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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Image Processing Device and Method for Spinal Canal Invasion Evaluation and Display.
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 20 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention because the claimed invention is directed to computer program per se. See MPEP 2106(I). A claim directed toward a non-transitory computer-readable medium having the program encoded thereon establishes a sufficient functional relationship between the program and a computer so as to remove it from the realm of “program per se”. MPEP 2111.05(III).
Claims 1-3, 7-12, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that Claims 1-3, 7-12, and 17 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories (i.e. process, a computer readable medium, i.e. a system)? YES. Claims 1-12 are directed to a device, Claim 17 is directed to a method, and Claim 20 currently does not fall into a statutory category, see the 101 rejection rationale above.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? YES, the claims are directed towards an abstract idea – mental process.
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
- Mathematical concepts — mathematical relationships, mathematical formulas or equations, mathematical calculations;
- Certain methods of organizing human activity — fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations
- Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgement, opinion).
Regarding Claim 1, representative of Claims 17 and 20, the claim recites an image processing device comprising processing circuitry configured to:
extract a spinal canal from a subject region captured in a medical image (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can identify a spinal canal from a medical image mentally);
extract an abnormal region in the spinal canal (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can identify an abnormal region in an image of a spinal canal mentally);
set a significance level in the abnormal region, according to a location in the spinal canal (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can identify a significance of an identified abnormal region); and
generate display data relating to the abnormal region, based on the significance level (see step 2A prong 2 – insignificant extra-solution activity – general output of data).
Regarding Claim 2, the claim recites the image processing device according to claim 1, wherein the processing circuity sets the significance level for each of a plurality of pixels representing the abnormal region (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can mentally evaluate a significance level of a region in an image).
Regarding Claim 3, the claim recites the image processing device according to claim 2, wherein the display data is data representing an index value representing a degree of abnormality relating to the abnormal region (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can mentally evaluate a degree of abnormality of a region in an image).
Regarding Claim 7, the claim recites the image processing device according to claim 1, wherein the display data is image data in which display color of a pixel corresponding to the abnormal region is changed based on the significance level (see step 2A prong 2 – insignificant extra-solution activity involving outputting data. Limitation can also be considered well understood, routine, and conventional).
Regarding Claim 8, the claim recites the image processing device according to claim 1, wherein the significance level is set based on distance from a contour of the spinal canal (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can observe and judge an abnormal region as having higher significance based on how far away it is from the edge of the canal in an image).
Regarding Claim 9, the claim recites the image processing device according to claim 8, wherein the significance level is set higher as the distance from the contour of the spinal canal increases (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional can observe and judge an abnormal region as having higher significance based on how far away it is from the edge of the canal in an image).
Regarding Claim 10, the claim recites the image processing device according to claim 1, wherein the processing circuitry extracts the abnormal region based on a difference image between the medical image and a past medical image of the subject (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes a medical professional could observe a past medical image and evaluate an abnormal region based on an observed difference).
Regarding Claim 11, the claim recites the image processing device according to claim 1, wherein the abnormal region is a region of spinal canal invasion where cancer bone metastasis has invaded the spinal canal (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement. Examiner notes the limitation only places limitations on what the abnormal region is. As such, the claim can still be performed mentally).
Regarding Claim 12, the claim recites the image processing device according to claim 1, wherein the significance level is a clinically significant level (Mental process – concepts easily performed in the human mind including observation, evaluation, and judgement).
These limitations, as drafted, is a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. The Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same). As such a medical professional could extract a spinal canal from a subject region in a medical image, extract an abnormal region in the spinal canal, set a significance level in the abnormal region according to a location in the spinal canal, and generate display data relating to the abnormal region based on the significance level mentally and/or by using pen and paper. The mere nominal recitation that the various steps are being executed by a device/in a device (e.g. processing unit) does not take the limitations out of the mental process grouping. Thus, the claims recite a mental process. Examiner notes that Claims 4-6 are recited as processing that cannot practically be performed in the human mind.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? NO, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Claims 1-3, 7-12, and 17 do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO, the claims do not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claims 1-3, 7-12, and 17 do not recite any additional elements that are not well-understood, routine or conventional.
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 1-12, 17, and 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 term “abnormal” in claims 1-5, 7, 10, 17, and 20 is a relative and/or subjective term which renders the claim indefinite. The term “abnormal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thereby it is unclear what the “abnormal region” is. For example, is it an abnormal shape? Is it noise in the image? Due to the term “abnormal” being unclear, it is also unclear what is meant by “abnormal region, based on the significance level” in Claim 1.
A claim that requires the exercise of subjective judgment without restriction renders the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014)
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-9, 11-12, and 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Lemay (Lemay, A., Gros, C., Zhuo, Z., Zhang, J., Duan, Y., Cohen-Adad, J., & Liu, Y. (2021). Automatic multiclass intramedullary spinal cord tumor segmentation on MRI with deep learning. NeuroImage. Clinical, 31, 102766. https://doi.org/10.1016/j.nicl.2021.102766).
Regarding Claim 1, representative of Claim 17 and 20, Lemay teaches an image processing device comprising processing circuitry configured to:
extract a spinal canal from a subject region captured in a medical image ([Section 2.4.1]: The spinal cord localization model was trained with a Dice loss (Milletari et al., 2016) using a single patch input of size 512 × 256 × 32 on T2w MRI scans. See Fig. 2 step 1, spinal cord localization and cropping which includes the spinal canal);
extract an abnormal region in the spinal canal ([Section 2.4.2]: tumor segmentation is multi-contrast since both gadolinium-enhanced T1w and T2w MRI scans carry valuable information. See Fig. 2 step 2, tumor segmentation from the cropped image);
set a significance level in the abnormal region, according to a location in the spinal canal ([Section 2.5]: Postprocessing steps are applied to the model’s prediction. The steps include: binarization with a threshold of 0.5, filling holes, and removing tumor prediction smaller than 0.2 cm3, as well as edema and cavity predictions smaller than 0.5 cm3 to limit false positives and noise, [Section 2.6.1]: Dice score was used to evaluate the segmentation performance of both spinal cord localization and tumor segmentation models…A structure was considered detected if there was an overlap of at least 6 mm3 between the ground truth and the prediction); and
generate display data relating to the abnormal region, based on the significance level (see Fig. 3: Sagittal MRIs showing the model’s prediction on a subject containing tumor, edema, and cavity).
Regarding Claim 2, Lemay teaches the image processing device according to claim 1. In addition, Lemay teaches wherein the processing circuity sets the significance level for each of a plurality of pixels representing the abnormal region ([Section 2.5]: Postprocessing steps are applied to the model’s prediction. The steps include: binarization with a threshold of 0.5, filling holes, and removing tumor prediction smaller than 0.2 cm3, as well as edema and cavity predictions smaller than 0.5 cm3 to limit false positives and noise. Examiner interpreting the significance level as tumor predictions greater than 0.2 cm3).
Regarding Claim 3, Lemay teaches the image processing device according to claim 2. In addition, Lemay teaches wherein the display data is data representing an index value representing a degree of abnormality relating to the abnormal region ([Section 2.5]: Postprocessing steps are applied to the model’s prediction. The steps include: binarization with a threshold of 0.5, filling holes, and removing tumor prediction smaller than 0.2 cm3. See Fig. 3, the tumor segmented in the image is representative of tumor predictions greater than 0.2 cm3).
Regarding Claim 7, Lemay teaches the image processing device according to claim 1. In addition, Lemay teaches wherein the display data is image data in which display color of a pixel corresponding to the abnormal region is changed based on the significance level ([Section 2.5]: Postprocessing steps are applied to the model’s prediction. The steps include: binarization with a threshold of 0.5, filling holes, and removing tumor prediction smaller than 0.2 cm3. See Fig. 3: Sagittal MRIs showing the model’s prediction on a subject containing tumor, edema, and cavity. Examiner notes the color change to red representing the tumor based on the significance level/predicted tumor regions larger than 0.2 cm3).
Regarding Claim 8, Lemay teaches the image processing device according to claim 1. In addition, Lemay teaches wherein the significance level is set based on distance from a contour of the spinal canal ([2.6.1]: Dice score was used to evaluate the segmentation performance of both spinal cord localization and tumor segmentation models…A structure was considered detected if there was an overlap of at least 6 mm^3 between the ground truth and the prediction. Examiner interpreting the significance level as the Dice score/model prediction where the score is set based on a distance from the ground truth/contour).
Regarding Claim 9, Lemay teaches the image processing device according to claim 8. In addition, Lemay teaches wherein the significance level is set higher as the distance from the contour of the spinal canal increases ([2.6.1]: Dice score was used to evaluate the segmentation performance of both spinal cord localization and tumor segmentation models…A structure was considered detected if there was an overlap of at least 6 mm^3 between the ground truth and the prediction. Examiner interpreting the significance level as the Dice score/model prediction where the score is set based on a distance from the ground truth/contour. Examiner notes dice loss increases as the distance from ground truth increases).
Regarding Claim 11, Lemay teaches the image processing device according to claim 1. In addition, Lemay teaches wherein the abnormal region is a region of spinal canal invasion where cancer bone metastasis has invaded the spinal canal ([Introduction, paragraph 1]: Intramedullary spinal cord tumors (IMSCT) …Segmentation informs the healthcare specialists on the tumor’s position, size, and growth rate leading to quantitative monitoring of the tumor’s progression. See Fig. 2, tumor prediction appears within the canal).
Regarding Claim 12, Lemay teaches the image processing device according to claim 1. In addition, Lemay teaches wherein the significance level is a clinically significant level ([Section 2.5]: Postprocessing steps are applied to the model’s prediction. The steps include: binarization with a threshold of 0.5, filling holes, and removing tumor prediction smaller than 0.2 cm3. Examiner notes the breadth of the term clinically significant and is interpreting it as Lemay’s set threshold).
Claim Rejections - 35 USC § 103
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.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lemay (Lemay, A., Gros, C., Zhuo, Z., Zhang, J., Duan, Y., Cohen-Adad, J., & Liu, Y. (2021). Automatic multiclass intramedullary spinal cord tumor segmentation on MRI with deep learning. NeuroImage. Clinical, 31, 102766. https://doi.org/10.1016/j.nicl.2021.102766) in view of Gawel (US 20250173860 A1).
Regarding Claim 10, Lemay teaches the image processing device according to claim 1. However, Lemay does not explicitly teach wherein the processing circuitry extracts the abnormal region based on a difference image between the medical image and a past medical image of the subject.
Gawel teaches wherein the processing circuitry extracts the abnormal region based on a difference image between the medical image and a past medical image of the subject ([0143]: The historical spinal analysis data can then be retrieved in a later spinal analysis process 540, e.g., to inform a change and/or a rate of change of one or more features or characteristics of one or more anatomical parts over time, [0147]: in some embodiments, the spinal analysis model(s) can compare current anatomical feature analyses with historical spinal analysis data retrieved at 546 to predict a spinal deformity assessment for the ROI).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the teachings of Lemay to include the teachings of Gawel by substituting the segmentation model for tumor identification by a comparison with a past medical image for ROI extraction as taught by Gawel. Doing so would provide the predictable result of an abnormal region extraction.
Allowable Subject Matter
Claims 4-6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Lemay (Lemay, A., Gros, C., Zhuo, Z., Zhang, J., Duan, Y., Cohen-Adad, J., & Liu, Y. (2021). Automatic multiclass intramedullary spinal cord tumor segmentation on MRI with deep learning. NeuroImage. Clinical, 31, 102766. https://doi.org/10.1016/j.nicl.2021.102766) is considered the closest prior art. Lemay teaches spinal cord segmentation and tumor segmentation from MRI scans using U-net models. Although Lemay teaches a certain volume being a threshold for a segmented tumor, Lemay does not explicitly teach determining an index value wherein the index value is based on a weighting of the significance levels of each of the pixels representing an abnormal region as required by Claim 4 and dependent Claim 5. Further although Lemay teaches display data representing an index value as required by Claim 3 in terms of outputting the segmented image, segmented with the tumor, Lemay does not explicitly teach the display data representing the index value being a graph where the index value is calculated for a cross section intersecting a running direction of a spinal canal and plotted along a running direction of a spinal canal in a target image. Lemay further teaches away from this limitation as the segmented image is in a sagittal view rather than a cross-section intersecting a running direction of a spinal canal. This limitation is found in Claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE VAZ whose telephone number is (703)756-4685. The examiner can normally be reached Monday-Friday 9:00-5:00pm.
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/JANICE E. VAZ/Examiner, Art Unit 2667
/Soo Shin/Primary Examiner, Art Unit 2667
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