DETAILED ACTION
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Response to Amendment
Applicant’s response to the last Office Action, filed on 02/06/2026 has been entered and made of record.
Rejection under 35 USC 112(b) is modified in view of amendments. See below.
Response to Arguments
Applicant's arguments filed on 02/06/2026 have been fully considered but they are not persuasive.
Rejection of independent claims has been updated to reflect claim amendments. Examiner finds that Itu teaches outputting, by the trained model, the complication information wherein the complication information includes a type of complication that is likely to occur and a use condition of a treatment device to be inserted into the lumen organ as an occurrence condition under which the complication of the type of complication is likely to occur; and (¶ 0029 and 0060 teach quantifying the risk under various occurrence conditions such as various types of blood vessel stenting procedures. Type of procedures/occurrence conditions are recommended and the associated risk is reported. ¶ 0056 and 0062-0065 teach outputting the reported complication information such as the risk and types of complications.)
Applicant remarks that Itu fails to teach “complication information wherein the complication information includes a type of complication that is likely to occur and a use condition of a treatment device to be inserted into the lumen organ as an occurrence condition under which the complication of the type of complication is likely to occur” but “merely disclosures discloses a recommendation for the treatment device rather than the use condition”. It is not clear to Examiner how Applicant is asserting the claims avoid the reference or are distinguish themselves other than by pointing out that the terminology is different. Examiner finds that the reference teachings meet the above-mentioned modifiers of the claim language and Applicant has not provided an explanation of how they differ, other than by stating that the language is different. The exact word does not need to appear in the reference.
Rejection under 35 USC 101 is updated in response to amendments as noted below. Regarding arguments directed to this rejection, Examiner notes that Applicant has provided an explanation of details found in this specification that are not necessarily present in the claims. For example, Examiner finds that Applicant has not provided persuasive arguments that the claims themselves are integrated into a practical application beyond generically recited computer elements that amount to simply implementing the abstract idea on a computer. In context of the 35 USC 101 analysis, the claims’ application of the abstract idea does not represent an improvement to the functioning of a computer or to any other technology or technical field. That is, the claims do not recite a technological solution to a technological problem. Examiner notes that claims 22 and 24 are not rejected under 35 USC 101.
Applicant argues the dependent claims are allowable by virtue of their dependence on allowable claims, but directs no independent arguments to these claims. Please see detailed response to arguments above.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture and 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 1-3, 6-16, 19-21 and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of assessing from a blood vessel image if a device insertion complication is likely. This idea could constitute a mental process, i.e., concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Under the 2019 Revised Patent Subject Matter Eligibility Guidance a multi-step analysis is used in order to evaluate eligibility.
Step 1: Examiner notes that the claim is directed to one of the statutory categories, ‘a process, machine, manufacture, or composition of matter’.
Step 2a – Prong One: Examiner notes that the claim does recite an abstract idea, in particular ‘assessing from a blood vessel image if a device insertion complication is likely’. This idea could constitute a mental process, i.e., concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Step 2a – Prong Two: Prong two is concerned with whether the claim recites additional elements that integrate the exception into a practical application, such that the claim is ‘more than a drafting effort designed to monopolize the exception’.
In the case of the independent claims, additional elements include a computer readable medium, a computer and the steps of acquiring images, outputting and displaying. In context of performing the identified abstract idea these elements represent insignificant extra-solution activity such that the abstract idea can be ‘applied’ on a generic computer as the tool to perform the abstract idea. Additional elements such as outputting complication type under a use condition are details of the abstract idea itself. Their application to the abstract idea does not represent an improvement to the functioning of a computer or to any other technology or technical field. That is, the claims do not recite a technological solution to a technological problem.
The dependent claims relate to outputting types and probabilities, and countermeasure information, assessing occurrence conditions, detecting regions, inputting certain modalities and updating the model. These are simply details of the abstract idea itself of assessing from a blood vessel image if a treatment complication is likely
Step 2b: Similarly to the analysis under step 2a – Prong Two the above claims are found ineligible as they are directed to a judicial exception that is not integrated into a practical application because generically recited computer elements do not add a meaningful limitation since they amount to simply implementing the abstract idea on a computer. These elements are recited at a high level of generality as performing generic computer functions routinely used in computer applications. The following were recognized by the courts as well-understood, routine or conventional computer functions: Performing computational steps on a computer, Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012), electronically extracting data from a sensor, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) and Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).. 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 § 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.
Claims 22 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims recite the term “the balloon catheter” but there is insufficient antecedent basis for this limitation in the claims.
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.
Claim(s) 1-3, 6-8 and 11-16, 19-21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itu (US PGPub 2021/0251577).
Regarding claim 1, Itu discloses a non-transitory computer-readable medium (CRM) storing computer program code executed by a computer processor that executes a process comprising (¶ 0086):
acquiring a medical image obtained by imaging a lumen organ of a patient before a percutaneous coronary intervention (PCI) treatment; (See ¶ 0027, 0050-0051 and Fig. 2 teach imaging a blood vessel during and before a blood vessel procedure to predict possible complications prior to a treatment.)
inputting the acquired medical image into a trained model that has learned to output complication information on a complication that is likely to occur after the treatment, (¶ 0027, 0031 and Fig. 3 teach inputting the acquired medical image into the trained neural network model. ¶ 0039 and Fig. 3 teach that the model is a machine-based risk prediction for complication, such as PMI (procedural myocardial infarction) that is likely to occur after treatment.
outputting, by the trained model, the complication information wherein the complication information includes a type of complication that is likely to occur and a use condition of a treatment device to be inserted into the lumen organ as an occurrence condition under which the complication of the type of complication is likely to occur; and (¶ 0029 and 0060 teach quantifying the risk under various occurrence conditions such as various types of blood vessel stenting procedures. Type of procedures/occurrence conditions are recommended and the associated risk is reported. ¶ 0056 and 0062-0065 teach outputting the reported complication information such as the risk and types of complications.)
displaying the complication information on a display screen. (¶ 0063-0065 teach displaying the complication information on a display screen.)
Itu does not expressly disclose that all of its above-cited teachings on PMI prediction are expressly disclosed as occurring in the same embodiment. That is, despite the reference being clear that these functions are disclosed, there is no express disclosure that the details are all found in the same embodiment. Instead, the reference presents some of the individual detailed disclosures as ‘according to some embodiments.’ It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the various teachings to provide a single system capable of the variety of tasks which are disclosed. In view of these teachings, this cannot be considered a non-obvious improvement over the prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 2, Itu discloses the computer-readable medium according to claim 1, further comprising: outputting the complication information that includes a type of the complication that is likely to occur and a probability value indicating an occurrence probability of the complication of the type. (¶ 0027, “The output 13 may be a PMI risk score at any given time point (pre-PCI, post-PCI, during PCI), indicating the risk of the patient to a suffer a PMI.”)
Regarding claim 3, Itu discloses the computer-readable medium according to claim 2, further comprising: outputting countermeasure information that indicates a countermeasure against the complication that is likely to occur according to the complication information. (¶ 0027, “indications for reducing the risk of PMI (e.g., preferred or suggested course of action) may be output 13 at any given time point relative to PCI.”)
Regarding claim 6, Itu discloses the computer-readable medium according to claim 5, wherein the lumen organ is a blood vessel, and further comprising: outputting an expansion condition of the blood vessel by the treatment device as the occurrence condition. (As above, see ¶ 0029 and 0060 which teach quantifying the risk under various procedures/occurrence conditions of blood vessel expansion via vessel stenting.)
Regarding claim 7, Itu discloses the computer-readable medium according to claim 1, further comprising: detecting a dangerous region in which a complication is likely to occur based on the medical image by using the trained model; and outputting a second medical image indicating the detected dangerous region. (See ¶ 0066 which teaches detecting the region and outputting an image with an overlay.)
Regarding claim 8, Itu discloses the computer-readable medium according to claim 1, further comprising: acquiring a tomographic image obtained by imaging inside of the lumen organ and a fluoroscopic image of inside of a body of the patient; and inputting the tomographic image and the fluoroscopic image into the trained model and outputting the complication information. (Fig 2 and ¶ 0046 inputting multiple imaging modes into a model to output complication information. ¶ 0046 and 0050 teaches that optical coherence tomography and intravascular tomography imaging such as intravascular ultrasound (IVUS) are used along with fluoroscopy.)
Regarding claim 11, the above combination discloses the computer-readable medium according to claim 1, further comprising: receiving correction input of the output complication information; and updating the trained model based on the medical image and the corrected complication information. (Itu teaches training the model via corrections to the complication information, see ground truth training at ¶ 0030 and re-training at ¶ 0038 and 0029.)
Regarding claim 12, the above combination discloses the computer-readable medium according to claim 1, wherein the medical image includes one or more of an ultrasound tomographic image, an optical coherence tomographic image, a fluoroscopic image, and a magnetic resonance imaging image of the lumen organ. (See rejection of claim 1. Examiner notes that the claimed list must be interpreted disjunctively in light of the specification, which is consistent with Fujifilm Corp. v. Motorola Mobility LLC, No. 12-CV-03587-WHO, 2015 WL 1265009 (N.D. Cal. Mar 19, 2015) which explained that, unlike the “’at least one of” phrase in SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870 (Fed. Cir. 2004), which concerned a list of categories of many possible values that users must choose, the list in the instant case involves modes of operation. As such, the phrase “one or more of” must be understood as “one or more of the following.”)
Regarding claim 21, the above combination discloses the computer-readable medium according to claim 1, further comprising: inputting the information on the treatment device into the trained model (see ¶ 0038 and 0029 as above) and wherein the treatment device is a balloon catheter. (¶ 0060)
Claim 13 is the apparatus claim corresponding the computer readable medium of claim 1. Itu ¶ 0079 teaches an apparatus and a processing server. Remaining limitations are rejected similarly. See detailed analysis above.
Claims 14-16, 19-20 and 23 are the method claims corresponding to the computer readable medium of claims 1-8. Remaining limitations are rejected similarly. See detailed analysis above.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itu (US PGPub 2021/0251577) in view of Bressloff (US PGPub 2017/0076014).
Regarding claim 9, Itu discloses the computer-readable medium according to claim 1, further comprising: acquiring transverse tomographic images along a longitudinal direction of the lumen organ and inputting the transverse tomographic images into the trained model and outputting the complication information. (¶ 0050 teaches using intravascular invasive imaging such as intravascular ultrasound (IVUS) extracted from the intravascular images (e.g., lumen and/or plaque related features) may be used.)
In the field of intravascular ultrasound imaging Bressloff teaches that said transverse tomographic images are a plurality of continuous images. (Bressloff teaches intravascular ultrasound imaging for the purpose of characterizing cardiac disease. ¶ 0111 that the tomographic ultrasound images are generated during a continuous pull-back starting distally to the disease, resulting in a plurality of images. See also Fig. 5 and ¶ 0131.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Itu’s intravascular ultrasound imaging with Bressloff’s intravascular ultrasound imaging. Itu teaches intravascular tomography imaging such as intravascular ultrasound (IVUS) but does not expressly disclose that multiple of the intravascular images are input are used. Itu does teach in other contexts inputting multiple of the images into the model. Bressloff teaches intravascular ultrasound imaging and discloses a plurality of continuous images and analyzing them for disease. The combination constitutes the repeatable and predictable result of simply applying Bressloff’s teaching for acquiring multiple images. This cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 10, the above combination discloses the computer-readable medium according to claim 9, further comprising: detecting the dangerous region in which the complication is likely to occur from each of the plurality of transverse tomographic images by using the trained model; and generating a vertical tomographic image indicating the dangerous region based on a detection result of the dangerous region in each of the plurality of transverse tomographic images. (Itu ¶ 0031, 0051 and 0066 which teaches detecting the lesion region and outputting an image with an overlay. Bressloff teaches intravascular ultrasound imaging for the purpose of characterizing cardiac disease and teaches detecting the dangerous regions and generating a vertical tomographic image indicating the dangerous region at Fig. 2b-2e and ¶ 0118-0122.)
Claim(s) 22 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Itu (US PGPub 2021/0251577 ) in view of Fox (US PGPub 2017/0035514).
Regarding claim 22, Itu discloses the computer-readable medium according to claim 1, including that the treatment device is a balloon catheter (¶ 0060) but not the remaining limitations.
In the field of catheterization procedure guidance Fox what Itu does not expressly disclose, namely, teaches that the use condition includes at least one of an inflated diameter, an inflated pressure, and an inflated time of a balloon of the balloon catheter. (Fox teaches a decision support system that facilitates clinical decisions during a catheterization procedure. ¶ 0026 teach identifying an inflation pressure.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Itu’s catheterization procedure guidance with Fox’s catheterization procedure guidance. Itu teaches catheterization procedure guidance such as recommending the type of stent, whether to use a balloon and other parameters but does not expressly disclose recommending the inflation pressure of the balloon. In the field of catheterization procedure guidance Fox teaches recommending the inflation pressure of the balloon. The combination constitutes the repeatable and predictable result of simply applying Fox’s teaching here. This cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Claim 24 is the method claim corresponding to the computer readable medium of claim 22. Remaining limitations are rejected similarly. See detailed analysis above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Raphael Schwartz whose telephone number is (571)270-3822. The examiner can normally be reached Monday to Friday 9am-5pm CT.
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/RAPHAEL SCHWARTZ/ Examiner, Art Unit 2671