DETAILED ACTION
The present office action represents a nonfinal action on the merits.
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 .
Priority
This application claims the priority date of provisional applications 63/424,557 dated November 11, 2022 and 371 of PCT/US2023/037179 dated November 13, 2023.
Status of Claims
Claims 18-19 and 23-36 are cancelled and claims 1-17 and 20-22 are pending.
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 1-17 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-15 are drawn to a method of facilitating a surgical procedure with a surgical management system, which is within the four statutory categories (i.e., process). Claims 16-17 are drawn to a method of facilitating a surgical procedure with a surgical management system, which is within the four statutory categories (i.e., process). Claims 20-22 are drawn to a method of facilitating a surgical procedure with a surgical management system, which is within the four statutory categories (i.e., process).
Claims 1-15 recite a method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, the method comprising:
receiving, through a first user input to the display interface, a manual count in of surgical articles being counted in to the surgical procedure;
displaying, on the primary display, a manual count of the surgical articles based on the manual count in;
receiving, at the one or more processors, identification information based on wireless detection, with the data reader, an identification tag from one or more of the surgical articles being counted in to the surgical procedure;
determining, with the one or more processors, an electronic count in of the surgical articles based on the identification information;
displaying, on the primary display, the manual count and the electronic count in; and
providing, on the primary display, a visual indication if the manual count of the surgical articles does not match the electronic count in of the surgical articles.
Claims 16-17 recite a method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, the method comprising:
preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state;
displaying, on the primary display, tiles of grouped content, wherein at least one of the tiles of grouped content is visually deemphasized;
receiving, from a database, stored procedure information including patient information and clinical information;
displaying, on the primary display, the patient information;
receiving patient information based on wireless detection by the data reader of a patient tag associated with a patient;
determining, with the one or more processors, the procedure information to be in a verified state based on the patient information matching the stored patient information;
altering, on the primary display, presentation of the deemphasized tile of grouped content based on the procedure information being in the verified state; and
enabling, with the one or more processors, the counting in of the surgical articles to the surgical procedure based on the procedure information being in the verified state.
Claims 20-22 recite a method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, the method comprising:
preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state;
displaying, on the primary display, a pre-procedure protocol including a series of actions to be performed before commencement of invasive aspects of the surgical procedure;
receiving, from a database, stored procedure information including patient information and clinical information;
displaying, on the primary display, the patient information and the clinical information;
receiving, on the display interface, inputs configured to satisfy each of the series of actions of the pre-procedure protocol;
altering, on the primary display, indicia corresponding to each of the series of actions as each of the inputs is determined to have been performed, by the one or more processors, to satisfy a respective one of the series of actions;
determining, with the one or more processors, the procedure information to be in a verified state based all of the series of actions of the pre-procedure protocol being satisfied; and
enabling, with the one or more processors, the counting in of the surgical articles to the surgical procedure based on the procedure information being in the verified state.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity. The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below. If a claim limitation, under its broadest reasonable interpretation, is managing personal behavior or interactions between people but for the recitation of generic computer components, then it fails within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Dependent claims 2-15, 17, and 21-22 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The dependent claims recite additional limitations but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 16, and 20.
The additional elements from claims 1, 16, and 20 include:
a surgical management system (apply it, MPEP 2106.05(f)).
a data reader (apply it, MPEP 2106.05(f)).
one or more processors (apply it, MPEP 2106.05(f)).
a display interface (apply it, MPEP 2106.05(f)).
a primary display (apply it, MPEP 2106.05(f)).
Furthermore, claims 1-17 and 20-22 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “a surgical management system”, “a data reader”, “one or more processors”, “a display interface”, and “a primary display”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see, Specification Paragraphs [0025]-[0026], [0044]-[0047], [0052], [0060]-[0061] (See MPEP 2106.05(f)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Specification Paragraphs [[0025]-[0026], [0044]-[0047], [0052], [0060]-[0061] disclose that the additional elements (i.e., a surgical management system, a data reader, one or more processors, a display interface, and a primary display) comprise a plurality of different types of generic computing systems that are configured to perform generic computer that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., implementing adjunct technology to facilitate a surgical procedure).
Dependent claims 2-15, 17, and 21-22 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves implementing adjunct technology to facilitate a surgical procedure or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1-17 and 20-22 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Satish (U.S. Pub. No. 2022/0296332 A1).
Regarding claim 1, Satish discloses method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, the method comprising (Paragraphs [0012], [0024], and [0106] discuss a display of information generated by a method for tracking surgical items implemented via one or more mobile computing devices, each of which may include one or more cameras or other image sensors, one or more processors, one or more displays.):
receiving, through a first user input (Examiner notes that the prior art does not reference “first”, “second”, or “third”, however, it references “users”, which Examiner interprets to include multiple users during a procedure.) to the display interface, a manual count in of surgical articles being counted in to the surgical procedure (Paragraphs [0025] discuss receiving of the first count of surgical items may comprise identifying one or more surgical items depicted in an image determined based at least in part on a user input.);
displaying, on the primary display, a manual count of the surgical articles based on the manual count in (Paragraph [0026] discuss displaying the first count of surgical items, the second count of surgical items, the notification, or any suitable combination thereof, on a display (e.g., a display screen).);
receiving, at the one or more processors, identification information based on wireless detection, with the data reader, an identification tag from one or more of the surgical articles being counted in to the surgical procedure (Paragraphs [0043] discuss a processor receives information regarding the surgical item, the type may be determined based on other identification (e.g., scanning a barcode or a radio-frequency identification (RFID) tag associated with the surgical item type.).);
determining, with the one or more processors, an electronic count in of the surgical articles based on the identification information (Paragraphs [0043]-[0044] discuss determine the first count of surgical items and additionally, the surgical item type may be determined based on other identification (e.g., scanning a barcode or a radio-frequency identification (RFID) tag associated with the surgical item type), a processor receives information regarding the surgical item, the type may be determined based on other identification (e.g., scanning a barcode or a radio-frequency identification (RFID) tag associated with the surgical item type.);
displaying, on the primary display, the manual count and the electronic count in (Paragraph [0044] discusses the graphical user interface provides selectable icons to allow the user to manually override the first count and provide a manual count.); and
providing, on the primary display, a visual indication if the manual count of the surgical articles does not match the electronic count in of the surgical articles (Paragraphs [0026], [0030], [0037] discuss the first count of surgical items may be received as a manual input or other user input and providing a notification on a display based on the comparison between the first count and the second count, and may include generating an alert in response to the first count not matching the second count.).
Regarding claim 2, Satish discloses further comprising:
receiving, through a second user input to the display interface, a manual count out of one or more of the of the surgical articles being counted out of the surgical procedure, wherein the one or more surgical articles were previously counted in to the surgical procedure (Examiner notes that the prior art includes “first” and “second” inputs however, the order of the input may be different.) (Paragraphs [0037]-[0040] discuss establish the first count of surgical items, for example, the first count of surgical items may be received as a manual input or other user input. As another example, the first count of surgical items may additionally or alternatively be established by one or more processors (e.g., through one or more computational techniques), the determining of the first count includes updating the first count by adding the number of surgical items the processor counted in the image to a number of surgical items previously counted (e.g., surgical items depicted in an image taken at a prior time point).).;
updating, with the one or more processors, the manual count of the surgical articles based on the manual count in and the manual count out (Paragraphs [0036]-[0037], [0040] discuss first count is updated throughout the course of procedure received as a manual input, the determining of the first count includes updating the first count by adding the number of surgical items the processor counted in the image to a number of surgical items previously counted (e.g., surgical items depicted in an image taken at a prior time point).);
displaying, on the primary display, the updated manual count (Paragraphs [0040] and [0044] discuss graphical user interface in FIG. 3 displays the type of surgical item being counted, and the current determination of the first count. Further, the graphical user interface provides selectable icons to allow the user to manually override the first count and provide a manual count, and to finish the first count (e.g., indicate that all surgical items of the selected type have, at least for now, been counted toward the first count).);
receiving the identification information based on wireless detection, with the data reader, of the identification tag from one or more of the surgical articles to be counted out of the surgical procedure (Paragraph [0043] discusses processor receives information regarding the surgical item to be counted, the surgical item type may be determined based on other identification (e.g., scanning a barcode or a radio-frequency identification (RFID) tag associated with the surgical item type.);
determining, with the one or more processors, an electronic count out the surgical articles based on the identification information of the one or more articles to be counted out (Paragraph [0043] discusses a plurality of surgical items may be placed onto a scale, and information about the weight of each individual surgical item may be used to determine the first count of surgical items and a processor in communication with the scale may receive information regarding the weight of a single surgical item, based on the received surgical item type.);
displaying, on the primary display, the manual count, the electronic count in, the electronic count out (Paragraphs [0049]-[0051], [0090]-[0093], FIGS. 7, 14-15 discuss display of the second count of surgical items compared to the first count of surgical items, the second count may be determined at any suitable time point in a procedure (e.g., a medical procedure, such as a surgical procedure) between a starting time point and an ending time point of the procedure. The second count may also be a final count at the end of the procedure, the count may be manual or one or more computational techniques, may be used to automate counting.); and
providing, on the primary display, the visual indication if the manual count of the surgical articles does not match the electronic count out of the surgical articles (Paragraphs [0030], [0033], [0090], [0093], and FIG. 1 discuss the notification on a display may be provided based on a comparison between the first count and the second count (e.g., to confirm reconciliation between the first count and the second count, to track progress toward incrementally increasing counts until the first count and the second count are reconciled, to alert a user when the first and second count fail to be reconciled (e.g., fail to match); providing users with a notification based on whether the first count matches the second count. If the first count and the second count do not match, such methods may comprise notifying or otherwise alerting a user to take one or more predetermined actions, use computational counting system or using manual counting.).
Regarding claim 3, Satish discloses determining, with the one or more processors, an electronic count of articles remaining as counted in as a difference between the electronic count in and the electronic count out (Paragraphs [0031]-[0033] and FIGS. 1-3 discuss one or more processors receiving a first count of surgical items, receiving one or more images, wherein each image is a field of view comprising one or more surgical items, and determining a second count of surgical items based at least in part on the one or more received images, providing a notification based on a comparison between the first count of surgical items and the second count of surgical items.); and
displaying, on the primary display, the electronic count of articles remaining as counted in (FIGS 11, 14-15 discuss displaying surgical textile accounting of items counted in, scanned out and remaining.); and
providing, on the primary display, the visual indication if the manual count of the surgical articles does not match the electronic count of articles remaining as counted in (Paragraphs [0026], [0030], [0037], and FIGS. 3, 15 discuss the first count of surgical items may be received as a manual input or other user input and providing a notification on a display based on the comparison between the first count and the second count, and may include generating an alert in response to the first count not matching the second count.).
Regarding claim 8, Satish discloses further comprising:
associating, on the display interface, the manual count with a first portion of the surgical procedure (Paragraphs [0032], [0035]-[0037] and FIG. 3 discuss receiving the first count is or includes the number of surgical items introduced prior to or at the beginning of the surgical procedure, the first count is subsequently updated throughout the course of the procedure (e.g., as surgical items are introduced into the operating room, removed from packaging, or both), for example, one package of surgical items may be introduced into the operating room and removed from packaging at the start of a procedure (e.g., before any operational steps on a patient begin), subsequently, at a point during the medical procedure, such as while an operation is being performed, a second package of surgical items may be retrieved, introduced into the operating room, and have its surgical items removed from packaging. Thus, the first count may be updated (e.g., incremented) with the number of surgical items in the second package as a manual input. The first count is associated with a first time.);
generating, on the display interface, indicia associated with a second portion of the surgical procedure (Paragraphs [0030]-[0035] discuss tracking surgical items and to display information to one or more users and determining a first count of one or more surgical items, determining a second count of one or more surgical items, and providing a notification based on at least one of the first count of one or more surgical items and the second count of one or more surgical items; receiving the first count is or includes the number of surgical items introduced prior to or at the beginning of the surgical procedure, the first count is subsequently updated throughout the course of the procedure, for example, one package of surgical items may be introduced into the operating room and removed from packaging at the start of a procedure (e.g., before any operational steps on a patient begin), subsequently, at a point during the medical procedure, such as while an operation is being performed, a second package of surgical items may be retrieved, thus, the first count may be updated (e.g., incremented) with the number of surgical items in the second package as a manual input.); and
receiving, through another input on the display interface, another manual count in of surgical articles being counted in to the second portion of the surgical procedure (Paragraphs [0030]-[0035] discuss receiving a second count of surgical items may correspond to a number of surgical items that are used during a medical procedure.); and
displaying, on the primary display, another manual count of the surgical articles in a display screen separate from a display screen associated with the manual count associated with the first portion of the surgical procedure (Paragraphs and FIGS. 9-15 discuss a graphical user interface showing information related to tracking surgical items at an intermediate time point during a surgical procedure.).
Regarding claim 15, Satish discloses wherein the surgical articles are one of surgical sponges and surgical instruments, and optionally, wherein the data reader is a radiofrequency identification (RFID) reader and the identification tag is an RFID tag (Paragraphs [0022] and [0043] discuss tracking surgical items, such as (e.g., surgical sponges or a pads of surgical gauze, surgical instruments or equipment) by scanning an electronic tag, such as a barcode or RFID tag, on the surgical item.).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Satish in view of Schlabach (U.S. Pub. No. 2007/0112649 A1).
Regarding claim 4, Satish discloses wherein each entry of the manual count in and the manual count out prior to an updated entry remain displayed on the primary display (Paragraphs [0049]-[0051], [0090]-[0093], FIGS. 7, 14-15 discuss display of the second count of surgical items compared to the first count of surgical items, the second count may be determined at any suitable time point in a procedure (e.g., a medical procedure, such as a surgical procedure) between a starting time point and an ending time point of the procedure. The second count may also be a final count at the end of the procedure, the count may be manual or one or more computational techniques, may be used to automate counting.).
Satish does not explicitly disclose:
wherein each entry of the manual count in and the manual count out prior to an updated entry indicated as a previous entry, and, optionally, wherein the previous entry is struck through.
Schlabach teaches:
wherein each entry of the manual count in and the manual count out prior to an updated entry indicated as a previous entry, and, optionally, wherein the previous entry is struck through (Paragraphs [0060]-[0068] and FIGS. 6-7 discuss system selects a new data value, marks a new data value, and enters a reason for the change or a comment, the display image may include individual data fields for receiving data representing a user entered reason code for editing the pre-populated list of item types, for example, a user may edit the history to indicate that a sponge was cut into two pieces or that a needle broke in half, and that the item is now counted as two pieces instead of one piece.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, wherein each entry of the manual count in and the manual count out prior to an updated entry indicated as a previous entry, and, optionally, wherein the previous entry is struck through, as taught by Schlabach, in order to provide comprehensive inventory control of items, such as in a critical environment, like an OR. (Schlabach Paragraphs [0010]).
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Satish in view of Hunter (U.S. Pub. No. 2013/0285947 A1) and Barral (U.S. Pat. 12119110 B2).
Regarding claim 5, Satish discloses wherein the manual count in is inputted by a first medical staff member, the method further comprising (Paragraphs [0037] and [0112] discuss a user (e.g., a doctor, a nurse, other medical personnel, or any suitable combination thereof) the first count of items may be performed manually.):
receiving, through a third user input to the display interface by a user, a second manual count in of additional surgical articles being counted in to the surgical procedure (Paragraphs [0035]-[0037] discuss receiving the first count is or includes the number of surgical items introduced prior to or at the beginning of the surgical procedure, the first count is subsequently updated throughout the course of the procedure (e.g., as surgical items are introduced into the operating room, removed from packaging, or both), for example, one package of surgical items may be introduced into the operating room and removed from packaging at the start of a procedure (e.g., before any operational steps on a patient begin), subsequently, at a point during the medical procedure, such as while an operation is being performed, a second package of surgical items may be retrieved, introduced into the operating room, and have its surgical items removed from packaging. Thus, the first count may be updated (e.g., incremented) with the number of surgical items in the second package as a manual input.);
updating, with the one or more processors, the manual count of the surgical articles based on the manual count in and the second manual count in (Paragraphs [0035]-[0037] discuss processor used to determine first count and first count may be updated with the number of surgical items introduced into the operating room and removed from packaging at the start of a procedure (e.g., before any operational steps on a patient begin). Subsequently, at a point during the medical procedure, such as while an operation is being performed, a second package of surgical items may be retrieved, introduced into the operating room as a manual input.); and
displaying, on the primary display, the updated manual count including the manual count in and the second manual count in, wherein the manual count in and the second manual count are displayed to identify as being inputted by user (Paragraphs [0035]-[0036], [0044], FIGS. 3, 11, 14 discuss display information to one or more users input of the manual surgical count.).
Satish does not explicitly disclose:
receiving, on the display interface or via the data reader, an identification input indicative of a change in staffing;
receiving, by a second medical staff member, a second manual count in; and
identify as being inputted by different medical staff members
Hunter teaches:
receiving, on the display interface or via the data reader, an identification input indicative of a change in staffing (Paragraphs [0043]-[0045] discuss a touchscreen device can be provided to facilitate the entry of information into system instead of, or in addition to, reader, for example, FIG. 3 illustrates where touchscreen device is configured to receive input relating to the medical personnel attending the surgical procedure.);
receiving, by a second medical staff member, a second manual count in (Paragraphs [0043]-[0045], [0053] discuss the graphical user interface allows an operator, such as the circulating nurse, to maintain a count of tools associated with the surgical procedure.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, receiving, on the display interface or via the data reader, an identification input indicative of a change in staffing and receiving, by a second medical staff member, a second manual count in, as taught by Hunter, in order to provide significant improvements in the communication of information to and from medical personnel before, during, and after medical procedures. (Hunter Paragraphs [0029]).
Barral teaches:
identify as being inputted by different medical staff members (Column 4 lines 24-28 and 38-42 discuss the surgeon, or another member of the team, may identify the surgeon (or multiple surgeons) as operating the surgical robot by selecting her name from the list of surgery personnel obtained from the repository, and the surgical procedure begins and a different surgeon may take control of the surgical robot to perform a portion of the procedure. Upon doing so, a member of the team may record the personnel change by selecting the new operator of the surgical robot.);
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, identify as being inputted by different medical staff members, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67).
Regarding claim 6, Satish discloses wherein the identification include text of different color (Paragraphs [0100] and [0113] discuss input patient information, the user interface may enable the user to select one or more display options (e.g., font, color, language, or any suitable combination thereof).).
Satish does not disclose:
wherein the identification as being entered by different medical staff.
Hunter teaches:
wherein the identification as being entered by different medical staff (Paragraphs [0006], [0038]-[0045], and [0053], and FIG. 2 discuss a touchscreen device can be provided to facilitate the entry of information into system instead of, or in addition to, reader, for example, FIG. 3 illustrates where touchscreen device is configured to receive input relating to the medical personnel attending the surgical procedure; color coding can be provided to indicate that a named tool has been activated.);
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, wherein the identification as being entered by different medical staff, as taught by Hunter, in order to provide significant improvements in the communication of information to and from medical personnel before, during, and after medical procedures. (Hunter Paragraphs [0029]).
Regarding claim 7, Satish does not explicitly disclose wherein the identification input is an optical barcode associated with each of the first and second medical staff members.
Hunter teaches:
wherein the identification input is an optical barcode associated with each of the first and second medical staff members (Paragraphs [0034] and [0037] discuss identifying staff members that are in the room, the system includes a reader capable of receiving information from a user's badge or other similar identification and/or information containing device, such as a barcode reader, and contains identifying information about a user.);
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, wherein the identification as being entered by different medical staff include text of different color, as taught by Hunter, in order to provide significant improvements in the communication of information to and from medical personnel before, during, and after medical procedures. (Hunter Paragraphs [0029]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Satish in view of Hunter.
Regarding claim 9, Satish discloses the first portion of the surgical procedure and the second portion of the surgical procedure (Paragraphs [0032], [0035]-[0037] and FIG. 3 discuss receiving the first count introduced prior to or at the beginning of the surgical procedure, the first count is subsequently updated throughout the course of the procedure (e.g., as surgical items are introduced into the operating room, removed from packaging, or both), for example, one package of surgical items may be introduced into the operating room and removed from packaging at the start of a procedure (e.g., before any operational steps on a patient begin), subsequently, at a point during the medical procedure, such as while an operation is being performed, a second package of surgical items may be retrieved, introduced into the operating room, and have its surgical items removed from packaging.).
Satish does not disclose:
further comprising receiving a toggle input to selectively toggle between article counts associated with the surgical procedure.
Hunter teaches:
further comprising receiving a toggle input to selectively toggle between article counts associated with the surgical procedure (Paragraphs [0038], [0052]-[0058] and FIGS. 6-7 discuss surgical tools used during the procedure are more accurately and efficiently tracked using interactive display system, text boxes or the like to allow for the entry of other inputs, such as the patient's name, the surgical procedure, etc. and can be combined with notice of medical personnel present during that procedure.);
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, further comprising receiving a toggle input to selectively toggle between article counts associated with the surgical procedure, as taught by Hunter, in order to provide significant improvements in the communication of information to and from medical personnel before, during, and after medical procedures. (Hunter Paragraphs [0029]).
Claims 10-14, 16, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Satish in view of Barral.
Regarding claim 10, Satish discloses wherein the second portion of the surgical procedure is based on an emergent portion of the surgical procedure (Paragraphs [0032], [0035]-[0037] and FIG. 3 discuss receiving the first count introduced prior to or at the beginning of the surgical procedure, subsequently, at a point during the medical procedure, such as while an operation is being performed, a second package of surgical items may be retrieved, introduced into the operating room, and have its surgical items removed from packaging.).
Satish does not disclose:
emergent portion of the surgical procedure necessitated by information discovered during the first portion.
Barral teaches:
emergent portion of the surgical procedure necessitated by information discovered during the first portion (Column 4 lines 29-42 discuss during the surgical procedure, the system records information generated during the surgery, such as, the user that performed each action, changes in the person operating the robot, etc., for example, during the procedure, a different surgeon may take control of the surgical robot to perform a portion of the procedure.);
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, emergent portion of the surgical procedure necessitated by information discovered during the first portion, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67).
Regarding claim 11, Satish does not explicitly disclose wherein the first portion of the surgical procedure is associated with a first surgeon, and wherein the second portion of the surgical procedure is associated with a second surgeon.
Barral teaches:
wherein the first portion of the surgical procedure is associated with a first surgeon, and wherein the second portion of the surgical procedure is associated with a second surgeon (Column 4 lines 29-42 discuss during the surgical procedure, the system records information generated during the surgery, such as, the user that performed each action, changes in the person operating the robot, etc., for example, during the procedure, a different surgeon may take control of the surgical robot to perform a portion of the procedure.);
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, wherein the first portion of the surgical procedure is associated with a first surgeon, and wherein the second portion of the surgical procedure is associated with a second surgeon, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Regarding claim 12, Satish discloses further comprising:
enabling, with the one or more processors, the data reader for the counting in of the surgical articles to the surgical procedure (Paragraphs [0024] and [0062] discuss the one or more processors for tracking surgical items, the surgical item detection model may provide the location of all the detected surgical items within one or more counting bags, and enable determination of a count (e.g., the first count, the second count, a further count, or any suitable combination thereof) of surgical items in one or more counting bags.).
Satish does not disclose:
prior to initiating surgical aspects of the surgical procedure, preventing, with the one or more processors, the data reader from counting in of surgical articles to the surgical procedure;
receiving, on the display interface, inputs configured to satisfy a pre-procedure protocol; and
based on satisfaction of the pre-procedure protocol.
Barral teaches:
prior to initiating surgical aspects of the surgical procedure, preventing, with the one or more processors, the data reader from counting in of surgical articles to the surgical procedure (Column 1 lines 32-35 discuss access to the robot devices is controlled by preventing physical access unless the user is present in the operating room, and by a login name and password to access functions of the robotic device.);
receiving, on the display interface, inputs configured to satisfy a pre-procedure protocol (Column 3 lines 36-42 discuss during the inputting of the information, the web portal confirms whether the requested resources are available, such as the OR and the personnel, and that the requested resources are suitable for the surgery, such as whether the selected surgical robot is capable of or otherwise suitable for the selected surgery and specific patient (e.g., the patient weight is not greater than what the table allows).); and
based on satisfaction of the pre-procedure protocol (Column 3 lines 13-35 discuss prior to a surgery, a user, such as the surgeon or an administrator, accesses a web portal or other information service to create a new surgery event. She logs into web portal using a typical authentication method (for example, username and password or multi-factor authentication) and is provided options that may be selected to create the surgery event based on preferences.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, prior to initiating surgical aspects of the surgical procedure, preventing, with the one or more processors, the data reader from counting in of surgical articles to the surgical procedure, receiving, on the display interface, inputs configured to satisfy a pre-procedure protocol, and based on satisfaction of the pre-procedure protocol, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Regarding claim 13, Satish discloses wherein the pre-procedure protocol is selected from the group consisting of patient information, procedure information, and fire risk assessment (Paragraph [0100] discusses receiving information related to the medical procedure that allow users to input patient information (e.g., patient data), such as patient statistics or characteristics (e.g., height, weight, sex, age, etc.), the medical procedure to be performed, the expected length of the medical procedure, whether the medical procedure is scheduled or emergency, one or more pre-existing conditions, other pertinent information.).
Satish does not disclose:
group consisting of verification of patient information, verification of procedure information, and fire risk assessment.
Barral teaches:
group consisting of verification of patient information, verification of procedure information, and fire risk assessment (Column 3 lines 36-42 and Column 13 lines 1-18 discuss during the inputting of the information, the web portal confirms whether the requested resources are available, such as the OR and the personnel, and that the requested resources are suitable for the surgery, such as whether the selected surgical robot is capable of or otherwise suitable for the selected surgery and specific patient (e.g., the patient weight is not greater than what the table allows); receives confirmation that the case code is valid and active, the controller transmits a request to the remote server(s) for information associated with the case code related to.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, group consisting of verification of patient information, verification of procedure information, and fire risk assessment, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Regarding claim 14, Satish discloses further comprising displaying, on the primary display, tiles of grouped content, wherein at least one of the tiles of grouped content is visually deemphasized (Paragraphs [0060]-[0061] and FIGS. 9-10 and 13-14 discuss receive the first count, the pre-processed image, or alternatively, an unprocessed image, of the one or more counting bags for analysis and a display of information generated by a method for tracking surgical items and display certain information that appears to be highlighted.).
Satish does not disclose:
altering, on the primary display, presentation of the deemphasized tile of grouped content based on satisfaction of the pre-procedure protocol.
Barral teaches:
altering, on the primary display, presentation of the deemphasized tile of grouped content based on satisfaction of the pre-procedure protocol (Column 10 lines 54-60, Column 15 lines 28-40, and FIG. 5 discuss the web portal that enables the user to view or edit a previously created surgery, in this example, the user is shown the options selected for the surgery and also provides other options the user may select to change the scheduled surgery; if the controller determines that the case code is properly formed, but specifies incorrect or incompatible information (e.g., it indicates a different OR than the robotic surgery system is located in), the controller may output a notification indicating the case code is valid, but may not be used with the robotic surgical system, the controller may provide an option to override the error, e.g., a surgeon may indicate that the scheduled OR has changed, an emergency requires use of the present OR, etc.; the display shows various tiles in different states.); and
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, altering, on the primary display, presentation of the deemphasized tile of grouped content based on satisfaction of the pre-procedure protocol, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Regarding claim 16, Satish discloses a method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, the method comprising (Paragraphs [0012], [0024], and [0106] discuss a display of information generated by a method for tracking surgical items implemented via one or more mobile computing devices, each of which may include one or more cameras or other image sensors, one or more processors, one or more displays.):
displaying, on the primary display, tiles of grouped content, wherein at least one of the tiles of grouped content is visually deemphasized (Paragraph and FIGS. 9-10 and 13-14 discuss a display of information generated by a method for tracking surgical items and display certain information that appears to be highlighted.);
receiving, from a database, stored procedure information including patient information and clinical information (Paragraph [0100] discusses receiving information related to the medical procedure. Such methods may allow users to input patient information (e.g., patient data), such as patient statistics or characteristics (e.g., height, weight, sex, age, etc.), the medical procedure to be performed, the expected length of the medical procedure, whether the medical procedure is scheduled or emergency, one or more pre-existing conditions, other pertinent information.);
displaying, on the primary display, the patient information (Paragraph [0102] discusses information about the medical procedure may also be displayed, such as the type of medical procedure, the length of the medical procedure, patient information, doctor information, hospital information.);
determining, with the one or more processors, the procedure information based on the patient information matching the stored patient information (Paragraphs [0100] discuss receiving information related to the medical procedure that allow users to input patient information (e.g., patient data), such as patient statistics or characteristics (e.g., height, weight, sex, age, etc.), the medical procedure to be performed, the expected length of the medical procedure, whether the medical procedure is scheduled or emergency, one or more pre-existing conditions, other pertinent information.); and
enabling, with the one or more processors, the counting in of the surgical articles to the surgical procedure (Paragraph [0024] discusses tracking surgical items includes receiving a first count of surgical items.).
Satish does not disclose:
preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state;
receiving patient information based on wireless detection by the data reader of a patient tag associated with a patient;
the procedure information to be in a verified state based on the patient information matching the stored patient information;
altering, on the primary display, presentation of the deemphasized tile of grouped content based on the procedure information being in the verified state;
based on the procedure information being in the verified state.
Barral teaches:
preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state (Column 1 lines 32-35 discuss access to the robot devices is controlled by preventing physical access unless the user is present in the operating room, and by a login name and password to access functions of the robotic device.);
receiving patient information based on wireless detection by the data reader of a patient tag associated with a patient (Column 12 lines 15-21 and FIGS. 10-11 discuss a radio frequency identification (“RFID”) tag, programmed with the case code and supplied to the patient in a wearable device, such as a wristband.);
the procedure information to be in a verified state based on the patient information matching the stored patient information (Column 3 lines 36-42 and Column 13 lines 1-18 discuss during the inputting of the information, the web portal confirms whether the requested resources are available, such as the OR and the personnel, and that the requested resources are suitable for the surgery, such as whether the selected surgical robot is capable of or otherwise suitable for the selected surgery and specific patient (e.g., the patient weight is not greater than what the table allows); receives confirmation that the case code is valid and active, the controller transmits a request to the remote server(s) for information associated with the case code related to.);
altering, on the primary display, presentation of the deemphasized tile of grouped content based on the procedure information being in the verified state (Column 10 lines 54-60, Column 15 lines 28-40, and FIG. 5 discuss the web portal that enables the user to view or edit a previously created surgery, in this example, the user is shown the options selected for the surgery and also provides other options the user may select to change the scheduled surgery; if the controller determines that the case code is properly formed, but specifies incorrect or incompatible information (e.g., it indicates a different OR than the robotic surgery system is located in), the controller may output a notification indicating the case code is valid, but may not be used with the robotic surgical system, the controller may provide an option to override the error, e.g., a surgeon may indicate that the scheduled OR has changed, an emergency requires use of the present OR, etc.; the display shows various tiles in different states.); and
based on the procedure information being in the verified state (Column 11 lines 11-25 and Column 12 lines 56-67 discuss confirming validity of the information associated with a scheduled surgery.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state, receiving patient information based on wireless detection by the data reader of a patient tag associated with a patient, the procedure information to be in a verified state based on the patient information matching the stored patient information, altering, on the primary display, presentation of the deemphasized tile of grouped content based on the procedure information being in the verified state, and based on the procedure information being in the verified state, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Regarding claim 20, Satish discloses method of facilitating a surgical procedure with a surgical management system including a data reader, one or more processors, a display interface, and a primary display separate from the display interface, the method comprising (Paragraphs [0012], [0024], and [0106] discuss a display of information generated by a method for tracking surgical items implemented via one or more mobile computing devices, each of which may include one or more cameras or other image sensors, one or more processors, one or more displays.):
displaying, on the primary display, a pre-procedure protocol including a series of actions to be performed before commencement of invasive aspects of the surgical procedure (Paragraphs [0035]-[0036] discuss tracking surgical items, a mobile application is configured to perform all of the steps in a method of tracking surgical items and to display information to one or more users based one or more of the operations (e.g., steps) in the performed method, for example, receiving a first count of surgical items one package of surgical items may be introduced into the operating room and removed from packaging at the start of a procedure (e.g., before any operational steps on a patient begin).);
receiving, from a database, stored procedure information including patient information and clinical information (Paragraph [0100] discusses receiving information related to the medical procedure. Such methods may allow users to input patient information (e.g., patient data), such as patient statistics or characteristics (e.g., height, weight, sex, age, etc.), the medical procedure to be performed, the expected length of the medical procedure, whether the medical procedure is scheduled or emergency, one or more pre-existing conditions, other pertinent information.);
displaying, on the primary display, the patient information and the clinical information (Paragraph [0102] discusses information about the medical procedure may also be displayed, such as the type of medical procedure, the length of the medical procedure, patient information, doctor information, hospital information.);
receiving, on the display interface, inputs configured to satisfy each of the series of actions of the pre-procedure protocol (Paragraph [0036] discusses receiving a first count of surgical items before any operational steps on a patient begins.);
determining, with the one or more processors, the procedure information based all of the series of actions of the pre-procedure protocol being satisfied (Paragraph [0100] discusses receiving information related to the medical procedure that allow users to input patient information (e.g., patient data), such as patient statistics or characteristics (e.g., height, weight, sex, age, etc.), the medical procedure to be performed, the expected length of the medical procedure, whether the medical procedure is scheduled or emergency, one or more pre-existing conditions, other pertinent information.); and
enabling, with the one or more processors, the counting in of the surgical articles to the surgical procedure (Paragraph [0024] discusses tracking surgical items includes receiving a first count of surgical items.).
Satish does not disclose:
preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state;
altering, on the primary display, indicia corresponding to each of the series of actions as each of the inputs is determined to have been performed, by the one or more processors, to satisfy a respective one of the series of actions;
to be in a verified state; and
based on the procedure information being in the verified state.
Barral teaches:
preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state (Column 1 lines 32-35 discuss access to the robot devices is controlled by preventing physical access unless the user is present in the operating room, and by a login name and password to access functions of the robotic device.);
altering, on the primary display, indicia corresponding to each of the series of actions as each of the inputs is determined to have been performed, by the one or more processors, to satisfy a respective one of the series of actions (Column 10 lines 54-60, Column 15 lines 28-40, and FIG. 5 discuss the web portal that enables the user to view or edit a previously created surgery, in this example, the user is shown the options selected for the surgery and also provides other options the user may select to change the scheduled surgery; if the controller determines that the case code is properly formed, but specifies incorrect or incompatible information (e.g., it indicates a different OR than the robotic surgery system is located in), the controller may output a notification indicating the case code is valid, but may not be used with the robotic surgical system, the controller may provide an option to override the error, e.g., a surgeon may indicate that the scheduled OR has changed, an emergency requires use of the present OR, etc.; the display shows various tiles in different states.); and
to be in a verified state (Column 11 lines 11-25 and Column 12 lines 56-67 discuss confirming validity of the information associated with a scheduled surgery.); and
based on the procedure information being in the verified state (Column 11 lines 11-25 and Column 12 lines 56-67 discuss confirming validity of the information associated with a scheduled surgery.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, preventing, with the one or more processors, counting in of surgical articles to the surgical procedure with procedure information in an unverified state, altering, on the primary display, indicia corresponding to each of the series of actions as each of the inputs is determined to have been performed, by the one or more processors, to satisfy a respective one of the series of actions, to be in a verified state, and based on the procedure information being in the verified state, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Regarding claim 21, Satish discloses wherein the pre-procedural protocol is displayed in a tile of grouped content that is visually deemphasized with the procedure information in the unverified state (Paragraphs [0060]-[0061] and FIGS. 9-10 and 13-14 discuss receive a first count the pre-processed image, or alternatively, an unprocessed image, of the one or more counting bags for analysis and a display of information generated by a method for tracking surgical items and display certain information that appears to be highlighted.).
Regarding claim 22, Satish does not explicitly disclose wherein one of the series of actions includes confirming surgical personnel, the method further comprising:
receiving personnel information based on wireless detection by the data reader of a personnel tag associated with the surgical personnel; and
determining, with the one or more processors, whether the personnel information matches the clinical information of the stored procedure information.
Barral teaches:
wherein one of the series of actions includes confirming surgical personnel, the method further comprising (Column 12 lines 22-28 discuss an RFID tag may be embedded within or affixed to a disposable plastic card, e.g., a credit-card sized card, and provided to one or more members of the surgical team assigned to the surgery.):
receiving personnel information based on wireless detection by the data reader of a personnel tag associated with the surgical personnel (Column 12 lines 22-28 discuss an RFID tag may be embedded within or affixed to a disposable plastic card, e.g., a credit-card sized card, and provided to one or more members of the surgical team assigned to the surgery. At the time of the surgery, the RFID tag may be scanned by a case code interface in communication with the robotic surgical system to provide the case code.); and
determining, with the one or more processors, whether the personnel information matches the clinical information of the stored procedure information (Column 3 lines 36-38 discuss the web portal confirms whether the requested resources are available, such as the OR and the personnel.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, wherein one of the series of actions includes confirming surgical personnel, the method further comprising, receiving personnel information based on wireless detection by the data reader of a personnel tag associated with the surgical personnel, and determining, with the one or more processors, whether the personnel information matches the clinical information of the stored procedure information, as taught by Barral, in order to provide access to the one or more users to the robotic surgical device to enable a robotic surgical procedure. (Barral Column 1 lines 65-67]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Satish in view of Barral and in further view of Kreiner (U.S. Pub. 2008/0147529 A1).
Regarding claim 17, Satish does not explicitly disclose further comprising providing an alert on the primary display and/or the display interface if the patient information does not match the stored patient information.
Kreiner teaches:
further comprising providing an alert on the primary display and/or the display interface if the patient information does not match the stored patient information (Paragraphs [0022] and [0025] discuss computing device contains information regarding the upcoming surgery including, for example, patient identification information, identification of the procedure(s) to be performed and identification of the device(s), equipment(s) or material(s) to be used during the procedure, patient can have an attached RFID tag (not shown) that also describes relevant information, such as the patient's identification and type of surgery to be performed, and the computing device then compares the received data to the information it previously received relating to the upcoming surgery and if the information does not match, an alarm could be produced on or by output device warning people in the surgical suite not to proceed with the operation.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Satish to include, group consisting of verification of patient information, verification of procedure information, and fire risk assessment, as taught by Kreiner, in order to provide a mechanism for resolving tracking problems and for improving practices in a surgical suite.. (Kreiner Paragraphs [0003]-[0005]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:30PM.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
Prosecution Insights