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 .
Specification
The disclosure is objected to because of the following informalities:
In ¶ 0081, “the analysis module 206” seems to be a grammatical error. Examiner recommends amending it to read -- the analysis module 20[[6]]4 --.
In ¶ 0087, “the analysis module 206” seems to be a grammatical error. Examiner recommends amending it to read -- the analysis module 20[[6]]4 --.
Appropriate correction is required.
Subject Matter Free of Prior Art
Claim(s) 2-7, 11-14, 16-20 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the dependent claims, in particular: “wherein determining the lung-cancer cure rates includes determining a decrease in a lung-cancer cure rate when the diagnostic workup was delayed by 90, 180, and 365 days between an initial scan and a subsequent scan for fast-growing non- small-cell-lung cancer (NSCLC), moderate-growing NSCLC, and slow-growing NSCLC, wherein scheduling the diagnostic workup is based on determining the decrease in the lung- cancer cure rates” and “estimating, using a fitted regression equation, an absolute change in the lung-cancer cure rates and a relative change in the lung- cancer cure rates for different initial tumor diameters and different delays in the diagnostic workup for fast-growing non-small-cell-lung cancer (NSCLC), medium-growing NSCLC, and slow-growing NSCLC.” Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in dependent claims 2, 6-7, 11, 16, claims 2, 6-7, 11, 16 are hereby deemed to be allowable over prior art. Originally numbered dependent claims 3-7, 12-14, 17-20 incorporate the allowable features of originally numbered dependent claims 2, 11, 16, through dependency, respectively.
However, the claims are still rejected under 101.
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(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a method which is within the four statutory categories (i.e., method). Claim 10 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 15 is drawn to a non-transitory computer-readable medium which is within the four statutory categories (i.e., manufacture).
Independent claim 10 (which is representative of independent claims 1, 15) recites… retrieving…data describing a size of nodules associated with lung cancer in individuals and a change in the size of the nodules after a plurality of time periods between scans of the nodules; determining lung-cancer cure rates for the individuals with lung cancer based on the plurality of time periods between scans of the nodules; receiving patient information associated with a patient that identifies that the patient has a patient nodule that is associated with lung cancer; determining whether the patient nodule is a fast-growing cancer based on the patient information; and responsive to determining that the patient nodule is the fast-growing cancer, prioritizing a scheduling of a diagnostic workup for the patient.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect and analyze data to schedule medical tests for a patient in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., computer to implement the method; a database). Claim 10 recites additional elements (i.e., A system comprising: a processor; and a memory coupled to the processor, with instructions stored thereon; a database). Claim 15 recites additional elements (i.e., A non-transitory computer-readable medium with instructions; one or more processors at a user device; a database). Looking to the specifications, a computer having a processor, memory with instructions stored thereon, non-transitory computer-readable medium with instructions is described at a high level of generality (¶ 0038; ¶ 0041-0045), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “a database” only invokes the data repository merely as a tool in its ordinary capacity to perform an existing process (i.e., storing, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only provides the input data for the performance of the abstract idea, and as such, amounts to insignificant extrasolution activity (i.e., mere data gathering), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computer having a processor, memory with instructions stored thereon, non-transitory computer-readable medium with instructions) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “a database” only invokes the data repository merely as a tool in its ordinary capacity to perform an existing process (i.e., storing, providing data), which does not impose meaningful limits on the scope of the claim and amounts to no more than a recitation of the words "apply it" (or an equivalent), and only provides the input data for the performance of the abstract idea, and as such, amounts to insignificant extrasolution activity (i.e., mere data gathering), which does not impose meaningful limits on the scope of the claim. Furthermore, receiving or transmitting data over a network, electronic recordkeeping, and storing and retrieving information in memory has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-9, 11-14, 16-20 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-9, 11-14, 16-20 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 9-10, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2018/0338741 A1 (hereinafter referred to as "Lyman") in view of U.S. Patent App. Pub. No. US 2019/0156947 A1 (hereinafter referred to as "Nakamura").
Regarding claim 1, Lyman teaches a computer-implemented method comprising:
receiving patient information associated with a patient that identifies that the patient has a patient nodule that is associated with lung cancer (Lyman: figure 8a, i.e., report data 830 mentions “a LungRADS score” for the “nodule…suspicious for malignancy” in visualization 825; ¶ 0051; i.e., “Some medical scans can include one or more abnormalities, which can be identified by a user or identified automatically. Abnormalities can include nodules”; ¶ 0131, i.e., “the medical scan assisted review system can retrieve a previous scan or a future scan for the patient from a patient database or from the medical scan database automatically or in response to the user electing to view past patient data”; ¶ 0132-0136);
determining whether the patient nodule is a fast-growing cancer based on the patient information (Lyman: figure 8a, i.e., report data 830 mentions “a doubling time of 100 days” for the “nodule…suspicious for malignancy” in visualization 825; ¶ 0134, i.e., “The medical assisted review system can automatically generate state change data such as a change in size, volume, malignancy, or other changes to various classifiers of the abnormality. This can be achieved by automatically comparing image data of one or more previous scans and the current scan and/or by comparing abnormality data of the previous scan to abnormality data of the current scan …state change data can be determined over time, and statistical data showing growth rate changes over time or malignancy changes over time can be generated, for example, indicating if a growth rate is…worsening over time”); and
responsive to determining that the patient nodule is the fast-growing cancer, prioritizing a scheduling of a diagnostic workup for the patient (Lyman: ¶ 0157, i.e., “The queue of scans can be displayed via the interactive interface 275 in an order based on an automatically generated priority score or a priority score retrieved from scan priority data 427 of the medical scan database 342. For example, the priority score can be…severity of previous diagnosis data of the scan, or severity of the diagnosis data 440 automatically generated for the medical scan, for example, based on a malignancy score indicated in diagnosis data 440”).
Yet, Lyman does not explicitly teach, but Nakamura teaches, in the same field of endeavor,
retrieving, from a database (Nakamura: ¶ 0096), data describing a size of nodules associated with lung cancer in individuals and a change in the size of the nodules after a plurality of time periods between scans of the nodules (Nakamura: ¶ 0097-0098);
determining lung-cancer cure rates for the individuals with lung cancer based on the plurality of time periods between scans of the nodules (Nakamura: ¶ 0044, i.e., “predictions 136 (e.g., prognosis, estimated disease recurrence rate, patient survival rates)”; ¶ 0062, i.e., “patient data is obtained from the respective data sources 122 and used to produce one or more generated automated insight results 125. From these generated insight results 125, various result data may be…provided in the form of findings 132, predictions 136”; ¶ 0080-0081);
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include retrieving, from a database, data describing a size of nodules associated with lung cancer in individuals and a change in the size of the nodules after a plurality of time periods between scans of the nodules; determining lung-cancer cure rates for the individuals with lung cancer based on the plurality of time periods between scans of the nodules, as taught by Nakamura, within the system of Lyman, with the motivation of “significantly assist within clinical decision support and improvement of accuracy in these and other clinical contexts” (Nakamura: ¶ 0061).
Regarding claim 9, Lyman and Nakamura teach the method of claim 1, wherein the patient information includes a computerized tomography (CT) scan that identifies the patient nodule (Lyman: abstract; ¶ 0050-0051).
Regarding claim 10, Lyman teaches a system comprising:
a processor; and
a memory coupled to the processor, with instructions stored thereon that, when executed by the processor, cause the processor to perform operations (Lyman: ¶ 0041; ¶ 0044; ¶ 0047)) comprising:
receiving patient information associated with a patient that identifies that the patient has a patient nodule that is associated with lung cancer (Lyman: figure 8a, i.e., report data 830 mentions “a LungRADS score” for the “nodule…suspicious for malignancy” in visualization 825; ¶ 0051; i.e., “Some medical scans can include one or more abnormalities, which can be identified by a user or identified automatically. Abnormalities can include nodules”; ¶ 0131, i.e., “the medical scan assisted review system can retrieve a previous scan or a future scan for the patient from a patient database or from the medical scan database automatically or in response to the user electing to view past patient data”; ¶ 0132-0136);
determining whether the patient nodule is a fast-growing cancer based on the patient information (Lyman: figure 8a, i.e., report data 830 mentions “a doubling time of 100 days” for the “nodule…suspicious for malignancy” in visualization 825; ¶ 0134, i.e., “The medical assisted review system can automatically generate state change data such as a change in size, volume, malignancy, or other changes to various classifiers of the abnormality. This can be achieved by automatically comparing image data of one or more previous scans and the current scan and/or by comparing abnormality data of the previous scan to abnormality data of the current scan …state change data can be determined over time, and statistical data showing growth rate changes over time or malignancy changes over time can be generated, for example, indicating if a growth rate is…worsening over time”); and
responsive to determining that the patient nodule is the fast-growing cancer, prioritizing a scheduling of a diagnostic workup for the patient (Lyman: ¶ 0157, i.e., “The queue of scans can be displayed via the interactive interface 275 in an order based on an automatically generated priority score or a priority score retrieved from scan priority data 427 of the medical scan database 342. For example, the priority score can be…severity of previous diagnosis data of the scan, or severity of the diagnosis data 440 automatically generated for the medical scan, for example, based on a malignancy score indicated in diagnosis data 440”).
Yet, Lyman does not explicitly teach, but Nakamura teaches, in the same field of endeavor,
retrieving, from a database (Nakamura: ¶ 0096), data describing a size of nodules associated with lung cancer in individuals and a change in the size of the nodules after a plurality of time periods between scans of the nodules (Nakamura: ¶ 0097-0098);
determining lung-cancer cure rates for the individuals with lung cancer based on the plurality of time periods between scans of the nodules (Nakamura: ¶ 0044, i.e., “predictions 136 (e.g., prognosis, estimated disease recurrence rate, patient survival rates)”; ¶ 0062, i.e., “patient data is obtained from the respective data sources 122 and used to produce one or more generated automated insight results 125. From these generated insight results 125, various result data may be…provided in the form of findings 132, predictions 136”; ¶ 0080-0081);
The obviousness of combining the teachings of Lyman and Nakamura are discussed in the rejection of claim 1, and incorporated herein.
Regarding claim 15, claim 15 recites substantially similar limitations analogous to those already addressed in claim 10, and thus, claim 15 is similarly analyzed and rejected in a manner consistent with the rejection of claim 10.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2018/0338741 A1 (hereinafter referred to as "Lyman") in view of U.S. Patent App. Pub. No. US 2019/0156947 A1 (hereinafter referred to as "Nakamura"), as applied to claims1, 9-10, 15, further in view of U.S. Patent App. Pub. No. US 2019/0177799 A1 (hereinafter referred to as "Gumireddy").
Regarding claim 8, Lyman and Nakamura teach the method of claim 1.
Yet, Lyman and Nakamura do not explicitly teach, but Gumireddy teaches, in the same field of endeavor, wherein the patient information is received responsive to sampling blood of a patient to identify a blood-based marker and determining that the blood- based marker indicates that the patient has the patient nodule (Gumireddy: ¶ 0018; ¶ 0021).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the patient information is received responsive to sampling blood of a patient to identify a blood-based marker and determining that the blood- based marker indicates that the patient has the patient nodule, as taught by Gumireddy, with the system of Lyman and Nakamura, with the motivation of “a non-invasive test for early detection of early stage lung cancer …to identify responders and non-responders in treatment and disease recurrence” (Gumireddy: ¶ 0021).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2022/0240881 A1 teaches determining a risk of lung cancer based on differences between time and size of nodules identified from imagines of the chest of a patient.
WO 01/78005 A2 teaches determining nodule size from chest images and correlating size with malignancy of lung cancer based on time.
“Dynamic Observation of Lung Nodules on Chest CT Before Diagnosis of Early Lung Cancer” teaches evaluating the size of lung nodules with respect to determining the advancement of the cancer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571) 272-8317. The examiner can normally be reached on M-Th 7-4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
