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 .
Status of the Claims
The office action is in response to the claims filed on September 18, 2025 for the application filed on May 24, 2024, which claims priority to Chinese Patent Application No. 2023-112520754 filed on September 26, 2023. Claims 1 – 2 have been cancelled, and new claim 3 has been added. Claim 3 has been examined as discussed below.
Priority
The certified copy of the foreign priority application was submitted on July 11, 2024, and it is a non-English language CN application (CN2023-112520754). When a claim to priority and the certified copy of the foreign application are received while the application is pending before the examiner, the examiner should review the certified copy to see that it contains no obvious formal defects and that it corresponds in number, date and country to the application identified in the application data sheet for an application filed on or after September 16, 2012, or oath or declaration or application data sheet for an application filed prior to September 16, 2012. See MPEP 215(I). Because the certified copy is a non-English language CN application, the Examiner is unable review the certified copy to determine whether it contains no obvious formal defects and whether it corresponds in number, date and country to the application identified in the application data sheet.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome the rejections because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP 215 and 216.
Accordingly, the Office requires that an English language translation of the associated non-English language CN application be filed, and submitted together with a statement that the translation of the associated certified copy is accurate.
Drawings
The color drawings must be of sufficient quality such that all details in the drawings are reproducible in black and white in the printed patent. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by:
the appropriate fee set forth in 37 CFR 1.17(h),
one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and,
unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). The scale to which a drawing is made must be large enough to show the mechanism without crowding when the drawing is reduced in size to two-thirds in reproduction. See 37 CFR 1.84(k). All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning. See 37 CFR 1.84(l).
Accordingly, the Office requires that a petition be filed under 37 CFR 1.84(a)(2) including the requirements under 37 CFR 1.84(a)(2)(i) through (iii) as copied above.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. New claim 3 recites the following elements: the “computer system,” “the one or more processors,” “the database,” and “the HCC recurrence risk prediction report,” which were not shown in the drawings of the original application as filed.
Therefore, “the computer system,” “the one or more processors,” “the database,” and “the HCC recurrence risk prediction report,” must be shown, or those features must be canceled from the claim. No new matter should be entered.
The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." See 37 CFR 184(u)(1).
In the instant application, on September 18, 2025, Applicant submitted four (4) replacement sheets of drawings (including 5 views). The drawings are objected to because: the first view on the first replacement sheet includes the label “(1)”, which should be replaced with the label “FIG. 1A”; the first view on the first replacement sheet also includes the text “Drawings”, which should be removed; the second view in the upper portion of the second replacement sheet includes the label “(2)”, which should be replaced with the label “FIG. 1B” and located closer to the second view on the upper portion of the second replacement sheet than the third view on the lower portion; the third view in the bottom portion of the second replacement sheet includes the label “FIG. 1” adjacent thereto, which should be removed.
The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in 37 CFR 184(g). These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking. See 37 CFR 184(t).
In the instant application, the drawings are objected to because:
the page number “1” located at the middle of the bottom of the first replacement sheet should be removed and the page number “1/4” should be added to the middle of the top of the first replacement sheet;
the page number “2” located at the middle of the bottom of the second replacement sheet should be removed and the page number “2/4” should be added to the middle of the top of the second replacement sheet;
the page number “3” located at the middle of the bottom of the third replacement sheet should be removed and the page number “3/4” should be added to the middle of the top of the third replacement sheet; and
the page number “4” located at the middle of the bottom of the fourth replacement sheet should be removed and the page number “4/4” should be added to the middle of the top of the third replacement sheet.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
the label “FIG. 1” in Paragraph [0017] should be replaced with “FIG. 1A”; and
the description “and constructing a risk assessment model to screen lecithin-cholesterol acyltransferase (LCAT) to be a recurrence gene of hepatocellular carcinoma (HCC)” in Paragraph [0017] should be removed; and
new paragraph [0017.1] should be added immediately after amended paragraph [0017] and before paragraph [0018] as follows:
[0017.1] FIG. 1B is a risk assessment model for applying lecithin-cholesterol acyltransferase (LCAT) to a recurrence gene of hepatocellular carcinoma (HCC).
the description “FIG. 1” in paragraph [0022] should be replaced with the description “FIGS. 1A and 1B”.
“the computer system,” “the one or more processors,” “the non-transitory computer readable storage medium,” “the database,” and “the HCC recurrence risk prediction report,” should be added to the relevant paragraphs of the detailed description because they are not disclosed in the original application as filed. In the alternative, the Office requests that Applicant confirm that the specific claim limitations of: “the computer system,” “the one or more processors,” “the non-transitory computer readable storage medium,” “the database,” and “the HCC recurrence risk prediction report,” are well known in the art. It is noted that Applicant argued (Seventh Paragraph on Page 5 of the Amendment filed September 18, 2025) that “the components such as processor, storage medium, database are commonly used for data processing“ are “known in the art.”
Claim Rejections - 35 USC § 112
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.
Claim 3 is 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 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 inventors, at the time the application was filed, had possession of the claimed invention. New claim 3 recites the following elements: “the computer system,” “the one or more processors,” “the non-transitory computer readable storage medium,” “the database,” and “the HCC recurrence risk prediction report,” which are not disclosed in the specification and were not disclosed in the original application as filed. While verbatim wording (I.e., using the same terms or in haec verba) is not necessary, Applicant must reply to indicate which paragraphs of the specification fully support the features of “the computer system,” “the one or more processors,” “the non-transitory computer readable storage medium,” “the database,” and “the HCC recurrence risk prediction report.”
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.
Claim 3 is 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.
Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the flowchart under MPEP 2016(III).
Eligibility Step 1:
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim as a whole falls within one of the statutory categories of invention (i.e., a process, machine, manufacture, or composition of matter). See MPEP 2106.03. In the instant application, claim 3 is directed to a system (i.e., a machine).
While claim 3 appears to fall within one or more statutory categories, the Office has determined that the full eligibility analysis is required because there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself. The Office has determined that eligibility of each claim is not self-evident at least because the claims do not recite any computer components whatsoever, and thus each claim as a whole does not appear to clearly improve a technology or computer functionality. To the contrary, each one of the claims as a whole seems to effectively seek coverage for a judicial exception itself.
Accordingly, it has been determined that claim 3 as a whole falls within one or more statutory categories under Step 1, and the Office proceeds with the full eligibility analysis (the Alice/Mayo test described in MPEP 2106(III)) as discussed below.
Eligibility Step 2A, Prong One:
Under Step 2A, Prong One of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim is directed to a judicial exceptions (i.e., a law of nature, natural phenomenon, or abstract idea). See MPEP 2106.04(II)(A)(1). After evaluation, it has been determined that claim 3 recites an abstract idea and thus are directed to a judicial exception.
Put another way, the test under Step 2A, Prong One does not require determining whether the claim includes limitations beyond judicial exceptions (as argued by Applicant in the Fourth Paragraph through Sixth Paragraph on Page 6 of the Amendment filed September 18, 2025). The test under Step 2A, Prong One is: “whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.” Step 2A, Prong One does not consider whether limitations beyond the judicial exception exist at all.
Claim 3 is determined to be directed to a judicial exception including abstract ideas (i.e., mathematical concept, mental process, and/or CMOHA). Claim 3 recites the abstract idea identified in bold limitations as:
A computer system for predicting recurrence of hepatocellular carcinoma (HCC) (mental process and/or CMOHA), comprising:
one or more processors;
a non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions; and
a database, configured to store Kyoto Encyclopedia of Genes and Genomes (KEGG) metabolism-related gene data from Gene Expression Omnibus (GEO);
wherein the computer-executable instructions, when executed by the one or more processors, cause the computer system to perform:
accessing and extracting a KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set;
based on the KEGG metabolism-related gene set, integrating a dataset in the GEO by a least absolute shrinkage and selection operator (LASSO) regression algorithm (mental process and/or CMOHA) to construct a risk assessment model; wherein constructing the risk assessment model follows one or more of risk probability, impact severity, and likelihood (mental process and/or CMOHA);
performing differential analysis on a postoperative tumor and surrounding normal tissue transcriptome sequencing data of a patient who undergoes hepatectomy, intersecting analysis results (mathematical concept, mental process, and/or CMOHA), and identifying LCAT as a high-risk recurrence gene for the patient (law of nature, mental process, and/or CMOHA);
generating an HCC recurrence risk prediction report based on the identified LCAT high-risk recurrence gene (mental process and/or CMOHA); and
transmitting the HCC recurrence risk prediction report to a user interface device and/or an electronic medical record system;
wherein the accessing and extracting the KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set comprises:
extracting the KEGG metabolism-related gene data in the GEO and integrating the KEGG metabolism-related gene data to obtain the KEGG metabolism-related gene data set; and
dividing the KEGG metabolism-related gene dataset by following a ratio of 6:1:1 of a training set, a verification set, and a test set (mathematical concept, mental process, and/or CMOHA).
Law of Nature:
Claim 3 recites the law of nature identified by the limitation in bold as “identifying LCAT as a high-risk recurrence gene for the patient” because it describes a naturally occurring relationship between a patient’s enzyme levels (i.e., a level of lecithin-cholesterol acyltransferase (LCAT)) and a phenotype (i.e., the patient’s risk of HCC recurrence). Thus, claim 3 recites a law of nature. See MPEP 2106.04(b) and Example 49 in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including Artificial Intelligence.
Mathematical Concept:
Claim 3 recites at least the abstract idea identified by the limitations in bold as “a least absolute shrinkage and selection operator (LASSO) regression algorithm,” “construct a risk assessment model; wherein constructing the risk assessment model follows one or more of risk probability, impact severity, and likelihood,” “performing differential analysis on a postoperative tumor and surrounding normal tissue transcriptome sequencing data of a patient who undergoes hepatectomy, intersecting analysis results,” and “dividing the KEGG metabolism-related gene dataset by following a ratio of 6:1:1 of a training set, a verification set, and a test set.” The broadest reasonable interpretation of these limitations require: organizing information and manipulating information through mathematical correlations (e.g., a least absolute shrinkage and selection operator (LASSO) regression algorithm, risk assessment model, difference analysis, etc.); mathematical equations (e.g., a risk assessment model); mathematical calculations (e.g., risk assessment model, difference analysis, etc.); and/or mathematical relationships (i.e., the ratio of 6:1:1 1 of a training set, a verification set, and a test set). Thus, claim 3 recites an abstract idea falling in the "mathematical concept" grouping. See MPEP 2106.04(a)(2)(I) and Example 49 in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence.
Mental Process:
Claim 3 recites at least the abstract idea identified by the limitations in bold as “predicting recurrence of hepatocellular carcinoma (HCC),” “a least absolute shrinkage and selection operator (LASSO) regression algorithm,” “construct a risk assessment model; wherein constructing the risk assessment model follows one or more of risk probability, impact severity, and likelihood,” “performing differential analysis on a postoperative tumor and surrounding normal tissue transcriptome sequencing data of a patient who undergoes hepatectomy, intersecting analysis results,” “identifying LCAT as a high-risk recurrence gene for the patient,” “generating an HCC recurrence risk prediction report based on the identified LCAT high-risk recurrence gene,” and “dividing the KEGG metabolism-related gene dataset by following a ratio of 6:1:1 of a training set, a verification set, and a test set.”
The combination of limitations identified in bold require an assessment of the gene data (i.e., on the postoperative tumor of the patient undergoing hepatectomy and on normal tissues surrounding the postoperative tumor) in order to identify informative gene data in evaluating patient recurrence risk and treatment. See MPEP 2106.04(a)(2)(III) and Example 49 in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence. For instance, an assessment of genes associated with LCAT high expression and inhibiting tumors may be used to evaluate the patient risk of recurrence (i.e., the LCAT high expression indicating a lower risk of HCC recurrence) and/or potential treatment (e.g., the LCAT high expression suppressing HCC recurrence). Furthermore, an assessment of MNK1 high expression in HCC tissues may be used to evaluate treatment (e.g., inhibition of MNK1 may suppress HCC recurrence). Thus, these limitations may be practically performed in the human mind using observation, evaluation, judgment, and opinion. Claim 3 does not recite any computer components (e.g., a processor, a memory, etc.) performing any of these activities, and nowhere in the specification is there any disclosure of those computer components. Even if claim 3 recited those computer components (which the Office does not concede), the claims would still amount to an abstract idea because no distinction should be made between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). There is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with tools such as pen and paper. Thus, these steps, individually or in combination, amount to an abstract idea in the "mental process" grouping.
CMOHA:
The limitations identified in bold in claim 3 above, individually or in combination, amount to acts of managing personal behavior (i.e., rules and instructions governing mental processes to be followed by a human). See MPEP 2106.04(a)(2)(II)). Thus, these steps, individually or in combination, amount to an abstract idea in the "CMOHA" grouping.
Therefore, the Office has determined that claim 3 recites judicial exceptions under Step 2A, Prong One.
Eligibility Step 2A, Prong Two:
Under Step 2A, Prong Two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claim recites any additional limitations individually or in combination that integrate a judicial exception (i.e., the identified abstract ideas) into a practical application. After evaluation, it has been determined that claim 3 does not recite any additional elements individually or in combination that integrate the abstract ideas into a practical application.
Claim 3 recites additional limitations identified in bold as:
A computer system for predicting recurrence of hepatocellular carcinoma (HCC), comprising:
one or more processors;
a non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions; and
a database, configured to store Kyoto Encyclopedia of Genes and Genomes (KEGG) metabolism-related gene data from Gene Expression Omnibus (GEO);
wherein the computer-executable instructions, when executed by the one or more processors, cause the computer system to perform:
accessing and extracting a KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set;
based on the KEGG metabolism-related gene set, integrating a dataset in the GEO by a least absolute shrinkage and selection operator (LASSO) regression algorithm to construct a risk assessment model; wherein constructing the risk assessment model follows one or more of risk probability, impact severity, and likelihood;
performing differential analysis on a postoperative tumor and surrounding normal tissue transcriptome sequencing data of a patient who undergoes hepatectomy, intersecting analysis results, and identifying LCAT as a high-risk recurrence gene for the patient;
generating an HCC recurrence risk prediction report based on the identified LCAT high-risk recurrence gene; and
transmitting the HCC recurrence risk prediction report to a user interface device and/or an electronic medical record system;
wherein the accessing and extracting the KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set comprises:
extracting the KEGG metabolism-related gene data in the GEO and integrating the KEGG metabolism-related gene data to obtain the KEGG metabolism-related gene data set; and
dividing the KEGG metabolism-related gene dataset by following a ratio of 6:1:1 of a training set, a verification set, and a test set.
Regarding the consideration under MPEP 2106.04(d)(2), none of the additional limitations are administering any treatment whatsoever – let alone a particular treatment. The claims merely provide necessary input data to the relevant audience (such as a physician or another medical professional) and at most adds a suggestion to take that necessary input data into account when treating patients. The additional limitations may thus be understood as no more than an attempt to generally link the judicial exception to a field of use. See MPEP 2106.05(h) and Example 49 in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence. Therefore, the additional limitations fail to meaningfully limit the claim because they do not require any particular application of the abstract idea and therefore amount only to a generic instruction to “apply” the exception or to a mere indication of the field of use or technological environment in which the abstract idea is performed.
Regarding the consideration under MPEP 2106.05(a), claim 3 as a whole does not “purport to improve the functioning of the computer itself" or "any other technology or technical field.” It is important to keep in mind that an improvement in the abstract idea itself is not an improvement in technology. See MPEP 2106.05(a)(II). To the contrary, claim 3 as a whole purports to improve only the abstract idea itself by applying the abstract idea in a computer environment (i.e., the computer system, the one or more processors, the non-transitory computer-readable storage medium storing computer-executable instructions, the database, etc.). Thus, it is determined that the additional elements individually or in combination fail to integrate the abstract ideas into a practical application under Step 2A, Prong Two.
Regarding the consideration under MPEP 2106.05(b), claim 3 merely adds generic computer components (i.e., the computer system, the one or more processors, the non-transitory computer-readable storage medium storing computer-executable instructions, the database, etc.) to perform conventional computer functions. It is important to note that a general purpose computer or generic computer components that apply a judicial exception, such as an abstract idea, by use of conventional computer functions do not qualify as a particular machine. See MPEP 2106.05(b)(1). Thus, claim 3 as whole does not integrate the exception into a practical application under Step 2A, Prong Two.
Regarding the consideration under MPEP 2106.05(f), claim 3 includes the additional limitations identified in bold as: “computer system,” “one or more processors,” “a non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions,” and “a database.” Looking at the additional limitations individually or in ordered combination, the Office has determined that claim 3 as a whole amounts to mere instructions to apply an abstract idea to computer components. For instance, claim 3 recites the abstract idea including the steps of identifying LCAT as a high-risk recurrence gene for the patient and generating an HCC recurrence risk prediction report based on the identified LCAT high-risk recurrence gene, and these steps are recited at a high level of generality such that the claim is no more than mere instructions to implement the abstract idea (i.e., CMOHA and mental processes) on generic computer components. Accordingly, for these additional reasons, claim 3 as a whole (including additional elements or in combination) do not integrate the abstract idea into a practical application under Step 2A, Prong Two.
Regarding the consideration under MPEP 2106.05(g), claim 3 includes the additional limitations identified in bold as “accessing and extracting a KEGG metabolism-related gene dataset from the database, … to obtain a KEGG metabolism-related gene set” and “extracting the KEGG metabolism-related gene data in the GEO … to obtain the KEGG metabolism-related gene data set” (i.e., gathering a set of gene data). These limitations are insignificant extra-solution activities that amount to well-known, necessary data gathering incidental to the main process of identifying LCAT as a high-risk recurrence gene for the patient and generating an HCC recurrence risk prediction report. Accordingly, these additional elements, individually or in ordered combination, amount to insignificant extra-solution activity and thus do not integrate the judicial exception into a practical application. See MPEP 2106.05(g) and Example 49 in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence.
Accordingly, in view of these considerations, the Office has determined that claim 3 do not have one or more additional limitations, individually or in combination, that integrate the abstract idea exception into a practical application under Step 2A, Prong Two.
Eligibility Step 2B:
Under Step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claims include an element or a combination of elements that are sufficient to amount to significantly more than the judicial exception (i.e., whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry). See MPEP 2106.05(II).
This evaluation is made with respect to the considerations that the Supreme Court has identified as relevant to the eligibility analysis, which are discussed in detail in MPEP 2106.05(a) through (h). See MPEP 2106.05(I)(A). Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. See MPEP 2106.05(II). Not all considerations will be relevant to every element, or every claim. Id. Although the conclusion of whether a claim is eligible at Step 2B requires that all relevant considerations be evaluated, most of these considerations were already evaluated in Step 2A Prong Two. Id. Thus, in Step 2B, examiners should:
Carry over their identification of the additional element(s) in the claim from Step 2A Prong Two;
Carry over their conclusions from Step 2A Prong Two on the considerations discussed in MPEP 2106.05(a) through (c), (e), (f) and (h);
Re-evaluate any additional element or combination of elements that was considered to be insignificant extra-solution activity per MPEP 2106.05(g), because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and
Evaluate whether any additional element or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d). Id.
Regarding claim 3, the Office carries over its identification of the additional elements from Step 2A, Prong Two so as to apply the same additional elements in Step 2B. See MPEP 2106.05(II). The Office further carries over conclusions from Step 2A, Prong Two on the considerations discussed in MPEP 2106.05(a) through (c), (e) through (h) so as to apply the same considerations in Step 2B.
The Office has re-evaluated the additional limitations considered to be insignificant extra-solution activity under MPEP 2106.05(g). The data gathering activities in limitations are recited at a high level of generality and have been recognized by the courts as being routine laboratory techniques. See Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1377 (Fed. Cir. 2016) (analyzing DNA to provide sequence information or to detect allelic variants is conventional in the art); MPEP 2106.05(d)(II); and Example 49 in the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence.
These limitations (i.e., when viewed individually or in ordered combination) simply amount to the well-understood conventional and routine process of using well-known computer technologies to construct a model for predicting the clinical outcome in hepatocellular carcinoma (HCC) patients. See NPL Engelmann (Pages 58 – 61). The limitations (i.e., when viewed individually or in ordered combination) represent insignificant conventional activities well-understood in the art of medical data mining and artificial intelligence diagnostics to predict recurrence of hepatocellular carcinoma (HCC) and is merely an attempt to limit the use of the abstract idea to a particular technological environment. Furthermore, the additional elements or combination of elements, other than the abstract idea per se, amount to no more than a recitation of:
A) Generic computer structure that serves to perform generic computer functions that serve to merely link the abstract idea to a particular technological environment.
B) Generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. determining, analyzing, and grouping).
Consequently, the Office has determined that each additional limitation is not unconventional or otherwise more than what is well-understood, routine, conventional activity in the field (i.e., the Office has determined that each additional limitation is conventional and thus merely well-understood, routine, conventional activity in the field). The additional limitations, individually or in combination with the judicial exception, do not provide an inventive concept; so, each one of the claims as a whole does not amount to significantly more than a generic instruction to “apply” the judicial exception. Therefore, this finding may not indicate that the additional limitations are no longer considered to be insignificant (i.e., the findings indicate that the additional limitations are still considered as insignificant).
Therefore, claim 3 is rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103(a) as being unpatentable over NPL Gu in view of Nakatsura (U.S. Pub. No. 2019/0066846 A1), and Popescu (U.S. Pub. No. 2022/0383986 A1).
Regarding claim 3, NPL Gu teaches the limitations identified in bold as:
A computer system for predicting recurrence of hepatocellular carcinoma (HCC), comprising:
one or more processors;
a non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions; and
a database, configured to store Kyoto Encyclopedia of Genes and Genomes (KEGG) metabolism-related gene data from Gene Expression Omnibus (GEO) (Page 2, Second Column of NPL Gu. In the instant application, the broadest reasonable interpretation of “Kyoto Encyclopedia of Genes and Genomes (KEGG) metabolism-related gene data from Gene Expression Omnibus (GEO)” reads on the activity in NPL Gu (Page 2, Second Column) of information on a total of 491 Lipid Metabolism-Associated Gene data (LMAGs) from the MSigDB and KEGG databases for subsequent analysis and identifying lipid metabolism associated gene subgroups by consensus clustering.);
wherein the computer-executable instructions, when executed by the one or more processors, cause the computer system to perform:
accessing and extracting a KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set (Page 2, Second Column of NPL Gu. In the instant application, the broadest reasonable interpretation of “accessing and extracting a KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set” reads on the activity in NPL Gu (Page 2, Second Column) of obtaining information on a total of 491 Lipid Metabolism-Associated Gene data (LMAGs) from the MSigDB and KEGG databases for subsequent analysis and identifying lipid metabolism associated gene subgroups by consensus clustering.);
based on the KEGG metabolism-related gene set, integrating a dataset in the GEO by a least absolute shrinkage and selection operator (LASSO) regression algorithm to construct a risk assessment model; wherein constructing the risk assessment model follows one or more of risk probability, impact severity, and likelihood (Page 2, Second Column of NPL Gu; Page 11, Second Column of NPL Gu. In the instant application, the broadest reasonable interpretation of “based on the KEGG metabolism-related gene set, integrating a dataset in the GEO by a least absolute shrinkage and selection operator (LASSO) regression algorithm” reads on the activity in NPL Gu (Page 2, Second Column) of utilizing Univariate Cox regression analysis to investigate the relationship between the overall survival (OS) and LMAG expression levels (i.e., data set) in patients with HCC, by performing LASSO Cox regression analysis (i.e., integrated by LASSO regression algorithm). The broadest reasonable interpretation of “to construct a risk assessment model; wherein constructing the risk assessment model follows one or more of risk probability, impact severity, and likelihood” reads on the activity in NPL Gu (Page 2, Second Column) of calculating the risk score of each HCC sample using the following equation (i.e., risk assessment model): risk score = β1 × Exp1 + β2 × Exp2 + βi × Expi, where Expi represents LMAG expression in HCC (i.e., possibility) and βi represents its coefficient (i.e., influence degree). The median risk score estimated by this equation was used to stratify patients with HCC, whose samples were retrieved from TCGA, into high- and low-risk groups (i.e., risk probability).);
performing differential analysis on a postoperative tumor and surrounding normal tissue transcriptome sequencing data of a patient who undergoes hepatectomy, intersecting analysis results, and identifying LCAT as a high-risk recurrence gene for the patient (Page 11, Second Column of NPL Gu; Page 12, Column 1 of NPL Gu. In the instant application, the broadest reasonable interpretation of “performing differential analysis on a postoperative tumor and surrounding normal tissue transcriptome sequencing data of a patient who undergoes hepatectomy, intersecting analysis results” reads on the activity in NPL Gu (Page 11, Second Column) comparing LMAGs expressed in HCC tissues to LMAGs expressed in normal tissues and correlating the LMAGs expressed in HCC tissues with immune cell infiltration. The broadest reasonable interpretation of “identifying LCAT as a high-risk recurrence gene for the patient” reads on the activity in NPL Gu (Page 11, Second Column) of screening and finding that LCAT is less active in patients with liver diseases, with LCAT being under-expressed in HCC, which may result in restricted cellular cholesterol efflux and an associated increase in the risk for ... liver cancer.);
generating an HCC recurrence risk prediction report based on the identified LCAT high-risk recurrence gene; and
transmitting the HCC recurrence risk prediction report to a user interface device and/or an electronic medical record system;
wherein the accessing and extracting the KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set (Page 2, Second Column of NPL Gu. In the instant application, the broadest reasonable interpretation of “accessing and extracting a KEGG metabolism-related gene dataset from the database, and processing the KEGG metabolism-related gene dataset to obtain a KEGG metabolism-related gene set” reads on the activity in NPL Gu (Page 2, Second Column) of obtaining information on a total of 491 Lipid Metabolism-Associated Gene data (LMAGs) from the MSigDB and KEGG databases for subsequent analysis and identifying lipid metabolism associated gene subgroups by consensus clustering.) comprises:
extracting the KEGG metabolism-related gene data in the GEO and integrating the KEGG metabolism-related gene data to obtain the KEGG metabolism-related gene data set (Page 2, Second Column of NPL Gu. In the instant application, the broadest reasonable interpretation of “l. extracting the KEGG metabolism-related gene data in the GEO and integrating the KEGG metabolism-related gene data to obtain the KEGG metabolism-related gene data set” reads on the activity in NPL Gu (Page 2, Second Column) of obtaining information on a total of 491 Lipid Metabolism-Associated Gene data (LMAGs) from the MSigDB and KEGG databases for subsequent analysis and identifying lipid metabolism associated gene subgroups by consensus clustering.); and
dividing the KEGG metabolism-related gene dataset by following a ratio of 6:1:1 of a training set, a verification set, and a test set.
NPL Gu does not appear to explicitly disclose, but Nakatsura teaches the limitation identified in bold as “a computer system for predicting recurrence of hepatocellular carcinoma (HCC)” (Paragraph [0014] of Nakatsura. In the instant application, the broadest reasonable interpretation of “the computer system for predicting recurrence of hepatocellular carcinoma (HCC)” reads on the computer in Nakatsura (Paragraph [0014]) provided with a computer program for acquiring data to assist prediction of recurrence risk for hepatocellular carcinoma patients.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and artificial intelligence diagnostics at the time of filing to modify the system and method of NPL Gu to include the computer system for predicting recurrence of hepatocellular carcinoma (HCC), as taught by Nakatsura (Paragraph [0014]) in order to continuously examine hepatocellular carcinoma patients after surgery because it is known that the recurrence rate of hepatocellular carcinoma patients as a whole is 70% or more in 3 years after surgery, even when treatment such as hepatectomy is performed (Paragraph [0002] of Nakatsura).
NPL Gu does not appear to explicitly disclose, but Nakatsura teaches the limitation identified in bold as “one or more processors” (Paragraph [0070] of Nakatsura. In the instant application, the broadest reasonable interpretation of “one or more processors” reads on the processor in Nakatsura (Paragraph [0070]).).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and artificial intelligence diagnostics at the time of filing to modify the system and method of NPL Gu to include the one or more processors, as taught by Nakatsura (Paragraph [0070]) in order to continuously examine hepatocellular carcinoma patients after surgery because it is known that the recurrence rate of hepatocellular carcinoma patients as a whole is 70% or more in 3 years after surgery, even when treatment such as hepatectomy is performed (Paragraph [0002] of Nakatsura).
NPL Gu does not appear to explicitly disclose, but Nakatsura teaches the limitation identified in bold as “a non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions” (Paragraph [0014] of Nakatsura. In the instant application, the broadest reasonable interpretation of “non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions” reads on the computer readable medium in Nakatsura (Paragraph [0014]) in which a computer program for making the computer execute steps for making a computer acquire data to assist prediction of recurrence risk for hepatocellular carcinoma patients.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and artificial intelligence diagnostics at the time of filing to modify the system and method of NPL Gu to include the non-transitory computer-readable storage medium, coupled in communication with the one or more processors; wherein the storage medium store computer-executable instructions, as taught by Nakatsura (Paragraph [0014]) in order to continuously examine hepatocellular carcinoma patients after surgery because it is known that the recurrence rate of hepatocellular carcinoma patients as a whole is 70% or more in 3 years after surgery, even when treatment such as hepatectomy is performed (Paragraph [0002] of Nakatsura).
NPL Gu does not appear to explicitly disclose, but Nakatsura teaches the limitation identified in bold as “a database, configured to store Kyoto Encyclopedia of Genes and Genomes (KEGG) metabolism-related gene data from Gene Expression Omnibus (GEO)” (Paragraph [0072] of Nakatsura. In the instant application, the broadest reasonable interpretation of “the database” reads on storage unit 302 in Nakatsura (Paragraph [0072]).).
Therefore, it would have been obvious to one of ordinary skill in the art of medical data mining and artificial intelligence diagnostics at the time of filing to modify the system and method of NPL Gu to include the database, configured to store Kyoto Encyclopedia of Genes and Genomes (KEGG) metabolism-related gene data from Gene Expression Omnibus (GEO), as taught by Nakatsura (Paragraph [0072]) in order to continuously ex