DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In January, 2019 (updated October 2019), the USPTO released new examination guidelines setting forth a two-step inquiry for determining whether a claim is directed to non-statutory subject matter. According to the guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g., an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that the claims are directed toward non-statutory subject matter, as shown below:
STEP 1: Do the claims fall within one of the statutory categories? Yes.
Claims 1-19 are directed towards a method, i.e., process.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? Yes, the claims are directed to an abstract idea.
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
1. Mathematical concepts — mathematical relationships, mathematical formulas or equations, mathematical calculations;
2. Certain methods of organizing human activity - fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
3. Mental processes - concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
Claim 1 is directed to the abstract idea and/or mental steps as follows:
First Prong:
(a) accessing with a computer system, magnetic resonance imaging (MRI) data acquired from a subject with an MRI system; (b) accessing with the computer system, magnetic resonance fingerprinting (MRF) data acquired from the subject, wherein the MRF data comprise quantitative parameter maps; (c) generating labeled MRI data and labeled MRF data with the computer system by identifying tumor regions in the MRI data and the MRF data and labeling the identified tumor regions; (d) performing radiomic analysis on the labeled MRI data and the labeled MRF data using the computer system, generating output as radiomic feature data; (hereinafter mentioned as “Mental-Steps/Calculations’).
(These limitations can be performed by mental steps using mathematical formulas that can also be performed using a general processor)
Second Prong:
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
The claimed Mental-Steps/Calculations above is neither implemented into any practical application (device or thing), nor effect any transformation/reduction of a particular article to a different state or thing.
STEP 2B: The Additional elements “generating a report based on the radiomic feature data using the computer system” in the independent claim 1 could be consider as not significantly more than the abstract idea because “generating a report based on the radiomic feature data using the computer system” appears to be post-solution activity and data gathering required to implement the abstract idea of preprocessing and data gathering. These additional elements do not amount to significantly more than the abstract idea. Furthermore “generating a report based on the radiomic feature data using the computer system” is insignificant extra solution activity and is routine, conventional and well known in the art. US PG Pub 2020/0341102 A1 discloses generating a report based on the radiomic feature data using the computer system in paragraph [0040]; US PG-Pub 2020/0341092 A1 discloses generating a report based on the radiomic feature data using the computer system in paragraph [0053].
4. Claim 2 is 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. Claim 2 depends on claim 1, therefore, it has the abstract idea and also has the routine and conventional structure above said claims.
Furthermore, Claim 2 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these/this limitation(s) are/is simply routine and conventional structures previously known to the pertinent industry that serve to generate the data to be processed by implementing the idea on a computer, and/or recitation of generic computer structure and also serve to perform generic computer functions that are well- understood routine, and conventional activities previously known to the pertinent industry.
5. Claim 3 is 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. Claim 3 depends on claim 1,
therefore, it has the abstract idea and also has the routine and conventional structure above said claims.
In addition, claim 3 is further recites the element(s) “wherein the radiomic feature data comprise at least one of shape data, first-order statistical feature data, or second-order statistical feature data’, which are/is simply more calculations/mental-steps, value numbers, insignificant extra solution activity(s), routine and/or conventional structure(s) previously known to the pertinent industry.
6. Claim 4 is 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. Claim 9 depends on claim 8, therefore, it has the abstract idea and also has the routine and conventional structure above said claims.
In addition, claim 4 is further recites the element(s) “wherein the shape data comprise at least one of volume or surface area of regions-of-interest in the MRI data and the MRF data’, which are/is simply more calculations/mental-steps, value numbers, insignificant extra solution activity(s), routine and/or conventional structure(s) previously known to the pertinent industry.
Furthermore, Claim 4 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these/this limitation(s) are/is simply routine and conventional structures previously known to the pertinent industry that serve to generate the data to be processed by implementing the idea on a computer, and/or recitation of generic computer structure and also serve to perform generic computer functions that are well- understood routine, and conventional activities previously known to the pertinent industry.
7. Claim 5 is 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. Claim 5 depends on claim 3,
therefore, it has the abstract idea and also has the routine and conventional structure above said claims.
In addition, claim 5 is further recites the element(s) “wherein the first-order statistical feature data comprise at least one of mean or variance of image values within the identified tumor regions in the labeled MRI data and the labeled MRF data”, which are/is simply more calculations/mental-steps, value numbers, insignificant extra solution activity(s), routine and/or conventional structure(s) previously known to the pertinent industry.
Furthermore, Claim 5 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these/this limitation(s) are/is simply routine and conventional structures previously known to the pertinent industry that serve to generate the data to be processed by implementing the idea on a computer, and/or recitation of generic computer structure and also serve to perform generic computer functions that are well- understood routine, and conventional activities previously Known to the pertinent industry.
8. Claim 6 is 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. Claim 6 depends on claim 3,
therefore, it has the abstract idea and also has the routine and conventional structure above said claims.
In addition, claim 6 is further recites the element(s) “wherein the second-order statistical feature data comprise at least one gray-level co-occurrence matrix-based features, gray-level run length matrix-based features, gray-level size zone matrix-based features, neighborhood gray tone difference matrix-based features, or gray level dependence matrix-based features computed for image values within identified tumor regions in the labeled MRI data and the labeled MRF data”, which are/is simply more calculations/mental-steps, value numbers, insignificant extra solution activity(s), routine and/or conventional structure(s) previously known to the pertinent industry.
Furthermore, Claim 6 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these/this limitation(s) are/is simply routine and conventional structures previously known to the pertinent industry that serve to generate the data to be processed by implementing the idea on a computer, and/or recitation of generic computer structure and also serve to perform generic computer functions that are well- understood routine, and conventional activities previously Known to the pertinent industry.
Dependent claim(s) 7-19 when analyzed as a whole are held to be patent ineligible under 35 USC 101 because the additional recited limitations only refine the abstract idea further.
For instance, in claim(s) 7-19 the steps, under the broadest reasonable interpretation, are further refinements of (organizing human activities, mental process, mathematical concepts/formulas) because these steps further describe the intermediary steps of the underlying process.
In all the dependent claim(s), the judicial exception is not integrated into a practical application because the limitations are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception using generic computer components. This is because the claim(s) do not affect an improvement to another technology or technical field; the claims do not amount to an improvement to the functioning of a computer system itself; the claims do not affect a transformation or reduction of a particular article to a different state or thing; and the claims do not move beyond a general link of the use of an abstract idea to a particular technological environment. In addition, the dependent claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements of the instant underlying process, when taken in combination, together do not offer substantially more than the sum of the functions of the elements when each is taken alone. Thus, the claims as a whole, do not amount to significantly more than the
abstract idea itself. For these reasons, the dependent claim(s) also are not patent eligible.
Dependent claim(s) 2-19 do not add any limitations that would remedy the deficiencies outlined above and are rejected accordingly.
Double Patenting
9. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
10. Claim 1 is provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of co-pending Application No. 17/661 ,661.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
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Current Application
17/661,656
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Co-pending Application
17/661,661
Claim 1
Claim 1
A
A method for radiomic analysis of magnetic resonance fingerprinting (MRF) data, the method comprising:
A
A method for generating radiomic feature data from magnetic resonance images and magnetic resonance fingerprinting maps, the method comprising:
B
(a) accessing with a computer system, magnetic resonance imaging (MRI) data acquired from a subject with an MRI system;
B
(a) accessing with a computer system, magnetic resonance imaging (MRI) data acquired from a subject with an MRI system;
C
(b) accessing with the computer system, magnetic resonance fingerprinting (MRF) data acquired from the subject, wherein the MRF data comprise quantitative parameter maps;
C
(b) accessing with the computer system, magnetic resonance fingerprinting (MRF) data acquired from the subject, wherein the MRF data comprise quantitative parameter maps;
D
(c) generating labeled MRI data and labeled MRF data with the computer system by identifying tumor regions in the MRI data and the MRF data and labeling the identified tumor regions;
D
(c) preprocessing the MRI data and the MRF data with the computer system;
E
(d) performing radiomic analysis on the labeled MRI data and the labeled MRF data using the computer system, generating output as radiomic feature data; and
E
(d) performing an integrated radiomic analysis on the preprocessed MRI data and the preprocessed MRF data with the computer system, generating output as radiomic feature data; and
F
(e) generating a report based on the radiomic feature data using the computer system.
F
(e) generating a report based on the radiomic feature data using the computer system.
Claim 3 is similar to claim 8 of co-pending application 17/661,661.
Claim 4 is similar to claim 9 of co-pending application 17/661,661.
Claim 5 is similar to claim 10 of co-pending application 17/661,661.
Claim 6 is similar to claim 11 of co-pending application 17/661,661.
Claim 12 is similar to claim 12 of co-pending application 17/661,661.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Cited Art
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang et al. (US 2022/0187405) discloses a system, comprising: at least one MRI scanner coupled to a network, wherein the at least one MRI scanner configured to: detect one or more MRI signals; and transmit the one or more MM signals over a network; a diffusion dictionary imaging (DDI) computing device, the DDI computing device including at least one memory and a processor, wherein the DDI computing device is coupled to the network and is configured to: receive the one or more MR signals from the at least one MRI scanner via the network; record the one or more MR signals to the at least one memory device; retrieve one or more DDI algorithms from the at least one memory device; reconstruct a diffusion MRI image based on the one or more MR signals using the retrieved one or more DDI algorithms; detect one or more microstructural features of the diffusion MRI image; and associate the one or more microstructural features with at least one immune response, wherein the MRI scanner is a clinical MRI scanner configured to provide longitudinal imaging, wherein the DDI computing device is further configured to: extract one or more values from the one or more MR signals; and input the one or more values into the one or more DDI algorithms when reconstructing the diffusion MM image.
ZAISS et al. (US 2022/0179026) discloses a method of processing magnetic resonance (MR) data of a sample under investigation, comprising the steps of provision of the MR data being collected with an MRI scanner apparatus, and machine learning based data analysis of the MR data by supplying the MR data to an artificial neural network being trained with predetermined training data, wherein at least one image parameter of the sample and additionally at least one uncertainty quantification measure representing a prediction error of the at least one image parameter are provided by output elements of the neural network, wherein the data analysis creates a parameter map of the at least one image parameter of the sample, and the at least one uncertainty quantification measure comprises an uncertainty map of an uncertainty quantity of the at least one image parameter, and wherein the at least one image parameter of the sample comprises at least one of an exponential T1, T2 map, a multi-exponential T1, T2 map, a spectroscopic imaging map, a compartmental map of parameters, an apparent diffusion coefficient (ADC)-map for varying B-values, a Kurtosis parameter map, a parameter map of perfusion and dynamic contrast enhanced imaging, a parameter map of spectroscopic imaging of nuclei, at least one CEST parameter, a field parameter map (B1, B0), and a parameter map representing at least one of motion, breathing and pulsation with known non-linear influence.
Kartaeusch et al. (US 11,237,238) discloses a method for controlling a magnetic resonance tomography system for a Magnetic Resonance Fingerprinting (MRF) measurement, the method comprising: creating or providing a dictionary group including at least two dictionaries, each of the at least two dictionaries containing a multiplicity of different intensity profiles with a specific sampling scheme; preparing a preliminary recording of magnetic resonance tomography (MRT) measurements; determining and defining a sampling scheme based on the preliminary recording; selecting a dictionary from the at least two dictionaries of the dictionary group based on the preliminary recording; and performing an MRF measurement using the defined sampling scheme and an MRF evaluation based on the selected dictionary, wherein: two sampling scheme types and/or two dictionary types are definable for at least one type of MRF measurement; a first of the sampling scheme types has a higher resolution than a second of the sampling scheme types, and the second of the sampling scheme types allows faster data recording than the first of the sampling scheme types; or a first of the dictionary types has a higher resolution than a second of the dictionary types, and the second of the dictionary types allows faster data recording than the first of dictionary types.
Schuelke et al. (US 2023/0186532) discloses a medical system comprising: a memory storing machine executable instructions and access to an image generating neural network, wherein the image generating neural network is configured for outputting synthetic magnetic resonance image data in response to receiving reference magnetic resonance image data as input, wherein the image generating neural network is configured to generate the synthetic magnetic resonance image data as a simulation of magnetic resonance image data acquired according to a first configuration of a magnetic resonance imaging system when the reference magnetic resonance image data is acquired according to a second configuration of the magnetic resonance imaging system; a computational system configured to control the medical system, wherein execution of the machine executable instructions causes the computational system to: access measured k-space data acquired according to the first configuration of the magnetic resonance imaging system, wherein the measured k-space data is descriptive of a region of interest of a subject; access the reference magnetic resonance image data, wherein the reference magnetic resonance image data is descriptive of the region of interest of the subject; generate access to the synthetic magnetic resonance image data by inputting the reference magnetic resonance image data into the image generating neural network; and arrange to reconstruct corrected magnetic resonance image data from the measured k-space data and the synthetic magnetic resonance image data, wherein execution of the machine executable instructions further causes the computational system to reconstruct synthetic k-space data from the synthetic magnetic resonance image data, wherein the measured k-space data is divided into groups of k-space data, wherein the corrected magnetic resonance image data is reconstructed by using the synthetic k-space data to modify at least a portion of the groups of k-space data.
Koerzdoerfer et al. (US 2020/0103481) discloses a method for determining parameter values in pixels of an examination object using a magnetic resonance fingerprinting (MRF) technique, the method comprising: loading previously created comparison signal characteristics; acquiring, by a MRF recording method on a low-field magnetic resonance (MR) scanner, at least one pixel time series of the examination object; determining the parameter values based on a signal comparison of at least one segment of a respective signal characteristic of the acquired at least one pixel time series with a corresponding segment of the loaded comparison signal characteristics; and providing, as an output of the MR scanner, an electronic signal representing the determined parameter values for the respective pixel, wherein, during creation of the comparison signal characteristics, at least one scan-specific parameter, from a group comprising a field strength of a constant magnetic field B0 present during recording of MR raw data and a field strength of a transmit field B1 present during the recording of the MR raw data, is excluded from consideration.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN H NGUYEN whose telephone number is (571)270-1229. The examiner can normally be reached M-F 7 am-4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abderrahim Merouan can be reached at (571) 270-5254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN H NGUYEN/ Primary Examiner, Art Unit 2683
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