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
The present Office Action is in response to the Request for Continued Examination dated 12 May 2026.
In the amendment dated 12 May 2026, the following occurred: Claims 7 and 13 have been amended.
Claims 2-9, 13-16, 18, and 20 are pending.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 May 2026 has been entered.
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) extracting from unstructured medical data information indicating whether a family member among a plurality of family members of a patient is known to have or have had a condition; transforming the extracted information into a structured data format; assigning, the plurality of family members of the patient at least one genotype, respectively, based on rules defining an inheritance mode of a condition and based on the structured 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:
PNG
media_image1.png
428
1188
media_image1.png
Greyscale
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 having modules and a device having a display and (Claim 13) a server having modules 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
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 2-9, 13-16, 18, and 20, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
The claim thus recites modules of the information process apparatus that are tied to perform specific operations described in the claims that is not directed to a judicial exception.
Regarding (a), the Examiner respectfully disagrees. The claim recites abstract idea as noted in the basis of rejection. The various modules alluded to by the Applicant are claimed to be part of the generic computer, which is an additional element. A generic computer cannot provide a practical application or significantly more (see, e.g., Alice Corp.). The Examiner notes that if the various modules are not part of the generic computer, Applicant would likely have an insurmountable written description issue because there is no description as to what the modules are; they are only functionally described.
claim 7 as currently recited is integrated into a practical application of a system that processes unstructured information from multiple environments/sources and provides a patient's health risk prediction with calculated risk probabilities of the patient of being affected by certain disease or being carrier of such disease.
Regarding (b), the Examiner respectfully disagrees. Initially, additional elements provide a practical application. These features are not additional elements. They are part of the abstraction; they are part of the rule or instructions for a person / persons to follow. The Applicant has not stated why these features provide a practical application and thus the Examiner really has nothing to respond to.
Moreover, claim 7 currently recites an interface that "cause[s] summary information about the patient to be displayed in an electronic health record system used by the doctor'' when "establishing the call with the doctor."
Regarding (c), the Examiner respectfully disagrees. Outputting data to a particular location for display based on an indication (a call). Is part of the abstraction. The remaining features were analyzed as additional elements and were found not to provide a practical application or significantly more. Again, the Applicant has not stated why these features provide a practical application or significantly more and thus the Examiner has no actual argument to respond to.
As stated previously, 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:
Rix et al. (U.S. Pre-Grant Patent Publication No. 2025/0372215) which discloses a system for providing a practitioner access to genetic data stored in a repository and for the practitioner to add data to the repository.
Chen (U.S. Pre-Grant Patent Publication No. 2020/0381083) which discloses a system for classifying genetic variants, gene function and other biological information into an image object for analysis by trained AI algorithms.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
Prosecution Insights