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 .
Claims 1-1,13 are pending in the application. Claims 1-11,13 are rejected herein. In the amendment received 29 April 2026 the following occurred: claim 13 was newly added and claims 1,9,10,11 were amended.
Distinguishing Prior Art
Claim 1,9,10,11 are distinguished above the prior art because they resolve the specific way in which a first and second medical image with associated target sites must be easily visible by an examination order. The dependent claims, including claims 2,3,4,5,6,7,8 are subject matter free of prior art due to their basis of dependency on the independent claims.
Claim 8 is also distinguished above the prior art because the prior art does not teach when it is analyzed that the second target site has a disease, the processing circuitry causes the display unit to display the second medical image including the second target site having the disease and the second medical image including the second target site analyzed as disease-free in the second target site in the past side by side.
Priority
This application claims priority to application JP 2022-063965, the effective priority date is 20 April 2022.
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 1-11,13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1: The Statutory Categories
Claims 1,9,10,11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite medical information processing systems, a non-transitory computer-readable storage medium and a medical information processing method. All are within a statutory class for subject matter eligibility purposes.
Step 2A Prong One: The Abstract Idea
The limitations of (claim 10 being representative): generating medical images of a patient by imaging the patient […]; obtaining a medical image […] according to an examination order; generating first medical image including a first target site specified by the examination order on the basis of the medical image; analyzing a second target site that is different from the first target site and is not specified by the examination order on the basis of the medical image; generating a second medical image including the second target site on the basis of an analysis result of the second target site; and […] displaying at least the second medical image between the first medical image and the second medical image as part of an […] medical record, where the first medical image is a medical image in which the first target site is more easily visible by an orderer of the examination order than other sites, including the target site, and wherein the second medical image is a medical image in which the second target site is more easily visible by the orderer than other sites, including the first target site as drafted is a process that, under the broadest reasonable interpretation, covers a mental process but for the recitation of generic computer components.
That is, other than reciting processing circuitry, a computer, a non-transitory computer readable medium and a display unit nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the processing circuitry and display unit this claim encompasses a person generating first medical image including a first target site specified by the examination order on the basis of the medical image; analyzing a second target site that is different from the first target site and is not specified by the examination order on the basis of the medical image; generating a second medical image including the second target site on the basis of an analysis result of the second target site; and displaying at least the second medical image between the first medical image and the second medical image as part of an medical record, where the first medical image is a medical image in which the first target site is more easily visible by an orderer of the examination order than other sites, including the target site, and wherein the second medical image is a medical image in which the second target site is more easily visible by the orderer than other sites in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A Prong 2: The Practical Application
This judicial exception is not integrated into a practical application. In particular, the independent claims recite the additional elements of processing circuitry, a computer, a non-transitory computer readable medium and a display unit that implements the abstract idea. These additional elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., a generic general-purpose computer or components thereof) such that they amount to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The independent claims recite an electronic medical record and a modality including a X-ray computed tomography apparatus, a magnetic resonance imaging apparatus, a mammography apparatus, an ultrasonic imaging apparatus, or a nuclear medicine diagnostic apparatus. These generally link the judicial exception to a particular technological environment. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application. See MPEP 2106.04(d)(l), Relevant Consideration for Evaluating Whether Additional Elements Integrate A Judicial Exception Into A Practical Application, and MPEP 2106.05(h).
The claim further recites the additional element of generating medical images of a patient by imaging the patient, which was also left as part of the bolded abstract idea above for continuity. This step is recited at a high level of generality and amounts to the mere data gathering, which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B: Significantly More
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of using a processing circuitry, a computer, a non-transitory computer readable medium and a display unit to perform the noted steps amounts to no more than mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
The independent claims recite an electronic medical record and a modality including a X-ray computed tomography apparatus, a magnetic resonance imaging apparatus, a mammography apparatus, an ultrasonic imaging apparatus, or a nuclear medicine diagnostic apparatus. These generally link the judicial exception to a particular technological environment. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application. See MPEP 2106.04(d)(l), Relevant Consideration for Evaluating Whether Additional Elements Integrate A Judicial Exception Into A Practical Application, and MPEP 2106.05(h). MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicates that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
The claim further recites the additional element of generating medical images of a patient by imaging the patient. This was determined to be extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. The prior art of record indicates that generating medical images of a patient by imaging the patient (US 2003/0179245 A1, hereafter Akagi, at para. [0076]) is well-understood, routine, conventional activity. Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Dependent Claim Abstractions and Dependent Additional Elements
Claims 2-8,13 are similarly rejected because they either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim 2 merely describes generating a second support information on the basis of restriction on data capacity and displaying the results. Claim 3 merely describes displaying at least the second medical image including the second target site as part of the electronic medical record. Claim 4 merely describes the analyzing the second target site on the first medical image and generates the second medical image according to the second target site analyzed on the first medical image.
Claim 5 merely describes the first target site is a site has a first disease, the second target site is the first target site has the first disease and also has a second disease, and the second medical image in which a presence or absence of the second disease is more easily visible that the first disease when it is analyzed that the second disease has occurred. Claim 6 merely wherein the processing circuitry further acquires auxiliary information including symptoms of the patient and generates the first medical image according to the symptoms at a time of generating the first medical image on the basis of the analysis result of the first target site. Claim 7 merely describes generating the first medical image according to symptoms using a database in which symptoms, diseases estimated from the symptoms, examinations according to the diseases and certain display modes are obtained by the examinations are systematized by ontology. Claim 8 merely describes when it is analyzed that the second target site has a disease, displaying the second medical image including the second target site having the disease and the second medical image including the second target site analyzed as disease-free in the second target site in the past side by side. Claim 13 merely describes generating the second medical image on the basis of characteristics of the second target site.
The dependent claims recite a variety of additional elements, including processing circuitry and system and a display unit. The processing circuitry and system and display unit were treated as generic computers or parts thereof. These additional elements are analyzed in the same way (see independent claims above) and are insufficient to provide a practical application or significantly more for the reasons noted above.
Response to Arguments
Claim 1 is directed to a combination of structural elements including the modality and processing circuitry. The modality is part of the system and is not simply generally linking the judicial exception to a particular technological environment.
The Examiner disagrees.
The imaging modality (the list of imaging modality options) was analyzed with the particular machine consideration at least at Step 2A prong two and Step 2B, and was found to be insufficient to integrate the judicial exception into a practical application of the exception. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. The independent claims also recite an electronic medical record and a modality including a X-ray computed tomography apparatus, a magnetic resonance imaging apparatus, a mammography apparatus, an ultrasonic imaging apparatus, or a nuclear medicine diagnostic apparatus. These generally link the judicial exception to a particular technological environment. Additional elements that generally link the judicial exception to a particular technological environment or field of use cannot serve to integrate the exception into a practical application. See MPEP 2106.04(d)(l), Relevant Consideration for Evaluating Whether Additional Elements Integrate A Judicial Exception Into A Practical Application, and MPEP 2106.05(h).
The relationship of these additional elements alone or in combination to each other and the abstract idea is such that they serve only to link the judicial exception to a particular technological environment. Applicant’s use of these listed additional elements does not serve to establish an improvement to any other technology nor technical field nor to establish an improvement to the computer nor any other of the ways of establishing a practical application or significantly more as outlined in the MPEP.
The apparatus of Claim 1 has the technical advantage of providing images related to two target sites with an examination order directed to one of the target sites.
The Examiner disagrees. As currently argued, the claims solve a non-technical problem of curing examination order inefficiency. This is not a technical solution to a technical problem because the issue of the efficiency of examination ordering is impacted by non-technical factors including, for example, insurance and/or hospital organization or protocol. Moreover, simply reciting any technical solution, particularly when it does not solve the problem, is not sufficient to overcome 35 U.S.C. 101. The problem must be redefined to be technical in nature and should be communicated during prosecution and the features resulting in the specific technical solution solving the technical problem must be reflected in the claims.
There is no improvement to technology recited.
The apparatus produces more information than a conventional system that delivers just an image of the first target site according to the order. It not only produces more information but produces information more efficiently as there is no need to generate a second order, obtain another medical image, and generate another first medical image based on the another medical image. See for example, page 15, line 18 to page 16, line 7 of the specification.
The Examiner respectfully disagrees. For example, independent claim 1 is directed to a mental process, because it covers performance of the limitation in the mind but for the recitation of generic computer components. Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. Currently the imaging modality from the list in the claims is used only nominally or insignificantly to the execution of the claimed method to gather images. The current claim uses essentially the equivalent of a processor (see specification) in connection with a imaging device (the list is given above) and display in addition to the imaging modalities to establish a “machine.” The imaging device is used nominally to collect data and the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more. The remaining additional elements are used as per generic computer parts to implement the abstract idea outlined in the 35 U.S.C. 101 rejection in bold above.
Additionally, the alleged efficiency is related to the process of issuing examination orders (i.e. allegedly alleviating the need for a second examination order). The problem that the claims allegedly solve is non-technical (could be caused by insurance requirements impacting the efficiency of examination orders, streamlined processes for dictating two examination orders on the original examination order etc.).
Finally, the generation of additional information with less input may be of detrimental effect to the computerized environment that Applicant is claiming. For example, the additional information may take additional physical computing resources without improving the computing environment itself, or have undesirable physical computing consequences, such as the generation of heat. There is no improvement to the computer environment recited.
Claim 1 is not directed to managing personal behavior or interaction between people but is directed to a physical system including a modality for image generation that is technically improved as discussed above. The system including the modality is clearly integrated in a practical application of providing improved and more comprehensive images for disease analysis having improved visibility due to the technical improvements of generating the second medical image.
The Examiner disagrees.
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claim of a practical application through the technical improvement of modalities which provide better images with more visible target sites is addressed as part of the abstract. This part of the amendment, alone and in combination with other limitations in the claim, reinforces the abstract idea, a certain method of organizing activity, which was determined to be specifically managing personal behavior or interaction between people. The visibility limitation is part of the abstract idea, and is specifically managing interaction between people. Even as an additional element, if an additional element does little more, alone or in combination with other additional elements, but point to yet another example of judicial exception than the additional element may not integrate the exception into a practical application of the exception. RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract").
The technical improvements discussed above are also achieved and Claim 9 is integrated into a practical application of providing improved and more comprehensive images for disease analysis having improved visibility.
See the relevant responses to this argument above.
Applicant respectfully submits that Claims 10 and 11 are also integrated into a practical application of improved medical imaging for disease analysis with improved and more comprehensive images. The method and computer program are clearly connected to the medical field for improved generation of images from modalities and their analysis.
See the relevant responses to this argument above. “Clearly connected to the medical field” does not necessarily ensure patentability as many abstract ideas, in particular, relevant to a certain method of organizing human activity, are firmly rooted in healthcare/the medical field.
New claim 13 recites the further feature of processing circuitry that generates the second medical image in a display mode selected on a basis of characteristics of the second target site. The apparatus is further technically improved by producing improved and more comprehensive images that are also generated based on characteristics of the second target site.
The Examiner disagrees. The features resulting in a technical improvement are not recited in the claims. The problem is not technical. No improvement to any other technology has been defined and/or presented during prosecution.
Given broadest reasonable interpretation, one of ordinary skill in the art could use the method as recited to generate a random medical image and to display medical images: “…analyzing a second target site that is different from the first target site and is not specified by the examination order on the basis of the medical image; generating a second medical image including the second target site on the basis of an analysis result of the second target site; and […] displaying at least the second medical image between the first medical image and the second medical image as part of an […] medical record,…”. The method includes selecting a second target site different from the first, which could be randomly chosen. Applicant has not argued how their method of generating a target site and image based on the characteristics of the random target site is a technical improvement/advantage. The problem solved is not technical in nature and the technical solution presented does not capture the features, steps or limitations that result in the specific alleged advantages. Applicant has not defined the meaning of “more comprehensive images” in arguments to be a specific technically relevant advantage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 11748598 B2 (hereafter Bai): Positron Emission Tomography. Bai teaches limitations on acquiring first and second medical training images via a modality.
US 2017/0319150 A1 (hereafter Goto) teaches a medical imaging diagnosis apparatus and management apparatus.
US 2014/0191756 A1 (hereafter Yokosawa) teaches a medical image imaging device.
WO 2013/036853 A2 (hereafter Butler). This document teaches medical electronic record and medical data processing systems, and in particular deals with receiving data.
Wang, Hong. Encryption of medical image with most significant bit and high capacity in piecewise linear chaos graphics. Measurement 135 (2019) 385-391. This nonpatent literature describes a MSB prediction-based high capacity reversible data hiding image encryption algorithm that is tangentially related to the topics of data capacity and medical imaging.
US 2015/0331995 A1 (hereafter Zhao) teaches medical data processing, in particular receiving medical data, generating image quantitative results, and generating the likelihood of a second medical condition of the patient based on the analysis.
Andrew Georgiou. The impact of computerized provider order entry systems on medical-imaging services: a systematic review, Journal of the American Medical Informatics Association, Volume 18, Issue 3, May 2011, Pages 335–340. Georgiou surveys articles related to the subject outcome measured assessed including the factors in Table 1. have been written related to the subject.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683
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