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(s) filed on 15 January 2025, 31 March 2025 and 15 July 2025, has been considered by the Examiner.
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 7 and 8 are rejected for lack of adequate written description.
Claims 7 and 8 are rejected for lack of adequate written description. The claim recites functional steps for which the Applicant has not adequately described the steps in sufficient detail for one of ordinary skill in the art to conclude that the Applicant had possession of the invention.
MPEP 2161.01(I): When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. [...] If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2161.01- § 2163.07(b).
Specifically, the claim recites “determine a survivorship predictive index”. The Applicant has provided no disclosure of how this survivorship predictive index is calculated. Any calculation could potentially read on the as-claimed invention.
The Specification states: at paragraph [0122], “data from the surgical outcomes database 66 for the comparable anatomical makeup classifications and a plurality of variables associated with a surgical plan for operating on the patient may be leveraged in order to determine one or more survivorship predictive indexes. The variables may include factors such as surgical implant type, surgical implant size, surgical implant orientation, a surgical procedure type, a surgical implant backside seating configuration, a fastener orientation, or any combinations thereof”
This is inadequate for a person of ordinary skill in the art at the time of the invention (or filing) to conclude that the Applicant had possession of the claimed algorithm. No algorithm is presented.
The Examiner prospectively notes that this written description rejection is not based on whether one skilled in the art would know how to program a computer to perform any form of determination of survivorship predictive index (i.e., an enablement rejection), but rather is directed to the Applicant’s lack of specificity as to how the survivorship predictive index is specifically performed with respect to the Applicant’s claimed invention, i.e., would a potential infringer know the metes and bounds of the Applicant’s invention such that they could avoid infringing the Applicant’s claimed invention. In this case, they would not because the Applicant's description of determination of survivorship predictive index claims any and all types of determination evidencing that the Applicant did not have possession of their invention at the time of filing.
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 1-20 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 11 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 preoperative surgical plan that has been approved by a surgeon; determine whether the surgeon has deviated from past preoperative surgical plans in less than a predefined percent of prior surgical procedures; command that deviation related information be [… output …]; and guide the surgeon for performing an arthroplasty procedure on a patient according to the preoperative surgical plan by recommending a first surgical kit for performing the arthroplasty procedure, […] includes only those [… tools …] necessary 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 surgical procedures.
Claim 11
approving a preoperative surgical plan for performing an arthroplasty procedure on a patient […]; receiving, […], 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 preoperative surgical plans in less than a predefined percent of prior surgical procedures, wherein the surgical planning guidance includes a first recommendation to use [… tools …] necessary 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 surgical procedures; and [… recommending to a surgeon of …] the patient according to the surgical planning guidance.
, 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), 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), 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. 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), which implements the abstract idea. The 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), 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 display module, a computing device including a memory device and processor (claim 1) and a surgical planning system (claim 11), 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 2-10 and 12-20 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.
Claims 2 and 13 further describe the percentage used, however do not recite any additional elements and therefore cannot provide a practical application and/or significantly more.
Claims 3 and 14 further describe surgical kits with implants and instrumentation, however this was already considered above and is incorporated herein.
Claims 4 and 19 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, 9 and 19 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.
Claims 7 and 8 recite determination of a survivorship predictive index, however the claims do 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.
Claims 10, 15-18 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 12 recites the additional element of “implanting at least a portion of the arthroplasty implants”, however this is recited at a high-level of generality (i.e., a generic operation performed by a human user during a standard procedure) 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.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “implanting at least a portion of the arthroplasty implants” were considered extra-solution activity and/or generally linking to a particular technological environment. The “implanting at least a portion of the arthroplasty implants” 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], [0095]; Plessers (20220054197): Figure 6, paragraph [0140]-[0142]; Dees (20210315640): paragraphs [0002]-[0004]; DiSilvestro (20160239779): Figures 6-7, paragraphs [0047]-[0053]; implanting during a surgical 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.
Claim 20 further describes the classification of data using an identifier, however the claim does not recite any additional elements and therefore cannot provide a practical application and/or significantly more.
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 and 11-18 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 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 […] (Codd: Figures 2, 4, 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”. Also see, paragraph [0091], [0097], claim 8. The Examiner interprets an operational procedure a preoperative surgical plan);
determine whether the surgeon has deviated from past preoperative surgical plans in less than a predefined percent of prior surgical procedures (Codd: Figures 2, 4, 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 [0084]-[0085], “collecting 402 instrument data over multiple similar surgeries by the same surgeon… determining 404 utility percentages and other metrics from collected instrument data”. Also see, paragraph [0067], [0084]-[0088].);
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”. Also see, paragraph [0096]); and
guide the surgeon for performing an […] procedure on a patient according to the preoperative surgical plan by recommending a first surgical kit for performing the […] procedure, wherein the first surgical kit includes only those implants and instrumentation necessary 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 surgical procedures (Codd: Figure 4, 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 [0084]-[0088], “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”).
Codd may not explicitly teach (underlined below for clarity):
retrieve, from a database, a preoperative surgical plan that has been approved by a surgeon;
guide the surgeon for performing an arthroplasty procedure on a patient according to the preoperative surgical plan by recommending a first surgical kit for performing the arthroplasty procedure, wherein the first surgical kit includes only those implants and instrumentation necessary 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 surgical procedures.
Schoenfeld teaches retrieve, from a database, a preoperative surgical plan that has been approved by a surgeon (Schoenfeld: Figures 1, paragraph [0006], “Approval of the preoperative surgical plan can be received, at the server”, 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”, paragraph [0086], “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”);
guide the surgeon for performing an arthroplasty procedure on a patient according to the preoperative surgical plan by recommending a first surgical kit for performing the arthroplasty procedure, wherein the first surgical kit includes only those implants and instrumentation necessary 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 surgical procedures (Schoenefeld: Figures 10-11, 16, 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 [0093], “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”).
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 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 surgical 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 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: recommend 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 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, a surgical planning guidance for performing the […] procedure (Codd: Figures 2, 4, 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”. 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 who approved the preoperative surgical plan has deviated from past preoperative surgical plans in less than a predefined percent of prior surgical procedures (Codd: Figures 2, 4, 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]-[007 l ], “the object use analyzer 148 may determine whether the surgical instruments are being used in accordance with the stored order and timing”, paragraphs [0084]-[0085], “collecting 402 instrument data over multiple similar surgeries by the same surgeon… determining 404 utility percentages and other metrics from collected instrument data”. Also see, paragraph [0067], [0084]-[0088]),
wherein the surgical planning guidance includes a first recommendation to use a first surgical kit that includes only those […] implants and […] instrumentation necessary 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 surgical procedures (Codd: Figure 4, 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 [0084]-[0088], "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”); and
performing the […] procedure on the patient according to the surgical planning guidance (Codd: Figure 4, 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, a surgical planning guidance for performing the arthroplasty procedure,
wherein the surgical planning guidance includes a first recommendation to use a first surgical kit that includes only those arthroplasty implants and arthroplasty instrumentation necessary 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 surgical procedures; and
performing the arthroplasty procedure on the patient according to the surgical planning guidance.
Schoenfeld teaches approving a preoperative surgical plan for performing an arthroplasty procedure on a patient within a surgical planning system (Schoenfeld: Figures 1, paragraph [0006], “Approval of the preoperative surgical plan can be received, at the server”, 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”, paragraph [0086], “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”);
receiving, from the surgical planning system, a surgical planning guidance for performing the arthroplasty procedure (Schoenefeld: Figures 10-11, 16, 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”),
wherein the surgical planning guidance includes a first recommendation to use a first surgical kit that includes only those arthroplasty implants and arthroplasty instrumentation necessary 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 surgical procedures (Schoenefeld: Figures 10-11, 16, 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 [0093], “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"); and
performing the arthroplasty procedure on the patient according to the surgical planning guidance (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”).
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 determinations about arthroplasty 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 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 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 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 surgical 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 claim 14, Codd and Schoenfeld teach the limitations of claim 11, and further teach wherein the surgical planning guidance includes a second recommendation to use a second surgical kit that includes a greater number of arthroplasty implants and arthroplasty 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 11, incorporated herein.
Regarding 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 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 surgical 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 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 surgical 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 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 surgical 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.
Claim(s) 4-10 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 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 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 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 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 claim 7, Codd, Schoenfeld and Plessers teach the limitations of claim 6, and further teach wherein, prior to recommending the surgical implant, the processor is further configured to: determine a survivorship predictive index associated with using the surgical implant on the patient (Codd: paragraph [0063], “a risk metric correlated to how much the surgery would be impacted if a specific instrument was not supplied”, paragraph [0085], “a metric for the degree of danger that could occur if it was not supplied”; Plessers: paragraphs [0122]-[0124], “historical-data analysis may, for instance, reveal how the chance or risk of a certain event, observation or outcome happening increases or decreases with a certain preoperative plan parameter… the historical-data analysis may relate the chosen size of a heart valve with the risk of leakage, or may relate a chosen amount of lateralization of a shoulder implant with the risk of acromion fracture”).
The motivation to combine is the same as in claim 4, incorporated herein.
Regarding claim 8, Codd, Schoenfeld and Plessers teach the limitations of claim 7, and further teach wherein the survivorship predictive index is a percentile representation of a confidence level that use of the surgical implant will result in a successful surgical outcome for at least a predefined amount of time (Plessers: Figure 12, paragraphs [0157]-[0158], “a confidence interval… the results of a historical-data analysis linking the chance or risk of an intra-operative or post-operative event, observation or outcome to a treatment decision or parameter may also be shown in graphs, area charts or bar charts-optionally with confidence intervals”. Also see, paragraphs [0122]-[0124]).
The motivation to combine is the same as in claim 4, incorporated herein.
Regarding 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 claim 10, Codd and Schoenfeld teach the limitations of claim 1, and further teach wherein the deviation related information is electronically displayed on the graphical user interface in a bar graph.
Plessers teaches (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 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 first 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 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Pub. No. 20160239779 (hereafter “DiSilvestro) teaches assisted surgery for orthopedic implantation.
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.
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/A.E.L./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684