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 .
DETAILED ACTION
In the amendment dated 08 December 2025, the following occurred: Claims 2-9, 13, 16, 18, and 20 have been amended; Claims 1, 10-12, 17, and 19 have been cancelled.
Claims 2-9, 13-16, 18, and 20 are pending.
Priority
This application claims priority to European Patent Application No. EP23382349.1 dated 17 April 2023.
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 2-9, 13-16, 18, and 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.
Claims 7 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a method and system for determining a person’s risk for a genetic disease, which are within a statutory category.
Step 2A1
The limitations of (Claim 7 being representative) assigning, a plurality of family members of a patient at least one genotype, respectively, based on rules defining an inheritance mode of a condition and based on information indicating whether a family member among the plurality of family members of the patient is known to have or have had the condition; determining a genetic risk score indicating a likelihood of the patient having the condition based on the at least one genotype assigned to the plurality of family members of the patient; determining a family history risk score indicating a likelihood of the patient having the condition based on: a number of family members of the patient that are known to have or have had the condition and who are not known to have died from the condition and at least one family member's age upon diagnosis with the condition, and a number of family members of the patient that are known to have died from the condition and at least one family member's age upon death; and determining a genetic family history risk score of the patient having the condition based on the genetic risk score and the family history risk score, and optionally transmitting the at least one determined genetic family history risk score and the condition associated; transmitting output information that is displayed, the output information comprising any of: at least one determined genetic family history risk score and the condition associated, and at least one of a determined diagnosis and the determined genetic family history risk score; receiving, input from a user and establishing, based on the input, a call with a doctor of the patient and causing summary information about the patient to be displayed to the doctor, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a method or system implemented on/by generic computer components, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the generic computer components, this claim encompasses a person collecting information about a patient and determining a genetic family history risk score based on analysis of the information in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The limitations of (Claim 7 being representative) wherein the determining of the family history risk score includes determining a contribution to the family history risk score which comprises computing a formula as follows:
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and wherein:
n1st, n2nd, and n3rd are numbers of first to third degree family members of the patient who are known to have or have had the condition and who are not known to have died from the condition, respectively;
m1st, m2nd, and m3rd are the numbers of first to third degree family members of the patient who are known to have died from the condition, respectively;
wn and wm are fourth and fifth weighting factors, respectively;
w1, w2, and w3 are sixth to eighth weighting factors, respectively;
in cond1, age indicates the age of the respective family member who is known to have or have had the condition and who is not known to have died from the condition upon diagnosis with the condition; and
in cond2, age indicates the age of the respective family member who is known to have died from the condition upon death
, as drafted, is a process that under broadest reasonable interpretation covers a mathematical concept that includes mathematical relationships, mathematical formulas or equations, and mathematical calculations but for the recitation of generic computer components. That is, other than reciting the generic computer components, the claim recites a mathematical calculation for determining a family history risk score that encompasses a mathematical concept. If a claim limitation, under its broadest reasonable interpretation, encompasses a mathematical concept but for the recitation of generic computer components, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The claim further recites performing analysis “using Mendelian and/or Bayesian analysis.” When given its broadest reasonable interpretation in light of the disclosure, also represents a mathematical concept. See Specification at Para. 00149 (Pg. 29), 00234 describing each of these as math. As such, the utilization of one of these in the claim represents a mathematical concept that is interpreted to be part of the identified abstract idea, supra.
The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Step 2A2
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of (Claim 7) an information processing apparatus and a device having a display and (Claim 13) a server and a device having a display that implements the identified abstract idea. These items are not described by the applicant and are recited at a high-level of generality (i.e., a generic computers or components thereof) such that it amounts no more than mere instructions to apply the exception using a generic computer or components thereof. See Spec. Para. 00362-00373.
The claims further recite the additional element of an electronic health record system. The electronic health record system merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Further, assuming arguendo that “a call” is an additional element, the call is recited at a high level of generality (i.e., as a general means of transmitting data) and amounts to the mere transmission of data, 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
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using one or more generic computers or components thereof to perform the noted steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using one or more generic computers or components thereof cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of an electronic health record system was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the “call” was alternatively considered 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. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible. Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
Claims 2-6, 8, 9, 14-16, 18, and 20 are similarly rejected because they either further define/narrow 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(s) 2 merely describe(s) how the inheritance mode is determined, which further defines the abstract idea.
Claim(s) 3, 5, 6 merely describe(s) how the family history risk score is determined, which further defines the abstract idea.
Claim(s) 4 merely describe(s) how additional contributions are determined, which further defines the abstract idea.
Claim(s) 8 merely describe(s) assigning genotypes and determining various scores, which further defines the abstract idea.
Claim(s) 9 merely describe(s) predicting a diagnosis, which further defines the abstract idea.
Claim(s) 14, 15, 16 merely describe(s) the additional element of “the device,” which, per the analysis of Claim 13, encompasses a generic computing device. Per the Office Action dated 06 August 2025, the device being an IOT and/or magnetic device is well-understood, routine, and conventional in the field.
Claim(s) 18, 20 merely describe(s) the second input and/or display of data, which further defines the abstract idea.
The additional element of a button in Claim 18 is interpreted to be part of the device—the generic computer.
Response to Arguments
Claim Objections
Regarding the objection(s) to Claims 1, 11, and 12, the Applicant has cancelled the claims rendering the objection moot.
Drawings
Regarding the drawing objection(s), the Applicant has submitted replacement drawings which have alleviated the drawing issues. The drawings are accepted.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-20, the Applicant has cancelled Claims 1, 10-12, 17, and 19, rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
As set forth below, the operations of claim 7 involve a large amount of information relating to the patient and their family members and it would not be practicable to perform the recited operations in the human mind.
Regarding (a), the Examiner respectfully disagrees. The abstract idea was not characterized as a mental process (see Office Action dated 06 August 2025 at numbered page 8) and thus this argument is immaterial. Further, whether a large amount of information is present (or not) is not a consideration with respect to the certain methods of organizing human activity characterization.
As such, claim 7 clearly and objectively evidences an improved determination for risk and diagnosis through the information processing apparatus.
Regarding (b), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computers that perform the abstract idea nor is there an improvement to another technology as no other technology is present in the claims. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Further, the argued improvement to “determination for risk and diagnosis” represents an improvement to the abstract idea. An improved abstract idea is still an abstract idea. The computers recited in the claim are merely being used as a tool to perform the abstract idea and is being used in the manner in which they are intended. See MPEP 2106.04(d)(I): “The courts have also identified limitations that did not integrate a judicial exception into a practical application: • Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);….”
In the present case, claim 7 recites at least "determining of the family history risk score [which] includes a specific method of obtaining of a contribution to the family history risk score." Thus, claim 7 is not directed to "mathematical equation"
Regarding (c), the Examiner respectfully submits that the portion of the claim identified as being directed to a mathematical concept is literally a math equation. It is unclear how the Applicant can argue otherwise. The remainder of the claim is characterized as certain methods of organizing human activity. The identified abstract idea characterizations are considered together for subject matter eligibility purposes.
In this way, the invention defined in claim 7 provides an improvement in the field of computer-implemented diagnosis.
Regarding (d), the Examiner respectfully submits that Applicant’s argument that the field of computer-implemented diagnosis is a technology and the claimed invention improves this field is not reflected in the claimed invention. The claims are confined to a general-purpose computer and do not claim all computer-implemented diagnosis. Moreover, the entire field of diagnosis is not reasonably understood to be a problem arising in technology, as it is instead a problem arising in medicine. The claimed invention is using a computer as a tool and any improvement present is an improvement to the abstract idea of, to paraphrase, using a mathematical model to determine genetic risk information. Finally, where Applicant’s line of reasoning correct, the invention in Alice Corp. would have been subject matter eligible because it was an improvement to the technology of settlement risk mitigation.
The above-quoted features in claim 7 represent interaction between a user and a device and a doctor to establish a call with the patient's doctor and to cause summary information about the patient to be displayed to the doctor in an EHR system used by the doctor.
Regarding (e), the Examiner respectfully submits that this does not provide an improvement by any measure in MPEP 2106. Performing an abstract idea in a computer environment (i.e., a plurality of networked computers) is merely using computers as a tool. See, e.g., MPEP 2106.05(a)(I).
In addition, the invention of claim 7 uses computation of the likelihood of the patient having the condition (which features provide improved diagnosis) and also provides the inventive concept of improved communication in a user-device-doctor interaction in relation to the patient and the potential condition and the claim thus amounts to significantly more than the alleged abstract idea.
Regarding (f), the Examiner respectfully disagrees. This does not provide significantly more by any measure in MPEP 2106.05. The improvement to diagnosis is an improvement to the abstract idea and is not an “improvement” within the meaning of the word. There is also no improvement to “communication” as the computer(s) are communicating in the same manner as they are intended to communicate.
The Examiner is unable to suggest a path forward with regard to the lack of subject matter eligibility.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Rabinowitz (U.S. Pre-Grant Patent Publication No. 2022/0157404) which discloses determining a non-Mendelian risk score using genotype and phenotype data from blood relatives.
Dite et al. (U.S. Pre-Grant Patent Publication No. 2025/0313897) which discloses a system for assessing risk for prostate cancer based on biomarkers.
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 JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683