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 5/11/26. Claims 1, and 12-19 are pending. Claims 16-19 are new.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/11/26 has been entered.
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 12-19 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, 12-13; and 16-19 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 and 15 recite a method, system, and product for:
acquiring…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;
identify, from among the plurality of items of past clinical data…, past clinical data in which the comparison target patient having a same diagnosis result as or a diagnosis result close to a diagnosis result of the diagnosis target patient is indicated;
perform an analysis process for evaluating whether the diagnosis result of the diagnosis target patient has been obtained through an appropriate diagnosis procedure by performing a clustering process for the patient reference data and the plurality of items of past reference data ; and
analyzing whether or not a trend of the flag information associated with the patient reference data matches a trend of the flag information associated with the plurality of items of past reference data.
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.
Claims 1, 14 and 15 also recite: acquiring…patient reference data based on the patient specific clinical data and past reference data based on the past clinical data. The additional step amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). More specificially, the additional steps amount to necessary data gathering, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
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 12-13 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. The additional limitations of claims 12-13 fail to recite significantly more than the abstract idea. More specifically, the additional limitations amount to insignificant extra solution activities. Therefore, claim(s) 12-13 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 16-19 recite additional steps which further define the abstract idea. The additional limitations of claims 16-19 fail to recite significantly more than the abstract idea. Therefore, claim(s) 12-13 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 12-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 14 and 15 have been amended to recite: “identify, from among the plurality of items of past clinical data read from the clinical database, past clinical data in which the comparison target patient having a same diagnosis result as or a diagnosis result close to a diagnosis result of the diagnosis target patient is indicated and acquire a plurality of items of past reference data based on the identified past clinical data.
It is unclear what is intended by the phrase “is indicated” in the recitation of “identify…past clinical data in which the comparison target patient having a same diagnosis result …as the diagnosis target patient is indicated and acquire a plurality of items of past reference data based on the identified past clinical data.”
The term “a diagnosis result close to a diagnosis result of the diagnosis target patient” in claim 1,14, and 15 is a relative term which renders the claim indefinite. The term “close too” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The judgement or determination of whether a diagnosis results are “close to” one another is vague and indefinite. For example, if multiple patients are diagnosed with “cancer,” but different tissue types (e.g. skin and colon), it cannot be ascertained whether those 2 diagnoses would be deemed “close to” one another for the purpose of interpreting the claim language.
Claims 12-19 inherit the deficiencies of claim 1 through dependency and are therefore also rejected.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The prior art has been withdrawn the pending claims. The closest prior art does not disclose: flagging first, second, third, or fourth data types, (information of a first flag, a second flag, a third flag, or a fourth flag being associated with a diagnosis result for each of types of reference data in the patient-specific clinical data and the past clinical data, the first flag indicating a type of data not referred to by either of a physician and a diagnosis support model, the second flag indicating a type of data referred to only by a physician, the third flag indicating a type of data referred to only by a diagnosis support model, and the fourth flag indicating a type of data referred to by both a physician and a diagnosis support model and using this information); and perform an analysis process for evaluating whether the diagnosis result of the diagnosis target patient has been obtained through an appropriate diagnosis procedure by performing a clustering process for the patient reference data and the plurality of items of past reference data and analyzing whether or not a trend of the flag information associated with the patient reference data matches a trend of the flag information associated with the plurality of items of past reference data in combination as claimed.
Response to Arguments
Applicant's arguments filed 5/11/26 have been fully considered but they are not persuasive.
(A) Applicant argues that the rejections of the claims under 35 USC 101. 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).
(B) Applicant argues that the claimed invention provides a technical advantage by reducing storage space and reducing processing load.
In response, the examiner disagrees. I n accordance with MPEP 2106.05 (a), if it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
An important consideration in determining whether a claim is directed to an improvement in technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other Step 2B considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
In the instant case, applicant’s disclosure fails to provide a technical explanation of the argued improvement. Moreover, the claimed invention does not recite the argued technological improvement. Applicant also 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.
(C) Applicant argues that the prior art does not disclose the claims as amended.
The prior art rejection has been withdrawn, and applicant’s arguments are moot.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Agnihotri et al (US 20090138432) – discloses a system and method for optimizing example-based CADx is accomplished by clustering volumes-of-interest (VOIs) in a database into respective clusters according to subjective assessment of similarity. An optimal set of volume-of-interest (VOI) features that includes image based and clinical (non-image based) features is then selected for fetching examples such that objective assessment of similarity, based on the selected features, clusters, in a feature space, the database VOIs so as to conform to the subjectively-based clustering (par. 7)
Yin et al (US 20190374160 A1) discloses a system and method of comparing the and bridging the different type of health data acquired to reach a diagnosis: a hierarchical health decision support system (HDSS) configured to receive data from one or more wearable medical sensors (WMSs) is disclosed. The system includes a clinical decision support system, which includes a diagnosis engine configured to generate diagnostic suggestions based on the data received from the WMSs. The HDSS is configured with a plurality of tiers to sequentially model general healthcare from daily health monitoring, initial clinical checkup, detailed clinical examination, and post-diagnostic treatment. (par. 11-12; par. 70-72; Fig. 6; Fig. 8)
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.
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.
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, 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
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