DETAILED ACTION
Notice to Applicant
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed on 9/18/25. Claims 1 and, 4-15 are pending.
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, and 4-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e, a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 1, 4-13 are drawn to a system; claim 14 is drawn to a method. Claim 15 is drawn to a computer program product (i.e. article of manufacture).
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1, and 4-15 recite(s) a method and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method and system are drawn to assessing the accuracy of a diagnosis determined for a patient.
In particular, the claims 1, 14-15 recite a method, system, and product for:
acquiring, by the computer, patient reference data based on the patient specific clinical data read from the clinical database and past reference data based on the past clinical data read from the clinical database;
performing, by the computer, an analysis process for evaluating whether the diagnosis result of the diagnosis target patient has been obtained through an appropriate diagnosis procedure, based on the patient reference data and the past reference data…
acquiring… a plurality of items of past reference data based on a plurality of items of past clinical data; and
performing… the analysis process based on a clustering process including the past reference data and the plurality of items of patient reference data, and
identifying…. the past clinical data in which the comparison target patient for the diagnosis target patient indicated in the patient-specific clinical data is indicated from among the plurality of items of past clinical data;
extracting…feature candidates indicating a feature of data necessary to obtain the diagnosis result of the diagnosis target patient in the patient-specific clinical data and feature candidates indicating a feature of data necessary to obtain the diagnosis result of the comparison target patient in the identified past clinical data to select at least the first data as feature data from among the extracted feature candidates;
generating…the patient reference data and the past reference data associated with reference information indicating whether or not the selected feature data has been referred to;
performing…an analysis process relating to a degree of matching between the patient reference data and the past reference data based on the feature data for the patient reference data and the past reference data associated with the reference information.
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1, 14, and 15 recite(s) additional limitation(s), including: “a clinical database…”; “processing circuitry configured to,” “by a computer” and “a computer readable non-transitory storage medium in which a program is stored… causing a computer to…”. The additional components is/are generic components that perform well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “The hardware processor is, for example, circuitry such as a central processing unit (CPU), a graphics processing unit (GPU), an application-specific integrated circuit (ASIC), or a programmable logic device (for example, a simple programmable logic device (SPLD), a complex programmable logic device (CPLD), or a field programmable gate array (FPGA)). Instead of storing the program in the memory (not shown), the program may be directly embedded in the circuit of the hardware processor. In this case, the hardware processor implements each function by reading and executing the program embedded in the circuitry. The hardware processor is not limited to being configured as a single circuit and may be configured as one hardware processor by combining a plurality of independent circuits to implement each function. A plurality of components may be integrated into one hardware processor to implement each function." (par. 23) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of generic system components.
Claims 4-13 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 4-13 fail to recite significantly more than the abstract idea. More specifically, the additional limitations further define the abstract idea with additional steps or details regarding data types; or additional steps which amount to insignificant extra solution activities. Therefore, claim(s) 4-13 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
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, and 4-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al (US 20050021375 A1) in view of Drakos (US 20250037860 A1)
Claims 1, and 14-15 Shimizu teaches a CRM, method and a medical diagnosis support device comprising:
a clinical database in which patient-specific clinical data relating to a diagnosis result of a diagnosis target patient and past clinical data relating to a diagnosis result of a comparison target patient for the diagnosis target patient are stored; (par. 31: diagnosis/treatment database; par. 70-stores diagnosis result) and
a computer including processing circuitry composed based on a processor, the method comprising: (par. 30-32) for:
acquiring, by the computer, patient reference data based on the patient specific clinical data read from the clinical database and past reference data based on the past clinical data read from the clinical database; (par. 31-32; par. 70-system stores and retrieves diagnosis result)
wherein the method further comprises:
acquiring, by the computer, a plurality of items of past reference data based on a plurality of items of past clinical data; and (Fig. 2; Fig. 9; par. 84-86; par. 89-90: the diagnostic terminal 131A may store the reference states of the medical image, and determine the validity of the diagnosis in accordance with the stored states…)
Claim 1 has been amended to recite:
performing, by the computer, an analysis process for evaluating whether the diagnosis result of the diagnosis target patient has been obtained through an appropriate diagnosis procedure, based on the patient reference data and the past reference data,
wherein the patient reference data includes first data that has been referred to by a first user to obtain the diagnosis result of the diagnosis target patient and second data that has been referred to by a diagnosis support model in order to obtain the diagnosis result of the diagnosis target patient, wherein the past reference data includes data that has been referred to by at least the first user or a second user different from the first user in order to obtain the diagnosis result of the comparison target patient,
performing, by the computer, the analysis process based on a clustering process including the past reference data and the plurality of items of patient reference data, and
identifying, by the computer. the past clinical data in which the comparison target patient for the diagnosis target patient indicated in the patient-specific clinical data is indicated from among the plurality of items of past clinical data;
extracting, by the computer, feature candidates indicating a feature of data necessary to obtain the diagnosis result of the diagnosis target patient in the patient-specific clinical data and feature candidates indicating a feature of data necessary to obtain the diagnosis result of the comparison target patient in the identified past clinical data to select at least the first data as feature data from among the extracted feature candidates;
generating, by the computer, the patient reference data and the past reference data associated with reference information indicating whether or not the selected feature data has been referred to; and
performing, by the computer, an analysis process relating to a degree of matching between the patient reference data and the past reference data based on the feature data for the patient reference data and the past reference data associated with the reference information.
Shimizu does not expressly disclose, but Drakos teaches a system and method further comprising:
performing, by the computer, an analysis process for evaluating whether the diagnosis result of the diagnosis target patient has been obtained through an appropriate diagnosis procedure, based on the patient reference data and the past reference data, (par. 69- to determine the most appropriate therapeutic courses of action once a diagnosis is made and recommend this course of action to the user; par. 222; par. 234)
wherein the patient reference data includes first data that has been referred to by a first user to obtain the diagnosis result of the diagnosis target patient and second data that has been referred to by a diagnosis support model in order to obtain the diagnosis result of the diagnosis target patient, wherein the past reference data includes data that has been referred to by at least the first user or a second user different from the first user in order to obtain the diagnosis result of the comparison target patient, (par. 59-standard of care data acquisition and evaluation; par. 63-64)
performing, by the computer, the analysis process based on a clustering process including the past reference data and the plurality of items of patient reference data, and (par. 64-65; claim 22-data clustering)
identifying, by the computer. the past clinical data in which the comparison target patient for the diagnosis target patient indicated in the patient-specific clinical data is indicated from among the plurality of items of past clinical data; ( par. 64-65)
extracting, by the computer, feature candidates indicating a feature of data necessary to obtain the diagnosis result of the diagnosis target patient in the patient-specific clinical data and feature candidates indicating a feature of data necessary to obtain the diagnosis result of the comparison target patient in the identified past clinical data to select at least the first data as feature data from among the extracted feature candidates; (par. 41; par. 55-56; par. 64)
generating, by the computer, the patient reference data and the past reference data associated with reference information indicating whether or not the selected feature data has been referred to; and (par. 41; par. 64)
performing, by the computer, an analysis process relating to a degree of matching between the patient reference data and the past reference data based on the feature data for the patient reference data and the past reference data associated with the reference information. (par. 41; par. 64; Par. 147; par. 316: The PreDICT system provides multiple decision makers, including those separated in time and/or space, with the same information and interpretation of that information to create a shared and accurate mental model and recommendations for interventions and courses of action.
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system /method of Shimizu with the teaching of Drakos to include these features with the motivation of reducing misdiagnosis and decreasing time to diagnosis. (par. 3)
claim 4. Shimizu discloses the medical diagnosis support device according to claim 3, wherein the processing circuitry identifies the second clinical data in which the comparison target having the same diagnosis result as the evaluation target is indicated. (par. 89- the management server 120 determines the validity of the diagnosis. However, the diagnostic terminal 131A may store the reference states of the medical image, and determine the validity of the diagnosis in accordance with the stored states.; par. 90- the validity of a diagnosis can be checked before the diagnosis result is returned)
claim 5. Shimizu discloses the medical diagnosis support device according to claim 3, wherein the processing circuitry identifies the second clinical data in which the comparison target having a diagnosis result close to a diagnosis result of the evaluation target is indicated. (par. 89-91)
claim 6. Shimizu teaches the medical diagnosis support device according to claim 3, wherein the processing circuitry selects the feature data including the second data. (par. 121- the system may also transmit the determination result of the display test. Comparing information concerning the date and time when the findings were input with the date and time when the image was downloaded makes it possible to determine whether the interval between the instant at which the image was downloaded and the instant at which the findings were transmitted exceeds a given period of time.)
claim 7 Shimizu teaches the medical diagnosis support device according to claim 6, wherein the processing circuitry selects all the first data and all the second data as the feature data. (par. 127-130- incorporation of all data of relevance for diagnosis)
claim 8. Shimizu teaches the medical diagnosis support device according to claim 6, wherein the processing circuitry selects the first data and the second data having the same data feature as the feature data from among all the first data and all the second data. (par. 121- the system may also transmit the determination result of the display test. Comparing information concerning the date and time when the findings were input with the date and time when the image was downloaded makes it possible to determine whether the interval between the instant at which the image was downloaded and the instant at which the findings were transmitted exceeds a given period of time.)
claim 9. Shimizu discloses the medical diagnosis support device according to claim 6, wherein the processing circuitry selects all the first data and the second data complementary to the first data as the feature data. (par. 121- the system may also transmit the determination result of the display test. Comparing information concerning the date and time when the findings were input with the date and time when the image was downloaded makes it possible to determine whether the interval between the instant at which the image was downloaded and the instant at which the findings were transmitted exceeds a given period of time; par. 127-130- incorporation of all data of relevance for diagnosis)
claim 10. Shimizu discloses the medical diagnosis support device according to claim 3, wherein the processing circuitry associates the reference information indicating whether or not the selected feature data has been referred to by the first user with the first reference data and the second reference data. (par. 111-112: The database 4b periodically searches for an image diagnosis request to extract the corresponding requested case, and generates a list of doctors or hospitals serving as diagnosing sides in consideration of designation/non-designation of diagnosing sides)
claim 11 Shimizu teaches The medical diagnosis support device according to claim 10, wherein the processing circuitry associates the reference information indicating whether or not the selected feature data has been referred to by the diagnosis support system with the first reference data and the second reference data. (par. 111-112; par. 114-115)
claim 12. Shimizu discloses the medical diagnosis support device according to claim 1, wherein the processing circuitry causes a display device to display content based on an analysis result of performing an analysis process relating to the diagnosis result of the evaluation target. (par. 114- the data center 4 searches the database 4b in which the determination result on the display apparatus on the diagnosing side is registered in advance, and stores the corresponding determination result on the diagnosing side in a temporary storage area…par. 115- the data center 4 executes a display performance test. In addition, if the interval between the previous determination and the current determination exceeds a predetermined period, a display performance test may be executed.)
claim 13. Shimizu discloses the medical diagnosis support device according to claim 12, wherein the processing circuitry causes the display device to display at least the display content indicating the second data to be referred to by the diagnosis support system without being referred to by the first user in the first reference data (par. (par. 111-112; par. 114-115)
Response to Arguments
Applicant's arguments filed 9/18/25 have been fully considered but they are not persuasive.
(A) Applicant’s amendments to the specification and the abstract are acknowledged and are acceptable.
(B) Applicant argues that the rejections of the claims under 35 USC 101. More specifically, applicant argues that claims recite significantly more than an abstract idea, and also that any abstract idea is integrated into a practical application.
In response, the examiner disagrees. The claims are drawn toward certain methods of organizing human activities (e.g. system and method for assessing the accuracy of a diagnosis determined for a patient based upon patient specific and past data). Moreover, the judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B).
Applicant argues that the claimed invention improves medical diagnoses provided to patients. However, it is respectfully submitted that the argued improvement is to the abstract idea, and does not reflect a technological improvement.
While the rejections have been updated to reflect the new claim language, the 101 rejections regarding the claims being drawn to an abstract idea have been maintained.
It should be noted that the amendments to claim 15 are sufficient to address the “software pe se” rejection. Therefore, that rejection has been withdrawn.
(C) Applicant argues that the prior art does not disclose the claims as amended.
In response, new grounds of rejection have been added to address the claims as amended.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sabol et al (US 20040122704 A1) discloses a system for drawing upon a wide range of available medical data for informing decisions related to diagnosis, treatment, further data processing, acquisition and analysis.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684