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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Response to Amendment
The amendment filed 11/12/2025 has been entered. Claims 1, 3-4, 7, 9-10, 12, 15-20, 23, 26-28, and 46-47 remain pending in the application.
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, 3-4, 7, 9-10, 12, 15-16, 19-20, 26-28, and 46-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Although the claims fall within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter), claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection as judicial exceptions.
Regarding claim 1, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “analyzing the at least one ultrasound image … to determine whether the at least one ultrasound image corresponds to a pathological class; and in response to determining that the at least one ultrasound image corresponds to a pathological class: preprocessing the at least one ultrasound image to produce a tensor; processing the tensor using a neural network to produce an intermediate tensor; the neural network comprising a depthwise separable convolutional neural network; downsampling the intermediate tensor to produce an output tensor, the downsampling comprising performing two-dimensional global average pooling; and processing the output tensor using an output neural network to generate a probability of presence of a first condition of the plurality of conditions in the at least one ultrasound image, the output neural network being different from the A-line versus B-line classifier and comprising a fully connected neural network with multiple output nodes.” This recitation, under its broadest reasonable interpretation, encompasses steps that are mental steps because analyzing the at least one ultrasound image and the determining can be done mentally while the other steps are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
The additional elements set forth in the claim “providing the at least one ultrasound image of the lung” and “analyzing … using an A-line versus B-line deep learning classifier” are pre-solution data gathering and mere instructions to implement the abstract idea on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 1 is therefore non-statutory and not patent eligible.
Regarding claim 3, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein the preprocessing further comprises selecting a still image from the video for use in the tensor.” This recitation, under its broadest reasonable interpretation, encompasses steps that can practically be performed in the mind, with the aid of pen/paper, or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform. The step is therefore deemed to recite a mental process type abstract idea.
The additional elements set forth in the claim “the at least one ultrasound image is a plurality of ultrasound images forming a video” is pre-solution data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 3 is therefore non-statutory and not patent eligible.
Regarding claim 4, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein the neural network is a depthwise separable convolutional neural network.” This recitation, under its broadest reasonable interpretation, further limits steps that are mathematical concept-type abstract ideas.
No additional elements set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 4 is therefore non-statutory and not patent eligible.
Regarding claim 7, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein the output tensor is one-dimensional.” This recitation, under its broadest reasonable interpretation, further limits steps that are mathematical concept-type abstract ideas.
No additional elements set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 7 is therefore non-statutory and not patent eligible.
Regarding claim 9, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein generating the probability further comprises generating an output classification vector, wherein the output classification vector represents a plurality of probabilities of each of the plurality of conditions.” This recitation, under its broadest reasonable interpretation, further limits steps that are mathematical concept-type abstract ideas.
No additional elements set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 9 is therefore non-statutory and not patent eligible.
Regarding claim 10, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of base claim that, under their broadest reasonable interpretation, encompasses steps that are mathematical concept-type abstract ideas.
The additional elements set forth in the claim “wherein the first condition is acute respiratory distress syndrome due to COVID-19 and wherein a second condition of the plurality of conditions is acute respiratory distress syndrome due to non-COVID-19 causes.” This recitation merely specifies the medical field without providing a practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 10 is therefore non-statutory and not patent eligible.
Regarding claim 12, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of base claim that, under their broadest reasonable interpretation, encompasses steps that are mathematical concept-type abstract ideas.
The additional elements set forth in the claim “wherein a third condition of the plurality of conditions is hydrostatic pulmonary edema.” This recitation merely specifies the medical field without providing a practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 12 is therefore non-statutory and not patent eligible.
Regarding claim 15, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of base claim that, under their broadest reasonable interpretation, encompass steps that are mathematical concept-type abstract ideas.
The additional elements set forth in the claim “wherein the at least one ultrasound image contains B-lines” is a limitation on pre-solution data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 15 is therefore non-statutory and not patent eligible.
Regarding claim 16, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “determining that the probability of the first condition exceeds a predetermined threshold.” This recitation, under its broadest reasonable interpretation, encompasses steps that can practically be performed in the mind, with the aid of pen/paper, or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform. The step is therefore deemed to recite a mental process type abstract idea.
No additional elements are set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 16 is therefore non-statutory and not patent eligible.
Regarding claim 19, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of base claim that, under their broadest reasonable interpretation, encompass steps that are mathematical concept-type abstract ideas.
The additional element set forth in the claim “wherein the at least one ultrasound image is obtained via a point-of-care ultrasound device” is pre-solution data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 19 is therefore non-statutory and not patent eligible.
Regarding claim 20, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “prior to processing the tensor, pre-training the neural network to obtain pre-trained weights by performing the obtaining the at least one ultrasound image, the preprocessing, the processing the tensor, the downsampling and the processing the output tensor”. This recitation, under its broadest reasonable interpretation, encompasses steps that are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
The additional elements set forth in the claim “wherein, during pre-training, the at least one ultrasound image is obtained from an image database” is pre-solution data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 20 is therefore non-statutory and not patent eligible.
Regarding claim 26, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein, during training, the downsampling further comprises applying dropout at a rate of about 0.6”. This recitation, under its broadest reasonable interpretation, encompasses steps that are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
No additional elements are set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 26 is therefore non-statutory and not patent eligible.
Regarding claim 27, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein, during training, the preprocessing further comprises performing an augmentation transformation to the at least one ultrasound image”. This recitation, under its broadest reasonable interpretation, encompasses steps that are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
No additional elements are set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 27 is therefore non-statutory and not patent eligible.
Regarding claim 28, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “wherein the augmentation transformation is selected from the group consisting of: random zooming by up to about 10%; horizontal flipping; horizontal stretching or contraction by up to about 20%; vertical stretching or contraction by up to about 5%; or rotation by up to about 100.” This recitation, under its broadest reasonable interpretation, encompasses steps that are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
No additional elements are set forth in the claim. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, Claim 28 is therefore non-statutory and not patent eligible.
Regarding claim 46, the claim is directed to a composition of matter and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “analyzing the at least one ultrasound image … to determine whether the at least one ultrasound image corresponds to a pathological class; and in response to determining that the at least one ultrasound image corresponds to a pathological class: preprocessing the at least one ultrasound image to produce a tensor; processing the tensor using a neural network to produce an intermediate tensor; the neural network comprising a depthwise separable convolutional neural network; downsampling the intermediate tensor to produce an output tensor, the downsampling comprising performing two-dimensional global average pooling; and processing the output tensor using an output neural network to generate a probability of presence of a first condition of the plurality of conditions in the at least one ultrasound image, the output neural network being different from the A-line versus B-line classifier and comprising a fully connected neural network with multiple output nodes.” This recitation, under its broadest reasonable interpretation, encompasses steps that are mental steps because analyzing the at least one ultrasound image and the determining can be done mentally while the other steps are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
The additional elements set forth in the claim “storing computer program instructions which, when executed by at least one processor, cause the at least one processor to carry out a method of processing data to distinguish between a plurality of conditions based on at least one ultrasound image of a lung, the method comprising:”, “obtaining the at least one ultrasound image of the lung from a subject”, and “using an A-line versus B-line deep learning classifier” are mere instructions to implement the abstract idea on a computer and pre-solution data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, claim 46 is therefore non-statutory and not patent eligible.
Regarding claim 47, the claim is directed to a machine and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites “analyze the at least one ultrasound image … to determine whether the at least one ultrasound image corresponds to a pathological class; and in response to determining that the at least one ultrasound image corresponds to a pathological class: preprocess the at least one ultrasound image to produce a tensor; process the tensor using a neural network to produce an intermediate tensor; the neural network comprising a depthwise separable convolutional neural network; downsampling the intermediate tensor to produce an output tensor, the downsampling comprising performing two-dimensional global average pooling; and processing the output tensor using an output neural network to generate a probability of presence of a first condition of the plurality of conditions in the at least one ultrasound image, the output neural network being different from the A-line versus B-line classifier and comprising a fully connected neural network with multiple output nodes.” This recitation, under its broadest reasonable interpretation, encompasses steps that are mental steps because analyzing the at least one ultrasound image and the determining can be done mentally while the other steps are mathematical concept-type abstract ideas. The claim describes a process of organizing information and manipulating information through mathematical correlations. The court explained that claims that describe a process of organizing information through mathematical correlations are directed to an abstract idea (MPEP 2106.04(a)(2).A.).
The additional elements set forth in the claim “a memory; and at least one processor configured to: obtain the at least one ultrasound image of the lung from a subject”, and “using an A-line versus B-line deep learning classifier”, are mere instructions to implement the abstract idea on a computer and pre-solution data gathering. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. 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.
For similar reasons set forth above with respect to integration, claim 47 is therefore non-statutory and not patent eligible.
Allowable Subject Matter
Claims 17-18 and 23 are allowed over prior art.
The following is an examiner’s statement of reasons for allowance:
Claims 17-18 and 23 are allowed because prior art fails to anticipate and/or render obvious, either solely or in combination a method, as recited in these claims.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but are not persuasive.
Response to the 35 U.S.C. §101 rejection arguments on pages 7-15 of the REMARKS.
Claims 1, 3-4, 7, 9-10, 12, 15-20, 23, 26-28, and 46-47
The Applicant argues that “The Examiner appears to be dismissing Director Squires comments in Ex parte Desjardins by arguing that each case is decided on its own facts.” (Page 9). The Examiner respectfully disagrees and notes that Examiner can only examine the facts of the case by following the MPEP -established claim analysis and updates to MPEP, and that now includes Ex parte Desjardins. However, the Applicant is reminded that Rule 1.132 declarations are a path to support subject matter eligibility of the claimed invention. The Applicant argues that “the claimed method improves the detection of subtle physical features in a lung which can be used to distinguish between similar appearing lung conditions… Accordingly, Applicant submits that the claimed subject matter as a whole, integrates the abstract idea into a practical application and therefore the claims are patent-eligible under the Second Prong of Step 2A.” (Pages 11-13). The Examiner respectfully disagrees and notes that the improvement is not evident at least because the invention as claimed in claims 1 and 46-47 lacks a recitation of training. It would be evident to a person of ordinary skill in the art that an untrained model could not be applied to improve the detection of subtle physical features in a lung. The Applicant argues that “the claimed subject matter, as a whole, recites meaningful limitations that provide an improvement to a field of technology and therefore are directed to significantly more than the alleged abstract idea” (Pages 13-14). The Examiner respectfully disagrees and notes that an inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). MPEP 2106.05.I. The additional limitations that are recited in amended claim 1 further limited the abstract idea. The additional elements set forth in amended claim 1 “providing the at least one ultrasound image of the lung” and “analyzing … using an A-line versus B-line deep learning classifier” are pre-solution data gathering and mere instructions to implement the abstract idea on a computer, not amounting to significantly more.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXEI BYKHOVSKI whose telephone number is (571)270-1556. The examiner can normally be reached on Monday-Friday: 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798
Prosecution Insights