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
In the response filed on 07 April 2026, the following has occurred: claims 1, 2-4, 10-14 and 16-19 have been amended; claims 7 and 8 have been canceled; claims 21 and 22 are newly added.
Now claims 1-6 and 9-22 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 1-6, 9-10 and 21-22 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 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite system and method for surgical planning. The limitations of:
Claim 1
[…] allow information to be [… output…]; and [… save …] computer executable instructions, and […] to execute the computer executable instructions to: [… obtain …], from a database, a surgeon-approved preoperative surgical plan for a
scheduled arthroplasty procedure to be performed on a patient; determine, prior to performing the scheduled arthroplasty procedure on the patient, whether the surgeon has deviated from past surgeon-approved preoperative surgical plans for prior arthroplasty procedures having comparable planned parameters in less than a predefined percent of prior arthroplasty procedures, wherein deviation is defined
as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past surgeon-approved preoperative surgical plans; command that deviation related information be [… output …]; and guide the surgeon for performing the scheduled arthroplasty procedure on the patient according to the preoperative surgical plan by automatically generating, prior to the scheduled arthroplasty procedure, a first recommended surgical kit for performing the scheduled arthroplasty procedure, wherein the first recommend[ation] includes only [… tools …] required for executing the surgeon-approved preoperative surgical plan when the surgeon has deviated from the past preoperative surgical plans in less than the predefined percent of the prior arthroplasty procedures.
Claim 22
at least one database [… maintaining …] surgeon-approved preoperative surgical plans associated with scheduled arthroplasty procedures; and [… maintaining …] computer-executable instructions that, when executed […]: identify a scheduled arthroplasty procedure for a specific patient having an associated surgeon-approved preoperative surgical plan; analyze historical surgical execution data corresponding to prior arthroplasty procedures performed by the surgeon to determine a surgeon-specific plan adherence metric indicative of how frequently the surgeon executed prior procedures in accordance with the surgeon-approved preoperative surgical plans; compare the surgeon-specific plan adherence metric to a predefined adherence threshold prior to commencement of the scheduled arthroplasty procedure; and based on the comparison of the surgeon-specific plan adherence metric to the predefined adherence threshold, automatically determine a preoperative surgical [… tool …] configuration for the scheduled arthroplasty procedure, wherein: when the surgeon-specific plan adherence metric satisfies the predefined adherence threshold, the preoperative surgical [… tool …] configuration includes only [… tools …] specified by the associated surgeon-approved preoperative surgical plan for the patient; and when the surgeon-specific plan adherence metric does not satisfy the predefined adherence threshold, the preoperative surgical [… tool …] configuration includes additional [… tools …] beyond those specified by the associated surgeon-approved preoperative surgical plan for the patient.
, as drafted, is a system, which under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) via human interaction with various generic computer components. That is, other than reciting a surgical planning system comprising a display module, a computing device including a memory device and processor (claim 1) and a surgical planning system (claim 11), a surgical planning system comprising a computing device including a processor and a memory (claim 22), the claimed invention amounts to managing personal behavior or interaction between people, the Examiner notes as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”. For example, via human interaction with a surgical planning system comprising a display module, a computing device including a memory device and processor (claim 1) and a surgical planning system (claim 11), a surgical planning system comprising a computing device including a processor and a memory (claim 22), the claim encompasses collection of human activity during performance of a procedure, analysis and organization of the collected data in determination of deviation of a plan, and providing recommendations and guidance for the human user to use in performance of the determined deviations for future human activities via organization of the users actions with the generic compute components. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a surgical planning system comprising a display module, a computing device including a memory device and processor (claim 1) and a surgical planning system (claim 11), a surgical planning system comprising a computing device including a processor and a memory (claim 22), which implements the abstract idea. The a surgical planning system comprising a display module, a computing device including a memory device and processor (claim 1) and a surgical planning system (claim 11), a surgical planning system comprising a computing device including a processor and a memory (claim 22), are recited at a high-level of generality (i.e., a general-purpose computers/ computer component implementing generic computer functions; see Applicant’s specification: Figure 2 and paragraphs [0031], [0036]) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim recites the additional elements of “store…”, “retrieve…”, “electronically displayed on the graphical user interface”, “first surgical kit includes… implants and instrumentation” and “performing the arthroplasty procedure”. The “store…” steps are recited at a high-level of generality. (i.e., as a general means of storing data) and amounts to the mere storage of data, which is a form of extra-solution activity. The “retrieve…” steps are recited at a high-level of generality (i.e., as a general means of receiving/transmitting data) and amounts to the mere transmission and/or receipt of data, which is a form of extra-solution activity. The “electronically displayed on the graphical user interface” is recited at a high-level of generality (i.e., as a general displaying data) and amounts to merely linking of the abstract idea to particular technological environment. The “first surgical kit includes… implants and instrumentation” is recited at a high-level of generality (i.e., generic surgical devices packaged together) and amounts to generally linking the abstract idea to a particular technological environment. The “performing the arthroplasty procedure” is recited at a high-level of generality (i.e., a generic surgical procedure performed by a human user) and amounts to generally linking the abstract idea to a particular technological environment. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a surgical planning system comprising a display module, a computing device including a memory device and processor (claim 1) and a surgical planning system (claim 11), a surgical planning system comprising a computing device including a processor and a memory (claim 22), to perform the noted steps amounts to no more than mere instructions to apply the exception using generic hardware components. Mere instructions to apply an exception using a generic hardware component cannot provide an inventive concept (“significantly more”).
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “store…”, “retrieve…”, “electronically displayed on the graphical user interface”, “first surgical kit includes… implants and instrumentation” and “performing the arthroplasty procedure” were considered extra-solution activity and/or generally linking to a particular technological environment. The “store…” steps have been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.0S(d)(II)(iv) "Storing and retrieving information in memory" is well-understood, routine, and conventional. The “retrieve…” steps have been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in MPEP 2106.0S(d)(II)(i) "Receiving or transmitting data over a network" is well-understood, routine, and conventional. The “electronically displayed on the graphical user interface” has been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Codd (2020/0395118): paragraphs [0067]-[0069]; Schoenfeld (2014/0303990): Fig. 13-16, paragraph [0007]; Plessers (20220054197): paragraph [0119]; display of data on a user interface is well-understood, routine, and conventional. The “first surgical kit includes… implants and instrumentation” has been re-evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Codd (2020/0395118): paragraphs [0084]-[0088]; Schoenfeld (2014/0303990): paragraph [0007], [0027]-[0028]; Plessers (20220054197): paragraph [0134]; recommending a kit with implants and instrumentation is well-understood, routine, and conventional. The “performing the arthroplasty procedure” has been evaluated under the "significantly more" analysis and determined to amount to be well-understood, routine, and conventional elements/functions. As described in Schoenfeld (2014/0303990): paragraph [0004], [0027]-[0028]; Plessers (20220054197): Figure 6, paragraph [0055], [0110]; Dees (20210315640): paragraphs [0002]-[0004]; DiSilvestro (20160239779): paragraphs [0005], [0033]; performing of an arthroplasty procedure is well-understood, routine, and conventional. Well-understood, routine, and conventional elements/functions cannot provide "significantly more." As such the claim is not patent eligible.
Claims 2-6, 9-10 and 21 are similarly rejected because either further define 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.
Claim 2 is further describe the percentage used, however do not recite any additional elements and therefore cannot provide a practical application and/or significantly more.
Claim 3 is further describe surgical kits with implants and instrumentation, however this was already considered above and is incorporated herein.
Claim 4 recite using image data to classify the anatomy of the patient using a model, however the claims do not recite any additional elements and therefore cannot provide a practical application and/or significantly more.
Claims 4-5 and 9 recites additional collection of data, however this was already considered above and is incorporated herein.
Claim 6 recites additional recommendations using a model, however the claim does not recite any additional elements and therefore cannot provide a practical application and/or significantly more.
Claim 9 recites updating of data, however storage of data was already considered above and is incorporated herein.
Claim 10 further describe the output of the data on the graphical user interface, however display of data on a graphical user interface was already considered above and is incorporated herein.
Claim 21 describes organization of implants and instrumentation, however implants and instrumentation in a surgical kit was already considered above and is incorporated herein.
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 11-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0395118 (hereafter “Codd”; already of record in the IDS), in view of U.S. Patent Pub. No. 2014/0303990 (hereafter “Schoenfeld”; already of record in the IDS).
Regarding (Currently Amended) claim 1, Codd teaches a surgical planning system (Codd: Figures 1-2, 4, paragraph [0016], “electronic identification tagging systems, methods, applicators, and tapes for tracking and managing medical equipment”, paragraph [0089], “a method for optimizing surgical instrument tray organization”), comprising:
a display module that is configured to allow information to be displayed within a graphical user interface (Codd: Figure 1, paragraph [0068], “object use analyzer 148 may control a display or other user interface to indicate the location of the user-identified surgical instrument(s). Further, the computing device 146 may present information on OR monitors and provide immediate verification or waning of instrument presence. Further, the system may be used in training module programs for new practitioners to display the name and picture of a tool as it is picked up for improving the accuracy of tool delivery”); and
a computing device that includes a memory device configured to store computer executable instructions, and a processor operably coupled to the memory device and configured to execute the computer executable instructions (Codd: Figure 1, paragraph [0048], “the object use analyzer 148 may include memory 152 and one or more processors 154 for implementing the functionality described herein”) to:
retrieve, from a database, a […] preoperative surgical plan for a scheduled […] procedure to be performed on a patient (Codd: Figures 2, 4, paragraph [0004], “maintaining schedule”, paragraph [0026], “for future surgeries”, paragraph [0046], “The object use analyzer 148 may include a database”, paragraphs [0070]-[0071], “determine an operational procedure associated with use of surgical instruments, and subsequently predict surgical instruments needed for a subsequent operational procedure based on the determined operational procedure and the usage of the surgical instruments… store information that indicates a standard order and timing of use of the medical equipment during a medical procedure… store information about an ideal order of use of surgical instruments and timing of use of the surgical instruments during a surgical procedure”, paragraph [0081], “Tool usage statistics may be obtained per surgeon per procedure. This list may be generated and sent to an appropriate party as an updated surgical preference card for the next surgery of the same or similar type”, paragraph [0094], “schedules for the same type or similar type of surgical instrument”. Also see, paragraph [0091], [0097], claim 8. The Examiner interprets an operational procedure a preoperative surgical plan);
determine, prior to performing the scheduled […] procedure on the patient, whether the surgeon has deviated from past […] preoperative surgical plans for prior […] procedures having comparable planned parameters in less than a predefined percent of prior […] procedures, wherein deviation is defined as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past surgeon-approved preoperative surgical plans (Codd: Figures 2, 4, paragraph [0006], “surgical preference cards and a lack of standardization. A preference card may be, for example, a listing of instruments or sets of instruments that are to be supplied to the surgeon for a particular surgery… provide a check for correct instrument supply and to motivate reassessment of which instruments are necessary to an operation”, paragraph [0026], “determine that the surgeon never uses a particular surgical instrument for a particular surgery or generally for any type of surgery”, paragraph [0046], “Prior to beginning a surgery, the surgical instruments may be brought into the OR 101 on a tray placed onto the Mayo stand 110. An RFID reader on the tray and/or the RFID reader 140 on the Mayo stand 110 may read each RFID tag attached to the surgical instruments. The ID of each read RFID tag may be communicated to the object use analyzer 148 for determining their presence and availability for use during the surgery. In this way, each surgical instrument made available for the surgery by the surgeon 104 can be tracked and recorded in a suitable database”, paragraphs [0059]-[0060], “store an inventory of the tags of surgical instruments that have gone through the sterilization process and have been read for comparison to tags of surgical instruments in a tray. The object use analyzer 148 may compare the list of the sterilized instruments to the inventor of the tray to determine whether any in the tray have not been sterilized. Those that have not been sterilized may be reported to medical practitioners, so the non-sterilized instrument are not used in surgery”, paragraph [0063], “thresholds for cutoff percentages… determine a utilization metric for one or more of the medical equipment (e.g., surgical instrument) … The metric can include the number of times a specific instrument was used”, paragraphs [0070]-[0071], “the object use analyzer 148 may determine whether the surgical instruments are being used in accordance with the stored order and timing”, paragraphs [0083]-[0085], “Preference cards may include instrument trays, being both general and specific to that surgeon or service line… collecting 402 instrument data over multiple similar surgeries by the same surgeon… determining 404 utility percentages and other metrics from collected instrument data”, paragraph [0096], “A check that all of the correct tools are present can be completed by cross referencing the surgical preference card with the census of the instrument tables. Nurses can be provided with a warning if there is any discrepancy between what was requested and what is provided”. Also see, paragraphs [0055], [0067], [0084]-[0088]. The Examiner notes before the surgery is performed surgery specific (i.e., particular type of procedure) preference card is compared to the prepared instruments/implants for the corresponding type of procedure, and any discrepancies (i.e., deviations) are determined, which one of ordinary skill in the art would find prima facie obvious teaches what is required of the claimed limitation under the broadest reasonable interpretation);
command that deviation related information be electronically displayed on the graphical user interface via the display module (Codd: Figure 1, paragraph [0068], “object use analyzer 148 may control a display or other user interface to indicate the location of the user-identified surgical instrument(s). Further, the computing device 146 may present information on OR monitors and provide immediate verification or waning of instrument presence. Further, the system may be used in training module programs for new practitioners to display the name and picture of a tool as it is picked up for improving the accuracy of tool delivery”, paragraph [0075], “In response to determining that it is time to use a surgical instrument, the object use analyzer 148 may control a user interface (e.g., display) to present the notification to a medical practitioner (e.g., the surgeon 104 or physician's assistant 106). The object use analyzer 148 may also present a notification that indicates that a surgical instrument has been misplaced during the surgery”, paragraph [0096], “A check that all of the correct tools are present can be completed by cross referencing the surgical preference card with the census of the instrument tables. Nurses can be provided with a warning if there is any discrepancy between what was requested and what is provided”); and
guide the surgeon for performing the scheduled […] procedure on the patient according to the […] preoperative surgical plan by automatically generating, prior to the scheduled […] procedure, a first recommended surgical kit for performing the scheduled […] procedure, wherein the first recommended surgical kit includes only implants and instrumentation required for executing the […] preoperative surgical plan when the surgeon has deviated from the past […] preoperative surgical plans in less than the predefined percent of the prior […] procedures (Codd: Figure 4, paragraph [0026], “Surgical instrument usage data collected by the system may be analyzed by the system to make recommendations as to which instruments should be supplied during specific surgeries for particular surgeons… for future surgeries, the system may recommend that the surgical instrument not be supplied in future surgeries for that surgeon. In this example, the system may update the surgeon's preference card such that the surgical instrument is not included for particular surgeries or for surgeries in general”, paragraph [0063], “object use analyzer 148, either during or post-surgery, may call data from the database in memory 152 and prepare and present overarching statistics”, paragraphs [0083]-[0088], “Preference cards may include instrument trays, being both general and specific to that surgeon or service line. Trays can contain a predetermined set of instruments. Preference cards may also include individual instruments… determining 406 supply recommendations based on utility percentages and/or other metrics… instruments used between 0 and 5 % of the time could be removed from a tray, while instrument used between 5 and 15% of the time could be supplied in peel packs or specialty trays. Instruments with utilities between 15 and 100% could remain in the trays and continue to be supplied… tray contents can be optimized based on utility percentages over individual surgeons”. The Examiner notes that a recommended kit may be provided for a particular type of surgery prior to beginning the surgery, and a recommendations are provided throughout to guide the user, which teaches what is required of the claim under the broadest reasonable interpretation).
Codd may not explicitly teach (underlined below for clarity):
retrieve, from a database, a surgeon-approved preoperative surgical plan for a scheduled arthroplasty procedure to be performed on a patient; determine, prior to performing the scheduled arthroplasty procedure on the patient, whether the surgeon has deviated from past surgeon-approved preoperative surgical plans for prior arthroplasty procedures having comparable planned parameters in less than a predefined percent of prior arthroplasty procedures, wherein deviation is defined as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past surgeon-approved preoperative surgical plans; […]; guide the surgeon for performing the scheduled arthroplasty procedure on the patient according to the surgeon-approved preoperative surgical plan by automatically generating, prior to the scheduled arthroplasty procedure, a first recommended surgical kit for performing the scheduled arthroplasty procedure, wherein the first recommended surgical kit includes only implants and instrumentation required for executing the surgeon-approved preoperative surgical plan when the surgeon has deviated from the past surgeon-approved preoperative surgical plans in less than the predefined percent of the prior arthroplasty procedures.
Schoenfeld teaches retrieve, from a database, a surgeon-approved preoperative surgical plan for a scheduled arthroplasty procedure to be performed on a patient; determine, prior to performing the scheduled arthroplasty procedure on the patient, whether the surgeon has deviated from past surgeon-approved preoperative surgical plans for prior arthroplasty procedures having comparable planned parameters in less than a predefined percent of prior arthroplasty procedures, wherein deviation is defined as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past surgeon-approved preoperative surgical plans; […]; guide the surgeon for performing the scheduled arthroplasty procedure on the patient according to the surgeon-approved preoperative surgical plan by automatically generating, prior to the scheduled arthroplasty procedure, a first recommended surgical kit for performing the scheduled arthroplasty procedure, wherein the first recommended surgical kit includes only implants and instrumentation required for executing the surgeon-approved preoperative surgical plan when the surgeon has deviated from the past surgeon-approved preoperative surgical plans in less than the predefined percent of the prior arthroplasty procedures (Schoenfeld: Figures 1, 3, 10-11, 16, paragraph [0006], “Approval of the preoperative surgical plan can be received, at the server”, paragraphs [0027]-[0028], “FIG. 10 is an exemplary illustration of a surgeon examining a patient for knee joint arthroplasty… FIG. 11 is an exemplary illustration of the patient in preparation for the knee joint arthroplasty”, paragraph [0066], “The preoperative surgical plan 176 can include or be saved as a data file, in the datastore 56 associated with the manufacturer 38 and the server 46”, paragraphs [0077]-[0079], “review the recommended implant in the preoperative plan 176 and make an implant selection (e.g., approval of the recommended implant) in an interactive user interface 258 displayed at user device 18… The surgeon 26 can optionally select a different implant… the surgeon 26 can make other plan adjustments or edits, including positional adjustments, cut or resection line adjustments, implant size adjustments, etc. … The recommended instrumentation can be determined in part by the integrated orthopedic system manager 74 in connection with the surgeon preferences 182… The recommended instrumentation can be updated based on the surgeon 26 choosing a different implant option than was initially recommended with the preoperative surgical plan 176. In this regard, the integrated orthopedic system manager 74 can be configured to flag, such as with a note to the surgeon 26, that the surgeon's optional implant selection may require instrumentation that he has previously indicated was not preferred”, paragraphs [0086]-[0086], “scheduling the surgical procedure… With the preoperative plan 176 approved and the surgery date scheduled, the integrated orthopedic system manager 74 can provide relevant information to a manufacturing planning system 298 (FIG. 6) of the manufacturer 38 at block 302 of FIG. l”, paragraphs [0093]-[0095], “the surgical plan 176 can be accessed via the web portal or user interface 70 though an internet connection 22 in the manner discussed above. The integrated orthopedic system manager 74 can cause the operating room client device 18 to display an interactive user interface 344 including details of the surgical plan 176 in real time, as shown in FIG. 16B with reference to FIG. 16A… At block 348, the integrated orthopedic system manager 74 can compare the transmitted implant identification information with the implant identification information in the surgical plan 176 and provide visual confirmation via user interface 344 that the delivered implants match the implants identified in the surgical plan 176. Instrumentation to be used with the surgery can also be scanned prior to or during surgery and compared with instrumentation identification information in the surgical plan 176.”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include use of an approved pre-op plan for making arthroplasty determinations about kit composition as taught by Schoenfeld within the determination of deviation with predefined percentages to recommend kits with only necessary instruments as taught by Codd with the motivation of “inventory can be more efficiently managed and/or reduced based on the information available from the surgeon approved preoperative plan 176 and surgical kit content selection” (Schoenfeld: paragraph [0086]).
Regarding (Currently Amended) claim 2, Codd and Schoenfeld teach the limitations of claim 1, and further teach wherein the predefined percent is five (5) percent of the prior arthroplasty procedures (Codd: paragraph [0067], “cutoff percentages may be decided by hospital management and may vary depending on the hospital”, paragraph [0086], “instruments used between 0 and 5%”).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 3, Codd and Schoenfeld teach the limitations of claim 1, and further teach wherein the processor is further configured to execute the computer executable instructions to: automatically generate, prior to the scheduled arthroplasty procedure, a second surgical kit that includes a greater number of implants and instrumentation than the first surgical kit when the surgeon has deviated from the past preoperative surgical plans in greater than the predefined percent of the prior surgical procedures (Codd: Figure 4, paragraphs [0084]-[0088], “determining 406 supply recommendations based on utility percentages and/or other metrics… if surgeon one uses 30% of the general tray, and surgeon two uses the same 30% and an additional 5% of the same tray, the general tray may be reduced to only that common 30% utility with surgeon two being supplied a separate specialized tray containing the additional 5%”. The Examiner notes a surgeon is provided a second kit with greater number of instruments based on being greater than the predefined percent of the prior procedures and teaches what is require of the claim under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 1, incorporated herein.
Regarding (Currently Amended) claim 11, Codd teaches a surgical method (Codd: Figures 1-2, 4, paragraph [0016], “electronic identification tagging systems, methods, applicators, and tapes for tracking and managing medical equipment”, paragraph [0089], “a method for optimizing surgical instrument tray organization”), comprising: […];
receiving, from the surgical planning system, prior to performing the […] procedure on the patient, a surgical planning guidance for performing the […] procedure (Codd: Figures 2, 4, paragraph [0004], “maintaining schedule”, paragraph [0026], “for future surgeries”, paragraph [0046], “The object use analyzer 148 may include a database”, paragraphs [0070]-[0071], “determine an operational procedure associated with use of surgical instruments, and subsequently predict surgical instruments needed for a subsequent operational procedure based on the determined operational procedure and the usage of the surgical instruments… store information that indicates a standard order and timing of use of the medical equipment during a medical procedure… store information about an ideal order of use of surgical instruments and timing of use of the surgical instruments during a surgical procedure”, paragraph [0081], “Tool usage statistics may be obtained per surgeon per procedure. This list may be generated and sent to an appropriate party as an updated surgical preference card for the next surgery of the same or similar type”, paragraph [0094], “schedules for the same type or similar type of surgical instrument”. Also see, paragraph [0091], [0097], claim 8. The Examiner interprets an operational procedure a preoperative surgical plan),
wherein the surgical planning guidance is at least partially derived based on whether a surgeon […] has deviated from past […] preoperative surgical plans in less than a predefined percent of prior […] procedures, wherein deviation is defined as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past […] preoperative surgical plans (Codd: Figures 2, 4, paragraph [0006], “surgical preference cards and a lack of standardization. A preference card may be, for example, a listing of instruments or sets of instruments that are to be supplied to the surgeon for a particular surgery… provide a check for correct instrument supply and to motivate reassessment of which instruments are necessary to an operation”, paragraph [0026], “determine that the surgeon never uses a particular surgical instrument for a particular surgery or generally for any type of surgery”, paragraph [0046], “Prior to beginning a surgery, the surgical instruments may be brought into the OR 101 on a tray placed onto the Mayo stand 110. An RFID reader on the tray and/or the RFID reader 140 on the Mayo stand 110 may read each RFID tag attached to the surgical instruments. The ID of each read RFID tag may be communicated to the object use analyzer 148 for determining their presence and availability for use during the surgery. In this way, each surgical instrument made available for the surgery by the surgeon 104 can be tracked and recorded in a suitable database”, paragraphs [0059]-[0060], “store an inventory of the tags of surgical instruments that have gone through the sterilization process and have been read for comparison to tags of surgical instruments in a tray. The object use analyzer 148 may compare the list of the sterilized instruments to the inventor of the tray to determine whether any in the tray have not been sterilized. Those that have not been sterilized may be reported to medical practitioners, so the non-sterilized instrument are not used in surgery”, paragraph [0063], “thresholds for cutoff percentages… determine a utilization metric for one or more of the medical equipment (e.g., surgical instrument) … The metric can include the number of times a specific instrument was used”, paragraphs [0070]-[0071], “the object use analyzer 148 may determine whether the surgical instruments are being used in accordance with the stored order and timing”, paragraphs [0083]-[0085], “Preference cards may include instrument trays, being both general and specific to that surgeon or service line… collecting 402 instrument data over multiple similar surgeries by the same surgeon… determining 404 utility percentages and other metrics from collected instrument data”, paragraph [0096], “A check that all of the correct tools are present can be completed by cross referencing the surgical preference card with the census of the instrument tables. Nurses can be provided with a warning if there is any discrepancy between what was requested and what is provided”. Also see, paragraphs [0055], [0067], [0084]-[0088]. The Examiner notes before the surgery is performed surgery specific (i.e., particular type of procedure) preference card is compared to the prepared instruments/implants for the corresponding type of procedure, and any discrepancies (i.e., deviations) are determined, which one of ordinary skill in the art would find prima facie obvious teaches what is required of the claimed limitation under the broadest reasonable interpretation),
wherein the surgical planning guidance includes an automatically generated preoperative recommendation to use a first recommended surgical kit that includes only […] implants and […] instrumentation specified in the preoperative surgical plan when the surgeon has deviated from the past surgeon-approved preoperative surgical plans in less than the predefined percent of the prior […] procedures (Codd: Figure 4, paragraph [0026], “Surgical instrument usage data collected by the system may be analyzed by the system to make recommendations as to which instruments should be supplied during specific surgeries for particular surgeons… for future surgeries, the system may recommend that the surgical instrument not be supplied in future surgeries for that surgeon. In this example, the system may update the surgeon's preference card such that the surgical instrument is not included for particular surgeries or for surgeries in general”, paragraph [0063], “object use analyzer 148, either during or post-surgery, may call data from the database in memory 152 and prepare and present overarching statistics”, paragraphs [0083]-[0088], “Preference cards may include instrument trays, being both general and specific to that surgeon or service line. Trays can contain a predetermined set of instruments. Preference cards may also include individual instruments… determining 406 supply recommendations based on utility percentages and/or other metrics… instruments used between 0 and 5 % of the time could be removed from a tray, while instrument used between 5 and 15% of the time could be supplied in peel packs or specialty trays. Instruments with utilities between 15 and 100% could remain in the trays and continue to be supplied… tray contents can be optimized based on utility percentages over individual surgeons”. The Examiner notes that a recommended kit may be provided for a particular type of surgery prior to beginning the surgery, and a recommendations are provided throughout to guide the user, which teaches what is required of the claim under the broadest reasonable interpretation);
receiving the first recommended surgical kit; and performing the […] procedure on the patient according to the preoperative surgical using the first recommended surgical kit (Codd: Figure 4, paragraph [0046], “Prior to beginning a surgery, the surgical instruments may be brought into the OR 101 on a tray placed onto the Mayo stand 110”, paragraph [0063], “during a medical procedure based on the analyzed usage of the medical equipment… object use analyzer 148, either during or post-surgery, may call data from the database in memory 152 and prepare and present overarching statistics”, paragraph [0055], “realtime or near real-time medical instrument census”, paragraph [0075], “the object use analyzer 148 may present the notification to a medical practitioner. For example, the object use analyzer 148 may determine when to use a surgical instrument during a surgery”, paragraphs [0084]-[0088], “determining 406 supply recommendations based on utility percentages and/or other metrics… tray contents can be optimized based on utility percentages over individual surgeons”).
Codd may not explicitly teach (underlined below for clarity):
approving a preoperative surgical plan for performing an arthroplasty procedure on a patient within a surgical planning system; receiving, from the surgical planning system, prior to performing the arthroplasty procedure on the patient, a surgical planning guidance for performing the arthroplasty procedure, wherein the surgical planning guidance is at least partially derived based on whether a surgeon who approved the preoperative surgical plan has deviated from past surgeon-approved preoperative surgical plans in less than a predefined percent of prior arthroplasty procedures, wherein deviation is defined as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past surgeon-approved preoperative surgical plans, wherein the surgical planning guidance includes an automatically generated preoperative recommendation to use a first recommended surgical kit that includes only arthroplasty implants and arthroplasty instrumentation specified in the preoperative surgical plan when the surgeon has deviated from the past surgeon-approved preoperative surgical plans in less than the predefined percent of the prior arthroplasty procedures; receiving the first recommended surgical kit; and performing the arthroplasty procedure on the patient according to the preoperative surgical using the first recommended surgical kit.
Schoenfeld teaches approving a preoperative surgical plan for performing an arthroplasty procedure on a patient within a surgical planning system; receiving, from the surgical planning system, prior to performing the arthroplasty procedure on the patient, a surgical planning guidance for performing the arthroplasty procedure, wherein the surgical planning guidance is at least partially derived based on whether a surgeon who approved the preoperative surgical plan has deviated from past surgeon-approved preoperative surgical plans in less than a predefined percent of prior arthroplasty procedures, wherein deviation is defined as execution of at least one of a different procedure type, a different implant type, or a different implant size relative to that which is defined by the past surgeon-approved preoperative surgical plans, wherein the surgical planning guidance includes an automatically generated preoperative recommendation to use a first recommended surgical kit that includes only arthroplasty implants and arthroplasty instrumentation specified in the preoperative surgical plan when the surgeon has deviated from the past surgeon-approved preoperative surgical plans in less than the predefined percent of the prior arthroplasty procedures; receiving the first recommended surgical kit; and performing the arthroplasty procedure on the patient according to the preoperative surgical using the first recommended surgical kit (Schoenfeld: Figures 1, 3, 10-11, 16, paragraph [0006], “Approval of the preoperative surgical plan can be received, at the server”, paragraphs [0027]-[0028], “FIG. 10 is an exemplary illustration of a surgeon examining a patient for knee joint arthroplasty… FIG. 11 is an exemplary illustration of the patient in preparation for the knee joint arthroplasty”, paragraph [0066], “The preoperative surgical plan 176 can include or be saved as a data file, in the datastore 56 associated with the manufacturer 38 and the server 46”, paragraphs [0077]-[0079], “review the recommended implant in the preoperative plan 176 and make an implant selection (e.g., approval of the recommended implant) in an interactive user interface 258 displayed at user device 18… The surgeon 26 can optionally select a different implant… the surgeon 26 can make other plan adjustments or edits, including positional adjustments, cut or resection line adjustments, implant size adjustments, etc. … The recommended instrumentation can be determined in part by the integrated orthopedic system manager 74 in connection with the surgeon preferences 182… The recommended instrumentation can be updated based on the surgeon 26 choosing a different implant option than was initially recommended with the preoperative surgical plan 176. In this regard, the integrated orthopedic system manager 74 can be configured to flag, such as with a note to the surgeon 26, that the surgeon's optional implant selection may require instrumentation that he has previously indicated was not preferred”, paragraphs [0086]-[0086], “scheduling the surgical procedure… With the preoperative plan 176 approved and the surgery date scheduled, the integrated orthopedic system manager 74 can provide relevant information to a manufacturing planning system 298 (FIG. 6) of the manufacturer 38 at block 302 of FIG. l”, paragraphs [0093]-[0095], “the surgical plan 176 can be accessed via the web portal or user interface 70 though an internet connection 22 in the manner discussed above. The integrated orthopedic system manager 74 can cause the operating room client device 18 to display an interactive user interface 344 including details of the surgical plan 176 in real time, as shown in FIG. 16B with reference to FIG. 16A… At block 348, the integrated orthopedic system manager 74 can compare the transmitted implant identification information with the implant identification information in the surgical plan 176 and provide visual confirmation via user interface 344 that the delivered implants match the implants identified in the surgical plan 176. Instrumentation to be used with the surgery can also be scanned prior to or during surgery and compared with instrumentation identification information in the surgical plan 176”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include use of an approved pre-op plan for making arthroplasty determinations about kit composition as taught by Schoenfeld within the determination of deviation with predefined percentages to recommend kits with only necessary instruments as taught by Codd with the motivation of “inventory can be more efficiently managed and/or reduced based on the information available from the surgeon approved preoperative plan 176 and surgical kit content selection” (Schoenfeld: paragraph [0086]).
Regarding (Currently Amended) claim 12, Codd and Schoenfeld teach the limitations of claim 11, and further teach wherein performing the arthroplasty procedure on the patient includes implanting at least a portion of the arthroplasty implants of the first recommended surgical kit within a joint of the patient. (Schoenfeld: paragraph [0007], “where the kit can include one or more of (i) an implant”, paragraph [0043], “implant can be planned for the surgery”, paragraphs [0027]-[0028], “FIG. 10 is an exemplary illustration of a surgeon examining a patient for knee joint arthroplasty... FIG. 11 is an exemplary illustration of the patient in preparation for the knee joint arthroplasty”, paragraph [0059], “include a recommendation of particular implants and associated instrumentation”, paragraphs [0097]-[0098], “During surgery, various intraoperative data can be obtained at 352 and transmitted… a validation of implant positioning and/or an analysis of kinematic data as compared to predetermined data or thresholds”).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Currently Amended) claim 13, Codd and Schoenfeld teach the limitations of claim 11, and further teach wherein the predefined percent is five (5) percent of the prior arthroplasty procedures. (Codd: paragraph [0067], “cutoff percentages may be decided by hospital management and may vary depending on the hospital”, paragraph [0086], “instruments used between 0 and 5%”).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Currently Amended) claim 14, Codd and Schoenfeld teach the limitations of claim 11, and further teach wherein the surgical planning guidance includes automatically generating a second recommended surgical kit that includes a greater number of arthroplasty implants and arthroplasty instrumentation than the first recommended surgical kit when the surgeon has deviated from the past surgeon-approved preoperative surgical plans in greater than the predefined percent of the prior arthroplasty procedures (Codd: Figure 4, paragraphs [0084]-[0088], “determining 406 supply recommendations based on utility percentages and/or other metrics… if surgeon one uses 30% of the general tray, and surgeon two uses the same 30% and an additional 5% of the same tray, the general tray may be reduced to only that common 30% utility with surgeon two being supplied a separate specialized tray containing the additional 5%”. The Examiner notes a surgeon is provided a second kit with greater number of instruments based on being greater than the predefined percent of the prior procedures and teaches what is require of the claim under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Original) claim 15, Codd and Schoenfeld teach the limitations of claim 11, and further teach wherein the surgical planning guidance includes deviation related information that is displayed on a graphical user interface of the surgical planning system (Codd: Figure 1, paragraph [0068], “object use analyzer 148 may control a display or other user interface to indicate the location of the user-identified surgical instrument(s). Further, the computing device 146 may present information on OR monitors and provide immediate verification or waning of instrument presence. Further, the system may be used in training module programs for new practitioners to display the name and picture of a tool as it is picked up for improving the accuracy of tool delivery”, paragraph [0075], “In response to determining that it is time to use a surgical instrument, the object use analyzer 148 may control a user interface (e.g., display) to present the notification to a medical practitioner (e.g., the surgeon 104 or physician's assistant 106). The object use analyzer 148 may also present a notification that indicates that a surgical instrument has been misplaced during the surgery”. Also see, paragraph [0096]).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Currently Amended) claim 16, Codd and Schoenfeld teach the limitations of claim 15, and further teach wherein the deviation related information includes an indication of an amount of the prior arthroplasty procedures that were executed as planned (Codd: paragraph [0004], “how many and which type of instrumentation should be supplied in the OR that optimizes the cost and the time efficiency of the operation”, paragraphs [0081], “process logged tool usage data and surgery information. The surgery information may include, but is not limited to, the names of operating surgeons, the date and duration of the surgery, the type of surgery, etc. Tool usage statistics may be obtained per surgeon per procedure. This list may be generated and sent to an appropriate party as an updated surgical preference card for the next surgery of the same or similar type… Preference cards may be updated at discrete intervals or continuously, between each surgery”. The Examiner notes the deviation information uses a surgical preference card for each surgeon, that indicates a number of procedures that the surgeon performed as planned and teaches what is required under the broadest reasonable interpretation).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Currently Amended) claim 17, Codd and Schoenfeld teach the limitations of claim 15, and further teach wherein the deviation related information includes an indication of a type of deviation that occurred during the prior arthroplasty procedures (Codd: paragraph [0004], “how many and which type of instrumentation should be supplied in the OR that optimizes the cost and the time efficiency of the operation”, paragraphs [0026]-[0029], “analyze instrument usage of a particular surgeon and determine that the surgeon never uses a particular surgical instrument for a particular surgery or generally for any type of surgery… identification of a type of surgical instrument”, paragraph [0046], “analyze usage of medical equipment. For example, multiple different types of surgical instruments may have RFID tags 142 attached to them”, paragraph [0063], “determine a utilization metric for one or more of the medical equipment… metric can include the number of times a specific instrument was used”, paragraph [0071], “object use analyzer 148 may subsequently present, to a medical practitioner such as the surgeon 104, information that indicates whether the surgical instruments are being used in accordance with the stored order and timing”).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Currently Amended) claim 18, Codd and Schoenfeld teach the limitations of claim 15, and further teach wherein the deviation related information includes an indication of an amount of implants that were implanted as planned during the prior arthroplasty procedures (Codd: paragraph [0004], “how many and which type of instrumentation should be supplied in the OR that optimizes the cost and the time efficiency of the operation”, paragraphs [0026]-[0029], “analyze instrument usage of a particular surgeon and determine that the surgeon never uses a particular surgical instrument for a particular surgery or generally for any type of surgery… identification of a type of surgical instrument”, paragraph [0046], “analyze usage of medical equipment. For example, multiple different types of surgical instruments may have RFID tags 142 attached to them”, paragraph [0063], “either during or post-surgery, may call data from the database in memory 152 and prepare and present overarching statistics on whether one or more surgical tools and/or other medical equipment was present in the surgical site, the amount of time the medical surgical instrument(s) and/or other medical equipment was present, and other actionable analytics that may be unique to each operation and surgeon… The metric can include the number of times a specific instrument was used”, paragraph [0071], “object use analyzer 148 may subsequently present, to a medical practitioner such as the surgeon 104, information that indicates whether the surgical instruments are being used in accordance with the stored order and timing”, claim 7, “the utilization metric includes the number of times an object was used in a particular operation by a specific surgeon”; Schoenfeld: paragraph [0059], “a recommendation of particular implants”, paragraph [0101], “include data from the patient pertaining to the patient experience with the implant or implants”).
The motivation to combine is the same as in claim 11, incorporated herein.
Regarding (Currently Amended) claim 21, Codd and Schoenfeld teach the limitations of claim 1, and further teach wherein automatically generating the first recommended surgical kit comprises issuing, prior to the scheduled arthroplasty procedure, an order for assembling the first recommended surgical kit including only the implants and the instrumentation specified by the surgeon-approved preoperative surgical plan (Codd: paragraph [0046], “Prior to beginning a surgery, the surgical instruments may be brought into the OR 101 on a tray placed onto the Mayo stand 110”, paragraph [0081], “list may be generated and sent to an appropriate party as an updated surgical preference card for the next surgery of the same or similar type. New surgeons or residents may be provided preference cards from the same or similar surgery types accomplished by senior surgeons as recommendations to their own preference.”, paragraph [0090], “receive a message prompt to sharpen a specific tagged tool or order a new tool”; Schoenfeld: paragraph [0011], “the patient specific kit can be assembled by a third party different from the manufacturer”, paragraph [0092], “receive the instrumentation data file and manufacture the instruments and assemble the kit”).
The motivation to combine is the same as in claim 11, incorporated herein.
Claim(s) 4-6, 9-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0395118 (hereafter “Codd”; already of record in the IDS) and U.S. Patent Pub. No. 2014/0303990 (hereafter “Schoenfeld”; already of record in the IDS) as applied to claims 1 and 11 above, and further in view of U.S. Patent Pub. No. 2022/0054197 (hereafter “Plessers”; already of record in the IDS).
Regarding (Currently Amended) claim 4, Codd and Schoenfeld teach the limitations of claim 1, and further teach wherein the processor is configured to execute the computer executable instructions to: receive image data associated with the patient to which the surgeon-approved preoperative surgical plan pertains; generate a first virtual three-dimensional anatomical bone model of a bone or a joint of the patient based on the image data (Schoenfeld: Figure 1, paragraph [0006], “receiving, at a server, preoperative image data of a patient's bone, and generating, at the server, a patient specific three-dimensional model of the patient's bone”); and
assign an anatomical makeup classification within a set of anatomical makeup classifications to an anatomy of the patient […] (Schoenfeld: Figures 1-2, paragraph [0007]-[0009], “patient specific three-dimensional model of the patient's bone joint can be generated automatically, at the server, and can include identification of anatomical landmarks based at least on the preoperative image data and the database three-dimensional model data”, paragraph [0095], “match the implants identified in the surgical plan 176. Instrumentation to be used with the surgery can also be scanned prior to or during surgery and compared with instrumentation identification information in the surgical plan 176”).
Codd and Schoenfeld may not explicitly teach (underlined below for clarity):
assign an anatomical makeup classification within a set of anatomical makeup classifications to an anatomy of the patient in response to fitting the first virtual three-dimensional anatomical bone model to one or more virtual three-dimensional anatomical bone models associated with a comparable anatomy of one or more patients within a representative patient population.
Plessers teaches assign an anatomical makeup classification within a set of anatomical makeup classifications to an anatomy of the patient in response to fitting the first virtual three-dimensional anatomical bone model to one or more virtual three-dimensional anatomical bone models associated with a comparable anatomy of one or more patients within a representative patient population (Plessers: paragraph [0087], “multiple classification systems may be combined”, paragraphs [0125]-[0126], “the population should preferably be limited to members that show a similarity to the patient to be treated. This similarity can relate to one or more patient characteristics”, paragraph [0131], “the system may also locate within a selected population the member that most closely matches the patient characteristics of the patient to be treated”, paragraph [0185], “the population is limited to patients who show a certain similarity to the patient to be treated in one or more patient characteristics. For example, bone density”, paragraph [0220], “Using the three-dimensional models based on the patient data, the defect is simulated in comparison with healthy anatomy”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include matching a model of similar patients for assigning an anatomical makeup classification as taught by Plessers with the determination of classifications using a model as taught by Codd and Schoenfeld with the motivation of “analysis can be made more accurate or more relevant to the patient to be treated by limiting the population to those patients that show a similarity to the patient to be treated” (Plessers: paragraph [0125]).
Regarding (Original) claim 5, Codd, Schoenfeld and Plessers teach the limitations of claim 4, and further teach wherein the processor is further configured to execute the computer executable instructions to: obtain surgical outcome data associated with the one or more patients of the representative patient population that have a comparable anatomical makeup classification to the anatomical makeup classification assigned to the patient (Plessers: Figure 8, paragraph [0099], “historical data available in the database is used to perform a historical-data analysis 802, relating either patient characteristics to planning decisions, or one or more planning parameters to surgery outcomes”, paragraphs [0125]-[0126], “the population should preferably be limited to members that show a similarity to the patient to be treated. This similarity can relate to one or more patient characteristics”, paragraph [0185], “the population is limited to patients who show a certain similarity to the patient to be treated in one or more patient characteristics. For example, bone density”).
The motivation to combine is the same as in claim 4, incorporated herein.
Regarding (Original) claim 6, Codd, Schoenfeld and Plessers teach the limitations of claim 5, and further teach wherein the processor is further configured to execute the computer executable instructions to: recommend a surgical implant for the patient that is most compatible with the anatomical makeup classification assigned to the first virtual three-dimensional anatomical bone model (Schoenfeld: Figures 1, 3, paragraph [0059], “Once the 3-D model 160 is generated, the integrated orthopedic system manager 74 can generate a preliminary preoperative surgical plan 176 at block 180… The preliminary preoperative plan 176 can be prepared for surgeon or other medical user 26 review, and can include the planning of various bone resections, sizes and types of implants, and various geometric requirements including relevant dimensions, such as height, width, orientation of particular features, etc.”, paragraph [0065], “recommending an implant for a patient. An implant type can be determined at block 196 and an implant size can be determined at block 200... drive creation of a custom implant, such as a patient specific implant, from the patient data and information in datastore 56”).
The motivation to combine is the same as in claim 4, incorporated herein.
Regarding (Original) claim 9, Codd, Schoenfeld and Plessers teach the limitations of claim 5, and further teach wherein the processor is configured to execute the computer executable instructions to: receive a postoperative patient outcome data associated with the patient; and update a surgical outcomes database with the postoperative patient outcome data (Schoenfeld: Figures 1-2, 5, paragraph [0006], “Postoperative image data of the patient's bone joint can be received, at the server, and can include an image of an implant associated with the patient's bone. A postoperative outcome study report can be generated, at the server, and can include a comparison of the preoperative surgical plan with the postoperative image data”, paragraph [0013], “Information from the patient satisfaction survey can be stored at a data store associated with the server”, paragraph [0097], “any notes, data, etc. that are generated or captured during the surgical procedure can be associated with corresponding times of surgery and stored in the patient's master date file 154”, paragraphs [0099]-[0100], “The postoperative 3-D model 370 can be generated using the statistical shape modeling software 170, models of the implants scanned from the operating room, and the transmitted postoperative X-ray data 360 and stored in the patient's master data file 154. Similar to the preoperative 3-D bone models 160, the postoperative 3-D models 370”).
The motivation to combine is the same as in claim 4, incorporated herein.
Regarding (Currently Amended) claim 10, Codd and Schoenfeld teach the limitations of claim 1, but may not explicitly teach wherein the deviation related information is electronically displayed on the graphical user interface in a form of a bar graph.
Plessers teaches wherein the deviation related information is electronically displayed on the graphical user interface in a form of a bar graph (Plessers: paragraph [0148], “The information generated as part of the decision-support processes may be presented to the user in any practical way. For example, when supporting a decision involving a limited number of discrete options or discrete parameter values—such as the choice between a number of treatment options or available implant sizes—distribution graphs or histograms may be shown for each of these options with one patient characteristic as independent variable”, paragraph [0242], “prompt the user (e.g., the surgeon) with warnings if the actual treatment deviates from the treatment plan or if other complications are encountered”).
The motivation to combine is the same as in claim 4, incorporated herein.
Regarding (Currently Amended) claim 19, Codd and Schoenfeld teach the limitations of claim 11, and further teach providing image data associated with an anatomy of the patient to the surgical planning system (Schoenfeld: Figure 1, paragraph [0006], “receiving, at a server, preoperative image data of a patient's bone, and generating, at the server, a patient specific three-dimensional model of the patient's bone”); and
receiving, from the surgical planning system, an anatomical makeup classification that characterizes an anatomical makeup of a bone or a joint associated with the anatomy […] (Schoenfeld: Figures 1-2, paragraph [0007]-[0009], “patient specific three-dimensional model of the patient's bone joint can be generated automatically, at the server, and can include identification of anatomical landmarks based at least on the preoperative image data and the database three-dimensional model data”, paragraph [0095], “match the implants identified in the surgical plan 176. Instrumentation to be used with the surgery can also be scanned prior to or during surgery and compared with instrumentation identification information in the surgical plan 176”),
wherein the automatically generated preoperative recommendation includes an identification of a surgical implant that is most compatible with the anatomical makeup classification assigned to the anatomy of the patient (Schoenfeld: Figures 1, 3, paragraph [0059], “Once the 3-D model 160 is generated, the integrated orthopedic system manager 74 can generate a preliminary preoperative surgical plan 176 at block 180… The preliminary preoperative plan 176 can be prepared for surgeon or other medical user 26 review, and can include the planning of various bone resections, sizes and types of implants, and various geometric requirements including relevant dimensions, such as height, width, orientation of particular features, etc.”, paragraph [0065], “recommending an implant for a patient. An implant type can be determined at block 196 and an implant size can be determined at block 200... drive creation of a custom implant, such as a patient specific implant, from the patient data and information in datastore 56”).
Codd and Schoenfeld may not explicitly teach (underlined below for clarity):
receiving, from the surgical planning system, an anatomical makeup classification that characterizes an anatomical makeup of a bone or a joint associated with the anatomy relative to a representative patient population,
Plessers teaches receiving, from the surgical planning system, an anatomical makeup classification that characterizes an anatomical makeup of a bone or a joint associated with the anatomy relative to a representative patient population (Plessers: paragraph [0087], “multiple classification systems may be combined”, paragraphs [0125]-[0126], “the population should preferably be limited to members that show a similarity to the patient to be treated. This similarity can relate to one or more patient characteristics”, paragraph [0131], “the system may also locate within a selected population the member that most closely matches the patient characteristics of the patient to be treated”, paragraph [0185], “the population is limited to patients who show a certain similarity to the patient to be treated in one or more patient characteristics. For example, bone density”, paragraph [0220], “Using the three-dimensional models based on the patient data, the defect is simulated in comparison with healthy anatomy”),
The motivation to combine is the same as in claim 4, incorporated herein.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0395118 (hereafter “Codd”; already of record in the IDS), U.S. Patent Pub. No. 2014/0303990 (hereafter “Schoenfeld”; already of record in the IDS) and U.S. Patent Pub. No. 2022/0054197 (hereafter “Plessers”; already of record in the IDS) as applied to claim 19 above, and further in view of U.S. Patent Pub. No. 2022/0233119 (hereafter “Shelton”).
Regarding (Original) claim 20, Codd, Schoenfeld and Plessers teach the limitations of claim 19, but may not explicitly teach wherein the anatomical makeup classification is a multi-character identifier for describing the anatomy of the patient, and each character of the multi-character identifier is a unitless character that is representative of a mode that describes an anatomical difference in the bone or the joint across a plurality of standard deviations of anatomical variances.
Shelton teaches wherein the anatomical makeup classification is a multi-character identifier for describing the anatomy of the patient, and each character of the multi-character identifier is a unitless character that is representative of a mode that describes an anatomical difference in the bone or the joint across a plurality of standard deviations of anatomical variances (Shelton paragraph [0880], “The sensing system may calculate the mean of the measurements excluding outlier measurements and transmit such mean. The sensing system may calculate the mean of the measurements and standard deviation of the measurement data set, and transmit the mean and the standard deviation. The sensing system may calculate an average of the highest measurement and the lowest measurement and transmit such average… sensing system may transmit to the computing system identifiers for such classifications, e.g., “H”, “M”, “L”, and “SL” for “high”, “moderate”, “low”, and “severely low”, respectively. Those of skill in the art will recognize other sensing systems described herein may also preprocess the biomarker measurement data and then transmit the preprocessed biomarker measurement data to the computing system as described”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include using a unitless identifier that represents a standard deviation of variance as taught by Shelton with the classification as taught by Codd, Schoenfeld and Plessers with the motivation of “improve a surgical outcome” (Shelton: paragraph [0155]).
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2020/0395118 (hereafter “Codd”; already of record in the IDS), in view of U.S. Patent Pub. No. 2014/0303990 (hereafter “Schoenfeld”; already of record in the IDS), in view of U.S. Patent Pub. No. 20200243199 (hereafter “Farley”).
Regarding (New) claim 22, Codd teaches a surgical planning system (Codd: Figures 1-2, 4, paragraph [0016], “electronic identification tagging systems, methods, applicators, and tapes for tracking and managing medical equipment”, paragraph [0089], “a method for optimizing surgical instrument tray organization”), comprising:
at least one database storing […] preoperative surgical plans associated with scheduled […] procedures (Codd: Figures 2, 4, paragraph [0004], “maintaining schedule”, paragraph [0026], “for future surgeries”, paragraph [0046], “The object use analyzer 148 may include a database”, paragraphs [0070]-[0071], “determine an operational procedure associated with use of surgical instruments, and subsequently predict surgical instruments needed for a subsequent operational procedure based on the determined operational procedure and the usage of the surgical instruments… store information that indicates a standard order and timing of use of the medical equipment during a medical procedure… store information about an ideal order of use of surgical instruments and timing of use of the surgical instruments during a surgical procedure”, paragraph [0081], “Tool usage statistics may be obtained per surgeon per procedure. This list may be generated and sent to an appropriate party as an updated surgical preference card for the next surgery of the same or similar type”, paragraph [0094], “schedules for the same type or similar type of surgical instrument”. Also see, paragraph [0091], [0097], claim 8. The Examiner interprets an operational procedure a preoperative surgical plan); and
a computing device including a processor and a memory storing computer-executable instructions that, when executed by the processor (Codd: Figure 1, paragraph [0048], “the object use analyzer 148 may include memory 152 and one or more processors 154 for implementing the functionality described herein”), cause the computing device to:
identify a scheduled […] procedure […] having an associated […] preoperative surgical plan (Codd: paragraph [0004], “maintaining schedule”, paragraph [0046], “Prior to beginning a surgery, the surgical instruments may be brought into the OR 101 on a tray placed onto the Mayo stand 110. An RFID reader on the tray and/or the RFID reader 140 on the Mayo stand 110 may read each RFID tag attached to the surgical instruments. The ID of each read RFID tag may be communicated to the object use analyzer 148 for determining their presence and availability for use during the surgery. In this way, each surgical instrument made available for the surgery by the surgeon 104 can be tracked and recorded in a suitable database”);
analyze historical surgical execution data corresponding to prior […] procedures performed by the surgeon to determine a surgeon-specific plan […] metric indicative of how frequently the surgeon executed prior procedures in accordance with the […] preoperative surgical plans (Codd: Figures 2, 4, paragraph [0006], “surgical preference cards and a lack of standardization. A preference card may be, for example, a listing of instruments or sets of instruments that are to be supplied to the surgeon for a particular surgery… provide a check for correct instrument supply and to motivate reassessment of which instruments are necessary to an operation”, paragraph [0026], “determine that the surgeon never uses a particular surgical instrument for a particular surgery or generally for any type of surgery”, paragraph [0046], “Prior to beginning a surgery, the surgical instruments may be brought into the OR 101 on a tray placed onto the Mayo stand 110. An RFID reader on the tray and/or the RFID reader 140 on the Mayo stand 110 may read each RFID tag attached to the surgical instruments. The ID of each read RFID tag may be communicated to the object use analyzer 148 for determining their presence and availability for use during the surgery. In this way, each surgical instrument made available for the surgery by the surgeon 104 can be tracked and recorded in a suitable database”, paragraphs [0059]-[0060], “store an inventory of the tags of surgical instruments that have gone through the sterilization process and have been read for comparison to tags of surgical instruments in a tray. The object use analyzer 148 may compare the list of the sterilized instruments to the inventor of the tray to determine whether any in the tray have not been sterilized. Those that have not been sterilized may be reported to medical practitioners, so the non-sterilized instrument are not used in surgery”, paragraph [0063], “thresholds for cutoff percentages… determine a utilization metric for one or more of the medical equipment (e.g., surgical instrument) … The metric can include the number of times a specific instrument was used”, paragraphs [0070]-[0071], “the object use analyzer 148 may determine whether the surgical instruments are being used in accordance with the stored order and timing”, paragraphs [0083]-[0085], “Preference cards may include instrument trays, being both general and specific to that surgeon or service line… collecting 402 instrument data over multiple similar surgeries by the same surgeon… determining 404 utility percentages and other metrics from collected instrument data”, paragraph [0096], “A check that all of the correct tools are present can be completed by cross referencing the surgical preference card with the census of the instrument tables. Nurses can be provided with a warning if there is any discrepancy between what was requested and what is provided”. Also see, paragraphs [0055], [0067], [0084]-[0088]. The Examiner notes historical surgical performance is used to determine surgeon specific preference cards which contain a metric of user usage in accordance with a preoperative plan and in combination with teachings below teach what is required under the broadest reasonable interpretation);
compare the surgeon-specific plan […] metric to a predefined adherence threshold prior to commencement of the scheduled arthroplasty procedure (Codd: Figure 1, paragraph [0068], “object use analyzer 148 may control a display or other user interface to indicate the location of the user-identified surgical instrument(s). Further, the computing device 146 may present information on OR monitors and provide immediate verification or waning of instrument presence. Further, the system may be used in training module programs for new practitioners to display the name and picture of a tool as it is picked up for improving the accuracy of tool delivery”, paragraph [0075], “In response to determining that it is time to use a surgical instrument, the object use analyzer 148 may control a user interface (e.g., display) to present the notification to a medical practitioner (e.g., the surgeon 104 or physician's assistant 106). The object use analyzer 148 may also present a notification that indicates that a surgical instrument has been misplaced during the surgery”, paragraph [0096], “A check that all of the correct tools are present can be completed by cross referencing the surgical preference card with the census of the instrument tables. Nurses can be provided with a warning if there is any discrepancy between what was requested and what is provided”); and
based on the comparison of the surgeon-specific plan […] metric to the predefined […] threshold, automatically determine a preoperative surgical kit configuration for the scheduled […] procedure, wherein: when the surgeon-specific plan […] metric satisfies the predefined […] threshold, the preoperative surgical kit configuration includes only implants and instrumentation specified by the associated surgeon-approved preoperative surgical plan for the patient; and when the surgeon-specific plan […] metric does not satisfy the predefined […] threshold, the preoperative surgical kit configuration includes additional implants or instrumentation beyond those specified by the associated […] preoperative surgical plan for the patient (Codd: Figure 4, paragraph [0026], “Surgical instrument usage data collected by the system may be analyzed by the system to make recommendations as to which instruments should be supplied during specific surgeries for particular surgeons… for future surgeries, the system may recommend that the surgical instrument not be supplied in future surgeries for that surgeon. In this example, the system may update the surgeon's preference card such that the surgical instrument is not included for particular surgeries or for surgeries in general”, paragraph [0063], “object use analyzer 148, either during or post-surgery, may call data from the database in memory 152 and prepare and present overarching statistics”, paragraphs [0083]-[0088], “Preference cards may include instrument trays, being both general and specific to that surgeon or service line. Trays can contain a predetermined set of instruments. Preference cards may also include individual instruments… determining 406 supply recommendations based on utility percentages and/or other metrics… instruments used between 0 and 5 % of the time could be removed from a tray, while instrument used between 5 and 15% of the time could be supplied in peel packs or specialty trays. Instruments with utilities between 15 and 100% could remain in the trays and continue to be supplied… tray contents can be optimized based on utility percentages over individual surgeons… with surgeon two being supplied a separate specialized tray containing the additional”. The Examiner notes based on a comparison of a surgeon specific utilization metric in comparison to a pre-op plan, a user’s preferences for future surgeries can be determined to include only necessary instruments or additional instruments, which one of ordinary skill in the art would find prima facie obvious teaches what is required of the claim under the broadest reasonable interpretation).
Codd may not explicitly teach (underlined below for clarity):
at least one database storing surgeon-approved preoperative surgical plans associated with scheduled arthroplasty procedures; and […]; identify a scheduled arthroplasty procedure for a specific patient having an associated surgeon-approved preoperative surgical plan; analyze historical surgical execution data corresponding to prior arthroplasty procedures performed by the surgeon to determine a surgeon-specific plan […] metric indicative of how frequently the surgeon executed prior procedures in accordance with the surgeon-approved preoperative surgical plans; compare the surgeon-specific plan […] metric to a predefined […] threshold prior to commencement of the scheduled arthroplasty procedure; and based on the comparison of the surgeon-specific plan […] metric to the predefined […] threshold, automatically determine a preoperative surgical kit configuration for the scheduled arthroplasty procedure, wherein: when the surgeon-specific plan […] metric satisfies the predefined […] threshold, the preoperative surgical kit configuration includes only implants and instrumentation specified by the associated surgeon-approved preoperative surgical plan for the patient; and when the surgeon-specific plan adherence metric does not satisfy the predefined adherence threshold, the preoperative surgical kit configuration includes additional implants or instrumentation beyond those specified by the associated surgeon-approved preoperative surgical plan for the patient.
Schoenfeld teaches at least one database storing surgeon-approved preoperative surgical plans associated with scheduled arthroplasty procedures; and […]; identify a scheduled arthroplasty procedure for a specific patient having an associated surgeon-approved preoperative surgical plan; analyze historical surgical execution data corresponding to prior arthroplasty procedures performed by the surgeon to determine a surgeon-specific plan […] metric indicative of how frequently the surgeon executed prior procedures in accordance with the surgeon-approved preoperative surgical plans; compare the surgeon-specific plan […] metric to a predefined […] threshold prior to commencement of the scheduled arthroplasty procedure; and based on the comparison of the surgeon-specific plan […] metric to the predefined […] threshold, automatically determine a preoperative surgical kit configuration for the scheduled arthroplasty procedure, wherein: when the surgeon-specific plan […] metric satisfies the predefined […] threshold, the preoperative surgical kit configuration includes only implants and instrumentation specified by the associated surgeon-approved preoperative surgical plan for the patient; and when the surgeon-specific plan adherence metric does not satisfy the predefined adherence threshold, the preoperative surgical kit configuration includes additional implants or instrumentation beyond those specified by the associated surgeon-approved preoperative surgical plan for the patient (Schoenfeld: Figures 1, 3, 10-11, 16, paragraph [0006], “Approval of the preoperative surgical plan can be received, at the server”, paragraphs [0027]-[0028], “FIG. 10 is an exemplary illustration of a surgeon examining a patient for knee joint arthroplasty… FIG. 11 is an exemplary illustration of the patient in preparation for the knee joint arthroplasty”, paragraph [0066], “The preoperative surgical plan 176 can include or be saved as a data file, in the datastore 56 associated with the manufacturer 38 and the server 46”, paragraphs [0077]-[0079], “review the recommended implant in the preoperative plan 176 and make an implant selection (e.g., approval of the recommended implant) in an interactive user interface 258 displayed at user device 18… The surgeon 26 can optionally select a different implant… the surgeon 26 can make other plan adjustments or edits, including positional adjustments, cut or resection line adjustments, implant size adjustments, etc. … The recommended instrumentation can be determined in part by the integrated orthopedic system manager 74 in connection with the surgeon preferences 182… The recommended instrumentation can be updated based on the surgeon 26 choosing a different implant option than was initially recommended with the preoperative surgical plan 176. In this regard, the integrated orthopedic system manager 74 can be configured to flag, such as with a note to the surgeon 26, that the surgeon's optional implant selection may require instrumentation that he has previously indicated was not preferred”, paragraphs [0086]-[0086], “scheduling the surgical procedure… With the preoperative plan 176 approved and the surgery date scheduled, the integrated orthopedic system manager 74 can provide relevant information to a manufacturing planning system 298 (FIG. 6) of the manufacturer 38 at block 302 of FIG. l”, paragraphs [0093]-[0095], “the surgical plan 176 can be accessed via the web portal or user interface 70 though an internet connection 22 in the manner discussed above. The integrated orthopedic system manager 74 can cause the operating room client device 18 to display an interactive user interface 344 including details of the surgical plan 176 in real time, as shown in FIG. 16B with reference to FIG. 16A… At block 348, the integrated orthopedic system manager 74 can compare the transmitted implant identification information with the implant identification information in the surgical plan 176 and provide visual confirmation via user interface 344 that the delivered implants match the implants identified in the surgical plan 176. Instrumentation to be used with the surgery can also be scanned prior to or during surgery and compared with instrumentation identification information in the surgical plan 176.”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include use of an approved pre-op plan for making arthroplasty determinations about kit composition as taught by Schoenfeld within the determination of deviation with predefined percentages to recommend kits with only necessary instruments as taught by Codd with the motivation of “inventory can be more efficiently managed and/or reduced based on the information available from the surgeon approved preoperative plan 176 and surgical kit content selection” (Schoenfeld: paragraph [0086]).
Codd and Schoenfeld may not explicitly teach (underlined below for clarity):
analyze historical surgical execution data corresponding to prior arthroplasty procedures performed by the surgeon to determine a surgeon-specific plan adherence metric indicative of how frequently the surgeon executed prior procedures in accordance with the surgeon-approved preoperative surgical plans; compare the surgeon-specific plan adherence metric to a predefined adherence threshold prior to commencement of the scheduled arthroplasty procedure; and based on the comparison of the surgeon-specific plan adherence metric to the predefined adherence threshold, automatically determine a preoperative surgical kit configuration for the scheduled arthroplasty procedure, wherein: when the surgeon-specific plan adherence metric satisfies the predefined adherence threshold, the preoperative surgical kit configuration includes only implants and instrumentation specified by the associated surgeon-approved preoperative surgical plan for the patient; and when the surgeon-specific plan adherence metric does not satisfy the predefined adherence threshold, the preoperative surgical kit configuration includes additional implants or instrumentation beyond those specified by the associated surgeon-approved preoperative surgical plan for the patient.
Farley teaches analyze historical surgical execution data corresponding to prior arthroplasty procedures performed by the surgeon to determine a surgeon-specific plan adherence metric indicative of how frequently the surgeon executed prior procedures in accordance with the surgeon-approved preoperative surgical plans; compare the surgeon-specific plan adherence metric to a predefined adherence threshold prior to commencement of the scheduled arthroplasty procedure; and based on the comparison of the surgeon-specific plan adherence metric to the predefined adherence threshold, automatically determine a preoperative surgical kit configuration for the scheduled arthroplasty procedure, wherein: when the surgeon-specific plan adherence metric satisfies the predefined adherence threshold, the preoperative surgical kit configuration includes only implants and instrumentation specified by the associated surgeon-approved preoperative surgical plan for the patient; and when the surgeon-specific plan adherence metric does not satisfy the predefined adherence threshold, the preoperative surgical kit configuration includes additional implants or instrumentation beyond those specified by the associated surgeon-approved preoperative surgical plan for the patient (Farley: paragraph [0117], “The Operative Patient Care System 320 is designed to utilize patient specific data, surgeon data, healthcare facility data, and historical outcome data to develop an algorithm that suggests or recommends an optimal overall treatment plan for the patient's entire episode of care (preoperative… tracks adherence to the suggested or recommended plan, and adapts the plan based on patient/care provider performance”, paragraph [0161], “The system may track adherence to the suggested plan and may adapt the plan based on the performance of the patient, surgeon, or care provider. Once the surgical treatment plan for a particular patient is complete, collected data may be logged in a historical database that is accessible for future patients and the development of future treatment plans”).
One of ordinary skill in the art before the effective filing date would have found it obvious to include use of adherence to a pre-op plan as taught by Farley within the tracking of instrument usage by a surgeon during a surgeon in view of a pre-op surgical plan taught by Codd and Schoenfeld with the motivation of “improving the chance of successful clinical outcomes and lessening the economic burden on the facility associated with near-term revision” (Farley: paragraph [0117]).
Response to Arguments
Applicant's arguments filed on 07 April 2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 07 April 2026.
Rejections under 35 U.S.C. § 112
Regarding claims 7 and 8, as the claims have been canceled the rejections have been removed.
Rejections under 35 U.S.C. § 101
Regarding the rejection of claims 1-20, the Examiner has considered the Applicant’s arguments but does not find them fully persuasive. The Examiner has attempted to address all of the arguments presented by the Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
Applicant argues:
a technical solution to a technical problem in the field of surgical planning… The present claims do not recite social activities, instructional schemes, rule enforcement, or behavioral interactions between people… The claimed system does not instruct a surgeon how to behave, enforce rules on individuals, or coordinate human interactions; rather, it uses data processing to optimize the preparation of tangible surgical resources in a manner that improves the overall planning process… Moreover, independent claim 11 explicitly requires the steps of receiving a recommended surgical kit and performing the arthroplasty procedure on the patient using the automatically generated surgical kit recommendation. Characterizing such a claim as a patent-ineligible method of organizing human activity would effectively render nearly all computer-assisted surgical methods ineligible, a result plainly inconsistent with the intended scope of§ 101… Here, the specification describes improvements in the technical field of surgical planning and medical logistics by introducing a novel deviation-based analysis that governs preoperative preparation of physical surgical resources. The claimed invention improves how surgical kits are generated and supplied by using surgeon-specific adherence modeling rather than generic utilization statistics. This approach is neither well-understood, routine, nor conventional…. Additionally, with specific reference to independent claim 11… The October 2019 Update to Subject Matter Eligibility specifically recognizes surgery as a form of such treatment. Independent claim 11 expressly recites performing an arthroplasty procedure on a patient using the automatically generated surgical kit, thereby applying the claimed system to effect a concrete medical treatment. This provides an additional, independent basis for concluding that claim 11 integrates any alleged judicial exception into a practical application…. Here, the Examiner has not established that the claimed deviation-based analysis within a surgical planning system, nor the corresponding preoperative, conditional generation of a plan-restricted surgical kit, is well-understood, routine, or conventional.
The Examiner respectfully disagrees.
It is respectfully submitted, that the claims under the broadest reasonable interpretation collect data, organize the collected data and provide a recommendation to a human user for a human user activity via human user interaction with generic computer components, which as stated in 2106.04(a)(2), “certain activity between a person and a computer… may fall within the “certain methods of organizing human activity” grouping”.
Only the additional elements may provide a practical application and/or significantly more, the as claimed additional elements do not recite a technical solution to a technical problem recited in Applicant’s specification. First, the Examiner notes no portions of the specification are argued for recitations of technical problems rooted in computer hardware technology, instead applicant argues the problem of surgical planning, which is at best a surgeon (i.e., a human activity) problem, the claims may improve upon the abstract idea of surgical planning, nevertheless an improved abstract idea is still an abstract idea. Finally, no particular treatment is claimed in claims 1 and newly added 22, the output of a generic variable black box recommended kit to use by a surgeon to perform an arthroplasty procedure, is not a particular treatment, no treatment is performed unlike claim 11, which the 101 has been removed, therefore claims 1 and 22 unlike claim 11 do not recite particular treatment and are not subject matter eligible.
Rejections under 35 U.S.C. § 103
Regarding the rejection of claims 1-20, the Examiner has considered the applicant’s arguments; however, the arguments are not persuasive as addressed herein. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons:
Applicant argues:
The Cited Art Does Not Disclose or Suggest Deviation from Surgeon-Approved Preoperative Surgical Plans… At no point does Codd disclose or suggest retrieving a surgeon-approved preoperative surgical plan for a specific, upcoming arthroplasty procedure, or determining whether the surgeon has deviated from past surgeon-approved preoperative surgical plans… Critically, the claimed invention is not directed to optimizing surgical kits based on historical usage frequency or inventory efficiency, as in Codd, but instead implements a preoperative risk-gating mechanism based on surgeon-specific adherence to past surgeon-approved preoperative surgical plans… The Claimed Definition of "Deviation" Is Absent from the Cited Art… The Art Does Not Teach Conditional, Preoperative Kit Generation Based on Plan Adherence… The Proposed Combination Would Require Hindsight Reconstruction
The Examiner respectfully disagrees.
It is respectfully submitted, that applicants’ amendments do not introduce the adherence as argued, only new claim 22 explicitly recites this argued feature, nevertheless newly applied Farley, as necessitated by amendment has been added to teach the new claim. With respect to the argued deviation, Codd explicitly teaches that prior to performing the surgery, the gathered instruments are compared to a pre-op plan for a corresponding type of procedure for determination of any discrepancies (see above but at least paragraphs [0026], [0046], [0096]). Furthermore, the surgeon is provided a recommended surgical kit based on the determined deviations being below a threshold (see above but at least paragraphs [0083]-[0088]), although the plans may not for pre-approved arthroscopy procedures, Schoenfeld explicitly teaches this (see above but at least paragraphs [0006], [0027]-0028]), and would be prima facie obvious to combine with the motivation of “inventory can be more efficiently managed and/or reduced based on the information available from the surgeon approved preoperative plan 176 and surgical kit content selection” (Schoenfeld: paragraph [0086]).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In addition, the Examiner respectfully notes that the cited reference was never applied as a reference under 35 U.S.C. 102 against the pending claims. As such, the Examiner respectfully submits that the issue at hand is not whether the applied prior art specifically teaches the claimed features, per se, but rather, whether or not the prior art, when taken in combination with the knowledge of average skill in the art, would put the artisan in possession of these features. Regarding this issue, it is well established that references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures, In re Bozek, 163 USPQ 545 (CCPA 1969). The issue of obviousness is not determined by what the references expressly state but by what they would reasonably suggest to one of ordinary skill in the art, as supported by decisions in In re DeLisle 406 Fed 1326, 160 USPQ 806; In re Kell, Terry and Davies 208 USPQ 871; and In re Fine, 837 F.2d 1071, 1074, 5 USPQ 2d 1596, 1598 (Fed. Cir. 1988) (citing In re Lalu, 747 F.2d 703, 705, 223 USPQ 1257, 1258 (Fed. Cir. 1988)). Further, it was determined in In re Lamberti et al, 192 USPQ 278 (CCPA) that:
(i) obviousness does not require absolute predictability;
(ii) non-preferred embodiments of prior art must also be considered; and
(iii) the question is not express teaching of references, but what they would suggest.
According to In re Jacoby, 135 USPQ 317 (CCPA 1962), the skilled artisan is presumed to know something more about the art than only what is disclosed in the applied references. In In re Bode, 193 USPQ 12 (CCPA 1977), every reference relies to some extent on knowledge of persons skilled in the art to complement that which is disclosed therein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew E Lee whose telephone number is (571)272-8323. The examiner can normally be reached M-Th 9-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
Prosecution Insights