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 .
Response to Arguments
Applicant’s arguments with respect to amended claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 8-13, filed 23 April 2026, with respect to 103 rejections for claims 8 and 15 have been fully considered and are persuasive in view of amendment. The 103 rejections for claims 8 and 15 of 05 February 2026 has been withdrawn.
Allowable Subject Matter
Claims 8 and 15 would be allowable if amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph and/or 101 rejection, set forth in this Office action.
Reasons for Indicating Allowable Subject Matter
Claims 8 and 15 are allowable.
The following is an examiner’s statement of reasons for indicating allowable subject matter:
The following prior art previously made of record is considered pertinent to the reasons of allowance:
“Malyarenko et al.,” US 2023/0053434 teaches diffusion MR images to access tumor and identifying a region of interest comprising one or more voxels ([0011]), and determining voxel values, identifying cancer severity for tissue types, metric of impeded diffusion fractions ([0019] and [0048]), thus using metric to assess tumor density from MR images on voxel-by-voxel basis ([0045]), and outputting an image with lesion identification overlay and IDF indication overlay to indicate the location of the cancer stage within the region of interest ([0048]).
However, the prior art previously and currently made of record fails to disclose or make obvious the limitation “voxel-wise ratio of the D-W MR image to the ADC MR image for the tissue of interest and identifying a primary target point in the fused 3-D image as a voxel in the severity image corresponding to the tissue of interest that includes a highest value” in combination with the rest of the limitations of independent claims 8 and 15. There is no reason absent hindsight to have combined and modified teachings of the cited references before the effective filing date of the claimed invention for a user to modify and/or combine prior arts in order to produce the claimed invention. Furthermore, such a configuration allows concurrent display of lives images of the sagittal and the transverse planes of the primary target point ([0031]), advantages claimed by present invention.
Therefore, claim(s) 8 and 15 overcome(s) previously and currently cited prior art and is/are found to be allowable.
Claim Objections
Claim 15 is objected to because of the following informalities: Claim 15 recites abbreviated limitation such as ADC MR image and D-W MR image without first defining what ADC MR and D-W MR refers to. Th examiner recommends amending limitations as in claim 8 initially, such as apparent diffusion coefficient (ADC) and a diffusion-weighted (D-W) and Magnetic resonance (MR). Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 15-20 currently recites “A computer readable medium.”
The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called computer-readable storage medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01.
A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments maybe amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the limitation “non-transitory” (e.g. a non-transitory computer readable medium) to the claim.
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: “a resampler configured to,” “a segmentor configured to,” “A registration engine,” “a primary point determinater” and “A rendering engine” in claims 1-7.
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.
With respect to recited claim limitations, paragraphs [0038]-[0044] of instant application discloses structure for performing the limitations as a console including processors.
Thus, the examiner will interpret claim limitation of resampler, segmentor, a registration engine, a primary point determiner, and rendering engine to be processor and/or equivalent structure thereof capable of performing the recites function.
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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 8 and 15 recite “determining a severity image.” The examiner has searched for specification for “a severity image” but could not find the limitation. Rather, a severity value is computed based on a ratio of the b-value to ADC plus a constant ([0075]). The disclosure does not provide adequate support to understand what a severity image is. The specification does not demonstrate that applicant has made an invention that achieves claimed element because the invention is not described with sufficient detail that one or ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Claims 9-14 and 16-20 are rejected as they inherit rejection of claims 8 and 15 as set forth above.
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 15-20 are 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.
Claim 15 recites the limitation "the third value" and “the fourth value” in lines 8 and 11 in page 6. There is insufficient antecedent basis for this limitation in the claim, since “a third value” and “a forth value” were not previously recited in claim 15.
Claim 15 recites the limitation "the second volume" in line 15 page 6. There is insufficient antecedent basis for this limitation in the claim, since “a second volume” was not previously recited in claim 15.
Claim 15 recites “severity value” and “severity image.” It is not clear whether applicant intended to recite “severity value” not the image, or recites two distinct elements of (1) severity value” and “severity image.”
Claim 15 recites “a predetermined second value” without reciting first value or a predetermined first value,”
Claim 15 further recites “less than a third threshold to a predetermined fourth value, wherein the third threshold is greater than the fourth value.” It is not clear whether a predetermined fourth value is same as “the forth value” and if there were first, second and third value prior to recited forth value.
Claim 16 recites “a second volume” and it is not clear whether it is different second volume recited in claim 15 or meant to recite a same “second volume.”
Claims 17-20 are rejected as they inherit the rejection of claim 15 as set forth above.
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.
The following rejection has been modified in view of applicant's arguments and/or amendments.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over “Martins et al.,” US 2020/0093464 (hereinafter Martins) and “Piper,” US 2022/0001207 (hereinafter Piper), and “Malyarenko et al.,” US 2023/0053434 (hereinafter Malyarenko).
Regarding to claim 1, Martins teaches an ultrasound imaging system, comprising:
a single transducer array having a long axis and configured to transmit and receive in either a first mode to acquire a live ultrasound image of a sagittal plane during a procedure or a second mode to acquire 3-D volumetric ultrasound data including a plurality of sagittal planes by rotating the single transducer array about an axis that is parallel to the long axis of the transducer array (the probe includes a transducer array with one or more transducer acquiring a series of 2D images, providing a sagittal field of view [0025] Fig. 3);
a resampler configured to resample the 3-D volumetric ultrasound data and generate a set of resampled ultrasound planes that are approximately orthogonal to a surface of tissue of interest (re-slicer processor [0033]-[0034], [0036], Fig. 5);
a segmentor configured to segment a first contour of the tissue of interest in the set of resampled ultrasound planes (2-D mask processor, a segmentation mask [0038] Fig. 6);
Martins does not further disclose a registration engine and a rendering engine as claimed.
However, in the analogous field of endeavor in ultrasound imaging system, Piper teaches an ultrasound imaging system disclosing following limitations:
A resampler (Reslicing module [0034]) reslices or resamples voxel data corresponding to a three dimensional volume image data according to user input ([0034])
a registration engine configured to register the first contour and a second contour of the tissue of interest in pre-procedure three-dimensional (3-D) magnetic resonance (MR) image data (contours of anatomical features, targets in previously acquired MR image data [0023]; resliced image data fused with other image data [0039]) and create a fused 3-D image (intra-operative fusion, [0023]; fused image data include feature information created with contour module and MR image data [0039], three-dimensional volume image data [0034]); and
a rendering engine configured to superimpose the live ultrasound image with contours of features segmented from the pre-procedure 3-D MR image data (fused image data include feature information created with contour module and MR image data [0039]; 3D image [0054]).
The examiner notes that Martins disclose reslicing image from 3D image, and Piper discloses reslicing image data (reslices or resamples voxel data corresponding to a three dimensional volume image data according to user input [0034]), thus, Martins can replace its reslicer with Piper’s reslicing module to manipulate voxel instead of image itself.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify a resampler and post processor as taught by Martins to incorporate teaching of Piper, since reslicing image data and further registration with pre-operative image data was well known in the art as taught by Piper. One of ordinary skill in the art could have combined the elements as claimed by Martins with no change in their respective functions, replacing its re-slicing image with reslicing image data, and superimposing image with pre-operative MR image data, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide improved planning and execution of the medical procedure ([0006]), and there was reasonable expectation of success.
With regards to amended limitation of “a primary point determiner configured to determine a primary target point for the tissue of interest in the fused 3-D image based on voxel severity values for the tissue of interest,” and “superimposing data with the primary target point,” the examiner submits that limitation recites determining region of interest, or a target, specifically for a tumor volume in the 3-D image.
Accordingly, Malyarenko teaches diffusion MR images to access tumor and identifying a region of interest comprising one or more voxels ([0011]), and determining voxel values, identifying cancer severity for tissue types, metric of impeded diffusion fractions ([0019] and [0048]), thus using metric to assess tumor density from MR images on voxel-by-voxel basis ([0045]), and outputting an image with lesion identification overlay and IDF indication overlay to indicate the location of the cancer stage within the region of interest ([0048]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify voxel data as taught by Martins and Piper to incorporate teaching of Malyarenko, since voxel-by-voxel quantification of metric of values representing severity was well known in the art as taught by Malyarenko. One of ordinary skill in the art could have combined the elements as claimed by Martins and Piper with no change in their respective functions, simply implementing voxel by voxel metric analysis using DW images, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to identify lesion with specific cancer severity ([0048]), and there was reasonable expectation of success.
Regarding to claim 2, Martins, Piper, and Malyarenko together teach all limitations of claim 1 as discussed above.
Martins further discloses wherein the set of resampled ultrasound planes includes only three to twelve planes (Figure 4 shows 12 slices, re-slice 3-D images to N slices [0036]).
Regarding to claim 3, Martins, Piper, and Malyarenko together teach all limitations of claim 1 as discussed above.
Piper further teaches limitation of claim 3, that a primary point determiner configured to determine a primary target point for the procedure based on 3-D MR image data (feature information in MR image data include target contours, treatment positions and treatment zones [0023], treatment zones Figures 11-12).
Malyarenko further discloses analyzing voxels using plot of DWI data as a function of b-value (Figures 4A and B [0032]), thus reads on claimed ratio of first MR image and second MR image and using voxels above threshold indicates and identifies cancer severity ([0048]).
Regarding to claim 4, Martins, Piper, and Malyarenko together teach all limitations of claim 1 as discussed above.
Piper further discloses limitation of claim 4, wherein the rendering engine is configured to superimpose indicia representing a location of the primary target point for the procedure over the fused 3-D image (Figure 12 shows treatment zones (its locations are visible in 3-D manner).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Martins, Piper, and Malyarenko as applied to claim 3 above, and further in view of “Lieblich et al.,” US 2019/0209130 (hereinafter Lieblich).
Regarding to claim 5, Martins, Piper, and Malyarenko together teach all limitations of claim 3 as discussed above.
Martins and Piper are both directed to re-slicing (resampling) image and image data. The examiner submits that beamforming is commonly used steps in processing data to generate an image, and accordingly, Martins teach using a beamformer to generate a 2-D image ([0031] and [0044]; [0046]).
In the analogous field of endeavor in ultrasound images, Lieblich teaches extracting 2-D plane from a 3D volume (which defines re-sampling step as claimed), wherein a beamformer configured to process the echoes to generate a real-time 2D sagittal ultrasound image ([0007]) and acquiring a set of planes, such as one or more sagittal planes ([0019]).
Thus, Martins can use beamformer of Lieblich to generate its 2D transverse image (resliced/resampled from 3D data) in real-time.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify two-dimensional images as taught by Martins to incorporate teaching 1of Lieblich, as all are directed to processing ultrasound signals to generate an ultrasound image, and since beamforming data to generate a real-time 2D image was well known in the art as taught by Lieblich. One of ordinary skill in the art could have combined the elements as claimed by Martins with no change in their respective functions, using beamformer to generate a real-time 2D image, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide real-time 2D image ([0007]) and there was reasonable expectation of success.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Martins, Piper, Malyarenko and Lieblich as applied to claim 5 as applied above, and further in view of “Papageorgiou et al.,” US 2013/0187903 (hereinafter Papageorgiou).
Regarding to claim 6, Martins, Piper, Malyarenko, and Lieblich together teach all limitations of claim 5, as discussed above.
Martins, Piper, Malyarenko, and/or Lieblich do not further disclose details of displaying sagittal and transverse plane in a first and second display port as claimed.
However, in the analogous field of endeavor in ultrasound imaging system and method, Papageorgiou teaches displaying medical images including an ultrasound image data ([0030]) displaying a 3D and 2D image together, using multiple sections (Figure 5), displaying tow dimensional view display windows including sagittal and transverse view boundaries, displaying sagittal and transverse images ([0093]), and displaying fusion of the image data of three dimensional volume data alongside with two dimensional sagittal and transverse image ([0112]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify two-dimensional images as taught by Martins to incorporate teaching of Papageorgiou, since displaying different view images alongside with three dimensional volume image simultaneously was well known in the art as taught by Papageorgiou. One of ordinary skill in the art could have combined the elements as claimed by Martins with no change in their respective functions, displaying sagittal and transverse images alongside with fused images, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide various views of the images ([0111]), and there was reasonable expectation of success.
Regarding to claim 7, Martins, Piper, Malyarenko, Lieblich, and Papageorgiou together teach all limitations of claim 6 as discussed above.
Piper further teaches wherein the rendering engine is configured to superimpose the indicia representing the location of the primary target point for the procedure over the beamform live transverse ultrasound image (Figures 6-7 show location of target in 2D image [0045]-[0046]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 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, Pascal Bui-Pho can be reached at 571-272-2714. 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.
/PATRICIA J PARK/Primary Examiner, Art Unit 3798
Prosecution Insights