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 .
Response to Arguments
Applicant’s arguments concerning the previous § 101 rejections have been fully considered but are not persuasive.
Applicant’s first argument is that the steps recited in the claims here cannot be practically performed by the human mind. More specifically, Applicant argues that the human mind cannot practically perform the step of “receiving a plurality of health data” because it “may be in a number of different formats and of impracticable quantities.” The Examiner respectfully disagrees. The human mind is fully capable of receiving and analyzing a plurality of health data of a patient, such as information concerning their speech, eye motion, facial expressions, etc. For example, this kind of diagnostic evaluation is routine for healthcare workers such as nurses and doctors; a doctor can view and listen to a patient to observe (i.e. “receive”) their speech, eye and facial movements, etc. and then make mental determinations based on those observations, including (but not limited to) inferring the existence of one or more latent variables (i.e., based on the doctor’s own training and experience) and then drawing various conclusions such as diagnosing a health condition. The claims here do not specify formats or quantities that are impracticable for the human mind. To the extent that some dependent claims require data that is captured by sensors, the human mind is still fully capable of reviewing the data captured by those sensors, and thus can mentally “receive” the data captured by those sensors. The actual recitation of the sensors themselves is otherwise considered insignificant pre-solution activity because it merely collects the data necessary to carry out the mental process, as noted in the rejection.
Applicant’s second argument is that the additional elements in the claims here were excluded, ignored, or otherwise not given proper consideration in Step 2A, Prong Two, and/or Step 2B. The Examiner respectfully disagrees. As correctly noted by Applicant, the § 101 analysis effectively separates the claim into two parts: the judicial exception (e.g. mental process), and the “additional elements.” This is the treatment that was given to the claims in this application. Claim 1, for instance, recites a mental process including “receiving, as input … a plurality of health data … and/or a plurality of first order features …” and [determining] “a plurality of latent variables” and then [determining] “one or more biomarker and/or health condition …” The “additional elements” in claim 1 are all of the remaining elements other than the mental steps. In this case, those additional elements are the “pre-trained artificial neural network” and “a pre-trained learning system” and “to… output ….” The rejection explains how merely carrying out a mental process using these generic computing tools and outputting the result of the mental process does not amount to a practical application in Step 2A, Prong Two, and does not amount to “significantly more” than the mental process in Step 2B. No part of the claims was “excluded” from consideration.
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 1-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 1-35 are directed either to methods.
Step 2A, Prong One: The claims recite a mental process including steps such as generating latent variables (see e.g. claims 1-4) and generating a biomarker and/or health condition of a patient (see e.g. claims 1 and 3) and/or synthesizing at least one value (see e.g. claim 4), which are steps could be performed by the human mind and/or by a human with a physical aid such as pen and paper.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the step of “receiving” the various types of data is either itself a mental step (since a person can mentally receive data), and/or it is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process; the step of “to output …” is considered insignificant post-solution activity since it merely outputs the result of the mental process. Furthermore, merely carrying out mental steps using generic computing technology such as pre-trained artificial neural networks and/or pre-trained learning systems is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing technologies including pre-trained artificial networks and/or learning systems and generic data collection components. The Examiner previously took official notice that these are basic, generic components/models which are well-understood, routine and conventional in the medical diagnostic arts (e.g. pre-trained artificial neural networks are incredibly well known and commonly used in medical diagnostics), and the claims here merely use them for their well-understood, routine and conventional functions. Applicant’s subsequent reply did not traverse the Examiner's assertion of official notice; therefore, the facts under official notice are now taken to be admitted prior art. See MPEP § 2144.03(C) (“If applicant does not traverse the examiner' s assertion of official notice or applicant' s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner' s assertion of official notice or that the traverse was inadequate.”). As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Concerning dependent claims 5-27 and 34-35, these claims merely further specify the type of data received, which is merely a further limitation of the mental process itself (since the human mind is fully capable of receiving any of the listed types of data in claims 5-27 and 34-35), and/or a type of insignificant pre-solution activity of data gathering since it merely involves collecting the data necessary to carry out the mental process. As such, these claims fall under the same § 101 analysis above.
Concerning dependent claims 28-32, these claims merely further specify the type of data output from the mental process. In other words, they merely add mental steps and thus do not change the § 101 analysis above.
Concerning dependent claims 33, this claim merely (1) further specifies the type of data received, which is merely a further limitation of the mental process itself (since the human mind is fully capable of receiving two or more biomarkers and/or health conditions), and/or a type of insignificant pre-solution activity of data gathering since it merely involves collecting the data necessary to carry out the mental process; and (2) further specifies the type of data output from the mental process, which involves only a change in the mental steps. As such, this claim follows the same § 101 analysis as the independent claims above.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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