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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an acquisition device configured to obtain magnetic resonance images . . .” in claim 24.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-11, 14-17 and 19-25 are rejected under 35 U.S.C. 102(a)(2) as being US 12,245,848 B2 by Weiss.
Regarding claim 1, Weiss discloses a system (Fig. 1, MR device 1) for generating a graphical presentation of one or more distortion levels (column 8, line 65 through column 9, line 5, wherein FIG. 4 shows examples of sagittal slices of MR image data of the head/neck region. The image values of the two top images (FIGS. 4a and 4b) indicate the local geometrical image distortion (the magnitude of the B0-induced voxel shift). The top image (FIG. 4a) shows the geometrical distortion derived from the mDIXON B0 map. The image below (FIG. 4b) shows the geometrical distortion derived from conventional dedicated B0 mapping), the system comprising: at least one memory configured to store instructions; and at least one processor configured to execute the instructions to cause the system (column 6, lines 13-16, a computer program running on a computer by which the MR device is controlled such that it performs the above-explained method steps of the invention) to perform a distortion mapping sequence to generate a field map, the field map including spatial information related to anticipated distortions caused by variations of a static magnetic field (column 7, lines 59-61, wherein step 23 includes the derivation of a fat map, a water map and a B0 map from the acquired mDIXON data, as field map), segment the spatial information into one or more distortion levels (column 7, line 62 through column 8, line 4, wherein in step 24, the derived B0 map is analyzed to determine one or more low fidelity regions, as segmenting the field map. This involves the steps depicted in FIG. 3. In step 33, the magnitude of the spatial gradient of the B0 map is calculated for every image position. A map G is generated in step 34 covering all regions (i.e. indicating all image positions) in which this magnitude is larger than a pre-determined threshold, as one distortion level. In step 35, a map D is calculated covering all regions in which the geometrical distortion resulting from the B0 map at the respective image positions is larger than a further pre-determined threshold, as second distortion level), display a graphical representation including the one or more distortion levels (column 9, lines 8-12, and Figs 4A-B, wherein as can be seen, geometrical distortions are well estimated by mDIXON in regions with low spatial variation (e.g. region indicated by white circle 42, distortion level 2). Differences exceeding 50% occur in regions with high spatial variation of B0 (circle 41, distortion level 1).
Regarding claim 4, Weiss discloses wherein the at least one processor is configured to execute the instructions to further cause the system to generate a localizer image based on a localizer scan (column 7, lines 42-43, wherein after positioning the body 10 in the examination volume of the main magnet coil 2, a first MR imaging scan, inherently as the localizer scan image, is started in step 21 for acquiring first MR imaging data, e.g. using a T.sub.2-weighted scan.); and generate the graphical representation of the field map by overlaying the one or more distortion levels on the localizer image (column 8, lines 17-19, wherein an overlay of the low fidelity map E with the results of the delineation of anatomical structures in step 22 is displayed on video monitor 18 in step 25.).
Regarding claim 5, Weiss discloses wherein each of the one or more distortion levels is displayed in the field map (Fig. 4B, levels 41 and 42).
Regarding claim 6, Weiss discloses wherein each of the one or more distortion levels is displayed in a distinct color (Fig. 4B, wherein levels 41 and 42 are inherently indicators of light or dark color areas).
Regarding claim 7, Weiss discloses wherein the field map is masked based on thresholding using an output of the distortion mapping sequence (column 8, lines 35-39, wherein the mDIXON B0 map is then updated in step 29 accordingly in the regions indicated by map R by replacing the B0 values of the mDIXON B0 map by the corresponding values obtained from the dedicated B0 mapping scan in these regions, as the masks. The result is a refined, i.e. higher fidelity B0 map)
Regarding claim 9, Weiss discloses wherein the at least one processor is configured to execute the instructions to further cause the system to preconfigure the distortion mapping sequence based on at least one of an expected maximum off-resonance of the field map, a field strength, or a body part to be imaged (column 4, lines 56-63, wherein It is therefore proposed to automatically identify those regions in which errors in the mDIXON based B0 mapping and the related distortion estimation are large, as field strength, such that it will compromise dose planning. It is proposed to automatically perform dedicated B0 mapping to refine the B0 map using a gradient echo sequence restricted to at least one region in which said delineated anatomical structure and said low fidelity region overlap, as preconfiguring the distortion map).
Regarding claim 10, Weiss discloses wherein the one or more distortion levels are metal distortion levels (column 2, lines 51-55, wherein spatial variations in susceptibility, most pronounced at interfaces with large susceptibility differences such as air/tissue or bone/metal, cause B0 field inhomogeneities up to about 4 ppm in the human head, which can cause distortions of up to 4 mm at the sinus/tissue interface in the brain).
Regarding method claims 11, 14-17 and 19-20, please refer to corresponding system claims 1, 4-7 and 9-10 above, respectively, for further teachings.
Regarding system claim 21, please refer to the corresponding system claim 1 above for further teachings.
Regarding claim 22, Weiss discloses wherein the at least one processor is configured to execute the instructions to further cause the system to adjust one or more imaging protocols based on the one or more distortion levels (column 5, lines 14-21, wherein only those regions will be subject to refined B0 mapping that will potentially lead to large errors in dose planning, as exemplary imaging protocol. These regions are characterized by a large geometrical distortion (i.e., a high B0 deviation) and simultaneously a high spatial gradient of B0 (i.e., a strong spatial variation of B0). The respective thresholds can be selected by a user so as to achieve an optimum tradeoff between scan time and geometrical correctness).
Regarding claim 23, Weiss discloses wherein the imaging protocols are magnetic resonance imaging protocols (column 4, lines 15-16, wherein correcting geometrical distortions in said first and/or second MR imaging data using the refined B0 map).
Regarding claim 23, Weiss discloses generating a graphical presentation of one or more distortion levels (Figs. 4A and 4B, depicting graphical presentations of the distortion levels); and an acquisition device configured to obtain magnetic resonance images based on the magnetic resonance imaging protocols (column 4, lines 15-16, wherein correcting geometrical distortions in said first and/or second MR imaging data using the refined B0 map).
Regarding claim 25, Weiss discloses wherein the distortion levels are determined for use in medical imaging (column 8, line 65 through column 9, line 2, wherein FIG. 4 shows examples of sagittal slices of MR image data of the head/neck region. The image values of the two top images (FIGS. 4a and 4b) indicate the local geometrical image distortion (the magnitude of the B.sub.0-induced voxel shift)).
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 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Weiss in view of US 10,638,949 B2 to Koch et al (hereinafter ‘Koch’).
Regarding claims 2 and 12, Weiss does not specifically disclose wherein the one or more distortion levels includes a first distortion level and a second distortion level, the first distortion level including field offsets of greater than a first threshold and less than a second threshold. Koch discloses the one or more distortion levels includes a first distortion level and a second distortion level, the first distortion level including field offsets of greater than a first threshold and less than a second threshold (column 8, lines 51-57, wherein in the examples from FIGS. 6 to 9, the mScores were computed using off-resonance thresholds of Ti=[350 400 450 500 550 600] Hz, as 350Hz being the first threshold and 600Hz as the second threshold at 50Hz offsets and cluster size thresholds of Sj=[0.3 0.6 1.2 1.8 2.4] cm3. The choice of a minimum off-resonance threshold of 350 Hz can provide a conservative buffer above the chemical shift threshold). Weiss and Koch are combinable because they both disclose reducing distortion involved in an MRI image. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine setting the first and second threshold in gathering field map data of Kock’s system/method with Weiss’ so that to reduce false-positive detection due to chemical shifts (column 8, lines 56-58).
Claims 3 and 13 rejected under 35 U.S.C. 103 as being unpatentable over Weiss in view of Koch and further in view of US 7,952,356 B2 to Koch et al (hereinafter ‘Koch ‘356’).
Regarding claims 3 and 13, in the combination of Weiss and Koch, Koch discloses wherein the first threshold is about 200Hz (column 7, lines 20-26, wherein the presence of chemical shift contamination establishes an off-resonance detection threshold, below which particulate deposits cannot be distinguished from normal fat/water tissue transitions (225 Hz at 1.5 T), inherently as about 200Hz, however, Weiss and Koch do not specifically disclose the second threshold being about 2kHz. Koch ‘356 discloses the second threshold being about 2kHz (column 10, lines 54-56, wherein the difference is negligible everywhere except for those locations where the B0 field varies extremely rapidly (e.g., over 1 kHz/pixel), inherently as about 2kHz). Weiss, Koch and Koch ‘356 are combinable because they all disclose reducing distortion involved in an MRI image. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the setting of the second threshold to in gathering field map data to about 2KHz, of Kock’s ‘356 system/method with Weiss’ and Koch’s so that to avoid data with fast variations (column 10, lines 57-58). Additionally, lack some criticality or unexpected results the exact range of frequency data detection range is within the skill level of the ordinary practitioner in this field who would select the most appropriate range for field map data gathering for a given application.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weiss in view of US 10191134 B2 to Pfeuffer et al (hereinafter ‘Pfeuffer’).
Regarding claims 8 and 18, Weiss does not specifically disclose wherein the at least one processor is configured to execute the instructions to further cause the system to adjust the spatial information based on discontinuities included in the field map to create a modified field map. Pfeuffer discloses adjust the spatial information based on discontinuities included in the field map to create a modified field map (column 4, line 64 through column 5, line 3, wherein the basic reference field map is recorded with a reduced spatial resolution and adjusted to the resolution of the image data with the aid of an interpolation method. Following a comparison with distorted, dynamically obtained B0 field maps the basic reference field map is then replaced, as adjusted, by one of these or by a combination, preferably a weighted total of a plurality of these). Weiss Pfeuffer are combinable because they both disclose MRI image distortion correction. Therefore, before the effective filing data of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the adjust the spatial information based on discontinuities included in the field map to create a modified field map, of Pfeuffer’s system/method with Weiss’ in order to adjust the resolution back to the resolution of the image (column 4, line 65).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHERVIN K NAKHJAVAN whose telephone number is (571)272-5731. The examiner can normally be reached Monday-Friday 9:00-12:00 PST.
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, Sue Lefkowitz can be reached at (571)272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHERVIN K NAKHJAVAN/Primary Examiner, Art Unit 2672