DETAILED ACTION
This office action is in response to the communication received on January 26, 2026 and March 10, 2026 concerning application No. 18/438,768 filed on February 2, 2024.
Claims 1-20 are currently pending.
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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 26, 2026 and March 10, 2026 have been entered.
Response to Arguments
Applicant's arguments filed 01/26/2026 regarding the claim objections have been fully considered. The amendments to the claims have been entered and overcome the claim objections of claims 1-3 and 7.
Applicant's arguments filed 01/26/2026 regarding the 35 USC 112 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112b rejection of claim 5 previously set forth.
Applicant's arguments filed 01/26/2026 regarding the 35 USC 101 rejection have been fully considered but they are not persuasive. In response to the applicant’s arguments that claims 1-12 and 17-20 are eligible under 35 USC 101, examiner respectfully disagrees. Applicant argues on pgs. 9-10 that the claims comprise claim limitations that cannot be practically performed in the human mind, provide specific technological improvements and/or integrate the judicial exceptions into a technical application. Applicant further argues the rejected claims “involve” a judicial exception and do not “recite” a judicial exception as discussed in the Kim memo. As set forth in the previous office action, the claims recite claim limitations that can be practically performed in the mind, do not provide specific technological improvement and do not integrate the judicial exception into a practical application. Further the claim limitations recite a judicial exception as outlined in the previous office action.
Applicant further argues on pg. 10 that amending the claims to recite “calculating peak-peak values of RBC oscillations”, the claim now provides an additional feature that cannot be practically performed in the mind. However, “calculating peak-peak values of RBC oscillations” is a process that can be practically performed in the mind, for example, a user can manually or mentally analyze the RBC application oscillation and locate the peak-peak values within the RBC oscillations. Therefore the limitation can be practically performed in the mind. Applicant further argues, “by the Action’s own statement should place these claims in condition for allowance”. Examiner notes that in the previous office action, the examiner was simply pointing out that the claims did not recite limitations the applicant was relying upon for their arguments. Pointing out limitations not present within the claims does not automatically make such limitations allowable.
In response to applicant’s arguments on pg. 10 that claim 18 involves a mathematical concept but does not recite one, examiner respectfully disagrees. Claim 18 specifically recites the use of a fitting function model (mathematical equation) that is used to perform the fitting. See the equation in [0048] of the present applications specification. For at least these reasons the limitation of claim 18 is considered a mathematical concept and recites an equation.
In response to applicant’s arguments on pg. 11 that “the RBC oscillations arise from a VERY LOW polarized 129 Xe signal that requires careful processing to identify and quantify that cannot be practically performed in the mind” and therefore the claim should not be classified as a mental process. Examiner notes that simply because the processing needs to be “careful processing”, it can still be practically performed in the mind.
In response to applicant’s arguments on pgs. 11-12 that the claim is not being considered as a whole, examiner respectfully disagrees. The claim is being considered as a whole in the rejection and each limitation within the claim is being addressed. The database, MRI scanner, and server recitations are considered additional elements within the claim that do not integrate the judicial exceptions into a practical application and are not considered to amount to significantly more than the judicial exception. For at least these reasons the claims are not patent eligible.
In response to applicant’s arguments on pg. 12 that “the database of cardiopulmonary diseases…provides a technological improvement over the prior art”, examiner respectfully disagrees. As set forth in the previous office action, the database is used for data gathering recited at a high level of generality which is required for performing the identifying step and the database has been determined to be well-understood, routine, and conventional activity in the field. Therefore the limitation is does not provide a technological improvement over the prior art.
In response to applicant’s arguments on pgs. 12-13 that the limitations of claims 2 and 17 are considered a technological improvement, examiner respectfully disagrees. The limitations of claims 2 and 17 provide examples of the information that is found within the database that is used for performing the judicial exception of identifying whether the patient ahs cardiopulmonary disease. Therefore the limitations are not considered a technological improvement.
In response to applicant’s arguments on pgs. 13-15 that the limitations of claim 3 cannot be practically performed in the mind, examiner respectfully disagrees. Applicant is reminded that if a claim under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. The computer system comprising a processor of claim 3 is considered a generic computer component. Further, as set forth in the previous office action, a user can either mentally or by hand input the 129 Xe magnetic resonance imaging parameter and 129 Xe spectroscopy parameters into a table or chart in order to generate a graphic signature. The claim does not go into detail about the specific graphic signature being used, therefore the graphic signature can be be interpreted as a multiple of examples. For at least these reasons claim 3 recites a judicial exception and is not patent eligible under 35 USC 101.
In response to applicant’s arguments on pgs. 15-16 that the limitations of claim 4 are patent eligible under 35 USC 101, examiner respectfully disagrees. As set forth above, if a claim under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, even though the claim recites “a system claim that recites at least one processor”, the claim is considered an abstract idea. Regarding applicant’s arguments that the “diagnostic model” is a technological improvement, as set forth in the previous office action, the providing of the diagnostic model is considered a mental process. Examiner further notes that the judicial exception itself cannot be considered a technological improvement. See MPEP 2106.04(d) and 2106.04(d)(1). Further, for the same reasons as recited above in the arguments for claim 1, “calculate a peak-to-peak amplitude of the obtained RBC amplitude oscillation” is considered an abstract idea. For at least these reasons claim 4 recites a judicial exception and is not patent eligible under 35 USC 101.
In response to applicant’s arguments on pgs. 16-17 that claim 7 does not recite limitation that can practically be performed in the mind, examiner respectfully disagrees. As set forth in the previous office action, the limitations of claim 7 can be practically performed in the mind.
In response to applicant’s arguments on pg. 17 that claim 8 is patent eligible because it depends from claim 1, examiner respectfully disagrees. For the same reasons as above regarding claim 1, claim 8 is not patent eligible under 35 USC 101.
In response to applicant’s arguments on pg. 17 that claims 9-11 are patent eligible, examiner respectfully disagrees. As set forth in the previous office action, the limitations of claim 9-11 are not patent eligible under 35 USC 101.
In response to applicant’s arguments on pgs. 17-18 that the limitations of claim 12 are patent eligible because “providing the inhalable hyperpolarized 129Xe gas is a physical step that cannot be performed in the human mind”, examiner respectfully disagrees. Additional steps are not considered an inventive concept and do not integrate the judicial exception into a practical application if they add insignificant extra-solution activity to the judicial exception. As set forth in the previous office action the providing of the inhalable hyperpolarized 129Xe gas is considered to amount to mere data gathering recited at a high level of generality which is required to obtain the input data for the obtaining step. The data gathering is considered extra-solution activity and therefore does not qualify as significantly more. See MPEP 2106.05. For at least these reasons claim 12 is not patent eligible under 35 USC 101.
In response to applicant’s arguments on pgs. 18-19 that claim 18 is patent eligible under 35 USC 101, examiner respectfully disagrees. As set forth in the previous office action the obtaining of the FIDs is considered extra-solution activity that does not integrate the judicial exception into a practical application. Examiner does not state that the obtaining of the FIDs can be practically performed in the human mind. Additionally, for the same reasons as recited above the fitting of real and imaginary components of the FIDs in a time domain is considered a mathematical concept. For at least these reasons claim 18 is not patent eligible under 35 USC 101.
In response to applicant’s arguments on pg. 19 that claim 19 is patent eligible under 35 USC 101, examiner respectfully disagrees. As set forth in the previous office action, the limitation of “pre-processing raw FIDs by Fourier transforming raw data” is considered a mathematical concept and is therefore considered an abstract idea. For at least these reasons claim 19 is not patent eligible under 35 USC 101.
In response to applicant’s arguments on pg. 20 that claim 20 is patent eligible under 35 USC 101, examiner respectfully disagrees. As set forth in the previous office action the additional step of “transmitting data of the obtained series of 129Xe free induction decays” is considered extra-solution activity that is well-understood, routine, and conventional activity in the field and therefore does not integrate the judicial exception into a practical application. For at least these reasons claim 20 is not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 101
Claims 1-12 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more:
Claims 1, 5 and 6, recite “identifying whether the patient has a cardiopulmonary disease based on the obtained 129Xe imaging parameters and the obtained 129Xe spectroscopy parameters and the electronic database”.
The limitation of identifying whether the patient has a cardiopulmonary disease, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “identifying” in the context of this claim encompasses a user analyzing parameters and mentally determining whether those parameter values correspond to a patient having a cardiopulmonary disease by comparing the values to those stored in the electronic database. The limitation falls within the “Mental Processes” grouping of abstract ideas. Claims 1, 5, and 6 recite the additional steps of “electronically obtaining a plurality of 129Xe magnetic resonance imaging parameters of at least one lung of the patient”, “electronically obtaining a plurality of 129Xe spectroscopy parameters of the at least one lung of the patient”, and “electronically calculating a peak-to-peak amplitude of the obtained RBC amplitude oscillation”. The additional electronically obtaining 129Xe imaging parameters step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, but for the “electronically” language, in order to obtain the imaging parameters a user reviews MRI images and can manually calculate the defect percentages as disclosed in [0187] of the specification. The additional electronically obtaining 129Xe spectroscopy parameters step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, but for the “electronically” language, in order to obtain the dynamic spectroscopy parameters a user reviews plots over time of the parameters as disclosed in [0018] of the specification. The additional electronically calculating a peak-to-peak amplitude of the obtained RBC amplitude oscillation step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, but for the “electronically” language, a user can either mentally or by hand analyze an RBC oscillation and determine the difference in amplitude of one peak to another peak in order to calculate the peak-to-peak amplitude. If a claim under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. For these reasons claims 1, 5 and 6 recite an abstract idea.
The judicial exception is not integrated into a practical application. The additional elements that apply to the claims is an electronic database of cardiopulmonary diseases. Claim 5 additionally recites an MRI scanner and a processor. The additional elements that apply to claim 6 are an MRI scanner, a processor and a server. The electronic data is used for data gathering and is recited at a high level of generality which is required for performing the identifying step. The MRI scanner in both claims is used for data gathering and is recited at a high-level of generality which is required to obtain input data for the identifying step. The processor in both claims and the server in claim 6 are recited at a high-level of generality (i.e., as a generic processor/computer component for performing a generic computer function of comparing parameter values) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these 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.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The use of storing and retrieving information from an electronic database (memory) has been determined to be well-understood routine and convention activity in the field (See MPEP 2106.06(d)(II)). The MRI scanner of claims 5 and 6 has been determined to be well-understood, routine, and conventional activity in the field. MRI scanners are widely known in the art as evidenced by [00111] of the present applications specification, “MRI scanners are well known to those of skill in the art”. Further, the additional elements of using a processor and server to perform the identifying steps of claims 5 and 6 amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive step. For these reasons, the additional steps do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Claims 2 and 17 further limit the information stored within the electronic database. The claims do not recite any additional elements.
Claim 3, recites “identify if the generated graphic signature matches one or more graphic signatures in the library”.
The limitation of identifying if the generated graphic signature matches one or more graphic signatures in the library, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “identify” in the context of this claim encompasses a user comparing the graphic signature to the graphic signatures in the library and determining if any of the signatures match. The limitation falls within the “Mental Processes” grouping of abstract ideas. Claim 3 further recites the additional steps of “obtain a plurality of 129Xe magnetic resonance imaging parameters of at least one lung of the patient”, “obtain a plurality of 129Xe spectroscopy parameters of the at least one lung of the patient”, “generate a graphic signature of patient cardiopulmonary health or disease state”, and “compare the generated graphic signature to a library of graphic signatures”. The additional obtaining a plurality of129Xe magnetic resonance imaging parameters step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, in order to obtain the imaging parameters a user reviews MRI images and can manually calculate the defect percentages as disclosed in [0187] of the specification. The additional obtaining 129Xe spectroscopy parameters step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, in order to obtain the dynamic spectroscopy parameters a user reviews plots over time of the parameters as disclosed in [0018] of the specification. The additional generating step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind or by hand. For example, a user can mentally or by hand input the parameters into a table or chart to display the data. The additional comparing step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, a user can mentally compare the generated graphic signatures to the graphic signatures stored in a library. For at least these reasons claim 3 recites an abstract idea.
The judicial exception is not integrated into a practical application. The claim does not recite any additional elements that would integrate the judicial exception into a practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 4 recites, “at least one processor configured to:…provide a diagnostic model that defines a likelihood of different diseases based on respective different values of the RBC oscillation”.
The limitation of providing a diagnostic model that defines a likelihood of different diseases, is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, but for the “processor” language, the providing consists of a user mentally or by hand generating a table or library of information that defines the likelihood of different diseases. The additional step of “obtain a plurality of 129Xe spectroscopy parameters of the at least one lung of the patient”, is a process that, under its broadest reasonable interpretation is a process that can be performed in the mind. For example, in order to obtain the dynamic spectroscopy parameters a user reviews plots over time of the parameters as disclosed in [0018] of the specification. The additional calculating a peak-to-peak amplitude of the obtained RBC amplitude oscillation step is a process that under its broadest reasonable interpretation is a process that can be performed in the mind. For example, but for the “electronically” language, a user can either mentally or by hand analyze an RBC oscillation and determine the difference in amplitude of one peak to another peak in order to calculate the peak-to-peak amplitude. For at least these reasons claim 4 recites an abstract idea.
The judicial exception is not integrated into a practical application. The claim does not recite any additional elements that would integrate the judicial exception into a practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 7 recites the additional step of generating at least one radar plot which is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind or by hand. For example, the user can simply plot either by hand or mentally the obtained parameters together. The additional steps do not result in the claim, as a whole, amounting to significantly more than the judicial exception. Claim 7 additionally, limits the obtaining of the 129Xe imaging parameters step by specifying which parameters are obtained.
Claim 8 recites the additional step of comparing the parameters electronically pre and post-administration of a pharmaceutical agent. The additional comparing step is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “electronically” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “electronically” language, a user can mentally compare the parameter values pre and post administration of the agent. The additional step does not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Claims 9-11 further limit the pharmaceutical agent of claim 8 by providing example of pharmaceutical agents. The claims do not recite any additional elements.
Claim 12 recites the additional step of providing at least one bolus amount of inhalable hyperpolarized 129Xe gas to the patient prior to the obtaining step. The providing step amounts to mere data gathering recited at a high level of generality which is required to obtain the input data for the obtaining steps. The providing step has been determined to be well-understood, routine, and conventional in the field. Providing inhalable hyperpolarized 129Xe gas to a patient prior to the obtaining step is widely known in the art, as evidenced by Kaushik et al. (“Single-Breath Clinical Imaging of Hyperpolarized 129Xe in the Airspaces, Barrier, and Red Blood Cells Using an Interleaved 3D Radial 1-Point Dixon Acquisition”), pg. 1425, “129Xe Polarization and delivery” subsection discloses accumulating the xenon in a Tedlar bag which is then inhaled by the patient using a mouthpiece connected to the bag. Patients then held their breath for the duration of the scan, meaning the can occurred after the inhaling of the Xenon. Robertson et al. (“Uncovering a Third Dissolved-Phase 129Xe Resonance in the Human Lung: Quantifying Spectroscopic Features in Healthy Subjects and Patients With Idiopathic Pulmonary Fibrosis”), pg. 1307, “129Xe Spectroscopy” subsection, “inhaling the 1-L gas mixture for the 13-second breath hold”. The additional step does not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Claim 18 recites the additional step of fitting real and imaginary components of the FIDs in a time domain, which is a step that, under its broadest reasonable interpretation is considered to be a mathematical concept and/or calculation (as disclosed in [0048] of the specification) which can be performed mentally or by hand and is therefore considered an abstract idea. The additional step of obtaining a series of 129Xe free induction decays amounts to mere data gathering recited at a high level of generality which is required to obtain the input data for the fitting step. the obtaining of a series of free induction decays has been determined to be well-understood, routine, and conventional activity in the field. Obtaining 129Xe free induction decays is widely known within the art, as evidenced by Ruppert et al. (“Detecting Pulmonary Capillary Blood Pulsations using hyperpolarized Xenon-129 chemical shift saturation recovery (CSS)) MR Spectroscopy”, the subsection “HXe data acquisitions” on pg. 1773 discloses “spectroscopy pulse repetition usually consists of four repeating elements…and 40 sampling of the free induction decay”, meaning any time a spectroscopy pulse is performed an FID is being obtained.
Claim 19 recites the additional step of pre-processing raw FIDs by Fourier transforming raw data along an indirect time domain with respect to a breath hold time of a breath hold of the breathing maneuver, retaining only coefficients that exceed a defined threshold, then Fourier transforming back along an indirect frequency domain to provide an FID with increased SNR relative to raw FIDs for the fitting to thereby filter non-dominant frequencies out of the indirect time domain providing time domain filtered FIDs to smooth temporal changes between different FIDs, while leaving spectral- frequency domain intact, which is a step that, under its broadest reasonable interpretation is considered to be a mathematical concept and/or calculation which can be performed mentally or by hand and is therefore considered an abstract idea.
Claim 20 recites the additional step of transmitting data of the obtained series of 129Xe free induction decays from an imaging site with an MR scanner to a remote server, wherein the remote server performs the fitting. The process of transmitting data has been determined to be well-understood, routine, and conventional activity in the field (see MPEP 2106.05(d)(II)). The additional element of using a server amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive step. For these reasons, the additional steps do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Allowable Subject Matter
Claims 13-16 are allowed.
Claims 1-12 and 17-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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