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 .
Applicant’s cancellation of claims 1-60, 63-73, 76-77, 82, 87-90, 92-103, 106-111, 113, and 115 in the response filed 10/17/2023 is acknowledged.
Claims 61, 62, 74, 75, 78-81, 83-86, 91, 104, 105, 112, 114, and 116-118 are the current claims hereby under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 61, 62, 74, 75, 78-81, 83-86, 91, 104, 105, 112, 114, and 116-118 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
A claim fails to satisfy the statutory requirement and is thus invalid for indefiniteness if its language, when read in light of the specification and the prosecution history, “fail[s] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014). In Nautilus, the Supreme Court expressly rejected that “insolubly ambiguous” or “amenable to construction” standard. Nautilus, 134 S. Ct. at 2124. Rather, the Court “h[e]ld that a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Id. The Court explained further: “[i]t cannot be sufficient that a court can ascribe some meaning to a patent’s claim; the definiteness inquiry trains on the understanding of a skilled artisan at the time of the patent application, not that of a court viewing matters post hoc.” Id. at 2130. “A patent must be precise enough to afford clear notice of what is claimed, thereby ‘appris[ing] the public of what is still open to them. Notably a claim is indefinite if its language “might mean several different things and no informed and confident choice is available among the contending definitions.” Id. At 2130 n.8. Although the Court recognized that “[s]ome modicum of uncertainty” may be tolerated, id. at 2128, the patent and prosecution history must disclose a single known approach or establish that, where multiple known approaches exist, a person having ordinary skill in the art would know which approach to select. See Teva, 789 F.3d at 1341, 1344–45 (holding claim indefinite where molecular weight could be measured three different ways and would yield different results and the patent and prosecution history did not provide guidance as to which measure to use).
Claims 61 and 116-117 (and all claims dependent therefrom) recite the steps of using a predictive model comprising at least one trained machine learning model wherein each particular machine learning model is trained based on the machine learning model processing of a set of features extracted from molecular data processing to generate first data indicating whether a cancer in a subject is likely to metastasize wherein the steps have been deemed as vague and indefinite. The instant claims are process claims and not result claims. Therefore, the steps are required to define how the process steps end in the recited results. For example, the claims are required to define how each of possible machine learning models achieve the result of indicating a likelihood of metastasis and what algorithms are used for achieving said result. The steps are clear with regards to the results they produce (e.g. data indicative of the likelihood of a cancer being metastatic), but are not clear as to exactly how they are produced. The claims also indicate that this is done using a predictive model comprising at least one machine learning model and wherein each particular machine learning model is trained using the particular machine learning model processing of the set of features extracted from molecular data. However, again, there is no algorithm or prose equivalent recited for performing said training of a single machine learning model or for the various possible machine learning models or for the machine learning processing of the set of features extracted from molecular data. Without defining each of the steps of using a predictive model that comprises at least one trained machine learning model using machine learning processing to determine the likelihood of metastasis it is not possible to have a clear measure of what applicant’s regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability. The lacking of properly defined method steps further makes the scope of the claim unclear so that a person of ordinary skill in the art would be informed of the boundaries of what constitutes infringement of the patent. Clarification via clearer claim wording is required.
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 61, 62, 74, 75, 78-81, 83-86, 91, 104, 105, 112, 114, and 116-118 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a method, non-transitory instructions, and system for predicting whether a cancer is likely to metastasize without significantly more.
Analysis of independent claims 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 61 is directed to a method and claims 116 and 117 are directed to computer program stored on and executed by the computer, which describes one or more of the four statutory categories of patentable subject matter, i.e., a process/machine. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 61 recites an abstract idea. In particular, the claim recites the following:
a. obtaining data;
b. generating features; and
c. using a predictive model comprising at least one trained machine learning model to determine likelihood of a cancer being metastatic;
These elements recited in claim 61 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper and/or they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations.
Step A involves the mental of obtaining data, which can be performed mentally or using pen and paper. Steps B and C at the recited high level of generality involve the mental and/or mathematical steps of generating data and using it in a trained machine learning model to determine a likelihood of a cancer being metastatic.
The identified abstract steps, recited at the high level of generality, do not suggest an undue level of complexity for a person with ordinary skill in the art to be practically performed in the human mind with the aid of pen and paper.
Prong Two: Claim 1 does not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea.
The additional elements merely:
a. Add insignificant extra-solution activity (e.g. output the determined data to a display).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 61 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all additional elements are directed to insignificant post-solution activity, which merely facilitates the abstract idea. Furthermore, the additional element is simply the addition of an element that is considered routine, conventional, and well-known (e.g. displaying data).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Analysis of other independent claims 116 and 117:
Claims 116-117 have the same analysis as above, but with the addition of the method being carried out on a program stored on a computer. Patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment. In the instant claims, the computer and/or program/product amount to mere instruction to implement an abstract idea. The hardware recited by the system claims do not offer a meaningful limitation beyond generally linking “the use of the method to a particular technological environment,’ that is, implementation via computers.” see Alice Corp v. CLS Bank Int’l 573 U.S. (2014).
Analysis of the dependent claims:
Claims 62, 74, 75, 78-81, 83-86, 91, 104, 105, 112, 114, and 117, depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely describe additional details of the acquired type of data, types of cancer, or types of samples the data was generated from. Therefore, the limitations are not considered to integrate the JE into a practice application nor add significantly to the JE itself.
Conclusion
No claim is allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Sims, whose telephone number is (571)-272-7540.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jonathan Moffat can be reached via telephone (571)-272-4390.
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the Central PTO Fax Center. The faxing of such papers must conform with the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central PTO Fax Center number is (571)-273-8300.
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/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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