DETAILED ACTION
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 .
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 not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea, without significantly more.
Step 1
The claimed inventions in claims 1-20 are directed to statutory subject matter as the claim(s) recite(s) a method and system of enhancing and analyzing ultrasound images.
Step 2A, Prong One
Claims 1 and 10 recite the following steps or instructions for “receive(ing) ultrasound images…”, “generate(ing) enhanced echo images…”, and “determine(ing) a major adverse cardiac event risk…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) and/or mathematical concept in MPEP 2106.04(a)(2)(I). These limitations concern data collection, modifying that data, and analyzing the modified data, directed to mental processes of performing concepts in a human mind or by a human using a pen and paper and mathematical concepts. For example, these limitations are nothing more than a professional receiving previously acquired ultrasound data, modifying those echo images based on a model, and analyzing the resultant image for signs of a cardiac event risk. Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claims 1 and 10 recite additional elements of “a handheld echocardiography device” and claim 1 further recites “processing circuitry comprising a processor and memory”.
Step 2A, Prong Two
The above-identified abstract idea in each of independent Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1 and 10), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional elements of: “processing circuitry comprising a processor and memory” are generically recited computer elements in independent Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and using mathematical concepts) using rules (e.g., computer instructions) executed by a computer (e.g., “processing circuitry comprising a processor and memory” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claims 1 and 10 do not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
These claims require the additional elements of: “processing circuitry comprising a processor and memory”. These additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification: a “handheld echocardiography device” is described in the disclosure as a component that is generic and conventionally used and known in the art, as exhibited by the known value and use in an article dating back to 206 (published application ¶¶ 23). Accordingly, in light of Applicant’s specification, a “handheld echocardiography device” and its function are considered well-understood routine and conventional in the art, performing presolution activities that are merely data gathering steps for the abstract idea in Claim 1.
Additionally, the claimed term “processing circuitry comprising a processor and memory” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “processing circuitry comprising a processor and memory”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system and methods of Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 and 10 (and their respective dependent claims 2-9 and 11-20) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al. (US 2021/0374947; hereinafter “Shin”).
Regarding claim 1, Shin discloses a system, comprising: a handheld echocardiography device configured to generate ultrasound (US) images of a patient (e.g. ¶¶ 568 – handheld scanner #4002 in Fig. 40A); and processing circuitry comprising a processor and memory, the processing circuitry configured to: receive the US images from the handheld echocardiography device (e.g. ¶¶ 568); generate enhanced echo images from the US images using a generative adversarial network (GAN) model (e.g. ¶¶ 569); and determine a major adverse cardiac event (MACE) risk for the patient based upon the enhanced echo images (e.g. ¶¶ 569 – “an image file generated during reconstruction 4006 may be used during detection 4008 to identify anomalies, objects, features, etc. In at least one embodiment, detection 4008 application may leverage an inference engine 4016 (e.g., as one of AI service(s) 3818) to perform inference on data to generate detections.”; ¶¶ 533 – “heart attack detection (e.g., in real-sparse time)”).
Regarding claim 10, Shin teaches a method, comprising: receiving ultrasound (US) images of a patient obtained with a handheld echocardiography device (e.g. ¶¶ 568 – handheld scanner #4002 in Fig. 40A); generating enhanced echo images from the US images using a generative adversarial network (GAN) model (e.g. ¶¶ 569); and determining a major adverse cardiac event (MACE) risk for the patient based upon the enhanced echo images (e.g. ¶¶ 569 – “an image file generated during reconstruction 4006 may be used during detection 4008 to identify anomalies, objects, features, etc. In at least one embodiment, detection 4008 application may leverage an inference engine 4016 (e.g., as one of AI service(s) 3818) to perform inference on data to generate detections.”; ¶¶ 533 – “heart attack detection (e.g., in real-time)”).
Regarding claim 11, Shin discloses the US images are received from the handheld echocardiography device (e.g. ¶¶ 568).
Regarding claims 2 and 12, Shin discloses the GAN model comprises a sparse skip connection U-Net model (e.g. ¶¶ 84, 102, etc.).
Regarding claims 3 and 13, Shin discloses the sparse skip connection U-Net model combines an encoder-decoder model and a U-Net model (e.g. ¶¶ 84 – “bidirectional encoder representations”; ¶¶ 102 – “modified 3D U-Net 404 comprise skip-connections” and “two decoder 412 layers”).
Regarding claims 4 and 14, Shin discloses the enhanced echo images comprise an apical four-chamber (A4C) view, an apical two chamber (A2C) view, a parasternal long-axis (PLAX) view and a parasternal short-axis (PSAX) view (e.g. ¶¶ 477).
Regarding claims 5 and 15, Shin discloses the MACE risk determination comprises: extracting features from the enhanced echo images; analyzing phenotypes based at least in part upon the extracted features; and predicting risk of the MACE using a machine learning model (e.g. ¶¶ 565 – “…real-time or near real-time processing may be particularly useful where a virtual instrument supports an ultrasound device or other imaging modality where immediate visualizations are expected or required for accurate diagnoses and analyses. In at least one embodiment, a cloud-computing architecture may be capable of dynamic bursting to a cloud computing service provider, or other compute cluster, when local demand exceeds on-premise capacity or capability. In at least one embodiment, a cloud architecture, when implemented, may be tuned for training neural networks or other machine learning models, as described herein with respect to training system 3704. In at least one embodiment, with training pipelines in place, machine learning models may be continuously learn and improve as they process additional data from devices they support. In at least one embodiment, virtual instruments may be continually improved using additional data, new data, existing machine learning models, and/or new or updated machine learning models”).
Regarding claims 6 and 16, Shin discloses the phenotype analysis comprises patient similarity analysis using topological data analysis (TDA) (e.g. ¶¶ 561 – “organ segmentation 3910 application and/or container may leverage AI services 3818 to perform inference on a normalized image, and AI services 3818 may leverage hardware 3722 (e.g., AI system 3824) to execute AI services 3818. In at least one embodiment, a result of an inference may be a mask file (e.g., as illustrated in visualization 3916C) that may be stored in a cache (or other storage device).”).
Regarding claims 7 and 17, Shin discloses the predicted risk is based upon the patient similarity analysis and clinical information associated with the patient (e.g. ¶¶ 478 – “configured to accelerate deep learning systems and applications including following non-limiting examples: autonomous vehicle platforms, deep learning, high-accuracy speech, image, text recognition systems, intelligent video analytics, molecular simulations, drug discovery, disease diagnosis”).
Regarding claims 8 and 18, Shin discloses extracting features of the enhanced echo images comprises: identifying end-systolic (ES) and end-diastolic (ED) frames from the enhanced echo images and selecting regions of interest (ROIs) from the identified ED/ES frames; and performing texture-based analysis (radiomics) and speckle tracking for phenotyping heterogeneous presentation (e.g. ¶¶ 477).
Allowable Subject Matter
Claims 9, 19, and 20 avoid the prior art of record, but remain rejected under 101, as indicated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796