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 claims
Claims 1-20 have been reviewed and addressed below.
Response to Arguments/Arguments
Applicant’s amendments filed on 6-25-26 has been entered and are addressed below.
Applicant argues that the amended claims are no longer directed to mental process or organizing human activity since the amended claims now include a plurality of first machine-learning models is then trained on that sampled training dataset to generate an ensemble of diagnostic models. Examiner respectfully disagrees. The instant claim still recite certain methods of organizing human activity. The MPEP 2106.04(a) recites in the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the "certain methods of organizing human activity" grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings.
Applicant argues that the amended claims disclose technical solution to machine learning problem since the claims requires determining the ratio of negative labeled feature vectors to positive labeled feature vectors in the training dataset and using a specified sampling technique including stratified sampling to selected features vectors which is not merely a field of use limitation of generic instruction to apply a diagnostic idea on a computer. Examiner respectfully disagrees. The instant claims does not solve a machine learning problem, it uses specific data type to train a model, however that is how artificial learning/machine learning works, it continues to get updated information to evolve. Unlike Des Jardins where the invention integrates an abstract concept into a practical application that demonstrably improves how the computer or model functions, it is patentable, the instant claim uses a generic computer to execute the abstract idea using models to diagnose a risk of Addisons’ disease. The instant claim lacks actual implementation such as personalized treatment similar to that of Vanda or Classen.
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 1-20, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-20 are drawn to processor, diagnostic system, non-transitory computer storage medium, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claims 1, 11, 20 recite “receiving first medical training data wherein the received first medical training data includes laboratory test data and medical record data for a population of patients”, “extracting machine-usable feature vectors from the received first medical training data, the extracted machine-usable feature vectors including complete blood count (CBC) feature vectors and serum chemistry feature vectors to generate a training dataset, each feature vector having a positive label or a negative label associated therewith”, “determining a ratio of negative labeled feature vectors to positive labeled feature vectors in the training dataset”, “using a data sampling technique selected from a group including stratified sampling, importance sampling, and uncertainty sampling to select feature vectors from the training dataset such that a sampled training dataset has a predefined target ratio of negative labeled feature vectors to positive labeled feature vectors”, “training a plurality of machine learning models on the sampled training dataset to generate an ensemble of diagnostic models”, “receiving second medical training data the second medical training data being different from the first medical training data”, “training second machine learning model on the received second medical training data to generate a knowledge based diagnostic model”, “receiving new patient data from the one or more stored medical databases, wherein the new patient data includes CBC data and serum chemistry data”, “extracting new feature vectors from the new patient data, the new feature vectors including new CBC feature vectors and new serum chemistry feature vectors”, “determining whether the ensemble of diagnostic models indicates a risk of Addison’s disease for the new patient data based on the new feature vector”, “in case where the ensemble of diagnostic models indicates a risk for Addison’s disease for the new patient data, assessing the risk of Addison’s disease using the knowledge based diagnostic model”.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover mental process since the steps can be performed manually using a pen and paper. Additionally the claims can also be interpreted as certain methods of organizing human activity under specifically managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “one or more stored medical databases at least a patient databases and a laboratory test result database”, “processor”, “memory”, “non-transitory computer readable medium” which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the “processor” language is incidental to what it is “configured” to perform). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The claims does not recite the additional element which can be considered limitations directed to insignificant extra-solution activity that does amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. See: MPEP 2106.05(g). (g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
paragraph 39 that “data processing device system 110 includes one or more data processing devices that implement or execute, in conjunction with other devices, such as one or more of those in the system 100, control programs associated with some of the various aspects of the disclosure. Each of the phrases “data processing device,” “data processor,” “processor,” and “computer” is intended to include any data processing device, such as a central processing unit (“CPU”), a circuit, a field programmable gate array (FPGA), a desktop computer, a laptop computer, a mainframe computer, a tablet computer, a personal digital assistant, a cellular phone, and any other device configured to process data, manage data, or handle data, whether implemented with electrical, magnetic, optical, biological components, or the like”.
The claims does not recite the additional element which can be considered limitations directed to insignificant extra-solution activity that does amount to an inventive concept because the limitations do not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. See: MPEP 2106.05(g). (g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-9, 10-19, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid R. Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684
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