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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in Korea on 10/18/2022 and 11/24/2022. It is noted, however, that applicant has not filed a certified copies of the KR1020220134461 and KR1020220159560 applications as required by 37 CFR 1.55.
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.
Claim 11 is rejected under 35 U.S.C 101. The claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the broadest reasonable interpretation of “a computer readable recording medium” as disclosed in the specification as filed at para 0057 encompasses a signal and signals are non-statutory. Applicant is advised to amend the claim as “A non-transitory computer readable recording medium---” in-order to make the claim statutory.
Claims 1-3, 6-8 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent claim 1:
Step 1: Independent Claim 1 is directed to a method. Therefore, the claim is eligible under Step 1 for being directed to a process.
Step 2A Prong 1:
Claim 1 recite:
“identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure;”
Under its broadest reasonable interpretation in light of the specification, this limitation encompasses the mental process of evaluating data and generating an inference/prediction result based on judgement, which is an evaluation or observation that is practically capable of being performed in the human mind (i.e by a doctor) with the assistance of pen and paper.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because they recite the additional elements:
“receiving a medical image and clinical information; and predicting a disease occurrence based on the clinical information and the quantitative data.”
As per MPEP 2106.05(g) “receiving a medical image and clinical information- the step recited at a high level of generality, and amounts to mere data input/outputting which is well known which is a form of insignificant extra-solution activity (see MPEP § 2106.05(g)).
As per MPEP 2106.04 I. “and predicting a disease occurrence based on the clinical information and the quantitative data.” do not integrate the judicial exception into a practical application because the courts have identified the above limitations as. Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP 2106.05(h). Examiner notes that under MPEP section 2106.04(h) “Examples of limitations that the courts have described as merely indicating a field of use or technological environment in which to apply a judicial exception include: vi Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). In the instant application claim “predicting a disease occurrence based on the clinical information and the quantitative data” is limited to use the abstract idea to a particular environment (i.e medical diagnosis) and therefore do not integrate the judicial exception into a practical application.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
No additional elements are recited for the consideration under step 2B.
Accordingly, since the claims elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 1 is ineligible.
Dependent claim 2:
Step 2A Prong 1: The claim recites the abstract ideas of claim 1.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because they recite the additional elements:
The disease prediction method of claim 1, wherein the medical image is a computed tomography (CT) image.- the steps recited at a high level of generality, and amounts to mere data input/outputting which is well known which is a form of insignificant extra-solution activity (see MPEP § 2106.05(g)).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are thus directed to the abstract idea.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
No additional elements are recited for the consideration under step 2B.
Accordingly, since the claims elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 2 is ineligible.
Dependent claims 3:
Step 2A Prong 1: The claim recites the abstract ideas of claim 1.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because they recite the additional elements:
“ The disease prediction method of claim 1, wherein the clinical information comprises an electronic medical record and/or blood test information.
” - the steps recited at a high level of generality, and amounts to mere data input/outputting which is well known which is a form of insignificant extra-solution activity (see MPEP § 2106.05(g)).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are thus directed to the abstract idea.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
No additional elements are recited for the consideration under step 2B.
Accordingly, since the claims elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 3 is ineligible.
Dependent claims 6:
Step 2A Prong 1: The claim recites the abstract ideas of claim 1.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because they recite the additional elements:
“ The disease prediction method of claim 1, wherein the receiving comprises receiving clinical information of a predefined type according to a type of a disease.
” - the steps recited at a high level of generality, and amounts to mere data input/outputting which is well known which is a form of insignificant extra-solution activity (see MPEP § 2106.05(g)).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are thus directed to the abstract idea.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
No additional elements are recited for the consideration under step 2B.
Accordingly, since the claims elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 6 is ineligible.
Dependent claim 7:
Step 2A Prong 1: The claim recites the abstract idea of claim 1.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because they recite the additional elements:
“The disease prediction method of claim 1, wherein the receiving comprises: receiving the medical image from a picture archiving and communication system (PACS); and receiving the clinical information from an electronic medical record system (EMS).”- - the steps recited at a high level of generality, and amounts to mere data input/outputting which is well known which is a form of insignificant extra-solution activity (see MPEP § 2106.05(g)).
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are thus directed to the abstract idea.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
No additional elements are recited for the consideration under step 2B.
Accordingly, since the claims elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 7 is ineligible.
Independent claim 8:
Step 1: Independent Claim 8 is directed to an apparatus. Therefore, the claim is eligible under Step 1 for being directed to a machine.
Step 2A Prong 1: Independent Claim 8 recite:
“a quantitative analyzing unit configured to identify, from the medical image, quantitative data comprising a volume of at least one anatomical structure;”
an inference/prediction result based on judgement, which is an evaluation or observation that is practically capable of being performed in the human mind (i.e by a doctor) with the assistance of pen and paper.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because they recite the additional elements:
“
As per MPEP 2106.05(g) “
As per MPEP 2106.04 I. “and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). In the instant application claim “predicting a disease occurrence based on the clinical information and the quantitative data” is limited to use the abstract idea to a particular environment (i.e medical diagnosis) and therefore do not integrate the judicial exception into a practical application.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
“a receiving unit configured to, a quantitative analyzing unit configured to and a predicting unit configured to” are general purpose computing elements (i.e computer implementation of a method/steps) not amounting to be significantly more. As per MPEP2106.05(a) I. “It is important to note that for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally). Similarly, a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology. See RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1328, 122 USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data using image codes assigned to particular facial features held ineligible because the process did not require a computer).
Accordingly, since the claim elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 8 is ineligible.
Dependent claim 11:
Step 1: Claim 11 is directed to a computer-readable recording medium—depending from claim 1. Therefore, the claim is eligible under Step 1 for being directed to a manufacture.
Step 2A Prong 1: The claim recites the abstract idea of claim 1.
Step 2A Prong 2: This judicial exception is not integrated into a practical application because the claim do not recite the additional elements:
No additional elements are recited for the consideration under step 2A prong 2.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are thus directed to the abstract idea.
Step 2B: The claims do not include additional elements that amount to significantly more than the judicial exception.
No additional elements are recited for the consideration under step 2B.
Accordingly, since the claims elements do not amount to significantly more than the judicial exception and also these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. As such, the independent claim 11 is ineligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Taerum et al,. (US20200085382) hereafter Taerum (Single reference 103 as the claimed limitations are shown/disclosed in multiple figs/embodiments)
1. Regarding claim 1, Taerum discloses a disease prediction method (figs 3, 13, 17-18, 23-29 and 51, paras 0029-0034, 0294-0323, 0387-0389, shows and discloses a method for classifying/predicting a lesion/disease) comprising:
receiving a medical image and clinical information (fig 29 shows receiving the image data at step 2904 and clinical information at step 2910 (paras 0311-0324), meeting the claim limitations);
identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure (fig 29 step 2908 discloses extracting image features from the medical image loaded at step 2904 and figs 3, 13, 17-18 and 23, paras 0029-0034, 0387-0389 shows and discloses identifying, from the medical image, quantitative data (i.e segmentations of 3D volume of cancerous anatomical structures) comprising a volume of at least one anatomical structure, fig 54 also shows the lesions localized and segmented in the image (5402, 5406 and 5410) meeting the limitations of identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure); and
predicting a disease occurrence based on the clinical information and the quantitative data (paras 0023-0024, 0290, 0323, 0324 and fig 29 element 2918 shows “classify query lesion” i.e predicting a disease occurrence based on the clinical information 2910 (paras 0311-0324), and the quantitative data (i.e fig 29 step 2908 discloses extracting image features from the medical image loaded at step 2904 and figs 3, 13, 17-18 and 23, paras 0029-0034, 0133-0134, 0387-0389 shows and discloses identifying, from the medical image, quantitative data (i.e segmentations of 3D volume of cancerous anatomical structures) comprising a volume of at least one anatomical structure fig 54 also shows the lesions localized and segmented in the image (5402, 5406, 5408 and 5410) meeting the limitations of identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure)) meeting the claim limitations). Before the effective filing date of the invention was made, different figs/embodiments in Taerum are combinable. The suggestions/motivation would be a fast and accurate method/system at para 0131.
2. Regarding claim 2, Taerum discloses the disease prediction method of claim 1, wherein the medical image is a computed tomography (CT) image (fig 29 and para 0023, 0313 discloses the medical image is a CT image).
3. Regarding claim 3, Taerum discloses the disease prediction method of claim 1, wherein the clinical information comprises an electronic medical record (paras 0420, 0425 and 0430 disclose EMR meeting the claim limitations).
4. Regarding claim 4, Taerum discloses the disease prediction method of claim 1, wherein the identifying of the quantitative data comprises: separating the at least one anatomical structure from the medical image by using a first artificial intelligence model; and identifying the volume of the at least one anatomical structure (i.e fig 29 step 2908 discloses extracting image features from the medical image loaded at step 2904 and figs 3, 13, 17-18 and 23, paras 0029-0034, 0133-0134, 0387-0389 shows and discloses identifying, from the medical image, quantitative data (i.e segmentations of 3D volume of cancerous anatomical structures) comprising a volume of at least one anatomical structure fig 54 also shows the lesions localized and segmented in the image (5402, 5406, 5408 (i.e first intelligence model or CNN) and 5410) meeting the limitations of identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure)) meeting the claim limitations).
5. Regarding claim 5, Taerum discloses the disease prediction method of claim 1, wherein the predicting of the disease occurrence comprises inputting the clinical information and the quantitative data to a second artificial intelligence model configured to output a disease prediction value (figs 29, 54 and paras 0133-0135 wherein the predicting of the disease occurrence comprises inputting the clinical information and the quantitative data to a second artificial intelligence model configured to output a disease prediction value (i.e cancerous anatomical structures with values above 0.5 and below 0.5 are non-cancerous) meeting the above claim limitations).
6. Regarding claim 6, Taerum discloses the disease prediction method of claim 1, wherein the receiving comprises receiving clinical information of a predefined type according to a type of a disease (fig 29 and para 0305, 0311-0324 shows and discloses wherein the receiving comprises receiving clinical information of a predefined type according to a type of a disease (i.e cancer or not)).
7. Regarding claim 7, Taerum discloses the disease prediction method of claim 1, wherein the receiving comprises: receiving the medical image from a picture archiving and communication system (PACS); and receiving the clinical information from an electronic medical record system (EMS) (paras 0425, 0430 discloses PACS and EMR (i.e EMS) meeting the claim limitations).
8. Claim 8 is a corresponding apparatus claim of claim 1. See the corresponding explanation of claim 1. Figs 26, 29 and 62, para 0102 shows and discloses an apparatus/system.
9. Regarding claim 9, Taerum discloses the disease prediction apparatus of claim 8, further comprising: a first artificial intelligence model configured to separate the at least one anatomical structure from the medical image (i.e fig 29 step 2908 discloses extracting image features from the medical image loaded at step 2904 and figs 3, 13, 17-18 and 23, paras 0029-0034, 0133-0134, 0387-0389 shows and discloses identifying, from the medical image, quantitative data (i.e segmentations of 3D volume of cancerous anatomical structures) comprising a volume of at least one anatomical structure fig 54 also shows the lesions localized and segmented in the image (5402, 5406, 5408 (i.e first intelligence model or CNN) and 5410) meeting the limitations of identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure)); and a second artificial intelligence model configured to output a disease prediction value in response to an input of clinical information and quantitative data thereto (fig 29 step 2914 and paras 0315-0317, 0471 shows and discloses a second artificial intelligence model configured to output a disease prediction value in response to an input of clinical information and quantitative data thereto), wherein the quantitative analyzing unit is further configured to identify the quantitative data by using the first artificial intelligence model (i.e fig 29 step 2908 discloses extracting image features from the medical image loaded at step 2904 and figs 3, 13, 17-18 and 23, paras 0029-0034, 0133-0134, 0387-0389 shows and discloses identifying, from the medical image, quantitative data (i.e segmentations of 3D volume of cancerous anatomical structures) comprising a volume of at least one anatomical structure fig 54 also shows the lesions localized and segmented in the image (5402, 5406, 5408 (i.e first intelligence model or CNN) and 5410) meeting the limitations of identifying, from the medical image, quantitative data comprising a volume of at least one anatomical structure)), and the predicting unit is further configured to predict the disease occurrence by using the second artificial intelligence model (fig 29 step 2914 and paras 0315-0317, 0471 shows and discloses a second artificial intelligence model configured to output a disease prediction value (occurrence) in response to an input of clinical information and quantitative data).
10. Regarding claim 10, Taerum discloses the disease prediction apparatus of claim 9, wherein the first artificial intelligence model is a convolutional neural network (CNN) model (para 0023, fig 54 element 5408 is a first intelligence model), and the second artificial intelligence model is a gradient boosting machine (GMB) model (para 0471 discloses the one or more models as Gradient boosted decision trees (i.e GMB).
11. Claim 11 is a corresponding computer-readable recording medium claim of claim 1. See the corresponding explanation of claim 1. Para 0028 discloses non-transitory computer readable medium.
Examiner's Note: Examiner has cited figures, and paragraphs in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested for the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Examiner has also cited references in PTO892 but not relied on, which are relevant and pertinent to the applicant’s disclosure, and may also be reading (anticipatory/obvious) on the claims and claimed limitations. Applicant is advised to consider the references in preparing the response/amendments in-order to expedite the prosecution.
NOTE: For example NPL2 (Figs 1 and 3) is also obvious/anticipatory reference reading on the limitations of claims 1, 8 and 11.
Conclusion
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/JAYESH PATEL/
Primary Examiner
Art Unit 2677
/JAYESH A PATEL/Primary Examiner, Art Unit 2677
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