Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed June 18, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The information disclosure statement cites the foreign reference Ayvali et al. (WO 2022106991 A1), however, there is no legible copy provided. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 1, 6, and 7 are objected to because of the following informalities: The term “PCNL” in line 11 of claim 1, “BMI” in line 2 of claim 6, and “CT” in line 2 and 3 of claim 7, should be spelled out completely before an abbreviation is used. Therefore, “PCNL” should read “percutaneous nephrolithotomy (PCNL), “BMI” should read “body mass index (BMI)”, and “CT” should read “computed tomography (CT)”. Appropriate correction is required.
Claims 4-13 are objected to because of the following informalities: Each claim starts the sentence with “Method according to claim…”, however, the claims should read as “the method of claim…”, similar to claims 2 and 3.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. The claim limitation comprising the word means is claim 14, “means for carrying out the steps of the method”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claim 1 is 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. Regarding claim 1, the phrase "such as" in line 10 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 is 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.
Regarding claim 14, claim limitation “means for carrying out the steps of the method” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. While the specification states “computer unit may be configured to perform or induce performing of the steps of the method”, on Pg. 12, line 16, it does not provide clear structure because it is unclear what the unit is. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are directed to a computer program, which does not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to signals per se. Claim 15 includes transitory forms of signal transmission and does not include non-transitory forms of signal transmission. See MPEP 2106.03(I), “Even when a product has a physical or tangible form, it may not fall within a statutory category. For instance, a transitory signal, while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine, is not a tangible article or commodity under the definition of a manufacture (even though it is man-made and physical in that it exists in the real world and has tangible causes and effects), and is not composed of matter such that it would qualify as a composition of matter. Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03. As such, a transitory, propagating signal does not fall within any statutory category. Mentor Graphics Corp. v. EVE-USA, Inc., 851 F.3d 1275, 1294, 112 USPQ2d 1120, 1133 (Fed. Cir. 2017); Nuijten, 500 F.3d at 1356-1357, 84 USPQ2d at 1501-03.”
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claims
Step 1 analysis:
Claim 1 is drawn to a method (i.e., process) and Claim 14 is drawn to a device, which is within the four statutory categories. (Step 1 – Yes, the claim falls into one of the statutory categories). Although Claim 15 is indicated as directed to signals ser se, claim 15 includes similar limitations to claims 1 and 14 and the 101 analysis applies to claim 15 as well.
Step 2A analysis – Prong One:
Claim 1 recites:
Computer-implemented method for determining planning data for a surgical process of a subject in a urology procedure, comprising:
providing, by a processor, a prediction model trained to predict planning data based on at least one of: historical patient data, historical task data, historical planning data, current patient data and current task data;
obtaining, by the processor, at least one of: current patient data and current task data;
inputting the at least one of the current patient data and current task data to the prediction model in order to determine planning data;
providing a user recommendation on planning of a urology procedure planning, such as a PCNL procedure, by the processor, based on the determined planning data.
The series of steps as recited above, excluding the underlined portions, describes managing personal behavior or relationships or interactions between people including following rules or instructions, and therefore fall within the scope of certain methods of organizing human activity. Fundamentally, the method is that of a person gathering patient data and task data pertaining to the patient, and planning a procedure using the information. A prediction model trained to predict planning data based on several data points, obtaining current patient data and task data, inputting the data into the prediction model, and providing a user recommendation on planning of a urology procedure encompasses tasks commonly performed by a medical provider in a healthcare setting, and is fundamentally a person interacting with another individual including following rules or instructions. Accordingly, the claim recites an abstract idea of managing interactions between people.
Step 2A analysis – Prong 2:
This judicial exception is not integrated into a practical application. Specifically, independent claim 1 recites the following additional element beyond the abstract idea: implementing by a computer and a processor. This limitation is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using generic computer components. The limitation does not impose any meaningful limits on practicing the abstract idea, and therefore does not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
The additional element does not show an improvement to the functioning of a computer or to any other technology, rather the additional element performs general computing functions and does not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. Accordingly, this additional element, when considered separately and as an ordered combination, does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Therefore, Claim 1 is directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional elements are not integrated into a practical application).
Step 2B analysis:
As discussed above in “Step 2A analysis – Prong 2”, the identified additional element in Independent Claim 1 is equivalent to adding the words “apply it” on a generic computer. Therefore, the claim as a whole does not amount to significantly more than the judicial exception itself.
For the role of a computer in a computer implemented invention to be deemed meaningful in the context of this analysis, it must involve more than performance of “well- understood, routine, [and] conventional activities previously known to the industry.” Further, “the mere recitation of a generic computer cannot transform a patent ineligible abstract idea into a patent-eligible invention.”
The applicant’s specification discloses: The processor may be part of a computer unit, a workstation or a virtual machine. The processor may be a single entity or distributed on a plurality of entities (pg. 11, lines 4-5).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the steps for planning a procedure amount to no more than using computer related devices to implement the abstract idea.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible. The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claims amount to significantly more than the abstract idea identified above (Step 2B: Independent claims - NO).
Dependent Claims
Dependent Claims 2-15 are directed towards elements used to describe the patient data, planning data, task data, and the model. These elements include: (claim 2) the user recommendation may comprise a recommendation on at least one of: workflow adjustment, risk stratification, possible side effects, procedural recommendations; (claim 3) the procedural recommendations are from at least one of: planned and realized access path, distance to organs, structures at risk, recommended procedure duration, recommended equipment, staff availability; (claim 4) receiving historical patient data, historical task data, and/or historical planning data; (claim 5) selecting, by utilizing the prediction model and the obtained current patient data and current task data a set of historical patient data, historical task data and historical planning data and providing the selected set; (claim 6) the patient data comprises at least one of the following: age, co-morbidities, BMI and/or wherein the historical planning data comprises at least determined planning data and realized planning data; (claim 7) the patient data comprises a CT image of the subject and/or wherein at least a part of the patient data is extracted from the CT image; (claim 8) the task data comprises at least information about an object being located in the subject to be treated and/or a standard access path to the object being in the subject; (claim 9) the planning data comprises at least one of the following: needed equipment for the surgical process, duration of the surgical process, staff required for the surgical process, risk for adverse events and an access path to an object being located in the subject to be treated; (claim 10) the planning data further comprises contact information of an attending physician and wherein the planning data comprises the contact information of the attending physician; (claim 11) determining an uncertainty measure for the determined planning data; (claim 12) based on the determined uncertainty measure a case report of the surgical process is selected and provided for further processing; (claim 13) the trained prediction model is continuously trained; (claim 14) determining planning data for a surgical process of a subject.
The limitations as shown above in claims 2-14 describe managing personal behavior or relationships or interactions between people including following rules or instructions, and therefore further limits the scope of certain methods of organizing human activity as in independent claim 1. Each limitation further limits the abstract idea and encompasses tasks commonly performed by a medical provider in a healthcare setting.
The elements as recited in claims 11, 12, and 14 also fall within the “mental processes” grouping of abstract ideas, and describes concepts that can be performed in the human mind through observation, evaluation, judgement, and opinion. Determining and uncertainty measure, selecting a case report of the surgical process, and determining planning data are all tasks that can be performed in the human mind. Therefore, the dependent claims recite an abstract idea of a mental process.
This judicial exception is not integrated into a practical application. Specifically, the dependent
claims recite the following additional elements beyond the abstract idea: (claim 4) a user interface, (claim 14) device, means for carrying out the steps of the method according to claim 1, and (claim 15) Computer program comprising instructions, which when the program is executed by a computer, cause the computer to carry out the method according to claim 1. These limitations are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. The limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
The additional elements do not show an improvement to the functioning of a computer or to
any other technology, rather the additional elements perform general computing functions and do not
indicate how the particular combination improves any technology or provides a technical solution to a
technical problem. Accordingly, these additional elements, when considered separately and as an
ordered combination, do not integrate the abstract idea into a practical application because they do not
impose any meaningful limits on practicing the abstract idea. Therefore, the dependent claims are
directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional
elements are not integrated into a practical application).
As discussed above, the identified additional elements in Dependent Claims 2-15 are equivalent to adding the words “apply it” on a generic computer. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself.
The use of a computer or processor to merely automate or implement the abstract idea cannot
provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the
additional limitations alone or in combination improves the functioning of a computer or any other
technology, improves another technology or technical field, or effects a transformation or reduction of a
particular article to a different state or thing. Therefore, the claims are not patent eligible.
The Examiner has therefore determined that no additional element, or combination of
additional claims elements is/are sufficient to ensure the claims amount to significantly more than the
abstract idea identified above (Step 2B: Dependent claims - NO).
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.
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.
Claims 1-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (WO 2020/033319 A1) (Hereinafter Yoshinaka) in view of Long et al. (EP 3399936 B1) (hereinafter Long).
Regarding Claim 1, Yoshinaka teaches the following:
Computer-implemented method for determining planning data for a surgical process of a subject in a urology procedure (Abstract, [0044]: method provided for identifying comparable cases to assist in preoperative surgical planning. Surgery types included are, but not limited to, radical nephrectomy, partial nephrectomy, donor nephrectomy, radical prostatectomy, and other types of surgery), comprising:
providing, by a processor, a prediction model trained to predict planning data based on at least one of: historical patient data, historical task data, historical planning data, current patient data and current task data ([0021], [0054], [0058]: a "comparable case" refers to a surgical case performed in the past that shares some degree of similar characteristics to a surgical case for which an operation is being planned. Similar characteristics may include various types of overlapping information or factors such as (a) patient demographics (e.g., age, gender, race, body mass index ("BMI")), (b) diagnosis (e.g., renal cell carcinoma), and (c) characteristics of the patient's anatomy (e.g., size of tumor, location of the tumor, number of kidneys, number of arteries and blood vessels, whether the tumor has invaded a blood vessel). Similar characteristics may also include similarity of images. Searching for comparable cases and/or providing a recommended surgical plan is performed using a model such as a trained neural network, a classification tree, a random forest model, etc. that has been trained using experience from surgical cases provided to a training algorithm. Such models may be neural networks, etc. that have been trained to identify comparable cases and/or, in some implementations, recommend surgical plans based on input patient information.);
obtaining, by the processor, at least one of: current patient data and current task data ([0006] The method comprises: receiving, from a computing device, (i) patient information about the patient and/or (ii) an image showing a region of the patient where the surgery is to be performed);
inputting the at least one of the current patient data and current task data to the prediction model in order to determine planning data ([0058] Such models may be neural networks, etc. that have been trained to identify comparable cases and/or, in some implementations, recommend surgical plans based on input patient information);
providing a user recommendation on planning of a urology procedure ([0044] Surgery type refers to the general type of surgery performed. Examples include but are not limited to radical nephrectomy (removing an entire kidney that contains a tumor), partial nephrectomy (removing a tumor from a kidney and some of the surrounding renal tissue but preserving the kidney itself), donor nephrectomy (transplanting a kidney from a donor to a recipient), radical prostatectomy (removing an entire prostate that contains a tumor)) planning, , by the processor, based on the determined planning data ([0062]-[0063] After the surgical planning system identifies comparable cases, the surgical planning system calculates analytics for surgical techniques from the comparable cases. A recommended surgical approach is determined and recommended. The surgical planning system may determine a recommended surgical technique based on its analysis of the metadata and/or medical image for the surgical case being planned.).
However, Yoshinaka does not disclose the following that is met by Long:
such as a PCNL procedure ([0012] method for determining a patient-specific surgical access plan for a medical procedure using at least one computer system. The medical procedure may be percutaneous nephrolithotomy)
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the method of Yoshinaka, with the urology procedure such as a PCNL procedure, as taught by Long, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Yoshinaka already discloses urology procedures including nephrectomies. Including PCNL procedures in the function of planning procedures, as taught by Long, would perform the same function as planning other urology procedures, as taught by Yoshinaka. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Regarding Claim 2, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
The method of claim 1, wherein the user recommendation may comprise a recommendation on at least one of: workflow adjustment, risk stratification, possible side effects, procedural recommendations ([0062]-[0063] After the surgical planning system identifies comparable cases, the surgical planning system calculates analytics for surgical techniques from the comparable cases. A recommended surgical approach is determined and recommended. The surgical planning system may determine a recommended surgical technique based on its analysis of the metadata and/or medical image for the surgical case being planned. The surgical planning system will then determine the surgical technique associated with the "best" surgical outcomes, and present such technique as the recommendation. It will be understood that the "best" outcomes may be dependent on the preferences, desires, or expectations of the user. For example, some users may be willing to have a higher risk of a positive margin after a prostatectomy but be less willing to forfeit sexual function, and some users may be more willing to risk a higher rate of complications in return for a faster recovery period.).
Regarding Claim 3, Yoshinaka and Long teaches the method of claim 2, and Yoshinaka further teaches:
The method of claim 2, wherein the procedural recommendations are from at least one of: planned and realized access path, distance to organs, structures at risk, recommended procedure duration, recommended equipment, staff availability ([0044], [0062], [0063] After the surgical planning system identifies comparable cases, the surgical planning system calculates analytics for surgical techniques from the comparable cases. A recommended surgical approach is determined and recommended. The surgical technique includes information about a contemplated or actual surgery performed on a patient. Surgical procedure describes the manner in which the surgery is performed, which may be described in terms of invasiveness and equipment used. Examples include laparoscopic, open, robotic-assisted laparoscopic, video-assisted thoracoscopic (VATS), robotic-assisted thoracoscopic, and keyhole (neurosurgery). Surgical approach describes the route taken by the surgeon to access the operative area.).
Regarding Claim 4, Yoshinaka and Long teaches the method of claim 1, and Long further teaches:
Method according to claim 1, further comprising receiving historical patient data, historical task data, and/or historical planning data by a user interface ([0042] The user device(s) may communicate with one or more of the servers over the network to receive data such as patient images (including any processed images) and other patient data, reference data. The user device(s) may include a display or graphical user interface for receiving user input).
It would have been obvious to one of ordinary skill in the art to have combined the method as taught by Yoshinaka with the receiving historical patient data and reference data by a user interface, as taught by Long, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Yoshinaka para. 49 already discloses receiving current patient data and metadata regarding surgeries by a user interface. Including historical information being received by the user interface, as taught by Long, would perform the same function of receiving data used for planning a surgery, as taught by Yoshinaka. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Regarding Claim 5, Yoshinaka and Long teaches the method of claim 2, and Yoshinaka further teaches:
Method according to claim 2, further comprising selecting, by utilizing the prediction model and the obtained current patient data and current task data a set of historical patient data, historical task data and historical planning data and providing the selected set ([0005] receive, from a user input, an indication of a selection of a recommended surgical technique for the surgery to be performed on the patient, and train a machine learning algorithm of the surgical planning system for identifying comparable cases and presenting a recommended surgical technique. The system can receive an indication of a selection of a comparable case to the surgery to be performed on the patient. The comparable cases are identified based on having similar patient information about the patient and the image showing the region of the patient where the surgery is to be performed. The surgical techniques include a description of at least a surgery type, surgical procedure, surgical approach, and secondary surgical decisions in performing a surgical operation (i.e., historical planning data). The patient information about the patient includes patient age, gender, weight, height, race, body mass index (BMI), comorbidity status, prior surgical history, or combinations thereof (i.e., historical patient data). In some implementations, the patient information further includes tumor size, tumor location, tumor orientation, tumor proximity to organs and/or tissue, tumor growth pattern, or combinations thereof (i.e., historical task data).).
Regarding Claim 6, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
Method according to claim 1, wherein the patient data comprises at least one of the following: age, co-morbidities, BMI and/or wherein the historical planning data comprises at least determined planning data and realized planning data ([0005], [0042]: the patient information about the patient includes patient age, gender, weight, height, race, body mass index (BMI), comorbidity status, prior surgical history, or combinations thereof.).
Regarding Claim 7, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
Method according to claim 1, wherein the patient data comprises a CT image of the subject and/or wherein at least a part of the patient data is extracted from the CT image ([0004], [0005] The surgical planning system comprises a database system configurable to receive, from a computing device, (i) patient information about the patient and/or (ii) an image showing a region of the patient where the surgery is to be performed, the image showing the region where surgery is to be performed includes a medical image of a computed tomography (CT) scan.).
Regarding Claim 8, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
Method according to claim 1, wherein the task data comprises at least information about an object being located in the subject to be treated and/or a standard access path to the object being in the subject ([0005] the patient information further includes tumor size, tumor location, tumor orientation, tumor proximity to organs and/or tissue, tumor growth pattern, or combinations thereof.).
Regarding Claim 9, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
-Method according to claim 1, wherein the planning data comprises at least one of the following: needed equipment for the surgical process, duration of the surgical process, staff required for the surgical process, risk for adverse events and an access path to an object being located in the subject to be treated ([0044], [0062], [0063] After the surgical planning system identifies comparable cases, the surgical planning system calculates analytics for surgical techniques from the comparable cases. A recommended surgical approach is determined and recommended. The surgical technique includes information about a contemplated or actual surgery performed on a patient. Surgical procedure describes the manner in which the surgery is performed, which may be described in terms of invasiveness and equipment used. Examples include laparoscopic, open, robotic-assisted laparoscopic, video-assisted thoracoscopic (VATS), robotic-assisted thoracoscopic, and keyhole (neurosurgery). Surgical approach describes the route taken by the surgeon to access the operative area.).
Regarding Claim 10, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
-Method according to claim 1, wherein the planning data further comprises contact information of an attending physician and wherein the planning data comprises the contact information of the attending physician ([0041], [0042]: The various types of metadata and/or media content specific to a patient that has been or will be treated by surgery may be stored and associated with a case profile. The basic information pertains to general information about the patient that has been or will be treated by a surgery. Examples of the basic information includes surgical information such as surgery type, surgery date, and surgeon name.).
Regarding Claim 11, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
Method according to claim 1, further comprising determining an uncertainty measure for the determined planning data ([0064] the surgical planning system may present a score for a proposed surgical plan or scores for multiple surgical plans. The surgical planning system assigns scores to the surgical techniques that can reflect a "confidence" rating for each of the surgical techniques being proposed. A confidence score is a measure of the statistical likelihood that a particular surgical technique (or one or more aspects of that technique such as a surgical approach or a surgical method used in the technique) will maximize a specified outcome, which may be defined in many ways.).
Regarding Claim 12, Yoshinaka and Long teaches the method of claim 11, and Yoshinaka further teaches:
Method according to claim 11, wherein based on the determined uncertainty measure a case report of the surgical process is selected and provided for further processing ([0019], [0020], [0065], [0066] a "case profile" refers to a summary of a surgical case that includes some or all of the metadata, and optionally additional information such as a medical image, the associated radiology report, a video of the operation and/or a three dimensional reconstruction of the medical image. Metadata may include basic information, preoperative parameters, surgical technique, postoperative information, and patient follow-up information. Case profiles are stored as data records and used in searching for comparable cases and/or returned as full or partial results for each comparable case identified. A user interface can display scores for surgical techniques associated with comparable cases that are identified by the planning system. Scoring alternative surgical techniques may give a surgeon confidence that one technique is superior to the others and will have a high likelihood of maximizing a positive outcome. The surgeon may then select that technique for her surgical plan.).
Regarding Claim 14, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
Device for determining planning data for a surgical process of a subject, comprising means for carrying out the steps of the method according to claim 1 ([0004] a surgical planning system for identifying surgical cases comparable to a surgery to be performed on a patient, including a computing device. The method causes the computing device to carry out tasks for surgical planning).
Regarding Claim 15, Yoshinaka and Long teaches the method of claim 1, and Yoshinaka further teaches:
Computer program comprising instructions, which when the program is executed by a computer, cause the computer to carry out the method according to claim 1 ([0035] the processor includes program code for executing logic for searching, identifying, analytics, and/or learning operations of the surgical planning system.).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshinaka et al. (WO 2020/033319 A1) (Hereinafter Yoshinaka) in view of Long et al. (EP3399936B1) (hereinafter Long), in further view of Gaborit et al. (WO 2021/113168 A1) (Hereinafter Gaborit).
Regarding Claim 13, Yoshinaka and Long teaches the method of claim 1, however, Yoshinaka and Long does not teach the following that is met by Gaborit:
Method according to claim 1, wherein the trained prediction model is continuously trained ([0130], [0174], [0338]: During the preoperative phase of the surgical procedure, a surgeon may use surgery planning module to develop a surgical plan for the surgical procedure. Surgery planning module may use one or more machine-learned models. Machine-learned model is continuously trained (or re-trained) as new training data becomes available).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the method as taught by Yoshinaka and Long, with the continuous training function, as taught by Garborit, because after generating the new training data pair, surgery planning module may use the new training data pair to continue the training of the neural network. In this way, the neural network may continue to improve as the step of the surgical procedure is performed more times (See Gaborit [0388]).
Conclusion
The relevant art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Mowery (US 2021/0142907) discloses a system for making surgical decisions using a prediction model.
Nawana et al. (US 2015/0261922) discloses a system for surgical planning that can provide recommendations regarding surgical treatment.
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/A.K.V./Examiner, Art Unit 3682
/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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