DETAILED ACTION
Claims 1, 3-10, & 12-18 are currently pending and have been examined.
This action is in response to the amendment filed on 12/22/2025.
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 .
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 1, 3-10, & 12-18 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1 & 3-9 are directed to a method (i.e., a process); Claims 10 & 12-18 are directed to a system (i.e., a machine). Accordingly, claims 1, 3-10, & 12-18 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 10 includes limitations that recite at least one abstract idea. Specifically, independent claim 10 recites:
10. A system for predicting a clinical outcome of metabolic dysfunction-associated steatotic liver disease (MASLD), the system comprising:
a processor;
a computer-readable memory coupled to the processor and having instructions stored thereon that are executable by the processor to:
receive image data of a liver biopsy sample, the liver biopsy sample having MASLD;
generate an initial set of fibrosis parameters from the image data;
selecting a reduced set of fibrosis parameters from the initial set of fibrosis parameters using sequential feature selection, and
calculate an index indicative of the clinical outcome from the reduced set of fibrosis parameters using linear regression, wherein the clinical outcome comprises at least one selected from the group of an all-cause mortality, a hepatic decompensation, and a hepatocellular carcinoma.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because generating fibrosis parameters from an image and calculating an index based on the parameters based on the exam parameters are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or with pen and paper. In addition, the underlined claim limitations can also be interpreted as performing mathematical calculations. The generating and calculating steps encompass evaluation information to generate values, or parameters, which are then used to calculate index values. Applicant’s specification also states that the generating and calculating steps “manipulates and transforms data represented as physical quantities within the computer system into other data similarly represented as physical quantities”.
Accordingly, independent claim 10 and analogous independent claim 1 recite at least one abstract idea.
Furthermore, dependent claims 3-9 & 12-18 further narrow the abstract idea described in the independent claims. Claims 3-7 & 12-16 recite selecting a reduced set of parameters and calculating the index using the parameters; Claims 8 & 17 recite classifying a risk of clinical outcome using the index. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 10 and analogous independent claim 1, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
10. A system for predicting a clinical outcome of metabolic dysfunction-associated steatotic liver disease (MASLD), the system comprising:
a processor;
a computer-readable memory coupled to the processor and having instructions stored thereon that are executable by the processor to:
receive image data of a liver biopsy sample, the liver biopsy sample having MASLD;
generate an initial set of fibrosis parameters from the image data;
selecting a reduced set of fibrosis parameters from the initial set of fibrosis parameters using sequential feature selection, and
calculate an index indicative of the clinical outcome from the reduced set of fibrosis parameters using linear regression, wherein the clinical outcome comprises at least one selected from the group of an all-cause mortality, a hepatic decompensation, and a hepatocellular carcinoma.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the processor, memory, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of receive image data of a liver biopsy sample, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of transmitting data over a network (see MPEP § 2106.05(d)(II)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 10 and analogous independent claim 1 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 9 and 18: These claims recite the source of the image sample data and merely represent insignificant extra-solution activity (e.g., receiving and transmitting data)(see MPEP § 2106.05(g)) and conventional activities as they merely consist of receiving and transmitting data over a network (see MPEP § 2106.05(d)(II)).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 10 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitations of the processor, memory, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of receive image data of a liver biopsy sample, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of transmitting data over a network (see MPEP § 2106.05(d)(II)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Regarding the additional limitations of collecting various types of data which the Examiner submits merely adds insignificant extra-solution activity to the abstract idea, the Examiner has reevaluated such limitations and determined them to not be unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
Therefore, claims 1, 3-10, & 12-18 are ineligible under 35 USC §101.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-10, 12, & 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20150339816) in view of Margetts (WO2024256807).
As per claim 1, Yu teaches a method for generating a clinical outcome of metabolic dysfunction-associated steatotic liver disease (MASLD), comprising:
imaging a liver biopsy sample having MASLD to obtain image data (para. 6, 40-41: image data obtained for diagnosing various fibrosis related diseases including metabolic syndrome diseases);
generate an initial set of fibrosis parameters from the image data (para. 42: objects identified and values extracted);
selecting a reduced set of fibrosis parameters from the initial set of fibrosis parameters using sequential feature selection (para. 57-58: feature reduction performed), and
calculate an index indicative of the clinical outcome from the reduced set of fibrosis parameters using linear regression, wherein the clinical outcome comprises at least one selected from the group of an all-cause mortality, a hepatic decompensation, and a hepatocellular carcinoma (para. 18, 131, 159: index calculated based on parameters obtained using linear regression model; condition can be obtained including decompensated cirrhosis).
Yu does not expressly teach to predicting a clinical outcome using machine learning for liver disease.
Margetts, however, teaches to generating predictions for a patient’s liver based on analyzing features extracted from images (pg. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Margetts with Yu based on the motivation of accurately assess fatty infiltration, inflammation and scarring by human interpretation of ultrasound images (Margetts – pg. 1)
As per claim 3, Yu and Margetts teach the method as claimed in claim 1. Yu teaches wherein the index comprises an all-cause mortality index, and wherein the reduced set of fibrosis parameters comprises selected first parameters (para. 130-132: various index values calculated using selected parameters).
As per claim 5, Yu and Margetts teach the method as claimed in claim 1. Yu teaches, wherein the index comprises a hepatic decompensation index, and wherein the reduced set of fibrosis parameters comprises selected second parameters (para. 130-132: various index values calculated using selected parameters; the Examiner asserts that Yu does not specifically describe a hepatic decompensation index however the specific type of index is not functionally related to the functions of the system. Thus, this descriptive information will not distinguish the claimed invention from the prior art in terms of patentability, see Cf. In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 40, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994)).
As per claim 6, Yu and Margetts teach the method as claimed in claim 5. Yu teaches wherein the selected second parameters comprise one portal feature and four periportal features (Table 3; para. 115-117: features selected including portal, periportal; the Examiner asserts that Yu teaches to obtaining morphological features including identified collagen areas, normal collagen areas, abnormal collagen areas, portal tracts and central veins; a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close – see MPEP 2144.05(I)).
As per claim 7, Yu and Margetts teach the method as claimed in claim 1. Yu teaches wherein the index comprises a hepatocellular carcinoma index, and wherein the reduced set of fibrosis parameters comprises selected third parameters (para. 130-132: various index values calculated using selected parameters; the Examiner asserts that Yu does not specifically describe a hepatic decompensation index however the specific type of index is not functionally related to the functions of the system. Thus, this descriptive information will not distinguish the claimed invention from the prior art in terms of patentability, see Cf. In re Gulack, 703 F.2d 1381, 1385, 217 USPQ 40, 404 (Fed. Cir. 1983); In re Lowry, 32 F.3d 1579, 32 USPQ2d 1031 (Fed. Cir. 1994)).
As per claim 8, Yu and Margetts teach the method as claimed in claim 1. Yu teaches further comprising classifying a risk of the clinical outcome based on the index (para. 175: risk score calculated based on index values).
As per claim 9, Yu and Margetts teach the method as claimed in claim 1. Yu teaches wherein imaging the liver biopsy sample comprises a second harmonic generation/two-photon excitation fluorescence (SHG/TPEF) microscopy (para. 19: SHG TPEF imaging system).
Claims 10, 12, & 14-18 recite substantially similar limitations as those already addressed in claims 1, 3, & 5-9, and, as such, are rejected for similar reasons as given above.
Claims 4 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US20150339816) in view of Margetts (WO2024256807) as applied to claims 3 and 12 above, and in further view of Ng (“Second-Harmonic Generated Quantifiable Fibrosis Parameters Provide Signatures for Disease Progression and Regression in Nonalcoholic Fatty Liver Disease”).
As per claim 4, Yu and Margetts teach the method as claimed in claim 3. Yu teaches wherein the selected first parameters comprise two portal features, one peri-portal features (Table 3; para. 115-117: features selected including portal, periportal).
Yu and Margetts do not specifically describe parameters including zone 2 features.
Ng, however, teaches to extracting features from images of a liver including features such as collagen fibril characteristics in the Zone 2 region (pg. 2).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Ng with Yu and Margetts based on the motivation providing a more dynamic approach to fibrosis assessment beyond conventional ordinal staging approaches particularly in relatively short-term studies (Ng – pg. 6)
Claim 13 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
Response to Arguments
Applicant’s arguments on pages 7-13 regarding claims 1, 3-10, & 12-18 being rejected under 35 USC § 101 have been fully considered but they are not persuasive. Applicant claims that:
The claims do not recite a mental process because the human mind is not equipped to perform the features of the claims.
The Examiner, however, asserts that the Applicant has not demonstrated how the claim limitations underlined above cannot practically be performed in the human mind or with pen and paper. For example, a doctor or physician can view image data, extract relevant parameters from the image data, reduce the number of parameters they are evaluating, and generating a risk index for the patient using the parameters obtained. Furthermore, the underlined claim limitations above have been identified as being directed to mathematical concepts such as performing mathematical calculations.
The claims provide additional elements that provide a practical and meaningful application of the image data of the liver to provide a prediction of a clinical outcome and provide improvements to a technical field or technology which is significantly more.
The Examiner, however, asserts that the additional elements argued by Applicant have been identified as being part of the abstract idea. Furthermore, there is no indication here that the claimed invention addresses a problem specifically arising in the realm of computer technology; the Applicant does not provide adequate evidence or technical reasoning how the process improves the efficiency of the computer, as opposed to the efficiency of the process, or of any other technological aspect of the computer. Further, the problems the invention is attempting to solve are “predicting a clinical outcome of metabolic dysfunction-associated steatotic liver disease”. (citing Spec. ¶ 14). These are not technological problems, but healthcare diagnostic problems. The solution provided here has not been described or claimed as anything more than a generic use of existing technology performing based, purely conventional functions of a computer. Therefore, the Examiner asserts that the claims as a whole are not directed significantly more than an abstract idea.
Applicant' s arguments with respect to the 35 U.S.C. § 103(a) rejection on pages 13-16 in regards to claims 1, 3-10, & 12-18 have been considered but are moot in view of the new ground(s) of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brozek (US20210192722) teaches an integrated, automated data management and analysis pipeline for the assessment of NASH disease activity, NASH fibrosis score, and hepatic fibrosis.
Cales (US20170215814) teaches to a method for automatically highlighting lesions or morphometric data on a medical image, based on dynamic enhanced digitized images and image analysis.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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, Anita Coupe can be reached at 571-270-7949. 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.
/Jonathan Ng/ Primary Examiner, Art Unit 3619