DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This communication is in response to the amendment filed 11/10/25. Claims 8 and 17-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/10/25 has been entered.
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 8 and 17-20 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.
Claim 8 recites: calculating a frequency at which the data retrieved from the adaptive evidence database locates the public database based on a correlated relationship between the driver gene and the gene mutation in the patient.
Moreover, it remains unclear what the claimed frequency calculation represents/reflect in this step. In particular it is unclear if the applicant is intending to determine a frequency or prevalence of the gene mutation (e.g. in a population) in the driver gene, or whether the calculation is determining data retrieval frequency (e.g. assessing how well the system retrieves data for a given search).
Claims 17-20 incorporate the deficiencies of claim 8 through dependency, and are therefore also rejected.
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 8 and 17-20 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 8 and 16 are drawn to methods.
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? If so, is the judicial exception integrated into a practical application of the judicial exception? 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 8 recite(s) certain methods of organizing human activities, and mathematical relationships, both of which are considered subject matter that falls within the enumerated groupings of abstract ideas described in the 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 methods are drawn to gathering patient information and public information, to rank and update rankings for patient treatment options (i.e. optimize the selection of a treatment plan for a patient).
In particular, claim 8 recites a method for:
processing and analyzing the data retrieved from the adaptive evidence database;
calculating a frequency at which the data retrieved from the adaptive evidence database locates the public database based on a correlated relationship between the driver gene and the gene mutation in the patient;
generating a ranking of a plurality of driver genes for a disease related to the patient based on the calculated frequency;
creating evidence based treatment ranking for targeted treatment of the disease, by generating a first aggregated score for each treatment provided to the patient according to a calculated relationship between the driver gene, the gene mutation in the patient, and the first set of structured patient specific data ;
analyzing the second set of data by the calculator;
generating updated evidence-based treatment ranking for targeted treatment of the disease;
calculating a second aggregated score based on changes to the ranking of the driver gene, and the second set of data;
and
generating a recommended treatment outcome based on the treatment ranking and a degree to which the patient specific parameter matches the driver gene, the clinical parameter, or the biomedical parameter used to update the treatment ranking.
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?
Claims 8 does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 8 recites additional limitation(s), including the steps of:
communicatively connecting a server to a medical experience register, an adaptive evidence database and a calculator in order to provide a shared database architecture the server having a processor configured to execute programming instructions,
creating a first set of structured patient specific data comprising a clinical parameter, a biomedical parameter, a treatment, a target gene for the treatment and a treatment outcome for the patient;
populating the medical experience register with the first set of structured patient specific data;
executing by the processor to perform the following operations in real-time:
receiving a second set of data comprising a clinical parameter, a biomedical parameter or a treatment outcome, wherein the second set of data is different from the first set of data;
updating the medical experience register with the second set of data;
receiving a request for a treatment recommendation, the request including a patient-specific parameter…
The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. The additional steps amount to necessary data gathering and outputting, (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 8 also recites: a server; a medical experience register (database), a adaptive evidence database, and at least one processor; a calculator (software/instructions for executing….). These additional components is/are generic components that perform generic computer functions 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 description of the system’s architecture: “Users can access the system on their own personal computer, tablet or portable communication devices (smartphones) or other comparable interfaces. These devices provide the communication interface to provide input and receive output. The patients' personal data is only available for the user who has authorization. The medical data and the encrypted personal data are stored in a central cloud server. This server also has all the software and databases necessary for the system.” (par. 115) Such language indicates that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of the additional (generic) components.
Moreover, the courts have recognized the certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features found in the additional steps of claims 8:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)) which is analogous to the steps of “causing a search of the evidence database;” and “populating the medical experience register with patient data from a plurality of sources connected to the network”
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.") which is analogous to “using the treatment calculator in communication with the evidence database and the medical experience register”
- Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, which is analogous to “causing a search of the evidence database;” and “populating the medical experience register with patient data from a plurality of sources connected to the network”
- Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
Claims 17-19 recite limitations which further define the abstract idea recited in claim 8. However, the claims fail to recite substantially more than the abstract idea, and do not render the claimed invention patent eligible. Claim 20 recites a limitation which is insignificant extra-solution activity.
Because Applicant’s claimed invention, as drafted in claims 8, and 17-20, 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.
Response to Arguments
Applicant's arguments filed 11/10/25 have been fully considered but they are not persuasive.
(A) Applicant argues the rejections under 35 USC 112 (b).
In response, the Applicant’s claim amendments to address the rejections under 35 USC 112(b) are noted. However, the claims remain rejected under 35 USC 112(b). The examiner has attempted to further clarify the issue in the current rejection. In particular, the examiner has attempted to further explain the lack of clarity regarding the “calculating the frequency step” in claim 8.
(B) Applicant argues the rejections of the claims under 35 USC 101. Applicant argues that the instant invention is patent eligible because the claims are not directed to an abstract idea, and cites passages from the specification for support.
In response, the Examiner disagrees. The claims are drawn to certain methods of organizing human activities, and mathematical relationships, both of which are considered subject matter that falls within the enumerated groupings of abstract ideas described in the 2019 Revised Patent Subject Matter Eligibility Guidance. In particular, the recited methods are drawn to gathering patient information and public information, to rank and update rankings for patient treatment options (i.e. optimize the selection of a treatment plan for a patient).
Moreover, in 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).
The citations from the application are noted. However, the passages cited by Applicant do not explain technological improvements provided by the inventive method. The passages explain improvements to the cited abstract idea, and improving the process of selecting targeted treatment for a patient.
(C) Applicant argues that the “invention relates generally to techniques for artificial intelligence based medical decision support systems,” and that “[c]laims reciting improved technological processes for adaptive artificial intelligence- based medical diagnosis-generating and sharing evidence-based treatment rankings in real-time-for targeted treatment of the disease cannot simply be directed to an abstract idea/judicial exception/method of organizing human activities…”
In response, it is also noted that passages regarding the incorporation of artificial intelligence are not commensurate with the scope of the invention as currently claimed. The most recent amendments have deleted references to artificial intelligence and adaptive decision support systems. Therefore, arguments regarding these features are moot.
The issue addressed by the claimed invention is not “specific computer- related problem.” The problem addressed by the claimed invention is one of organizing and processing of information to refine the process of treatment selection for patients.
(D) Applicant argues that the Office has oversimplified the invention, which creates an adaptive database which is modified by newly added information.
In response,.the claims recite gathering data from multiple sources to create a new data store, and updating that new datastore when new information is acquired. The data transmission and retrieval steps do not render the claims patent eligible, and do not distinguish from the well‐understood, routine, and conventional computer functions recognized by the courts have recognized when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)).
(E) Applicant argues that claimed invention provides an advantage for physicians and patients, and integrates any abstract idea into a practical application.
In response, the judicial exception(s) recited in the claimed invention 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).
However, as previously explained, an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019). Applicant’s arguments regarding advantages to the physician and patient would reflect an improvement an abstract idea, in refining the process of identifying the best treatment options for a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Janevski et al (US 20180089392 A1)-teaches a system and method which includes ranking gene expression signatures according to their statistical relevance to a particular patient.(par. 215, par. 230)
Ramarajan et al (US 20120016690 A) recommends a treatment among a plurality of treatment options for a given medical condition of a patient. The system and method receive patient information related to the patient and the medical condition, and search a database with a plurality of indexed studies relating to the plurality of different treatment options for the given medical condition.
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 on M-F, 10-6:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on 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 3626