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 .
Claims 1-9 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 1-9 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 applications subject to pre-AIA 35 U.S.C. 112, 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 1 and 5 (and all claims dependent therefrom) recite the steps of “estimating binding free energy of the target interface by feeding, into a model for estimating binding free energy……” and additionally “wherein the model is implemented by a deep neural network” 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 the model (and deep neural network) processes the different data values to arrive at the result. In other words what algorithm is used for ingesting the atomic distance related to the target interface, atomic interaction force of the target interface and the relevant information to estimate binding free energy. The steps are clear with regards to the results they produce, but are not clear as to exactly how they are produced. There is no algorithm or prose equivalent recited for performing said estimation. Without defining the steps of the model (and deep nueral network) 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.
Furthermore, the specification (and fig. 3) only discloses a general framework for a DNN implementation involving an input layer, 3 hidden layers, and an output layer. The specification generally describes the hidden layers comprising a variety of neuron for the different layers (64, 32, and 16 respectively) wherein each is implemented by a rectified linear unit activation function. However there are many ways of implementing input layers, ReLU activation functions, and output layers wherein the multiple methods of implementation may lead to different results. Without guidance as to which method should be used renders the steps/system/claims indefinite. In addition, the specification does not provide any guidance on which method should be used or even whether the possible universe of methods is limiting. Because the variety of methods of implementing a DNN using the different layers (hidden layers implemented using ReLU activation functions) do not produce the same results, the method chosen for implementation could affect whether or not a given product infringes the claims (see CAFC Dow v Nova August 2015). 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 1-9 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 determining whether a fetus has a chromosomal aneuploidy or a generating a classification model for doing so without significantly more.
Analysis of independent claims 1:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-4 are directed to a method and claims 5-9 are directed to a system comprising a storage device and connected processor to implement the model on the storage device, 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 1 recites an abstract idea. In particular, the claim recites the following:
obtaining spatial coordinate sets data;
b. calculating Euclidean distances;
c. identifying interaction interfaces between residues;
d. selecting an interaction interface;
e. determining a mutant residue;
f. obtaining inferred rotation angles;
g. calculating spatial coordinate sets;
h. calculating a value of atomic-level energy and Euclidean distance based on the spatial coordinate sets for the target interfaces and every two heavy atoms respectively of the mutant residue and paired residue of the mutant protein complex;
i. calculating an atomic distance related to the target interface and an atomic interaction force of the target interface;
j. obtain relevant information that is related to the specific residue of the reference protein complex and mutant residue of the mutant protein complex from amino acid physicochemical properties data; and
k. estimating binding free energy of the target interface using a model and a deep neural network.
These elements recited in claims 1 and 5 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind using pen and paper and/or they involve mathematical concepts in the form of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations. The claims do not require overly large mutant protein complexes, so seemingly said method can be applied to short mutant protein complexes involving small numbers of amino acids making said claims capable of being performed using pen and paper.
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.
There are no identified limitations beyond the abstract idea above in claims 1-4 or beyond the use of a computer to implement the abstract idea (claims 5-9). Claims 5-9 have the same analysis as above, but with the addition of the method being carried out 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).
Therefore there is no identifiable 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).
Claims 1 and 5 do 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.
Therefore the claims do not appear to comprise limitations that integrate the exception into a practical application nor 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 the dependent claims:
Claims 2-4 and 6-9 depend from the independent claims. Claims 2 and 6-7 recite additional abstract steps of training the model using a plurality of training sets that respectively correspond to a plurality of training protein complexes, each of the training complexes including at least one pair of the training residues. The additional abstract step recited at such a high level of generality does not require any specifically undue complexity that cannot be performed with pen and paper by a person of ordinary skill in the art. Therefore, the additional step of training the model is considered part of the JE and does not either integrate the JE into a practical application nor add significantly to the JE.
The dependent claims 3-4 and 8-9 merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely describe additional details of calculations. Therefore, the additional 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