DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Amendments
Claims 1, 4-9, and 12-17 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 11/20/2025.
Claims 1, 6, 9, 14, and 17 are amended claims.
Claims 4-5, 7-8, 12-13, and 15-16 are original claims.
Claims 2-3 and 10-11 have been cancelled and will not be considered at this time.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-17 are drawn to a system, method, and article of manufacture, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a system comprising receive compatibility information identifying secondary surgical [systems] compatible with the surgical [instrument]; update a virtual compatibility list with the received compatibility information, the received compatibility information characterizing a level of compatibility between the surgical instrument and one or more secondary surgical systems; generate a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical [systems] selected based on the updated virtual compatibility list; and append the first virtual kit with one or more tertiary [systems], the one or more tertiary [systems] being determined based on a preference of a surgeon performing the first surgical procedure.
Independent claim 9 recites a method comprising receiving compatibility information identifying secondary surgical systems compatible with the surgical instrument updating a virtual compatibility list with the received compatibility information, the received compatibility information characterizing a level of compatibility between the surgical instrument and one or more secondary surgical systems; generating a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical [systems] selected based on the updated virtual compatibility list; and appending the first virtual kit with one or more tertiary systems, the one or more tertiary [systems] being determined based on a preference of a surgeon performing the first surgical procedure.
Independent claim 17 recites a non-transitory computer program product comprising receive compatibility information identifying secondary surgical [systems] compatible with the surgical [instrument]; update a virtual compatibility list with the received compatibility information, the received compatibility information characterizing a level of compatibility between the surgical instrument and one or more secondary surgical systems; generate a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical [systems] selected based on the updated virtual compatibility list; and append the first virtual kit with one or more tertiary [systems], the one or more tertiary [systems] being determined based on a preference of a surgeon performing the first surgical procedure.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
Claim 1 recites a manufacturer-sealed sterile surgical package comprising a surgical instrument, an electronic management system comprising a processor, one or more secondary surgical systems, one or more tertiary surgical systems, and generate a control signal configured to indicate the first virtual kit. Claim 9 recites one or more secondary surgical systems, surgical instrument, one or more tertiary surgical systems, and generating a control signal configured to indicate the first virtual kit. Claim 17 recites a non-transitory computer program product, at least one data processor, and at least one computing system, one or more secondary surgical systems, and one or more tertiary surgical systems and generate a control signal configured to indicate the first virtual kit.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
Claim 1 recites a manufacturer-sealed sterile surgical package comprising a surgical instrument, an electronic management system comprising a processor, one or more secondary surgical systems, and one or more tertiary surgical systems. Claim 9 recites one or more secondary surgical systems, surgical instrument, and one or more tertiary surgical systems. Claim 17 recites a non-transitory computer program product, at least one data processor, and at least one computing system, one or more secondary surgical systems, and one or more tertiary surgical systems.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
For the reasons stated, these claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claim 4 and 12 recite swapping, after receiving a notice characterizing an error concerning the selected at least one of the one or more secondary surgical systems, the selected at least one of the one or more secondary surgical systems with another of the one or more secondary surgical systems based on the compatibility list.
Dependent claim 5 and 13 recite wherein the error is a lack of available inventory of the at least one of the one or more secondary surgical systems.
Dependent claim 6 and 14 recite creating a second virtual kit for a second surgical procedure, the second virtual kit including the surgical package and at least one of the one or more secondary surgical systems selected based upon the virtual compatibility list.
Dependent claim 7 and 15 recite wherein the first surgical procedure and the second surgical procedure are different types of surgical procedures.
Dependent claim 8 and 16 recite ordering the surgical systems listed in the first virtual kit from a supplier.
Each of these steps of the preceding dependent claims 4-8 and 12-16 only serve to further limit or specify the features of independent claims 1 or 9 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-9, and 12-17 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 9, and 17 recite “generating a control signal configured to indicate the first virtual kit” (Claim 9 being representative). The Specification makes no mention of a control signal. The Specification states “The compatibility information can characterize a level of compatibility between the primary surgical system and one or more secondary surgical systems in electronic communication with the electronic management system, create a first virtual kit for a surgical procedure, and provide the first virtual kit” (Para. 0029). The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
As per Claims 4-8 and 12-16, the claims depend on Claims 1 and 9 and do not remedy the written description requirement issues of Claims 1 and 9. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 12-16, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the surgical instrument" in Lines 3 and 6. Claim 17 recites the limitation “the surgical instrument” in Lines 5 and 8. There is insufficient antecedent basis for these limitations in the claims.
Examiner notes that a similar amendment was made to Claim 1, but Claim 1 had an additional step not recited in Claims 9 and 17 introducing a surgical instrument as being part of a manufacturer-sealed sterile surgical package.
As per Claims 12-16, the claims depend on Claim 9 and do not remedy the lack of antecedent basis issue of Claims 9. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roh (US 20230104580 A1) in view of Uthgenannt (US 20180168690 A1) in view of Frank (US 20070017535 A1) in view of Dye (US 20110313894 A1).
REGARDING CLAIM 1
Roh teaches a surgical system, comprising:
receive compatibility information identifying secondary surgical systems compatible with the surgical instrument; ([Para. 0021] The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility (i.e. compatibility information) of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit.)
update a virtual compatibility list with the received compatibility information, the received compatibility information characterizing a level of compatibility between the surgical instrument and one or more secondary surgical systems; ([Para. 0021] The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application. [Para. 0161] The assembly module 624 updates the implant database 622 with the implant component 618b, its design specifications, and whether the part was sourced from available generic components 618a or alternatively was custom manufactured. In step 824, the assembly module 624 further indicates the implant 616 of which the implant component 618b is a part and the patient in whom it is to be installed. [Para. [0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory). Based on the simulations, the system can determine additional instruments, implants, or other equipment suitable for the procedure. This enables the system to provide surgical kits based on available components according to the surgical plan.)
generate a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical systems selected based on the updated virtual compatibility list; ([Para. 0145] The implant database 622 is used by the planning module 626 or the optimization module 628 to further customize the implant components 618b and generate a kit of implant components 618 to be used during implantation of the implant 616. [Para. 0148] The planning module 626 generates a virtual model of a portion of the patient's anatomy or body, selects the implant components 618, places models of the implant components 618 in the virtual model. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory). Based on the simulations, the system can determine additional instruments, implants, or other equipment suitable for the procedure. This enables the system to provide surgical kits based on available components according to the surgical plan.)
Roh does not explicitly teach, however Uthgenannt teaches
append the first virtual kit with one or more tertiary systems, the one or more tertiary systems being determined based on a preference of a surgeon performing the first surgical procedure: ([Para. 0007] preparing a pre-operative surgical plan for a patient and selecting a set of surgical instruments based on the pre-operative surgical plan. [Para. 0046] the pre-operative surgical plan can be approved. Approval of the pre-operative surgical plan can require approval of the surgeon and/or other users. The surgeon can further approve the implant to be used and the associated instruments (i.e. one or more tertiary systems).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh and incorporate preparing surgical kits as taught by Uthgenannt, with the motivation of preparing backup kits can contain replacement instruments, including implant components, that can be selectively used to replace selected instruments of the surgeon instrument kit (Uthgenannt Para. 0006).
Roh/ Uthgenannt do not explicitly teach, however Frank teaches
and generate a control signal configured to indicate the first virtual kit. ([Para. 0014] The method begins by creating a virtual surgical instrument kit in the computer prior to surgery by selecting a name for the kit and associating a memory location with the kit. Each instrument to be used in surgery is designated to be added to the kit. The number of designated instruments to be used in surgery is selected to be added to the kit to form the pre-surgical count for the kit. The pre-surgical count of the kit is then stored in the computer. [Para. 0020] The method also includes displaying the contents of the stored kit and displaying the history of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, and incorporate creating a virtual surgical kit as taught by Frank, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
Roh/ Uthgenannt/ Frank do not explicitly teach, however Dye teaches
a manufacturer-sealed sterile surgical package comprising a surgical instrument ([Para. 0030] The surgical pack 100 is configured for disposable use, i.e., each item in the surgical pack 100 is intended to be used once during a procedure, then discarded. [Para. 0032] Examples of items that can be included in the surgical pack 100 include tubing, trays, bandaging materials, scalpels, syringes, needle and blade disposal devices, drapes, clamps, suturing implements, disinfectants, antibiotic creams and lotions, masks, gloves, and so forth. [Para. 0033] all of the implements in the surgical pack 100 may be sterile.)
and an electronic management system comprising a processor configured to: ([Para. 0049] Each of the control devices 506,606,706,666,776 is configured to be able to wirelessly identify its corresponding surgical pack (100) to a remote reader. For example, in one embodiment, the control devices 506,606,706,666,776 can comprise a memory and processor. Identification information concerning the contents of the surgical pack (100) can be stored in the memory. The memory can be read by the remote reader through the radiating elements 507,607,707,777. In addition to contents information, the memory can store other information as well, such as manufacture date, shipment date, expiration dates, customer information, and so forth.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, and incorporate monitoring a surgical pack as taught by Dye, with the motivation of making and using custom surgical packs having radio frequency identification (RFID) tags capable of detecting use of the surgical packs to coordinate manufacturing and inventory control (Dye Para. 0002).
REGARDING CLAIM 4
Roh/ Uthgenannt/ Frank/ Dye the surgical system of claim 1, Roh further teaches wherein the electronic management system, is further configured to swap the at least one of the one or more secondary surgical systems with another of the one or more secondary surgical systems based on the virtual compatibility list. ([Para. 0142] An inventory database 630 stores data describing a stock of generic implant components 618a. The implant components 618a can include any of screws, rods, plates, or commercially available implant components. In some embodiments, one or more processors of the system of FIG. 6 determine absence of the customized surgical implant component 618b in an inventory. [Para. 0154] The assembly module 624 determines whether the customized implant component 618b matches an implant component 618a in stock according to the inventory database 630. A matching implant component 618a can be an exact match or can match required design parameters while not necessarily matching optional design parameters. For example, the customized implant component 618b is a 1.5-inch titanium screw having 18 threads per inch and a tulip head. The assembly module 624 determines that the screw is immediately available as indicated by a quantity of 5 returned by the inventory database 630. Alternatively, the material is optional and the screw is available in stainless steel; therefore, the assembly module 624 selects the stainless steel alternative as a matching generic component. Examiner interprets the selection of the alternative matching generic component to be indicative of swapping one or more secondary surgical systems [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list).)
Roh does not explicitly teach, however Frank teaches
after receiving a notice characterizing an error concerning the at least one of the one or more secondary surgical systems ([Para. 0015] The actual number of each of the designated instruments present at that time is counted. That number is entered into the computer to form the entered count of the stored kit. The computer then compares the pre-surgical count and the entered count of the selected kit and displays any difference between the pre-surgical count and the entered count of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, and incorporate creating a virtual surgical kit as taught by Frank, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
REGARDING CLAIM 5
Roh/ Uthgenannt/ Frank/ Dye the surgical system of claim 4, Frank further teaches wherein the error is a lack of available inventory of the at least one of the one or more secondary surgical systems. ([Para. 0015] The actual number of each of the designated instruments present at that time is counted. That number is entered into the computer to form the entered count of the stored kit. The computer then compares the pre-surgical count and the entered count of the selected kit and displays any difference between the pre-surgical count and the entered count of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh and incorporate creating a virtual surgical kit as taught by Frank, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
Claim(s) 9, 12-13, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roh (US 20230104580 A1) in view of Uthgenannt (US 20180168690 A1) in view of Frank (US 20070017535 A1).
REGARDING CLAIM 9
Roh teaches a method, comprising:
receiving compatibility information identifying secondary surgical systems compatible with the surgical instrument; ([Para. 0021] The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory).)
updating a virtual compatibility list with the received compatibility information, the received compatibility information characterizing a level of compatibility between surgical instrument and one or more secondary surgical systems; ([Para. 0021] The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application. [Para. 0161] The assembly module 624 updates the implant database 622 with the implant component 618b, its design specifications, and whether the part was sourced from available generic components 618a or alternatively was custom manufactured. In step 824, the assembly module 624 further indicates the implant 616 of which the implant component 618b is a part and the patient in whom it is to be installed. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit.)
generating a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical systems selected based on the updated virtual compatibility list; ([Para. 0145] The implant database 622 is used by the planning module 626 or the optimization module 628 to further customize the implant components 618b and generate a kit of implant components 618 to be used during implantation of the implant 616. [Para. 0148] The planning module 626 generates a virtual model of a portion of the patient's anatomy or body, selects the implant components 618, places models of the implant components 618 in the virtual model. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory). Based on the simulations, the system can determine additional instruments, implants, or other equipment suitable for the procedure. This enables the system to provide surgical kits based on available components according to the surgical plan.)
Roh does not explicitly teach, however Uthgenannt teaches
appending the first virtual kit with one or more tertiary systems, the one or more tertiary systems being determined based on a preference of a surgeon performing the first surgical procedure; ([Para. 0007] preparing a pre-operative surgical plan for a patient and selecting a set of surgical instruments based on the pre operative surgical plan. [Para. 0046] the pre-operative surgical plan can be approved. Approval of the pre-operative surgical plan can require approval of the surgeon and/or other users. The surgeon can further approve the implant to be used and the associated instruments (i.e. one or more tertiary systems).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh and incorporate preparing surgical kits as taught by Uthgenannt, with the motivation of preparing backup kits can contain replacement instruments, including implant components, that can be selectively used to replace selected instruments of the surgeon instrument kit (Uthgenannt Para. 0006).
Roh/ Uthgenannt do not explicitly teach, however Frank teaches
and generating a control signal configured to indicate the first virtual kit. ([Para. 0014] The method begins by creating a virtual surgical instrument kit in the computer prior to surgery by selecting a name for the kit and associating a memory location with the kit. Each instrument to be used in surgery is designated to be added to the kit. The number of designated instruments to be used in surgery is selected to be added to the kit to form the pre-surgical count for the kit. The pre-surgical count of the kit is then stored in the computer. [Para. 0020] The method also includes displaying the contents of the stored kit and displaying the history of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, and incorporate creating a virtual surgical kit as taught by Frank, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
REGARDING CLAIM 12
Roh/ Uthgenannt/ Frank teach the method of claim 9, Roh teaches further comprising swapping, the selected at least one of the one or more secondary surgical systems with another of the one or more secondary surgical systems based on the compatibility list. ([Para. 0142] An inventory database 630 stores data describing a stock of generic implant components 618a. The implant components 618a can include any of screws, rods, plates, or commercially available implant components. In some embodiments, one or more processors of the system of FIG. 6 determine absence of the customized surgical implant component 618b in an inventory. [Para. 0154] The assembly module 624 determines whether the customized implant component 618b matches an implant component 618a in stock according to the inventory database 630. A matching implant component 618a can be an exact match or can match required design parameters while not necessarily matching optional design parameters. For example, the customized implant component 618b is a 1.5-inch titanium screw having 18 threads per inch and a tulip head. The assembly module 624 determines that the screw is immediately available as indicated by a quantity of 5 returned by the inventory database 630. Alternatively, the material is optional and the screw is available in stainless steel; therefore, the assembly module 624 selects the stainless steel alternative as a matching generic component. Examiner interprets the selection of the alternative matching generic component to be indicative of swapping one or more secondary surgical systems [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list).)
Roh does not explicitly teach, however Frank teaches
after receiving a notice characterizing an error concerning the selected at least one of the one or more secondary surgical systems ([Para. 0015] The actual number of each of the designated instruments present at that time is counted. That number is entered into the computer to form the entered count of the stored kit. The computer then compares the pre-surgical count and the entered count of the selected kit and displays any difference between the pre-surgical count and the entered count of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, and incorporate creating a virtual surgical kit, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
REGARDING CLAIM 13
Roh/ Uthgenannt/ Frank teach the method of claim 12, Frank further teaches wherein the error is a lack of available inventory of the selected at least one of the one or more secondary surgical systems. ([Para. 0015] The actual number of each of the designated instruments present at that time is counted. That number is entered into the computer to form the entered count of the stored kit. The computer then compares the pre-surgical count and the entered count of the selected kit and displays any difference between the pre-surgical count and the entered count of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, and incorporate creating a virtual surgical kit, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
REGARDING CLAIM 17
Roh teaches a non-transitory computer program product storing instructions which, when executed by at least one data processor forming part of at least one computing system, cause the at least one data processor to implement operations comprising:
receive compatibility information identifying secondary surgical systems compatible with the surgical instrument; ([Para. 0021] The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory). Based on the simulations, the system can determine additional instruments, implants, or other equipment suitable for the procedure. This enables the system to provide surgical kits based on available components according to the surgical plan.)
update a virtual compatibility list with the received compatibility information, the received compatibility information characterizing a level of compatibility between the surgical instrument and one or more secondary surgical systems; ([Para. 0021] The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application. [Para. 0161] The assembly module 624 updates the implant database 622 with the implant component 618b, its design specifications, and whether the part was sourced from available generic components 618a or alternatively was custom manufactured. In step 824, the assembly module 624 further indicates the implant 616 of which the implant component 618b is a part and the patient in whom it is to be installed. [Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory). Based on the simulations, the system can determine additional instruments, implants, or other equipment suitable for the procedure. This enables the system to provide surgical kits based on available components according to the surgical plan.)
generate a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical systems selected based on the updated virtual compatibility list; ([Para. 0145] The implant database 622 is used by the planning module 626 or the optimization module 628 to further customize the implant components 618b and generate a kit of implant components 618 to be used during implantation of the implant 616. [Para. 0148] The planning module 626 generates a virtual model of a portion of the patient's anatomy or body, selects the implant components 618, places models of the implant components 618 in the virtual model. Para. 0170] The system identifies one or more components in inventory suitable for a surgical plan based on virtual modeling or simulations (i.e. compatibility list). The system can select the components (e.g., patient-sized components, patient-specific components, etc.) (i.e. surgical instrument) based on compatibility of the patient-sized component (i.e. surgical instrument) with other available components (i.e. secondary surgical system) for a surgical kit. For example, the system can perform simulations using available equipment (e.g., surgical instruments in inventory). Based on the simulations, the system can determine additional instruments, implants, or other equipment suitable for the procedure. This enables the system to provide surgical kits based on available components according to the surgical plan.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of operating a surgical assembly as taught by Shelton and incorporate customized kit assembly for surgical implants as taught by Roh, with the motivation of preventing surgical errors and adverse events during surgery (Roh Para. 0003).
Roh does not explicitly teach, however Uthgenannt teaches
append the first virtual kit with one or more tertiary systems, the one or more tertiary systems being determined based on a preference of a surgeon performing the first surgical procedure; ([Para. 0007] preparing a pre-operative surgical plan for a patient and selecting a set of surgical instruments based on the pre-operative surgical plan. [Para. 0046] the pre-operative surgical plan can be approved. Approval of the pre-operative surgical plan can require approval of the surgeon and/or other users. The surgeon can further approve the implant to be used and the associated instruments (i.e. one or more tertiary systems).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh and incorporate preparing surgical kits as taught by Uthgenannt, with the motivation of preparing backup kits can contain replacement instruments, including implant components, that can be selectively used to replace selected instruments of the surgeon instrument kit (Uthgenannt Para. 0006).
Roh/ Uthgenannt do not explicitly teach, however Frank teaches
and generate a control signal configured to indicate the first virtual kit. ([Para. 0014] The method begins by creating a virtual surgical instrument kit in the computer prior to surgery by selecting a name for the kit and associating a memory location with the kit. Each instrument to be used in surgery is designated to be added to the kit. The number of designated instruments to be used in surgery is selected to be added to the kit to form the pre-surgical count for the kit. The pre-surgical count of the kit is then stored in the computer. [Para. 0020] The method also includes displaying the contents of the stored kit and displaying the history of the stored kit.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, and incorporate creating a virtual surgical kit as taught by Frank, with the motivation of increasing the accuracy of surgical instrument and sponge counting so as to reduce the incidence of instruments and sponges being accidentally left in the body of surgical patients after surgery (Frank Para. 0002).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roh (US 20230104580 A1) in view of Uthgenannt (US 20180168690 A1) in view of Frank (US 20070017535 A1) in view of Dye (US 20110313894 A1) in view of Palo (US 20180289434 A1).
REGARDING CLAIM 6
Roh/ Uthgenannt/ Frank/ Dye teach the surgical system of claim 1, however Palo teaches wherein the electronic management system is further configured to create a second virtual kit for a second surgical procedure, the second virtual kit including the surgical package and at least one of the one or more secondary surgical systems selected based upon the virtual compatibility list. ([Para. 0010] Enables a plurality of administratively controlled authorized users comprised of medical staff and representatives to schedule, prepare, coordinate and bill surgical procedures and inventory using a plurality of scalable surgical coordination templates. Each of the scalable coordination templates may be shared and edited by authorized users and allows for pre-populated data field (i.e. compatibility list) based on past user inputs and surgeon preferences. [Para. 0041] A master surgical template is created which enables Dr. Smith to select “total hip replacement” from a drop-down menu of surgical procedures. [Para. 0042] The system 10 described includes a recommender module 18 with a collaborative filter 19 which provides a recommended list of instruments based on Dr. Smith's surgical habits and past inputs on a plurality of surgical templates wherein new cards are populated using the past inputs of the surgeon and authorized users who have performed the same or similar medical procedures (i.e. second surgical procedure). The instruments are then “pulled” by the medical center material management department who provide the quantity, cost, and hospital number for each of the items pulled from the master inventory list to the pick sheet.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, monitoring a surgical pack as taught by Dye, and incorporate the surgical management and coordination system as taught by Palo, with the motivation of assisting in the efficient preparation and execution of surgical procedure (Palo Para. 0002).
REGARDING CLAIM 7
Roh/ Uthgenannt/ Frank/ Dye/ Palo teach the surgical system of claim 6, Palo further teaches wherein the first surgical procedure and the second surgical procedure are different types of surgical procedures. ([Para. 0035] plurality of programmed information relating to the various medical procedures (i.e. first and second surgical procedures), surgeons, medical center, and pre-defined quantities of instruments available for a surgical procedure at a medical center. [Para. 0042] The system 10 described includes a recommender module 18 with a collaborative filter 19 which provides a recommended list of instruments based on Dr. Smith's surgical habits and past inputs on a plurality of surgical templates wherein new cards are populated using the past inputs of the surgeon and authorized users who have performed similar medical procedures (i.e. second surgical procedure).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, monitoring a surgical pack as taught by Dye, and incorporate the surgical management and coordination system as taught by Palo, with the motivation of assisting in the efficient preparation and execution of surgical procedure (Palo Para. 0002).
REGARDING CLAIM 8
Roh/ Uthgenannt/ Frank/ Dye teach the surgical system of claim 1, however Palo teaches wherein the electronic management system is further configured to order the surgical systems listed in the first virtual kit from a supplier. ([Para. 0010] The system includes a microprocessor including a memory module configured to store a plurality of pre-programmed medical and logistical data which coordinate and direct both the medical staff and medical centers in efficiently scheduling surgical cases, audit inventory, and ordering medical supplies. [Para. 0042] The instruments are then “pulled” by the medical center material management department who provide the quantity, cost, and hospital number for each of the items pulled from the master inventory list to the pick sheet. [Para. 0043] The pick sheet (further illustrated in FIG. 3) provides a list of instruments and materials that are required for Dr. Smith to perform his total hip replacement surgery.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, monitoring a surgical pack as taught by Dye, and incorporate surgical management and coordination system as taught by Palo, with the motivation of assisting in the efficient preparation and execution of surgical procedure (Palo Para. 0002).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Roh (US 20230104580 A1) in view of Uthgenannt (US 20180168690 A1) in view of Frank (US 20070017535 A1) in view of Palo (US 20180289434 A1).
REGARDING CLAIM 14
Roh/ Uthgenannt/ Frank teach the method of claim 9, however Palo teaches further comprising creating a second virtual kit for a second surgical procedure, the second virtual kit including the surgical package and at least one of the one or more secondary surgical systems selected based upon the compatibility list. ([Para. 0010] Enables a plurality of administratively controlled authorized users comprised of medical staff and representatives to schedule, prepare, coordinate and bill surgical procedures and inventory using a plurality of scalable surgical coordination templates. Each of the scalable coordination templates may be shared and edited by authorized users and allows for pre-populated data field (i.e. compatibility list) based on past user inputs and surgeon preferences. [Para. 0041] A master surgical template is created which enables Dr. Smith to select “total hip replacement” from a drop-down menu of surgical procedures. [Para. 0042] The system 10 described includes a recommender module 18 with a collaborative filter 19 which provides a recommended list of instruments based on Dr. Smith's surgical habits and past inputs on a plurality of surgical templates wherein new cards are populated using the past inputs of the surgeon and authorized users who have performed the same or similar medical procedures (i.e. second surgical procedure). The instruments are then “pulled” by the medical center material management department who provide the quantity, cost, and hospital number for each of the items pulled from the master inventory list to the pick sheet.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, and incorporate the surgical management and coordination system as taught by Palo, with the motivation of assisting in the efficient preparation and execution of surgical procedure (Palo Para. 0002).
REGARDING CLAIM 15
Roh/ Uthgenannt/ Frank/ Palo teach the method of claim 14, however Palo teaches wherein the first surgical procedure and the second surgical procedure are different types of surgical procedures. ([Para. 0035] plurality of programmed information relating to the various medical procedures (i.e. first and second surgical procedures), surgeons, medical center, and pre-defined quantities of instruments available for a surgical procedure at a medical center. [Para. 0042] The system 10 described includes a recommender module 18 with a collaborative filter 19 which provides a recommended list of instruments based on Dr. Smith's surgical habits and past inputs on a plurality of surgical templates wherein new cards are populated using the past inputs of the surgeon and authorized users who have performed similar medical procedures (i.e. second surgical procedure).)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, and incorporate the surgical management and coordination system as taught by Palo, with the motivation of assisting in the efficient preparation and execution of surgical procedure (Palo Para. 0002).
REGARDING CLAIM 16
Roh/ Uthgenannt/ Frank teach the method of claim 9, however Palo teaches further comprising ordering the surgical systems listed in the first virtual kit from a supplier. ([Para. 0010] The system includes a microprocessor including a memory module configured to store a plurality of pre-programmed medical and logistical data which coordinate and direct both the medical staff and medical centers in efficiently scheduling surgical cases, audit inventory, and ordering medical supplies. [Para. 0042] The instruments are then “pulled” by the medical center material management department who provide the quantity, cost, and hospital number for each of the items pulled from the master inventory list to the pick sheet. [Para. 0043] The pick sheet (further illustrated in FIG. 3) provides a list of instruments and materials that are required for Dr. Smith to perform his total hip replacement surgery.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of a customized kit assembly for surgical implants as taught by Roh, preparing surgical kits as taught by Uthgenannt, creating a virtual surgical kit as taught by Frank, and incorporate surgical management and coordination system as taught by Palo, with the motivation of assisting in the efficient preparation and execution of surgical procedure (Palo Para. 0002).
Response to Arguments
Applicant’s arguments, see pg. 6 “Claim Rejections – 35 U.S.C. 112(a)”, filed 09/16/2025, with respect to Claims 1, 9, and 17 have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pg. 6 “Claim Rejections – 35 U.S.C. 112(b)”, filed 09/16/2025, with respect to Claims 1, 3-4, 6, 9, and 17 have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant's arguments, see pgs. 6-8-10 “Claim Rejections – 35 U.S.C. 103”, filed 09/16/2025, have been fully considered but they are not persuasive.
Applicant submits that the cited prior art does not teach append[ing] the first virtual kit with one or more tertiary systems, the one or more tertiary systems being determined based on a preference of a surgeon performing the first surgical procedure. Examiner respectfully disagrees. Uthgenannt teaches at Para. 0007 preparing a pre-operative surgical plan for a patient and selecting a set of surgical instruments based on the pre-operative surgical plan. Para. 0046 further teaches the pre-operative surgical plan can be approved. Approval of the pre-operative surgical plan can require approval of the surgeon and/or other users. The surgeon can further approve the implant to be used and the associated instruments (i.e. one or more tertiary systems). This is indicative of append[ing] the first virtual kit with one or more tertiary systems, the one or more tertiary systems being determined based on a preference of a surgeon performing the first surgical procedure.
Applicant's arguments, see pgs. 8-10 “Claim Rejections – 35 U.S.C. 101”, filed 09/16/2025, have been fully considered but they are not persuasive.
Applicant submits that the amended independent claims provide an improvement to the technical field of technology. Examiner respectfully disagrees.
As Examiner has identified receiv[ing] compatibility information identifying secondary surgical systems compatible with the surgical instrument; generat[ing] a first virtual kit for a first surgical procedure, the first virtual kit comprising the surgical package and at least one of the one or more secondary surgical systems selected based on the updated virtual compatibility list; append[ing] the first virtual kit with one or more tertiary systems, the one or more tertiary systems being determined based on a preference of a surgeon performing the first surgical procedure; and generat[ing] a control signal configured to indicate the first virtual kit as part of the abstract idea, these functions are not considered under Step 2A, Prong Two analysis.
An improvement to the abstract idea of evaluating the compatibility of secondary/ tertiary systems to a surgical instrument for their inclusion in a virtual kit for a surgical procedure does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG,921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to collecting and organizing inventory data and determining compatibility between surgical instruments and secondary/ tertiary surgical systems. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
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 Patricia K Edouard whose telephone number is (571)272-6084. The examiner can normally be reached Monday - Friday 7:30 AM - 5:00 PM.
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/P.K.E./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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