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 1-11 are pending in the application. Claims 1-11 are rejected herein. In the amendment received 14 October 2025 the following occurred: claim 12 was newly canceled and claims 1,9,10,11 were amended.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 October 2025 has been entered.
Distinguishing Prior Art
Claim 1,9,10,11, and the claims that depend on claim 1, 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.
Claim 8 is 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 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.
Dependent claims 2-8 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. The dependent claims are directed to and fall under the certain methods of organizing human activities subgrouping.
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 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 method of organizing human activity (i.e., managing personal behavior including following rules or instructions) 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 the claimed invention amounts to managing personal behavior or interaction between people. 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.
The Examiner notes that “certain methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at pg. 5). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic components, then it falls within the “certain methods of organizing human activity” grouping of abstract idea. 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 obtaining medical image of a patient from the modality according to an examination order. This step was 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.
Also the additional element of obtaining medical image of a patient from the modality according to an examination order 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 obtaining medical image of a patient from the modality according to an examination order is well-understood, routine, conventional activity (see US 2009/0175417 A1, hereafter Sesano, at the Abstract and US 2008/0037849 A1, hereafter Sakaida at para. [0038])). 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 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.
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
35 U.S.C. 101
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, being one of an X-ray computed tomography apparatus, a magnetic resonance imaging apparatus, a mammography apparatus, an ultrasonic imagining apparatus or a nuclear medicine diagnostic apparatus. None of these apparatuses amount to managing personal behavior or interaction between people but are physical structures designed to generate images by performing an imaging process on a subject.
The Examiner respectfully disagrees. The claim is directed to a certain method of organizing human activity, specifically managing personal behavior or interaction between people. 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 modality 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, namely to implement the abstract idea outlined in the 35 U.S.C. 101 rejection in bold above.
Claim 1 recites significantly more than an abstract idea and is integrated into a practical application of improved medical imagining technology. The modalities are improved through the generation of first and second medical images having more easily visible target sites. The system including the modality is clearly connected to the medical field of image generation and analysis with improved visibility. Claim 1 is integrated into the practical application of medical image generation and image analysis. Applicant respectfully submits that Claim 1 recite eligible subject matter.
The Examiner respectfully 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).
As discussed above, the additional elements failed to integrate the abstract idea (the judicial exception) into a practical application of the exception or to provide significantly more by the standards set forth in the MPEP. The application or use of the judicial exception in this manner does not meaningfully limit the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, thereby transforming the claim into patent eligible subject matter. The claims required further subject matter eligibility analysis at Step 2B as described elsewhere (see particular machine consideration above).
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. 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").
Claim 9 also recites a system having one of the above-listed apparatuses along with processing circuitry which acquires a medical image of a patient from the modality and produces images which are more easily visible. As discussed above, such a system is integrated into a practical application through the technical improvement of modalities which provide better images with more visible target sites. Claim 9 is also believed to recite patentable subject matter.
The Examiner disagrees.
The claim that a system is integrated into a practical application through the technical improvement of modalities which provide better images with more visible target sites is addressed above. 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 processing circuitry and display were treated as generic computer components in the 35 U.S.C. 101 rejection. 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, as described above, 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.
Applicant argues that Claim 10 and 11 are also integrated into a practical application of improved medical imaging using modalities from one of the above-listed apparatuses which produce images which provide better visibility. The method and computer program are clearly connected to the medical field for improved generation of images from modalities and their analysis.
The Examiner respectfully disagrees. As described elsewhere the additional elements do not integrate the judicial exception (the abstract idea) into a practical application of the exception or provide significantly more. The Examiner agrees that the method and computer program are generally linked to medical field. For example, additional elements in the subject matter eligibility analysis were found to be generally linking. “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.
35 U.S.C. 103
Applicant has incorporated claim 12 into the independent claims to overcome the prior art.
The Examiner notes this.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRISTAN ISAAC EVANS whose telephone number is (571)270-5972. The examiner can normally be reached Mon-Thurs 8:00am-12:00pm & 1:00pm-7:00pm, off Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.I.E./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683