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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/15/2023, 02/07/2024, and 07/31/2024 have been made record of and considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because “The invention relates to for method” is neither clear nor concise. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-20 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.
The phrases “one of a first modality and a first source” and “one of a second modality and a second source” are unclear, which renders claims 1 and 17 indefinite. It is unclear whether the claim requires exactly one modality or source, both together, or either/both as alternatives, thereby failing to inform a person of skill in the art of the scope of the invention. As seen in the specification, ‘source’ and ‘modality’ are separately defined:
[0005] ‘In other words, data of different modalities may comprise data of the same source (for example ultrasound) but of different modalities (for example different ultrasound acquisition modes).’
[0006] ‘The different sources may also comprise data obtained by different systems, for example by an ultrasound system and another imaging system, for example a medical imaging system like computer tomography, magnetic resonance or positron emission tomography.’
Additionally, it is unclear to the Examiner whether first/second modality/source is different from the first/second modality/source. For example, the claim could read as:
[for at least one of a plurality of volume units of the medium, determining an optical property based on the data of one of a first modality (first mode) and a first source (ultrasound),
for at least one of the volume units, determining a fluorescence property based on the data of one of a second modality (second mode) and a second source (ultrasound).
OR
for at least one of a plurality of volume units of the medium, determining an optical property based on the data of one of a first modality (first mode) and a first source (ultrasound),
for at least one of the volume units, determining a fluorescence property based on the data of one of a second modality (first mode (for MR)) and a second source (magnetic resonance imaging).]
See also the ‘and/or’ language of the specification. Appropriate correction is required.
The amended claim language could look like:
A method for processing
for at least one of a plurality of volume units of the medium, determining an optical property based on the data
for at least one of the volume units, determining a fluorescence property based on the data wherein the second modality is different from the first modality, and the second source is different from the first source, and
rendering a data representation of the medium based on the determined optical and fluorescence properties of the volume units.
Claims 9 and 10 recite the limitation "the shape of the intervention device." There is no previous recitation of “shape.” There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 1-9, 14, and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: In claim 1 it is entirely obscure how to determine "an optical property" "based on the data of one of a first modality and a first source" or "a fluorescence property" "based on the data of one of a second modality and a second source". When reading the claim it would appear that some form of light or optical acquisition would be necessary.
The additional features of the dependent claims add further ambiguity:
According to claim 3:
- the optical property at least one of comprises at least a light absorption rate of a volume unit, and the optical property is determined according to a first medium-light interaction mapping applied to the data of the first modality and/or source of the at least one volume unit.
There is no indication as to how "one of multi-modality and multi-source data" could be used to determine a light absorption rate. Moreover, it is impossible to understand is meant by a "medium-light interaction.” These questions become all the more pressing when taking into account that according to claim 8:
- the data of one of the first modality and the first source comprise reflectivity information from B-mode ultrasound imaging, and the data of one of the second modality and the second source comprise tissue elasticity information from shear wave elastography ultrasound imaging.
So there is no light involved whatsoever.
For example, it unclear how the "fluorescence property" could be determined by applying a "light emission and/or absorption mapping", in particular since emission and absorption are contrary to one another (claim 4).
Further, it does not appear that the specification clarifies how to determine the optical and the fluorescence property. For example, paragraphs [0096] to [0099] basically repeat the features of the claims. There is no technical teaching in the description how to carry out the "optical determination" or the "fluorescence determination". Hence, when trying to construe the subject-matter of the claims, it can only be guessed that some form of volume rendering is meant that overlays 3D ultrasound B-mode data into with color 3D shear wave data in order to get an image after rendering. 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.
Claim 16 is rejected under 35 USC 101 because the claimed invention is directed to non-statutory subject matter. Claim 16 claims the non-statutory subject matter of a computer program. Data structures not claimed as embodied in non-transitory computer-readable media are descriptive material per se and are not statutory because they are not capable of causing functional change in the computer. Therefore, since the claimed program is not tangibly embodied in a non-transitory physical medium and encoded on a non-transitory computer-readable medium, the Applicants have not complied with 35 USC 101.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kanitsar (US 2012/0038649 A1), in further view of Fan (US 2015/0150535 A1), and in further view of Youk (“Three-dimensional shear-wave elastography for differentiating benign and malignant breast lesions: comparison with two-dimensional shear-wave elastography”).
Consider claims 1 and 17, Kanitsar discloses a method for processing one of multi-modality and multi-source data of a medium (Abstract; “method and a corresponding apparatus for multimodal visualization of volume data sets of an object”), the method comprising:
[Claim 17: A system for processing one of multi-modality and multi-source data of a medium, the system comprising a processing unit configured to (Abstract, ¶17 processing unit):]
for at least one of a plurality of volume units of the medium, determining an optical property based on the data of one of a first modality and a first source (¶16; “acquiring a first volume data set of the object with a first imaging modality … establishing a transfer function, said transfer function defining optical properties of certain values of said first and second volume data set”),
for at least one of the volume units, determining a (¶16; “acquiring … a second volume data set of the object with a second imaging modality … establishing a transfer function, said transfer function defining optical properties of certain values of said first and second volume data set”), and
rendering a data representation of the medium based on the determined optical (¶16; “visualizing the optical properties of said certain values of said first and second volume data set”; ¶17-20; data fusion; ¶40; “FIG. 10 shows that the multimodal rendering in (c)”).
Kanitsar fails to specifically disclose determining a fluorescence property based on the data of one of a second modality and a second source, and
rendering a data representation of the medium based on the determined optical and fluorescence properties of the volume units.
In related art, Fan discloses determining a fluorescence property based on the data of one of a second modality and a second source (Fan ¶42; “The direction of strain may be mapped to color or other display characteristic.” ¶60-61; “elasticity values for different voxels are estimated in act 36 … a shear wave, longitudinal wave, strain, or other image is generated.”), and
rendering a data representation of the medium based on the determined optical and fluorescence properties of the volume units (Fan ¶61; “For three-dimensional imaging, any rendering technique may be used, such as maximum intensity projection.”, ¶62; “the elasticity image is combined with or overlaid on the B-mode image”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the fluorescence property of Fan into the multimodality method of Kanitsar to combine their strengths [modalities], providing the user with a consistent interface (Kanitsar ¶). Further, Fan enables a three dimensional representation of the elasticity in the three-dimensional region to be displayed (Fan ¶6).
In related art, Youk discloses rendering a data representation of the medium based on the determined optical and fluorescence properties of the volume units (pg. 1520 Ultrasound Examinations; “Volume data were reconstructed and displayed simultaneously in three orthogonal planes. Just as in 2D SWE, a semitransparent color overlay map was obtained using Q-Box, and the quantitative values obtained by placing 2×2-mm ROIs were calculated in all three orthogonal planes of 3D SWE. After completing the ultrasound examination, the acquired 3D volume data were also rendered and saved on the ultrasound machine console as a multislice display”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the fluorescence property of Youk into the multimodality method of Kanitsar, as modified by Fan, to combine their strengths [modalities], providing the user with a consistent interface (Kanitsar ¶). Further, Fan enables a three dimensional representation of the elasticity in the three-dimensional region to be displayed (Fan ¶6). Youk further offers 3D color-coded elasticity maps of tissue stiffness and a quantitative 3D elastography volume images in a single acquisition (Youk Introduction).
Consider claim 2, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein the data representation of the volumetric medium comprises at least one of a visual representation, a 2D image or a 3D image (Fan ¶61-62; Youk Ultrasound Imaging).
Consider claim 3, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein at least one of:
the optical property at least one of comprises at least a light absorption rate of a volume unit (Kanitsar ¶17, Fan ¶42, 60-61), and
the optical property is determined according to a first medium-light interaction mapping applied to the data of the first modality and/or source of the at least one volume unit (Kanitsar ¶17, Fan ¶60-61, Youk Ultrasound Examinations).
Consider claim 4, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein the fluorescence property is determined according to at least one of a first light emission and absorption mapping applied to the data of one of the second modality and source of the at least one volume unit (Fan ¶60-61, Youk Ultrasound Examinations).
Consider claim 5, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein in the optical determination step an at least one of:
determining the optical property comprises determining the optical property for at least one of the volume units based on the data of a third modality and/or source and according to a second medium-light interaction mapping being different to the first medium-light interaction mapping (Kanitsar ¶16-20, Fan ¶60-61, Youk Ultrasound Examinations), and
determining the fluorescence property comprises determining the fluorescence property for at least one of the volume units based on the data of a fourth modality and/or source and according to a second light emission and/or absorption mapping being different to the first light emission and/or absorption mapping (Kanitsar ¶16-20, Fan ¶42, 60-61, Youk Ultrasound Examinations).
Consider claim 6, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein determining the fluorescence property and determining the optical property are carried out simultaneously (Fan ¶60-61, Youk Ultrasound Examinations).
Consider claim 7, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein the determined optical and fluorescence properties are stored in a data storage and the rendering step is carried out afterwards one or several times based on the stored properties, or the rendering step is carried out simultaneously with at least one of determining the fluorescence property and determining the optical property (Fan ¶60-61, 80, Youk Ultrasound Examinations).
Consider claim 8, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein at least one of:
the data of one of the first modality and the first source comprise reflectivity information from B-mode ultrasound imaging (Fan ¶60-61, Youk Ultrasound Examinations), and
the data of one of the second modality and the second source comprise tissue elasticity information from shear wave elastography ultrasound imaging (Fan ¶42, 60-61, 72, Youk Ultrasound Examinations).
Consider claim 13, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein at least one of:
the one of multi-modality and multi-source data comprise one of image data and 3D data of the medium (Fan ¶61-62; Youk Ultrasound Imaging), and/or
the at least one of the volume units comprises at least one voxel (Fan ¶6, 18).
Consider claim 14, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein at least one of the determining the optical property, determining the fluorescence property, and rendering the data representation are implemented via at least one first artificial-intelligence-based algorithm and machine learning algorithm (Kanitsar ¶7, 12-13, Fan ¶33, 34, 80).
Consider claim 15, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein at least one second artificial-intelligence-based algorithm and a pre-trained machine learning algorithm carries out a predefined task as a function of the rendered data representation (Kanitsar ¶7, 12-13, Fan ¶33, 34, 80).
Consider claim 16, Kanitsar, as modified by Fan and Youk, discloses a computer program comprising computer-readable instructions which when executed by a data processing system cause the data processing system to carry out the method according to the claimed invention (Fan ¶7, 80).
Consider claim 18, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein the first medium-light interaction mapping determines at least one of a reflectivity, directivity and absorption rate as a function of the data of the first modality and/or source (Fan ¶23, 28, 42, 60-61).
Consider claim 19, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein determining the fluorescence property and determining the optical property are carried out in parallel (Fan ¶72, Youk Ultrasound Examinations).
Consider claim 20, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein the predefined task comprises at least one of a regression task, a classification task, and a segmentation task (Kanitsar ¶11, Fan ¶33).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kanitsar, in view of Fan and Youk, as applied to claims 1-8 and 13-20 above, and further in view of Takehiro (JP2008012150A).
Consider claim 9, Kanitsar, as modified by Fan and Youk, fails to specifically disclose the claimed invention wherein:
the data of one of the second modality and the second source comprise intervention device information indicating one of the position and orientation of an intervention device placed in relation to the medium and/or predetermined information of the shape of the intervention device, and
determining the fluorescence property based on the intervention device information comprises identifying those volume units which are occupied by the intervention device.
In related art, Takehiro discloses the data of one of the second modality and the second source comprise intervention device information indicating one of the position and orientation of an intervention device placed in relation to the medium and/or predetermined information of the shape of the intervention device (Takehiro ¶48-51), and
determining the fluorescence property based on the intervention device information comprises identifying those volume units which are occupied by the intervention device (Takehiro ¶48-51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the visualization of the intervention device of Takehiro into the teachings of Kanitsar, as modified by Fan and Youk, to, for example, distinguish between cancer tissue and the puncture needle on the three-dimensional image (Takehiro ¶49).
Consider claim 10, Kanitsar, as modified by Fan and Youk, fails to specifically disclose the claimed invention wherein at least a portion of the data representation is rendered based on intervention device information indicating one of the position and orientation of an intervention device placed in the medium and predetermined information of the shape of the intervention device.
In related art, Takehiro discloses wherein at least a portion of the data representation is rendered based on intervention device information indicating one of the position and orientation of an intervention device placed in the medium and predetermined information of the shape of the intervention device (Takehiro ¶48-51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the visualization of the intervention device of Takehiro into the teachings of Kanitsar, as modified by Fan and Youk, to, for example, distinguish between cancer tissue and the puncture needle on the three-dimensional image (Takehiro ¶49).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kanitsar, in view of Fan and Youk, as applied to claims 1-8 and 13-20 above, and further in view of Shinsuke (JP2016220765A).
Consider claim 11, Kanitsar, as modified by Fan and Youk, discloses the claimed invention wherein the rendering comprises rendering the data representation according to a ray tracing volume rendering method.
In related art, Shinsuke discloses wherein the rendering comprises rendering the data representation according to a ray tracing volume rendering method (Shinsuke ¶7-8, 25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the ray tracing of Shinsuke into the teachings of Kanitsar, as modified by Fan and Youk, to calculate pixel values corresponding to each ray (Shinsuke ¶25).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten (1) in independent form including all of the limitations of the base claim and any intervening claims, and (2) to overcome any other applied objects/rejections.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2025/0078261 A1 discloses systems and methods for object detection and measurements in multimodal imaging.
US 2021/0018606 A1 discloses systems and methods for elastographic and viscoelastographic imaging.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY HYTREK whose telephone number is (703)756-4562. The examiner can normally be reached M-F 9:00-5:00.
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/ASHLEY HYTREK/Examiner, Art Unit 2665
/Stephen R Koziol/Supervisory Patent Examiner, Art Unit 2665