DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-20, as filed 01/06/2026, are currently pending and have been considered below.
Priority is generally acknowledged as shown on the filing receipt with the earliest date being 04/07/2022.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon and the rationale supporting the rejection would be the same under either status.
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 non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter 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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
Claim 1. A medical system comprising: a memory; and processing circuitry communicatively coupled to the memory, the processing circuitry being configured to: (additional element – generally applying the abstract idea with a computer)
receive first imaging data, the first imaging data captured by one or more image sensors during a first cardiac catheterization medical procedure, the first cardiac catheterization medical procedure associated with a first clinician; (additional element – generally linking to a technical field)
execute at least one computer vision model to identify a second cardiac catheterization medical procedure of a plurality of cardiac catheterization medical procedures stored in the memory, wherein the second cardiac catheterization medical procedure is associated with a second clinician, wherein to identify the second cardiac catheterization medical procedure, the processing circuitry is configured identify and select a single cardiac catheterization medical procedure from the plurality of cardiac catheterization medical procedures stored in the memory which includes a most similar lesion to a lesion of the first imaging data based on one or more lesion characteristics as the second cardiac catheterization medical procedure; (mental process. The machine vision is recited at such a high level that it encompasses object identification techniques that a human technician could perform mentally.)
output, for display, a comparison of at least one of lesions, treatment techniques, or treatment strategies between the first cardiac catheterization medical procedure and the second cardiac catheterization medical procedure, the comparison comprising a representation of the first imaging data and a second representation of imaging data from the second cardiac catheterization medical procedure. (additional element – generally applying the abstract idea with a computer)
Claims 1-11 are analyzed in particular, but the same logic applies to the other claims.
Step 2A Prong One
These steps, as drafted, under the broadest reasonable interpretation, include mental processes. Machine vision, recited at such a high level as the claims, includes mental steps such as identifying, comparing, and analyzing information that are performable in the human mind. Other than reciting generic computer terms like memory and processing circuitry. Nothing in the claims precludes the italicized portions from practically being performed in the mind.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, claims 2-5 recites additional details of the steps that can be performed mentally such as finding similar cases. Claims 7-9 recite further mental processes such as filtering data based on various characteristics but for recitation of generic computer components.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, processing circuitry performing steps amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0097], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, receiving cardiac catheterization data amounts to mere data gathering and selecting a particular data source or type of data to be manipulated, see MPEP 2106.05(g))
generally link the abstract idea to a particular technological environment or field of use such as receiving imaging data from one or more image sensors during a first cardiac catheterization medical procedure, see MPEP 2106.05(h))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claims 6 and 10-11 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea such as displaying processed data. Claim recites additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering and output. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields. For example, amounts to receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-9 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fox (US20170035514A1) in view of Kondo (US20150317434A1).
Regarding claim 1, Fox discloses: A medical system comprising: a memory; and processing circuitry communicatively coupled to the memory, the processing circuitry (“server 204 may be running instances of software applications 210 for performing computing processes on the intervention data stored in the intervention case history database 208,” [0030]) being configured to:
--receive first imaging data, the first imaging data captured by one or more image sensors during a first cardiac catheterization medical procedure, the first cardiac catheterization medical procedure associated with a first clinician (“Referring to FIG. 4, a flowchart of a method to transmit current intervention data from a client device to a server device is shown in accordance with an embodiment. In an embodiment, a catheterization procedure may be performed in catheterization lab 100 to treat a cardiovascular condition of a patient,” [0035]);
--execute at least one computer vision model to identify a second cardiac catheterization medical procedure of a plurality of cardiac catheterization medical procedures stored in the memory, (“The decision support system may incorporate computational models and predictive analytics to identify a treatment approach for a given patient and anatomy to result in a predicted favorable clinical outcome,” [0026]; “For example, server 204 may be running an instance of an image analysis software application or software module 212 for performing image registration, thresholding, pattern recognition, digital geometry, or other processing of image data stored in intervention case history database 208. The image analysis may generate additional intervention data, e.g., anatomical data or device delivery data representative of the catheterization procedure.,” [0030]);
--wherein the second cardiac catheterization medical procedure is associated with a second clinician (“determining the similarity between the current catheterization procedure and a subset of the past catheterization procedures includes identifying matching data values of historical intervention data 902 and current intervention data 904 in intervention case history database 20,” [0072]; the historical images are interpreted as being from second and other clinicians),
--wherein to identify the second cardiac catheterization medical procedure, the processing circuitry is configured identify and select a single cardiac catheterization medical procedure from the plurality of cardiac catheterization medical procedures stored in the memory which includes (retrieving and displaying a subset of similar images for analysis in [0072]); and
--output, for display, a comparison of at least one of lesions, treatment techniques, or treatment strategies between the first cardiac catheterization medical procedure and the second cardiac catheterization medical procedure, the comparison comprising a representation of the first imaging data and a representation of second imaging data from the second cardiac catheterization medical procedure (“the similarity between the current catheterization procedure and the subset of past catheterization procedures may be determined based on the similarity scores,” [0009]; “Decision support data may include a portion of historical intervention data 902 records corresponding to the subset of past catheterization procedures having the similarity to the current catheterization procedures,” [0076]; 1102 and 1104 in FIG. 11).
Fox does not expressly disclose but Kondo teaches: narrowing the plural received cases down to a single most similar case and displaying it side-by-side with the current image (“narrows down a similar medical image to be referred to from a plurality of similar medical images displayed in a thumbnail view in the second display region. Subsequently, the similar medical image eventually selected as a reference image can be moved to the first display region in which a medical image that is a diagnostic interpretation object is displayed,” [0110]; “in addition to displaying the medical image that is the diagnostic interpretation object, the first display region displays the first similar medical image selected as the final candidate so as to be adjacent to the medical image and displays the first similar medical image and the medical image as a group,” [0113]; [0076]; FIG. 11).
One of ordinary skill in the art before the effective filing date would have been motivated to expand Fox’s decision support during catheterization procedures to include the similar image display techniques of Kondo because this would improve treatments by improving clinical judgements (Kondo [0117]).
Additionally, it can be seen that each element is taught by either Fox or Kondo. Kondo’s image matching and display techniques does not affect the normal functioning of the elements of the claim which are taught by Fox. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Fox with the teachings of Kondo since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 2, Fox discloses: wherein the second cardiac catheterization medical procedure includes a similar patient condition as the first cardiac catheterization medical procedure, and to execute the computer vision model, the processing circuitry is configured to use propensity matching (interpreted according to specification [0073]: The classification of the lesion may be such that lesions having a large degree of similarity are classified the same or close to each other, which in some examples may be called "propensity matching.") to find the second cardiac catheterization medical procedure in the memory (“analysis of the historical and current intervention data may be performed to identify past catheterization procedures having a similarity to the current catheterization procedure. The similar past catheterization procedures may represent a subset of the entire group of past catheterization procedures, and historical intervention data representative of the subset may be transmitted as decision support data that identifies options for next procedural steps and indicates likely clinical outcomes associated with the steps,” [0006]; similarity scoring in [0009]).
Regarding claim 3, Fox discloses: wherein the processing circuitry is configured to: perform propensity matching by comparing the first imaging data to imaging data of each of the plurality of cardiac catheterization medical procedures stored in the memory (“analysis of the historical and current intervention data may be performed to identify past catheterization procedures having a similarity to the current catheterization procedure. The similar past catheterization procedures may represent a subset of the entire group of past catheterization procedures, and historical intervention data representative of the subset may be transmitted as decision support data that identifies options for next procedural steps and indicates likely clinical outcomes associated with the steps,” [0006]; “Determining the similarity between the current catheterization procedure and the subset of past catheterization procedures may be based on matching one or more data values of the historical intervention data, the current intervention data, and the additional intervention data,” [0009]; similarity matching in [0071]-[0074]).
Regarding claim 4, Fox discloses: wherein the processing circuitry is configured to perform propensity matching by comparing the one or more lesion characteristics of the lesion of the first imaging data with the one or more lesion characteristics of a lesion of the imaging data of each of the plurality of cardiac catheterization medical procedures stored in the memory (historical intervention data includes lesion type in [0072]-[0074] and FIG. 9; “referring again to FIG. 9, it will be seen that the historical intervention data 902 record corresponding to UCI number “20140813B15” includes historical intervention data 902 with some values matching corresponding values of current intervention data 904 record (see matching values of patient data (age and sex), anatomical data (diameter and lesion type), and device data (device type and device size)),” [0072]; “At operation 812, after determining a subset of the historical intervention data 902 records having the similarity to the current intervention data 904 record (which in the above example includes the historical intervention data 902 record corresponding to UCI number “20140813B15”), decision support data may be transmitted from server 204 to client 202…help an operator select the most appropriate size and characteristics of a subsequent implant device or accessory device, as well as next procedural steps to achieve the same historical outcomes,” [0076]; receiving and displaying past similar procedures in FIG. 11).
Regarding claim 5, Fox discloses: wherein the one or more lesion characteristics include at least one of a lesion length, shape, geometry, location, degree, vessel take-off angle, or degree of calcification (“Derived historical anatomical data may include information such as dimensions of the target anatomical site, the degree, eccentricity, and length of calcification at the anatomical site, or the presence of multi-vessel disease,” [0056]; “As an example, in an embodiment in which intervention case history database 208 includes data values for the following data types, the data types may have the percentage importance indicated in respective parentheses: patient-specific history (5%), access site (5%), vessel location (10%), vessel diameter (15%), lesion length (5%), degree of tortuosity (10%), degree of calcification (10%), bifurcation/side-branch involvement (5%), degree of stenosis (5%), details of lesion preparation (15%), and degree of scaffold malapposition (15%),” [0074]).
Regarding claim 6, Fox discloses: wherein the processing circuitry is further configured to: (“Decision support data may be filtered and/or focused by stratifying the historical database records that are used in the determination of decision support data. More particularly, the portion of the historical database being used to drive the comparison of past and present data to produce decision support data may be a subset of the overall historical data set. For example, only data for a particular site, e.g., a particular hospital, or a particular subset of operators, e.g., high-volume operators who provide more than 300 PCI procedures per year or more than 50 heart valve clip implantation procedures per year, may be used in the data analysis. Such stratification of the historical data may be used to improve the relevancy of the decision support data that is generated by the decision support tool, and may be refined through an iterative approach.”; operator 404 filters similar cases via selections made in [0039-[0042]).
Fox does not expressly disclose that the filtering (i.e., similarity or stratification) is driven by a clinician’s option on a user interface, but Kondo teaches a clinician making selections to change the display (“similar cases displayed in the case display region 710 can be narrowed down by a disease name displayed in the disease name list display region 730 or by a lesion distribution displayed in the distribution list display region 750,” [0247]).
The motivation to combine is the same as in claim 1.
Regarding claim 7, Fox discloses: wherein, to present the clinician an option to filter the plurality of cardiac catheterization medical procedures stored in the memory, the processing circuitry is configured to present a clinician an option to filter (this filtering limitation is taught by Li as described above in the rejection of claim 6) by one or more of a patient characteristic, a patient condition, a medical tool or equipment used during a cardiac catheterization medical procedure, an operating clinician, a treatment or class of treatments used, a hospital type, a sequence of tools or treatments used, or a length of procedure (“only data for a particular site, e.g., a particular hospital, or a particular subset of operators, e.g., high-volume operators who provide more than 300 PCI procedures per year or more than 50 heart valve clip implantation procedures per year, may be used in the data analysis. Such stratification of the historical data may be used to improve the relevancy of the decision support data that is generated by the decision support tool, and may be refined through an iterative approach,” [0086]).
Regarding claim 8, Fox discloses: wherein the patient characteristic includes at least one of a patient age, height, weight, sex, disease, or diagnosis (“Patient data may include age, sex, medical history data (including information about symptoms and/or underlying conditions and diagnostic data), or medication data (including information about types of medications prescribed, amount per time period prescribed, and other prescription information), as shown,” [0040]).
Regarding claim 9, Fox discloses: wherein the medical tool or equipment used includes one or more of a catheter size or geometry (“Device data may include dimensional characteristics of the device, e.g., a nominal device size such as a nominal deployment length or diameter of the device as specified by the manufacturer,” [0042]; “Device data may include a type of device (including device genus information, e.g., “stent”, and device species information, e.g., “bioabsorbable”), device size (including specified deployment size and length), and a target anatomy for the device, such as a specific coronary vessel or other well-defined anatomical location, as shown,” [0043]; device type and size in FIG. 9).
Claims 12-19 and 20 are substantially similar to claims 1-8 and 1 (respectively) and are rejected with the same reasoning.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fox (US20170035514A1) in view of Kondo (US20150317434A1) and Andersen (Andersen DS, Cabrera ME, Rojas-Muñoz EJ, Popescu VS, Gonzalez GT, Mullis B, Marley S, Zarzaur BL, Wachs JP. Augmented Reality Future Step Visualization for Robust Surgical Telementoring. Simul Healthc. 2019 Feb;14(1):59-66).
Regarding claim 10, Fox discloses: wherein the imaging data from the first cardiac catheterization medical procedure is video data (“That is, captured images may include captured video, i.e., a time series of individual images, and thus, video may be stored for processing. More particularly, object recognition techniques may be employed to identify a moving object, e.g., an implanted clip during a cardiac cycle will move, and to make measurements of the object,” [0068]).
Fox does not expressly disclose but Andersen teaches: the second cardiac catheterization medical procedure is stored in the memory as video data, and the processing circuitry is configured to cause a display to overlay the video data from the second cardiac catheterization medical procedure over the video data from the first cardiac catheterization medical procedure (“When using the telementoring system, the trainee can select each pregenerated video clip from the knowledge base to be automatically overlaid onto the live video frames of the trainee's operating field. The video clips appear as semitransparent overlays on the tablet screen, so the trainee can see their own hands and surgical instruments and also those of the expert mentor as the expert performs that step of the procedure,” page 6).
One of ordinary skill in the art would have been motivated to expand Fox and Kondo’s decision support during catheterization with case stratification to include Andersen’s video overlay because this guidance would help users more effectively conduct their imaging exams (Andersen page 5).
Additionally, it can be seen that each element is taught by either Fox, Kondo, or Andersen. Andersen’s guidance videos do not affect the normal functioning of the elements of the claim which are taught by Fox. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Andersen with the teachings of Fox since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fox (US20170035514A1) in view of Kondo (US20150317434A1) and Ninh (US20210378484A1).
Regarding claim 11, Fox discloses: wherein the imaging data from the first cardiac catheterization medical procedure is video data, the second cardiac catheterization medical procedure is stored in the memory as video data (“That is, captured images may include captured video, i.e., a time series of individual images, and thus, video may be stored for processing. More particularly, object recognition techniques may be employed to identify a moving object, e.g., an implanted clip during a cardiac cycle will move, and to make measurements of the object,” [0068]).
Fox does not expressly disclose, but Ninh teaches: the processing circuitry is configured to cause a display to display the video data from the second cardiac catheterization medical procedure adjacent to the video data from the first cardiac catheterization medical procedure (“Real-time overlay on the endoscope video image displayed on monitor 102 (illustratively includes bounding box 103 a) informs the endoscopist of color or textural changes in the mucosal surface that require closer examination. Additional textual information,” [0051]).
One of ordinary skill in the art would have been motivated to expand Fox and Kondo’s decision support during catheterization with case stratification to include Ninh’s adjacent display of guidance because it would assist the clinician in maneuvering the imaging apparatus and thus “improve examination quality” (Ninh [0001]).
Additionally, it can be seen that each element is taught by either Fox, Kondo, or Ninh. Ninh’s guidance videos do not affect the normal functioning of the elements of the claim which are taught by Fox. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Ninh with the teachings of Fox since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Response to arguments
Applicant's arguments filed 01/06/2026 have been fully considered and are discussed below.
Regarding the subject matter ineligibility rejections, Applicant argues that the claimed invention amounts to a technical solution to a technical problem. Remarks pages 8-9. Applicant further argues that the claimed invention does not merely use computers as tools but provides targeted clinician feedback. Remarks pages 10-11. These arguments are not persuasive because the technical solution or practical application analysis requires more than beneficial uses of the claimed invention. That the claimed decision support “provide[s] desirable learning and education benefits which may upskill a clinician and better prepare them to perform an upcoming procedure” (specification [0010] is not sufficient because these benefits flow from the abstract idea itself rather from any particular technology. See MPEP 2160.05. A person sitting next to the clinician and suggesting similar cases could in theory provide the same learning and education benefits. In other words, the claimed invention purports to improve human activity (i.e., clinical education and decision support), not a computer or other technology.
Applicant further argues that the claimed invention amounts to a particular technical means, not the idea of a solution. Remarks pages 10-11. This is not persuasive because the claimed invention does not require a particular solution. Instead, it merely requires a particular outcome (i.e., displaying a comparison) with no particular means to achieve the outcome.
Regarding the prior art rejections, Applicant’s arguments are moot in view of the new combinations including Kondo.
Conclusion
Prior art made of record but not relied upon for any rejection includes Oosawa (“Development of “SYNAPSE” Case Match”). This article describes a case similarity system that matches lesions with reference images.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office Action (See MPEP 706.07(a)). Accordingly, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624