit as one of ordinary skill in the art would recognize.
(re: cl 18) A method of determining a disposal methodology of a surgical component t of a surgical system, the method comprising: (a) identifying a geographical location of use for the medicament (¶220-“can include information regarding proper disposal of the drug administration device”; ¶223-“proper disposal of the drug administration device can be provided based on a geographic location of the user”, “the drug administration device including a geographic sensor”),
(b) sending the geographical location of use to a resource device storing a plurality of disposal methodologies (¶224-“ in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”; ¶222-“the remote computer system can be configured to transmit a request to the device administration device to provide the information regarding proper disposal of the drug administration device.”).
(c) receiving a particular disposal methodology from the resource device based at least in part on the geographical location provided to the resource device (¶225-“ disposal database also includes carbon footprint information regarding disposal of the drug administration device. Carbon footprint information can be correlated with each of the geographic locations, e.g., in a lookup table. The carbon footprint information can be provided with the drug administration device disposal instructions to help inform users of environmental factors associated with the drug administration device. Alternatively, the carbon footprint information can be calculated once the geographic location of a particular drug administration device is known based on the disposal requirements for that geographic location, e.g., based on the facility that will discard or recycle the drug administration device, and/or based on the geographic location itself”, ¶228-“ the drug administration device, smart container, or smart carton can have a label attached thereto (or otherwise part of the drug administration device, smart container, or smart carton) that is configured to be read electronically to provide information regarding proper drug administration device disposal for the drug administration device”);
and (d) displaying, on a display configured to be used with the surgical system
(¶308-display of or control of medical instrument), a set of instructions based on the particular disposal methodology received from the resource device (¶229- displays notification).
Blair et al. teaches what Bakos et al. explicitly lacks of:
The surgical object-component is a surgical instrument (¶6-surgical instrument);
surgical instrument based on a device code or a serial number that is read from a memory of the surgical system, or a regional code that is received, after the surgical system connects to a network, from a remote server (¶316-reads data carriers associated with device ; ¶317- may trigger a transponder on the device being read ; ¶318 – transponder triggered to read RFID tag ),
device, the set of instructions comprising instructions for disposal and instructions for reuse (¶7-track objects returned during surgery; ¶7-checklists to return objects during surgery; ¶93-sterilization for reuse or disposal).
It 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, to modify Bakos et al. with the teachings of Blair et al. in that the surgical object is a surgical instrument as taught by Blair et al. and to track all medical items as one of ordinary skill in the art would recognize.
It 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, to modify Bakos et al. with the teachings of Blair et al. to identify the surgical instrument based on a device code or a serial number that is read from a memory of the surgical system, or a regional code that is received, after the surgical system connects to a network, from a remote server to identify the procedures for disposal specific to that instrument in return or reused as taught by Blair et al. in order to identify the item and the data contents on its disposal as taught by Blair et al. and to make sure the item is sent to the correct post-surgical location ordinary skill in the art would recognize.
It 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, to modify Bakos et al. with the teachings of Blair et al. to determine where to return surgical components in order to assure items are not left behind in the patient as taught by Blair et al. and to make sure surgical components are sent for proper cleaning and reuse and disposal reusing and sterilizing surgical equipment would save the expense of single time use and prevent cross contamination of infection between patients as one of ordinary skill in the art would recognize.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakos et al. (WO2021059210) in view of Blair et al. (US20110004276) in further view of Kuratan (JP2019144986) wherein Bakos et al. in view of Blair et al. teaches the elements previously discussed and Kuratan, with cites per the machine translation, teaches what Bakos et al. lacks of:
(re: cl 19) wherein the set of instructions are arranged in a chronological order (¶57-chronological order of return).
It 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, to have the return instructions in chronological order as taught by Kuratan to ensure the instructions are followed accurately and to prevent improper actions that could cause harm to a user and/or damage products/systems.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonny (US20200390506) in view of Bakos et al. (WO2021059210) wherein Bonny teaches:
(re: cl 20) A surgical system comprising:
(a) a generator (¶33- #100 generates and displays surgery and post-surgery procedure; ¶27-28-provides for user to select options to provide steps) configured to energize a surgical instrument; ¶38- #306 surgical tool driven by motor #305 attached to articulating support device #204 ),
(b) a surgical kit comprising a plurality of surgical subcomponents, the plurality of surgical subcomponents configured to be assembled into a surgical instrument (¶37- cut guides can be assembled for the surgeon),
wherein the surgical instrument is configured to be disassembled into a first set of used surgical subcomponents that are reusable components (¶33-instruction for sterilization means reusable) and a second set of used surgical instrument subcomponents (¶33-“tear-down instructions” for plurality of components means at least plurality of sets of one),
(c) an identification feature associated with either the generator or the surgical kit (¶30( a) identifies the tracked surgical device 204 based on a reference member (e.g., an attached tracking array or fiducial markers 314 having a unique geometry, a unique emitting wavelength, or a unique emitted signal) associated with the surgical device 204; ¶33-teadown instructions displayed on GUI by workflow generator),
and (d) a disposal assistance device configured to display a set of instructions on how to:
disassemble the surgical instrument into the first set of used surgical subcomponents and the second set of used surgical subcomponents (¶33-“ tear-down instructions,” for plurality of components means at least plurality of sets of one),
wherein the set of instructions is dependent on data obtained from the identification feature (¶30( a) identifies the tracked surgical device 204 based on a reference member (e.g., an attached tracking array or fiducial markers 314 having a unique geometry, a unique emitting wavelength, or a unique emitted signal) associated with the surgical device 204; b) determines which step in the surgical workflow 100 utilizes the surgical device 204).
Bakos et al. teaches any elements that Bonny lacks including:
the second set of used medical components are disposable (¶ 243-devices sent for disposal, sterilization, reuse, and reconditioning; ¶220, ¶226- user interface identifying proper disposal instructions),
and read from a memory or an RFID tag (¶228-RFID tag and reader for reading),
wherein the identification feature comprises data that provides or is used to derive geographical location data (¶224 geographic location in remote computer system; from user location ;¶223, location from a remote server-¶224, and more generally ¶220-224; ¶223-“the drug administration device including a geographic sensor or, for another example, by the user’s mobile device including location sensing capability “; ¶224-“ in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”);
the second set of components are disposable (¶220, ¶226- user interface identifying proper disposal instructions);
prepare the first and second sets of used surgical subcomponents for reuse (¶33-“ sterilization instructions”) or disposal respectively (the second set of components are disposable (¶220, ¶226- user interface identifying proper disposal instructions; ¶243-devices sent for disposal, sterilization, reuse, and reconditioning)
, and
store the first and second sets of used surgical subcomponents for reuse or disposal respectively (¶220, ¶223-dispose items per geographic jurisdictional requirements ;¶226- user interface identifying proper disposal instructions; ¶243- instructions for disposal, reuse, sterilization, reconditioning of devices and sending to reconditioning facility).
It 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, to modify Bonny with the teachings of Bakos et al. to the second set of used medical components are disposable as taught by Bakos et al. as some medical components are not economically sterilizable, nor having an undamaged life beyond use and might risk infection spread to another patient as one of ordinary skill in the art would recognize.
It 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, to modify Bonny with the teachings of Bakos et al. to the second set of used medical components are disposable as taught by Bakos et al. as some medical components are not economically sterilizable, nor having an undamaged life beyond use and might risk infection spread to another patient as one of ordinary skill in the art would recognize.
It 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, to modify Bonny with the teachings of Bakos et al. to read from a memory or an RFID tag as taught by Bakos et al. and to make sure surgical kit components are sent for proper cleaning and reuse and disposal as one of ordinary skill in the art would recognize.
It 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, to modify Bonny with the teachings of Bakos et al. to wherein the identification feature comprises data that provides or is used to derive geographical location data to comply with local jurisdictional medical disposal requirements (¶223) as taught by Bakos et al. to determine where to send the medical items after use as one of ordinary skill in the art would recognize.
It 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, to modify Bonny with the teachings of Bakos et al. to the second set of used medical components are disposable as taught by Bakos et al. as some medical components are not economically sterilizable, nor having an undamaged life beyond use and might risk infection spread to another patient as one of ordinary skill in the art would recognize.
It 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, to modify Bonny with the teachings of Bakos et al. to store the first and second sets of used surgical subcomponents for reuse or disposal as taught by Bakos et al. to assure the medical components are sent to a place for reconditioning or to a location preventing harm to other patients, environment, or medical personnel as one of ordinary skill in the art would recognize.
Response to Amendments/Arguments
Applicant’s amendment was sufficient to overcome the 101 subject matter rejections.
Applicant’s amendment was sufficient to overcome the anticipatory rejection on claim 20 evidenced by Bonny. However, Bonny teaches:
(re: cl 20) A surgical system comprising:
(a) a generator (¶33- #100 generates and displays surgery and post-surgery procedure; ¶27-28-provides for user to select options to provide steps) configured to energize a surgical instrument; (38-#306 surgical tool driven by motor #305 attached to articulating support device #204)
(b) a surgical kit comprising a plurality of surgical subcomponents, the plurality of surgical subcomponents configured to be assembled into a surgical instrument (¶37- cut guides can be assembled for the surgeon),
wherein the surgical instrument is configured to be disassembled into a first set of used surgical subcomponents that are reusable components (¶33-sterilization means reusable)
and a second set of used components (¶33-“tear-down instructions” plurality of components means first & second sets)
(c) an identification feature associated with either the generator or of the surgical kit (¶30( a) identifies the tracked surgical device 204 based on a reference member (e.g., an attached tracking array or fiducial markers 314 having a unique geometry, a unique emitting wavelength, or a unique emitted signal) associated with the surgical device 204;¶33-teadown instructions displayed on GUI by workflow generator).
Bakos et al. teaches:
subcomponents that are disposable (¶220, ¶226- user interface identifying proper disposal instructions),
and read from a memory or an RFID tag (¶228-RFID tag and reader for reading),
wherein the identification feature comprises data that provides or is used to derive geographical location data (¶224 geographic location in remote computer system; from user location ; ¶223, location from a remote server-¶224, and ¶220-224);
(b) generating a location data set based on the geographical location in which the surgical instrument kit medical item is being used (¶223-“the drug administration device including a geographic sensor or, for another example, by the user’s mobile device including location sensing capability “; ¶224-“ in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”);
(c) sending providing the location data set to a resource device (¶224-“ in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”
(¶228-RFID tag and reader for reading),
¶224-geographic location in remote computer system; ¶223-from user location; ¶224- location from a remote server, and ¶220-224);
(¶223-“the drug administration device including a geographic sensor or, for another example, by the user’s mobile device including location sensing capability “; ¶224-“ in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”);
Applicant’s amendment was insufficient and arguments unpersuasive in overcoming the obviousness rejections to claims 1-8, 12-13, and 15-19. Bakos et al. teaches:
(a) determining a geographical location in which the surgical instrument system kit is being used (¶220-“can include information regarding proper disposal of the drug administration device”; ¶223-“proper disposal of the drug administration device can be provided based on a geographic location of the user”, “the drug administration device including a geographic sensor”) based on at least one of: (i) reading a device code or a serial number embedded in: (A) a memory of the surgical instrument, or (B) a memory of a generator of the surgical system (¶ 224 geographic location in remote computer system;¶223-from user location; ¶224-location from a remote server, and generally ¶220-224) ,
and (iii) receiving, after one of the disposal assistance device or a surgical hub of the surgical system connects to a network (¶223-geographic location from a remote computer system ¶224, Cl1-item key in remote server ),
(b) generating a location data set based on the geographical location in which the surgical instrument system kit is being used (¶223-“the drug administration device including a geographic sensor or, for another example, by the user’s mobile device including location sensing capability “; ¶224-“ in a lookup table correlating each of a plurality of geographic locations with drug administration device disposal instructions specific to that geographic location”);
a regional code comprising the geographical location from a remote server (¶224 geographic location in remote computer system; from user location; ¶223-geographic location sensor with local disposal requirement from a remote computer system-¶224, Cl1-item key in remote server; and more generally ¶220-224); and (e) displaying, on a display of the disposal assistance device or another display configured to be used with the surgical system, a set of instructions based on the disposal methodology received from the resource device (¶223-dispose items per geographic jurisdictional requirements l¶220, ¶226- user interface identifying proper disposal instructions ; ¶229- displays notification on use ; ¶243-devices sent for disposal, sterilization, reuse, and reconditioning; ¶228-administration device instructs on disposal of medical items drugs ).
Blair et al. teaches:
The surgical object is a surgical instrument (¶6-surgical instrument);
and instructions for reuse (¶7-track objects returned during surgery; ¶7-checklists to return objects during surgery; ¶93-sterilization for reuse or disposal), surgical instrument based on a device code or a serial number that is read from a memory of the surgical system, or a regional code that is received, after the surgical system connects to a network, from a remote server (¶316-reads data carriers associated with device ; ¶317- may trigger a transponder on the device being read ; ¶318 – transponder triggered to read RFID tag).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL E BUTLER whose telephone number is (571)272-6937.
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/M.E.B/Examiner, Art Unit 3655
/JACOB S. SCOTT/Supervisory Patent Examiner, Art Unit 3655