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 .
Applicant's Amendment/Request for Reconsideration-After Non-Final Rejection filed 24 June 2025, has been entered and fully considered.
Status of Claims
Claim 3-4, 6, 9-10, 12 and 14 are cancelled.
Claims 1-2, 5, 7-8, 11, 13 and 15-24 are pending and examined on the merits.
Priority
As detailed on the 6/11/2024 filing receipt, this application claims benefit over foreign application REPUBLIC OF KOREA 10-2023-0109872 filed 08/22/2023. Consequently a priority date is given as early as 8/22/2023.
Withdrawn Rejections/Objections
The objection to claim 5 in the Office Action mailed 26 March 2025 is withdrawn in view of claim amendment filed 6/24/2025.
The rejection to claim 1 under 35 USC § 112(d) in the Office Action mailed 26 March 2025 is withdrawn in view of claim amendment filed 6/24/2025.
Claim Rejections - 35 USC § 112 -- First Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 is a “system”, which is interpreted as a machine. The specification does not describe how this machine conducts “performing, by the one or more of the plurality of user terminals, an additional treatment and/or surgery with a certain interval of time, and with a certain number of time, as indicated in result of the detection of the minimal residual disease.” The newly recited limitation is New Matter.
Claim Rejections - 35 USC § 112 -- Second Paragraph
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.
Claim 20 is 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 20 is a “system”, which is interpreted as a machine. It is not clear how this machine conducts “performing, by the one or more of the plurality of user terminals, an additional treatment and/or surgery with a certain interval of time, and with a certain number of time, as indicated in result of the detection of the minimal residual disease”. The disclosure provides no description of the machine structure configured to perform the real world operation of performing a treatment.
Claim Rejections - 35 USC § 101
The instant rejection is maintained from the Office Action of 03/26/2025 and modified to address amendments filed 06/24/2025
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 1-2, 5, 7-8, 11, 13 and 15-24 are rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 1-2, 5, 7-8, 11, 13, 15-18, 21 and 23-24 are directed to a process, here a "method," for detecting minimal residual disease.
Claim 19 is directed to a machine or manufacture, here a “non-transitory computer-readable recording medium.”
Claim 20 and 22 are directed to another machine or manufacture, here a “system.”
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s):
Performing, by the processor of the information processing system, detection of minimal residual disease for the patient based on the first sequencing data, the second sequencing data, and the third sequencing data (claims 1 and 20).
Detection of disease based on first, second and third sequencing data, is interpreted as a series of judgements and decision-making with respect to the data sets. The step equates to an abstract idea of a mental process;
Deciding, by the processor of the information processing system, a type of additional treatment and/or surgery, to be conducted for a target patient, based on a result of the detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph (claims 1 and 20).
The step recites a decision-making process based on a previously determined result in the first part, which reads on a human decision-making process based on data (information) provided. Hence this part equates to an abstract idea of mental process. Under a BRI, the “neural network model“ recited in the 2nd part is interpreted as artificial neural network. The 2nd part “detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph” is directed to mathematical operations of fitting the mathematical models inside the artificial neural network. The neural network is recited at a high degree of generality and reads on matrix mathematics. Therefore the whole step is directed to abstract ideas of mental processes and mathematical concepts.
Calculating a limit of detection for the patient based on the number of tumor tissue mutations of the patient detected by comparing the first sequencing data and the second sequencing data and an average sequencing depth of the third sequencing data (claims 1 and 20).
This step recites a mathematical calculation, which equates to an abstract idea of mathematical concept.
Detecting tumor tissue mutation information of the patient by comparing the first sequencing data and the second sequencing data (claims 1 and 20).
This step recites comparing two data sets, which can be achieved in human mind. Therefore this step equates to an abstract idea of mental processes.
Performing background error filtering on the detected tumor tissue mutation information using genetic data associated with a plurality of sample patients who are distinct from the patient (claims 1 and 20).
This step recites comparing detected mutation information against background information and filtering background information, which can be achieved in human mind. Therefore this step equates to an abstract idea of mental processes.
Calculating a tumor cell fraction (TCF) for the patient based on the filtered tumor tissue mutation information (claims 1 and 20).
This step recites a simple calculation that can be achieved in mind. Therefore this step equates to an abstract idea of mental processes.
Correcting the tumor cell fraction using the genetic data associated with the plurality of sample patients (claims 1 and 20).
This step recites data manipulation, which equates to an abstract idea of mental process.
Determining whether the patient has tumor recurrence based on the limit of detection and the third sequencing data (claims 1 and 20).
This step recites a decision-making process based on data observation, which equates to an abstract idea of mental process.
Step 2A Prong Two: Consideration of Practical Application
Claims 1-2, 5, 7-8, 11, 13, 15-18, 21 and 23-24 result in a process of computerized “performing” of additional treatment and/or surgery. The claims do recite an additional element but is too general. There is nothing more than “apply it.” Claims 1-2, 5, 7-8, 11, 13, 15-18, 21 and 23-24 do not integrate the abstract idea/judicial exception into a practical application.
Claim 1 result in a process of “performing” of additional treatment and/or surgery. This additional element is too generic in terms of treatment and/or surgery. It is equivalent to saying “apply the result” received in the previous “transmitting” step. See MPEP 2106.05(f) and 2106.05(g). Further, this additional element does not capture the judicial exception completely, by integrating the abstract idea steps into a particular treatment. Because neither “an additional treatment” nor “surgery” recited in the step is particular. First the “or” (used to connect the “treatment” and the “surgery”) is conditional, hence the “treatment” is not a particular treatment; Second “surgery” is not a particular surgery related to the determination of a minimum residual disease. The claim is not particular with respect to how the surgery is related to the minimum residual disease or how the surgery is intended to be a treatment for a minimum residual disease. Reciting a particular type of surgery related to tumor tissue or tumor removal (see spec page 15, line 23; page 16, line 1; page 29, line 5) is suggested.
Claims 20 and 22 result in a process of computerized “performing” of additional treatment and/or surgery. The claims do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application.
Claim 19 is a computer medium. The claim do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea:
Acquiring, by a processor of the information processing system, first sequencing data associated with a first sample from a patient (claims 1, 20);
acquiring, by a processor of the information processing system, second sequencing data associated with a second sample from the patient (claims 1, 20);
acquiring, by a processor of the information processing system, third sequencing data associated with a third sample from the patient (claims 1, 20);
displaying, on the one or more of the plurality of user terminals, a notification regarding the type of additional treatment and/or surgery (claims 21 and 22. This step equates to data outputting);
A non-transitory computer-readable recording medium storing instructions (claim 19);
A system (claim 20);
An information processing system and a plurality of user terminals (claim 20);
A communication module (claim 20);
One or more processors (claim 20);
A memory (claim 20);
Detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph (claims 1 and 20); and
Performing, by the one or more of the plurality of user terminals, an additional treatment and/or surgery with a certain interval of time, and with a certain number of time, as indicated in result of the detection of the minimal residual disease (claim 1).
The above additional elements can be divided into three groups: 1) elements of sample and data acquiring (first five elements); 2) elements of displaying results (to the users) at the terminals (the 6th elements); 3) elements of computer systems and parts (the last 6 elements); and 4) treatment and/or surgery. Group 1 and group 2 additional elements are insignificant extra-solution activities as they are required for data inputting and outputting. Group 3 additional elements are merely executing abstract idea in the computer environment. Group 4 is generic and does not recite a particular treatment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are insignificant extra-solution activity or generic computer to execute abstract ideas.
The claims do not include additional elements that are sufficient to amount of significantly more than the judicial exception because it is routine and conventional to perform the acts of acquiring necessary data for analysis. Other elements of the method include hardware which are recitations of generic computer components that serve to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Applicant’s Arguments
In the Remarks (pages 9-13) filed 06/24/2025, Applicant argues that claims are not directed to abstract ideas (pages 10, 2nd para through penultimate para, page 11). Applicant further argues “the operations performed based the data of the machine learning process using the neural network model and the real world operations of performing the additional treatment and/or surgery with the certain interval of time, and with the certain number of time, as indicated in result of the detection of the minimal residual disease” (page 11, 2nd para). Applicant’s argument refers to Step 2A/Prong One in the 101 analysis. The argument is not persuasive.
As discussed above in the 101 rejection, the step “deciding, by the processor of the information processing system, a type of additional treatment and/or surgery, to be conducted for a target patient, based on a result of the detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph” (recited in both claims 1 and 20) recites a decision-making process based on a previously determined result in the first part, which reads on a human decision-making process based on data (information) provided. Hence this part equates to an abstract idea of mental process. Under a BRI, the “neural network model“ recited in the 2nd part is interpreted as artificial neural network.” The 2nd part “detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph” is directed to mathematical operations to fit the mathematical models inside the artificial neural network. Therefore the whole step is directed to abstract ideas of mental processes and mathematical concepts.
The real world operations of performing the additional treatment and/or surgery with the certain interval of time, and with the certain number of time is classified as an additional element. However, all of those steps are part of the abstract idea. They are leading up to the determination of residual disease. The result of these abstract idea steps is the final determination of the residual disease (which is also an abstract idea step). .The claims as a whole recite abstract ideas.
The determination of a minimum residual disease is not integrated into a particular treatment. The claims might be amended by reciting performing a particular treatment such as a particular tumor surgery that pertains to the determined MRD.
The system claims may need be cancelled because the disclosure has no support for a system that performs surgery.
In the Remarks (pages 11, last para through page 12, 4th para), Applicant argues that claims are integrated in a practical application. Applicant further argues that the operations determined by the neural network model and the real world operations of performing the additional treatment and/or surgery are both additional elements which integrate the claims into a practical application at Step 2A/Pong Two (page 12, 2nd para). Applicant’s argument is not persuasive.
As discussed above in the 101 rejection, the step “deciding, by the processor of the information processing system, a type of additional treatment and/or surgery, to be conducted for a target patient, based on a result of the detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph” (recited in both claims 1 and 20) recites a decision-making process based on a previously determined result in the first part, which reads on a human decision-making process based on data (information) provided. Hence this part equates to an abstract idea of mental process. Under a BRI, the “neural network model“ recited in the 2nd part is interpreted as artificial neural network”. The 2nd part “detection of the minimal residue disease, by using a machine learning process using a neural network model, which is implemented as collections of nodes that are connected in an acyclic graph” is directed to mathematical operations to fit the mathematical models inside the artificial neural network. Therefore the whole step is directed to abstract ideas of mental processes and mathematical concepts.
The real world operations of performing the additional treatment and/or surgery with the certain interval of time, and with the certain number of time is classified as an additional element. However, this additional element is too general in terms of treatment and/or surgery. It is equivalent to say “apply the result” received in the previous “transmitting” step. Further, this additional element does not capture the judicial exceptions completely. What if the detection of MRD is a negative result? To conduct an additional treatment and/or surgery when the MRD result is negative would be ridiculous.
Therefore, claims do recite additional elements and the additional elements do not integrate the abstract idea/judicial exception into a practical application.
In the Remarks (page 12, penultimate para), Applicant argued that claim 20 recites similar features (operations determined by the neural network model and the real world operations of performing the additional treatment and/or surgery) as argued above hence claim 20 recites patent-eligible subject matter. This argument is not persuasive, for the same reason (regarding the operations determined by the neural network model and the real world operations of performing the additional treatment and/or surgery) outlined above.
In the Remarks (page 12, last para), Applicant argued that both claims 1 and 20 recite patent-eligible subject matter and depend claims are patent-eligible too. This argument is not persuasive, for the same reason (regarding the operations determined by the neural network model and the real world operations of performing the additional treatment and/or surgery) outlined above.
Therefore, the 101 rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635