DETAILED ACTION
Status of Claims
This is the first office action on the merits in response to the application filed on 17 September 2025.
Claim(s) 1-10 are currently pending and have been examined.
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
This application claims priority of JP Application No. 2024-170825 filed on 30 September 2024. Applicant’s claim for the benefit of this prior filed application is acknowledged.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 10, which is representative of claim 1, recites a medical information processing method
specifying, in each of the images, a target organ region where the target organ is depicted;
specifying, in each of the images, a device region where a device attached to the target organ is depicted; and
specifying, based on the target organ region and the device region, an index relating to a state of the target organ to which the device is attached, the index being specified from change in a relative position of the device with respect to the target organ in a specific attention direction.
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of evaluating an image of a device attached to an organ. This concept describes a mental process that a cardiologist should follow to evaluate a mitral valve repair similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the managing personal behavior or relationships or interactions between people sub-grouping of methods of organizing human activity. As such, these limitation set forth a method of organizing human activity. Alternatively, this concept is analogous to the examples of “observation”, “evaluation”, “judgement”, and “opinion” given in MPEP 2106.04(a)(2)(III). Further, this concept as claimed does not require a scale of data beyond the mental faculties of a human being and the operations of the abstract idea can be practically performed in the human mind. As such, these limitations are determined to recite a mental process. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 1 recites the additional element of processing circuitry. Claim 10 describes the method as implemented by a computer. These additional elements are recited at an extremely high level of generality and are interpreted as generic computing devices used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application.
The claims further recite an additional element of acquiring a plurality of images of a target organ captured in time series. This additional element does not impose any meaningful limitation on the claims and instead amounts to necessary data gathering. Therefore this additional element is considered insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea and extra-solution activity to a technological environment of a computer device. As such, combination of additional elements does not integrate the abstract idea into a practical application. Thus the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more.
As previously noted, the claims recite an additional element of acquiring a plurality of images of a target organ captured in time series. This additional element does not impose any meaningful limitation on the claims and instead amounts to necessary data gathering. Therefore this additional element is considered insignificant extra-solution activity. As such, this additional element does not amount to significantly more.
There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea and extra-solution activity to a technological environment of a computer device. As such, combination of additional elements does not amount to significantly more. Therefore, when considered individually and as a combination, the additional elements of the independent claims do not amount to significantly more than the abstract idea. Thus the independent claims are not patent eligible.
Claims 2-9 further narrow the abstract idea, but the claims continue to recite an abstract idea. Claims 2-5 and 7-9 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the abstract idea of these claims into a practical application for the same reasons given above. As such, claims 2-5 and 7-9 are determined to be directed to an abstract idea. At step 2B, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the abstract idea for the same reasons given above. Claim 6 recites the additional element of a display. This additional element only generally links the abstract idea to a technological environment of a computing device. Thus, this additional element does not integrate the abstract idea into a practical application. When considered in combination, the additional elements only generally link the abstract idea and extra-solution activity to a technological environment of a computer device. As such, combination of additional elements does not integrate the abstract idea into a practical application. As such, claim 6 is determined to be directed to an abstract idea. At Step 2B, Yabe et al. (US 2004/0252118 A1) demonstrates (“conventional data display devices” [0004]) that displays were conventional long before the claimed invention. Thus this additional element does not amount to significantly more. When considered as a combination, the additional elements only generally link the abstract idea and extra-solution activity to a technological environment of a computer device. As such, combination of additional elements does not amount to significantly more. Because the dependent claims remain directed to an abstract idea without reciting significantly more, the dependent claims are not patent eligible.
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 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 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Vaan et al. (US 2020/0082531 A1) [hereafter referenced as Vaan] in view of Scutaru et al. (US 10297027 B2).
Regarding Claims 1 and 10: Vaan discloses a medical information processing apparatus comprising processing circuitry (See at least [0118]) configured to:
acquire a plurality of images of a target organ captured in time series (As described in step 101 of FIG. 4, a contrast enhanced 4D (3D+time) CT dataset is obtained. The 4D CT dataset can be obtained from a database or acquired directly from a CT imaging modality. See at least [0071]).
specify, in each of the images, a target organ region where the target organ is depicted (Within step 103 of FIG. 4, the object of interest needs to be segmented in one of the heart phases within the obtained 4D CT dataset. See at least [0072]);
specify, in each of the images, a region attached to the target organ is depicted (the anteroposterior (AP) diameter can be extracted from the 3D annulus contour within each phase based on the result of step 104 of FIG. 4. The AP diameter is defined as the distance between the most anterior and the most posterior point of the mitral annulus through the center of the mitral annulus as can be seen in FIG. 1, 101. See at least [0098]); and
specify, based on the target organ region and the region, an index relating to a state of the target organ, the index being specified from change in a relative position with respect to the target organ in a specific attention direction (dynamic analysis can be performed as described in step 105 of FIG. 4. To provide as much information as possible to the clinician, several parameters regarding annulus anatomy and geometry and geometry deformation can be taken into account. See at least [0097]. Also: For instance, the anteroposterior (AP) diameter can be extracted from the 3D annulus contour within each phase based on the result of step 104 of FIG. 4. The AP diameter is defined as the distance between the most anterior and the most posterior point of the mitral annulus through the center of the mitral annulus as can be seen in FIG. 1, 101. See at least [0098]. Also: During the cardiac cycle in healthy subjects the AP diameter has a saddle shaped response and is at its minimum when the mitral valve closes (end systole). However, for patients suffering from ischemia or myxomatous the AP diameter response during the cardiac cycle can differ. In ischemic patients the AP diameter response is flatter due to less motion and contraction. See at least [0099] and Fig. 9). Vaan separately discloses a device (mitral valve replacement devices [0004]) but does not contemplate analyzing the device location.
Scutaru teaches specify, in the image, a device region where the device is attached to the target organ (Intra-operative imaging is used to guide the mitral repair procedure. See at least Column 1, Lines 43-44. Also: Any landmark or ensembles of landmarks, representing arbitrary structures. such as organs and medical devices or implants, may be detected or manually placed and tracked for imaging and/or quantification and intraoperative guidance. Anatomy or landmarks may be detected and tracked for real-time visualization as an overlay on other types of images, such as overlaying an organ model or landmarks based on real-time detection on a fluoroscopy image showing a catheter or other device interacting with the organ. See at least Column 18, Lines 34-43).
Vaan describes a system which uses organ imaging and identifying and organ and points of the organ to assess the organ, which differs by the substitution of the claimed invention’s identifying of points of a device attached to an organ. However, Scutaru demonstrates that the prior art already knew of identifying points of a device attached to an organ. One of ordinary skill in the art could have easily substituted the device identifying techniques of Scutaru into the system of Vaan. Further, one of ordinary skill in the art would have recognized that such an application of Scutaru would have resulted in a system which would assess the organ based on motion analysis of the organ and a device attached to the organ. As such, the identified substitution and the claimed invention would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Vaan and the teachings of Scutaru.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over de Vaan et al. (US 2020/0082531 A1) [hereafter referenced as Vaan] in view of Scutaru et al. (US 10297027 B2), and further in view of Karlapudi et al. (US 2024/0173134 A1).
Regarding Claim 9: Vaan in view of Scutaru makes obvious the above limitations. Vaan further discloses wherein the target organ is a mitral valve of the heart (A pre-operative analysis of the mitral valve (consisting of the annulus, leaflets and the like) and surrounding structures, such as for instance the left ventricle outflow tract, based on information obtained from CT datasets is valuable for clinicians as it helps the clinician to better understand the complex structure of the mitral valve as shown in FIG. 1. See at least [0005]). The limitation that the index is a numerical value indirectly indicating tension of the mitral valve in a state of being gripped by the device is considered non-functional descriptive material. However, Vaan does not expressly disclose that the device serves to grip tip ends of an anterior leaflet and a posterior leaflet of the mitral valve. Karlapudi et al. discloses a device that serves to grip tip ends of an anterior leaflet and a posterior leaflet of the mitral valve (The mitral valve leaflets may be repaired by creating an artificial “edge-to-edge” connection which may produce a double-orifice configuration to help improve valve coaptation or closure of the leaflets, reduce the backflow of blood, and improve overall valve function. [0003]).
Vaan and Scutaru suggest a system which assesses placement of mitral valve repair devices, which differ from the claim invention by the substitution of Vaan and Scutaru’s devices for a leaflet gripping device. However, Karlapudi demonstrates that the prior art already knew of mitral valve repair devices that use a leaflet gripping technique. One of ordinary skill in the art could have trivially substituted Karlapudi’s device into the system of Vaan and Scutaru. Further, one of ordinary skill in the art would have recognized that such a substitution would have predictably resulted in a system which would assess the motion of such leaflet gripping devices. As such, the identified substitution and the claimed invention would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Vaan and the teachings of Scutaru and Karlapudi.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 Notice of References Cited.
Wei et al. (US 2023/0009891 A1) generally describes using imaging to support the placement of transcatheter mitral valve repair devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/ Primary Examiner, Art Unit 3685 2026-07-24
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