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 .
Drawings
The drawings are objected to because the flowchart in fig. 2 contains multiple typos. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 7 recite the limitation weight the second set of MR images against the material configured to change the MR contrast. It is unclear what the term against means in regards to the weighting. For the purposes of this office action, any user selectable weighting that includes two separate datasets will be considered analogous to the limitation in question.
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 and 7 are rejected under 35 U.S.C. 103 as being obvious over Rosen (US 20180113185 A1) in view of Sato (US 20230062864 A1).
Regarding claim 1, Rosen teaches a magnetic resonance (MR) imaging system ([0009] a MRI system is disclosed)
a magnet system configured to generate a static magnetic field (B0) about at least a portion of a subject including an organ receiving blood from multiple, different supplies ([0009] The MRI system includes a magnet system configured to generate a static magnetic field about at least a region of interest (ROI) of a subject arranged in the MRI system; [0067] The report may indicate at least one of hyper-acute or mild blood brain barrier (BBB) disruption the organ receiving blood from multiple supplies is a limitation regarding the target population rather than the system itself, see MPEP 2112.02, furthermore, seeing as this reference is investigating the brain and blood brain barrier, it is understood that the brain is an organ receives blood from multiple supplies)
and having received a dose of a material configured to change MR contrast ([0011] the subject having received solution comprising nanodiamonds, wherein the excitation pulses comprises at least one embedded electron paramagnetic resonance (EPR) pulse and a controller configured to manipulate dynamic nuclear polarization (DNP) contrast caused by the nanodiamonds)
a plurality of gradient coils configured to apply magnetic gradients to the static magnetic field ([0009] The MRI system includes at least one gradient coil configured to establish at least one magnetic gradient field with respect to the static magnetic field)
a radio frequency (RF) system configured to apply an excitation field to the subject and acquire MR image data from the subject ([0009] The system also includes a radio frequency (RF) system configured to deliver excitation pulses to the subject)
a computer system programmed to acquire an MR dataset from the organ receiving the blood from multiple, different supplies ([0009] The computer system is programmed to: control the at least one gradient coil and the RF system to perform a MRI pulse sequence; acquire data corresponding to signals from the subject having received solution comprising nanodiamonds; and reconstruct, from the data, at least one anatomical image of the subject and spatially distributed nanodiamonds within the subject relative to the anatomical image)
reconstruct the MR dataset into a first set of MR images using a first reconstruction process configured to weight the first set of MR images to the material configured to change the MR contrast ([0010] The method includes arranging a subject to receive solution comprising nanodiamonds and performing a magnetic resonance imaging (MRI) process to acquire a first data from the subject)
reconstruct the MR dataset into a second set of MR images using a second reconstruction process configured to weight the second set of MR images against the material configured to change the MR contrast ([0010] The method also includes performing an Overhauser-enhanced magnetic resonance imaging (OMRI) process to acquire a second data from the subject and reconstructing the first and second data to generate a report indicating a spatial distribution of the nanodiamonds in the subject; [0042] processing may, for example, include one or more of the following: reconstructing two-dimensional or three-dimensional images by performing a Fourier transformation of raw k-space data; performing other image reconstruction algorithms, such as iterative or backprojection reconstruction algorithms; applying filters to raw k-space data or to reconstructed images; generating functional magnetic resonance images; calculating motion or flow images; [0073] The MRI system may reconstruct, from the second data, at least one DNP image of the subject and spatially distributed nanodiamonds within the subject relative to the anatomical image)
and a display configured to display the first set of MR images and the second set of MR images ([0033] The MRI system 100 includes an operator workstation 102, which will typically include a display 104, one or more input devices 106, such as a keyboard and mouse, and a processor 108. The processor 108 may include a commercially available programmable machine running a commercially available operating system. The operator workstation 102 provides the operator interface that enables scan prescriptions to be entered into the MRI system 100. In general, the operator workstation 102 may be coupled to four servers: a pulse sequence server 110; a data acquisition server 112; a data processing server 114; and a data store server 116. The operator workstation 102 and each server 110, 112, 114, and 116 are connected to communicate with each other; [0043] Images reconstructed by the data processing server 114 are conveyed back to the operator workstation 102 where they are stored. Real-time images are stored in a data base memory cache (not shown in FIG. 1), from which they may be output to operator display 112 or a display 136 that is located near the magnet assembly 124 for use by attending physicians. Batch mode images or selected real time images are stored in a host database on disc storage 138. When such images have been reconstructed and transferred to storage, the data processing server 114 notifies the data store server 116 on the operator workstation 102. The operator workstation 102 may be used by an operator to archive the images, produce films, or send the images via a network to other facilities).
Rosen fails to teach a user-selectable weighting of the first set of MR images relative the second set of MR images.
However, Sato teaches a user-selectable weighting of the first set of MR images relative the second set of MR images ([0080] a GUI for receiving user designation with respect to processing in the image processing unit 22, in particular, processing in the weight calculation unit 222; [0088] The image processing device 2 may also be provided with a UI unit to receive a user instruction regarding the filter size and thresholds for the weight)
Rosen and Sato are considered analogous because both disclose systems that analyze MR image data. Furthermore, seeing as the weighting done in Sato is done on an intensity image (first MR image) relative to a phase image (second MR image) as depicted in fig. 7 of the Sato disclosure, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to include a user interface that allows image weights to be manually toggled in order to improve SNR (Sato [0002])
Regarding claim 7, Rosen teaches a method for imaging a portion of a subject including an organ receiving blood from multiple, different supplies using a magnetic resonance imaging (MRI) system ([0009] a MRI system is disclosed)
delivering a dose of a material configured to change MR contrast to the subject following delivery of the dose of the material configured to change MR contrast to the subject, simultaneously acquiring MR data from multiple, different supplies to form an MR dataset ([0011] the subject having received solution comprising nanodiamonds, wherein the excitation pulses comprises at least one embedded electron paramagnetic resonance (EPR) pulse and a controller configured to manipulate dynamic nuclear polarization (DNP) contrast caused by the nanodiamonds)
reconstructing the MR dataset into a first set of MR images using a first reconstruction process configured to weight the first set of MR images to the material configured to change the MR contrast; reconstructing the MR dataset into a second set of MR images using a second reconstruction process configured to weight the second set of MR images against the material configured to change the MR contrast ([0010] The method includes arranging a subject to receive solution comprising nanodiamonds and performing a magnetic resonance imaging (MRI) process to acquire a first data from the subject. The method also includes performing an Overhauser-enhanced magnetic resonance imaging (OMRI) process to acquire a second data from the subject and reconstructing the first and second data to generate a report indicating a spatial distribution of the nanodiamonds in the subject)
and displaying the first set of MR images and the second set of MR images together ([0033] The MRI system 100 includes an operator workstation 102, which will typically include a display 104, one or more input devices 106, such as a keyboard and mouse, and a processor 108. The processor 108 may include a commercially available programmable machine running a commercially available operating system. The operator workstation 102 provides the operator interface that enables scan prescriptions to be entered into the MRI system 100. In general, the operator workstation 102 may be coupled to four servers: a pulse sequence server 110; a data acquisition server 112; a data processing server 114; and a data store server 116. The operator workstation 102 and each server 110, 112, 114, and 116 are connected to communicate with each other).
Rosen fails to teach a user-selectable weighting of the first set of MR images relative the second set of MR images.
However, Sato teaches a user-selectable weighting of the first set of MR images relative the second set of MR images ([0080] a GUI for receiving user designation with respect to processing in the image processing unit 22, in particular, processing in the weight calculation unit 222; [0088] The image processing device 2 may also be provided with a UI unit to receive a user instruction regarding the filter size and thresholds for the weight)
Rosen and Sato are considered analogous because both disclose systems that analyze MR image data. Furthermore, seeing as the weighting done in Sato is done on an intensity image (first MR image) relative to a phase image (second MR image) as depicted in fig. 7 of the Sato disclosure, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to include a user interface that allows image weights to be manually toggled in order to improve SNR (Sato [0002])
Claim(s) 2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen in view of Sato as applied to claims 1 and 7 respectively above, and further in view of Kimura (US 20100253342 A1).
Regarding claim 2, Rosen discloses the system set forth above, but fails to teach the first set of MR images includes maximum intensity projection images and the second set of MR images includes minimum intensity projection images.
However, Kimura teaches the first set of MR images includes maximum intensity projection images and the second set of MR images includes minimum intensity projection images ([0046] The synthesis includes cumulative addition of pixel values, maximum intensity projection (MIP), minimum intensity projection (minIP))
Rosen and Kimura are considered analogous because both disclose systems of reconstructing contrast MRI images. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a maximum and minimum intensity projection so that fluids flowing at a lower velocity can be visualized in a more enhanced manner than fluids flowing at a higher velocity.
Regarding claim 8, Rosen discloses the method set forth above, but fails to teach the first set of MR images includes maximum intensity projection images and the second set of MR images includes minimum intensity projection images.
However, Kimura teaches the first set of MR images includes maximum intensity projection images and the second set of MR images includes minimum intensity projection images ([0046] The synthesis includes cumulative addition of pixel values, maximum intensity projection (MIP), minimum intensity projection (minIP))
Rosen and Kimura are considered analogous because both disclose systems of reconstructing contrast MRI images. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a maximum and minimum intensity projection so that fluids flowing at a lower velocity can be visualized in a more enhanced manner than fluids flowing at a higher velocity.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen in view of Sato as applied to claim 1 above, and further in view of Block (US 20150226815 A1).
Regarding claim 3, Rosen teaches the system set forth above, but fails to teach the computer system is configured to acquire the MR dataset from the organ receiving the blood from multiple, different supplies during a single MR acquisition.
However, Block teaches the computer system is configured to acquire the MR dataset from the organ receiving the blood from multiple, different supplies during a single MR acquisition ([0003] DCE-MRI at a temporal resolution of only a few seconds from a single, continuous image acquisition)
Rosen and Block are considered analogous because both disclose contrast MRI systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a single MRI acquisition in order to reduce the requirements on bolus timing accuracy and can thereby significantly simplify the imaging workflow (Block [0003])
Claim(s) 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen in view of Sato as applied to claims 1 and 7 respectively above, and further in view of Wang (US 20220187405 A1).
Regarding claim 4, Rosen discloses the system set forth above, but fails to teach wherein the organ includes a placenta and the multiple, different supplies include a supply from a mother and a supply from a fetus.
However, Wang teaches wherein the organ includes a placenta and the multiple, different supplies include a supply from a mother and a supply from a fetus ([0067] FIGS. 10A-10L depict examples of DDI application in a human placenta. FIG. 10A illustrates an example human placenta including an umbilical cord, a chorionic plate, chorioamniotic membranes, a chorionic villous tree, and a basal plate. Two aspects of the immunologic nature of Villous Inflammation include 1) circulating maternal T cells entering the intervillous space that can infiltrate the villus, and 2) after maternal T-cell infiltration, Hofbauer cells, or fetal placental macrophages, may be activated. In summary, infiltration T cell and activated macrophage in placental inflammation)
Rosen and Wang are considered analogous because both disclose contrast MRI systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to perform the system disclosed in Rosen on a human placenta in vivo in order to enable safe longitudinal inflammation imaging of a placenta during human pregnancy (Wang [0067]).
Claim(s) 5, 6, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen in view of Sato as applied to claims 1 and 7 above, and further in view of Xu (US 20230241255 A1).
Regarding claim 5, Rosen teaches the system set forth above, but fails to teach the material configured to change MR contrast includes iron.
However, Xu teaches the material configured to change MR contrast includes iron ([0008] contrast agent compositions comprising iron)
Rosen and Xu are considered analogous because both disclose contrast MRI systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use iron as a contrast agent in order to require less magnetic field force generated by MRI scanner (Xu [0009]).
Regarding claim 6, Rosen discloses the system set forth above, but fails to teach the material configured to change MR contrast includes Ferumoxytol.
However, Xu teaches the material configured to change MR contrast includes Ferumoxytol ([0073] In addition, Ferumoxytol, an FDA-approved iron oxide nanoparticle used for anemia treatment, can be used as another comparative contrast agent)
Rosen and Xu are considered analogous because both disclose contrast MRI systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use in anemia treatment (Xu [0073]).
Regarding claim 10, Rosen teaches the method set forth above, but fails to teach the material configured to change MR contrast includes iron.
However, Xu teaches the material configured to change MR contrast includes iron ([0008] contrast agent compositions comprising iron)
Rosen and Xu are considered analogous because both disclose contrast MRI systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use iron as a contrast agent in order to require less magnetic field force generated by MRI scanner (Xu [0009]).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen in view of Sato and Kimura as applied to claim 8 above, and further in view of Xu.
Regarding claim 11, Rosen as modified fails to teach the material configured to change MR contrast includes Ferumoxytol.
However, Xu teaches the material configured to change MR contrast includes Ferumoxytol ([0073] In addition, Ferumoxytol, an FDA-approved iron oxide nanoparticle used for anemia treatment, can be used as another comparative contrast agent)
Rosen and Xu are considered analogous because both disclose contrast MRI systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use in anemia treatment (Xu [0073]).
Response to Arguments
Applicant’s arguments, see page 10, filed 12/11/2025, with respect to the rejection(s) of the independent claims under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the newly cited Sato reference.
Particularly, applicant makes a persuasive argument that there is no user selectable weighting to be found in the Rosen reference. As a result, an updated search uncovered the Sato reference which performs weighting of first image data relative to second image data in response to user manual input, thus obviating the limitation in view of the teachings of the primary Rosen reference.
Additionally, applicant argues that Rosen has a fundamentally different technical focus from the claimed invention due to the fact that Rosen does not suggest imaging organs that receive blood from multiple sources. However, as was explained in the rejection, this is a limitation regarding the target population which is given no patentable weight as per MPEP section 2112.02. Rosen teaches imaging organs and without specifying the number of sources of blood flow, the prior art can be applied to the claim as per the MPEP. Applicant is making an argument based on intended use which bears no weight in a rejection when the system in the prior art is materially analogous under broadest reasonable interpretation. Furthermore, the Rosen reference is directed to crossing the blood brain barrier and it is thus understood that the organ imaged is the brain, an organ known in the art to receive blood from multiple supplies including but not limited to the carotid arteries as well as the vertebral arteries and spinal arteries.
Applicant further argues that Rosen does not teach any way to acquire or reconstruct data of multiple blood supply visualization. Applicant provides an explanation of the operation of the device and explains the perceived differences between the pending application and the prior art. However, the point stands that the claim language as currently written can be interpreted as analogous to the prior art under broadest reasonable interpretation. Rosen images the flow of nanodiamonds, which can be understood to be a contrast agent, in the blood stream, and furthermore does that utilizing two reconstruction modalities as required by the claim. The differences that applicant highlights in the remarks section are not features which are present in the claims as they are currently written. Thus, it is noted that the features upon which applicant relies (i.e., a maximum intensity projection and a minimum intensity projection) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In order to overcome the outstanding rejection, applicant is advised to provide an amendment to the claim which provide more detail into the processes through which the imaging is performed that amounts to more than describing the target population. For at least the aforementioned reasons, the claim set remains rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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/GABRIEL VICTOR POPESCU/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798