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 .
The following is a non-final, first office action on the merits, in response to application filed 5/17/2022. Claims 1-9 have been examined and are currently pending.
Priority
No benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is claimed or acknowledged.
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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Alice Corp. also establishes that the same analysis should be used for all categories of claims, regardless of a system/apparatus, a method, or a product claim.
The claimed invention (Claims 1-9) is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea “of itself”, which have been identified/found by the courts as abstract ideas in new 101 memos of the subject matter eligibility in here (https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility) including 2019 Revised Patent Subject Matter Eligibility Guidance. This judicial exception is not integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it/they is/are recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-9 are directed to a method (i.e., a process). Accordingly, claims 1-9 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Step 2A-Prong One
Independent claim 1 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, and “Mental process”.
Claim 1, Steps of,
combining a plurality of cancer characteristics into a characteristic assembly of SPC risk evaluation;
obtaining clinical data of a plurality of first participants corresponding to the characteristic assembly of SPC risk evaluation to establish a database of SPC risk evaluation;
entering the database of SPC risk evaluation into a machine learning algorithm;
using the machine learning algorithm to establish a SPC risk evaluation model;
using a characteristic interpreter to analyze the SPC risk evaluation model;
calculating a risk value of each cancer characteristic;
presenting the risk values in graphics to establish a clinical decision support system with visualization;
obtaining clinical data of a plurality of second participants corresponding to the characteristic assembly of SPC risk evaluation;
inputting the clinical data into the clinical decision support system;
using the machine learning algorithm for comparison and analysis;
predicting risk for SPC;
calculating a risk value of each cancer characteristic with respect to each second participant;
presenting the risk values on the clinical decision support system using visualization;
giving suggestions of decreasing the risk for SPC with respect to each cancer characteristic; and
monitoring changes of the risk for SPC based on the presentation shown on the clinical decision support system.
fall within “Certain Methods of Organizing Human Activity” grouping of abstract idea because the instant claims recite “combining data, obtaining data, inputting data, using an algorithm, predicting risk, calculating risk value, presenting data, giving suggestions,, monitoring risk changes“ which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer/a device.
The instant claim 1 also falls within “a mental process” because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). As an example, a person could practically in their mind (e.g., with pen and paper) review various types of collected “clinical data, patient characteristics” to enter data into database/algorithm/a system, to observe/use existing machine learning model/analyzer to predict the risk, to observe/calculate a risk value, to observe/present/display the risk value, to observe/suggest/adjust the risk, and to observe/monitor the changes.
Additionally, the instant claim 1 is substantially drawn to mathematical concepts. As to the calculating limitations, they are used similarly/formulas to computations using math to do so. If a claim limitation, under its broadest reasonable interpretation, covers mathematical concepts, then it falls within the "(a) Mathematical concepts" grouping of abstract ideas (2019 PEG Step 2A, Prong One: Abstract Idea Grouping? = Yes, (a) Mathematical concepts).
Accordingly, the claim recites at least one abstract idea.
In addition, steps of “obtaining data/inputting data/presenting data” is insignificant extra-solution activity as they are merely collecting data, providing data, and displaying data/sending data.
Subject Matter Eligibility Criteria - Step 2A - Prong Two:
Independent claim 1, Step 2A (Prong II): Accordingly, the claim recites an abstract idea(s) as pointed out above. This judicial exception(s) is/are not integrated into a practical application. In particular, the claim recites additional element (a system, a database, a machine learning algorithm (merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished, see MPEP § 2106.05(f))). There are no hardware/computer to actually perform the steps. Other than reciting “using a machine learning algorithm”, nothing in the claim element precludes the step from practically being performed in the human mind or by paper and pen. There is no specificity regarding any technology, just broadly, executing the programming instructions, couple of databases to store data, to receive/provide/present data over internet, calculating and monitoring data.
It should be noted the limitations of the method claims are claimed as being performed by a processor/a computer recited in method claim 1 and reciting them as though they are performed by the generically recited physical computing device does not constitute an improvement to another technology or technical field. The limitations are merely instructions to implement the abstract idea on a computer and require no more than a generic computer to perform generic computer functions such as determining data, and generating data that are well-understood, routine and conventional activities previously known to the industry.
Thus, the computing system/processor are not an essential element to actually create, change, or display functionality, and is simply used as a tool to automate the mental tasks. Applicant simply use a generic computer/processor/server/computing device as a tool to implement the abstract ideas. The Examiner notes the instant claimed invention is in fact merely carried out by a generically recited computing platform; that is, essentially any computing system as seen in the applicant’s specification. The additional element limitations are simply a field of use that attempt to limit the abstract idea to a particular technological environment. The type of information being manipulated does not impose meaningful limitations or render the idea less abstract. Further the courts have found that simply limiting the use of the abstract idea to a particular environment does not add significant more.
Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. There is neither improvement to another technology or technical field nor an improvement to the functioning of the computer itself, and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Subject Matter Eligibility Criteria - Step 2B:
Independent claim 1 (step 2B): The additional element (i.e. a system, a database, a machine learning algorithm), is recited at high level of generality and are generic computing components, and add nothing of substance to the underlying abstract idea; thus, they are not significantly more than the identified abstract idea.
This component is merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer/device components recited as performing generic computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/store/transmit/send/display information does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
Regarding Step 2B, representative independent claim 1 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.
Regarding the additional limitations of the memory and processing device, the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of how the “establish a SPC rick evaluation model” is performed using a “machine learning algorithm,” the Examiner submits that this limitation amounts to merely reciting the idea of a solution or outcome without reciting details of how a solution to a problem is accomplished which is equivalent to the words “apply it” (see MPEP § 2106.05(f)).
Furthermore, the reciting of “using the machine learning algorithm” merely as a tool to perform an existing AI/machine learning model/process and/or merely adding the words "apply it" to the judicial exception. See MPEP 2106.05(f).
(1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished.
(2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process.
(3) The particularity or generality of the application of the judicial exception.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Dependent claims 2-9, are merely add further details of the abstract steps/elements recited in claim 1 without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 2-9 are also non-statutory subject matter.
Viewed as a whole, the claims (1-9) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Thus, the claims do NOT recite limitations that are “significantly more” than the abstract idea because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment.
Therefore, claims 1-9 are ineligible under 35 USC §101, and is non-statutory subject matter.
Prior Art Rejection
A search of publicly available prior art fails to yield a reference or combination of references that would make the claimed combination obvious when considered as a whole.
Independent claims 1, as a whole, recite a combination of limitations that has Not been found as define over prior art of record (the combination of
NPL-1, Jégu et al. “The effect of patient characteristics on second primary cancer risk in France “, BMC Cancer 2014, 14:94, http://www.biomedcentral.com/1471-2407/14/94 (Year: 2014),
NPL-2, Cavers D, Duff R, Bikker A, Barnett K, Kanguru L, Weller D, Brewster DH, Campbell C. Patient and GP experiences of pathways to diagnosis of a second primary cancer: a qualitative study. BMC Cancer. 2021 May 3;21(1):496. doi: 10.1186/s12885-021-08238-0. PMID: 33941114; PMCID: PMC8094599. (Year: 2021),
NPL-3 Herman M, Liu Z, Shepherd FA, Leighl N, Liu G, Bradbury PA. The effect of prior cancer on non-small cell lung cancer trial eligibility. Cancer Med. 2021 Jul;10(14):4814-4822. doi: 10.1002/cam4.4049. Epub 2021 Jun 18. PMID: 34145985; PMCID: PMC8290254. (Year: 2021),
Cohen et al. (WO 2016/094330), Domingez et al. (US 2016/0342764), Lee et al. (US 2021/0210177), and Czerniecki et al. (US 2021/0375472).
The prior art made of record and relied upon is considered pertinent to applicant’s disclosure.
Yu et al. (US 2020/0126636, provides a method of treating a patient having cancer, to determine concentrations of multiple clinicopathological markers of the patient; and to provide, to a gradient boosting machine learning model, the determined concentrations of the multiple clinicopathological markers),
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN M LI whose telephone number is (571)270-5489. The examiner can normally be reached on Mon-Thurs, 8:30am--5pm. Fax is 571-270-6489.
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/SUN M LI/Primary Examiner, Art Unit 3685