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 papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/06/2023 is in compliance with the provisions on 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Amendments
Acknowledgement of receiving amendments to the claims, which were received by the office on 02/04/2026.
Response to Arguments
Applicant’s arguments filed 02/04/2026 have been fully considered but they are not persuasive.
In the remarks, regarding the Rejections under 35 U.S.C. 101, applicant argues in substance:
The applicant argues claim 1, involves operations that are inherently incompatible with human mental activity. In particular, claim 1 expressly requires processing of “voxel data constituting the target image,” and “pixels data in at least once cross section corresponding to each small region”, which is what the amended claim recites.
Examiner’s Response: The Examiner respectfully disagrees with the Applicant’s line of reasoning. The analysis below proceeds on that understanding of the applicant’s statements above.
Applicant’s Point 1 (Step 2A, Prong 1: mental process) — Not persuasive
Applicant contends the claim cannot be a mental process because it recites “voxel” and “pixel” data. However, under the 2019 PEG, claims can recite multiple categories of judicial exceptions, including mathematical concepts independent of human-mental feasibility. The recited steps “derive a first evaluation value,” “derive at least one second evaluation value representing a relationship,” and “derive a third evaluation value indicating presence/absence” are mathematical calculations/relationships and data analysis/comparison operations. Mathematical concepts are judicial exceptions under Step 2A, Prong 1 regardless of whether the calculations occur on computer-native data structures (voxels/pixels).
Authorities:
USPTO, 2019 Revised Guidance, Step 2A, Prong 1 (mathematical concepts include mathematical relationships, formulas, and calculations).
SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1167–70 (Fed. Cir. 2018) (statistical calculations and result-oriented data analysis are abstract, notwithstanding computer implementation).
Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1353–54 (Fed. Cir. 2016) (collecting information, analyzing it, and displaying results is abstract).
Content Extraction & Transmission LLC v. Wells Fargo, 776 F.3d 1343, 1347–49 (Fed. Cir. 2014) (extracting data from documents and storing it in a computer is abstract despite digital form).
MPEP 2106.04(a) (mathematical concepts) and 2106.04(d) (mental processes; analysis focuses on the nature of the concept, not the mere presence of a computer).
Conclusion under Prong 1: The claim “recites” a judicial exception at least as a mathematical concept. The fact that voxels/pixels are computer-native does not avoid Prong 1.
Applicant’s Point 2 (Step 2A, Prong 2: integration into a practical application) — Not persuasive on the present record
Applicant argues the claim applies a “specific technical manner” by considering inter-regional relationships. However, the claim language is results-oriented and functional: “set a plurality of small regions,” “derive a first evaluation value,” “derive at least one second evaluation value representing a relationship,” and “derive a third evaluation value.” The claim does not recite how any of these are specifically performed beyond generic data manipulation on a generic “processor.” There is no recitation of a particular algorithm or architecture (e.g., a defined segmentation model, centerline extraction method, cross-section sampling scheme, or specified formulas beyond “a relationship”), nor a particular machine integral to the claim, nor a transformation of matter, nor a technological improvement to the functioning of the computer itself.
Under the 2019 PEG (Step 2A, Prong 2), integration requires more than generic computer implementation or field-of-use limitation. Improvements must be tied to specific technological means, not aspirational goals. See:
Enfish, LLC v. Microsoft, 822 F.3d 1327, 1335–36 (Fed. Cir. 2016) (eligible where claim recited a specific improved data structure).
McRO, Inc. v. Bandai Namco, 837 F.3d 1299, 1313–16 (Fed. Cir. 2016) (eligible where claim recited specific rules that improved animation technology).
Two-Way Media Ltd. v. Comcast, 874 F.3d 1329, 1337–40 (Fed. Cir. 2017) (claims using result-focused, functional language without how-to lacked integration/improvement).
Electric Power Group, 830 F.3d at 1354 (applying rules to organize/display data of any type using generic computers is not an improvement to computer functionality).
MPEP 2106.05(a) (improvements to computer functionality), 2106.05(f) (mere instructions to apply the exception), 2106.05(h) (field of use).
Conclusion under Prong 2: As drafted, the claim does not integrate the abstract calculations into a practical application; it instead implements them on a generic processor in a medical imaging context. The asserted advantage (considering inter-regional relationships) is not claimed as a specific technical solution.
Step 2B (inventive concept) — Not shown
Even if proceeding to Step 2B, the claim does not recite “significantly more.” The only hardware is “at least one processor,” and the operations (segmentation of an organ, definition of regions, computing per-region metrics, computing inter-region relationships, and deriving an abnormality flag) are generic data processing steps long prevalent in medical image analysis and ML workflows. The claim lacks any specified unconventional arrangement, specialized hardware, or particular algorithmic improvements.
While factual allegations can be relevant under Berkheimer, here the claim itself does not include non-conventional elements; and the specification describes conventional implementations (e.g., CNN/U-Net for segmentation; vesselness/Hessian methods; basic ratios/differences; RNN encoder/decoder) as options, reinforcing conventionality.
Authorities:
Alice, 573 U.S. at 223–24 (generic computer implementation does not supply an inventive concept).
SAP v. InvestPic, 898 F.3d at 1169–71 (improved results of math analysis do not supply an inventive concept without a specific technological solution).
Univ. of Fla. Research Found. v. GE, 916 F.3d 1363, 1367–69 (Fed. Cir. 2019) (collecting/processing patient data on generic computers is abstract; no inventive concept).
MPEP 2106.05(d) (well-understood, routine, conventional activities).
Summary or Examiner’s response to 102/103 Arguments:
For the reasons above, the §101 rejection of claim 1 (and claims standing/falling therewith) would be maintained. The arguments do not show the claim avoids reciting a judicial exception under Step 2A, Prong 1, nor do they show integration into a practical application under Prong 2, nor do they identify additional elements that amount to “significantly more” at Step 2B.
In the remarks, regarding the Rejections under 35 U.S.C. 102/103, applicant argues in substance:
The applicant argues the prior art, particularly Ross does not disclose evaluation framework being based on relationships among multiple spatial regions but it rather a single temporal voxel-change analysis framework.
Examiner’s Response: The Examiner respectfully disagrees with the Applicant’s line of reasoning. The Examiner has thoroughly reviewed the Applicant’s arguments but respectfully believes the cited reference to reasonably and properly meet the claimed limitations. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims (See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Further Applicant's' argument does not address the actual reasoning of the Examiner's rejections. Instead, Applicants attack the references singly for lacking teachings that the Examiner relied on a combination of references to show. It is well established that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (See In re Keller, 642 F.2d 413). The court requires that references must be read, not in isolation, but for what they fairly teach in combination with the prior art as a whole (See In re Keller, 642 F.2d 413, 425 (CCPA 1981); In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986)).
With a broad interpretation, Examiner understands Ross does more than a purely temporal, same-voxel analysis: it (i) defines and analyzes multiple spatial subregions of the organ (e.g., lobes, bronchial branches), (ii) derives per-region quantitative measures from pixel/voxel data displayed on cross-sections, (iii) analyzes relationships among region-level measures (including comparative and multivariate relationships), and (iv) determines organ-level abnormality based on those relational/aggregate measures.
Applicant’s characterization of Ross as “only temporal, same-voxel” is incomplete:
Ross certainly performs voxel-wise temporal comparisons (e.g., ΔHU between inspiration/expiration), but Ross also expressly:
defines and analyzes spatial subregions (lobes, bronchial segments) and computes PCM metrics per region supported by the specification in:
[0108]–[0109]: “individual lobes of the lung were manually contoured… PCM metrics were calculated over the individual lobe VOI… extended to analyze the bronchi… different branches of the bronchi are analyzed separately.”
retains and uses spatial information and distributions, not merely global pooling supported in the specification by:
[0053]–[0054]: emphasizes retaining spatial information via voxel-wise classification and overlays.
[0094]–[0096]: computes the center of distribution and principal eigenvector on the voxel distribution, reflecting structural relationships.
Claim element: “derive a first evaluation value… of each of the plurality of small regions, based on pixel data in at least one cross section corresponding to each… region”
Ross teaches first-level, region-specific quantitative values derived from pixel/voxel data:
Per-region metrics: relative volume fractions of PCM classes (e.g., PCM(blue), PCM(yellow), PCM(red)) computed for lobes and bronchi; see [0108]–[0109] and figures showing region-specific bar graphs.
Pixel/cross-section basis: Ross repeatedly operates on tomographic cross-sections (CT slices) and overlays PCM color maps on “representative slices,” i.e., cross-sections:
[0045]: “voxel-by-voxel, or pixel-by-pixel” analysis.
[0079]: “PCM color-overlays of a representative slice… with corresponding scatter plots… thresholds.”
Figs. 5, 10, 11 show PCM overlays on cross-sectional images used to derive/report metrics.
While Ross’s primary “physical quantity” is intensity/ΔHU-based and volume fractions, the claim’s “physical quantity” is not limited to geometric size; it reasonably reads on these quantitative, per-region measures derived from pixel/voxel data displayed on cross-sections.
Claim element: “derive at least one second evaluation value representing a relationship between the first evaluation values in the plurality of small regions”
Ross discloses and uses inter-region relationships in multiple ways:
Comparative regional metrics:
[0108]: lobe-by-lobe PCM(blue) values decrease with GOLD; within-lung anterior vs posterior comparisons (inter-regional comparisons).
[0109]: branch-level PCM metrics compared across bronchial segments (see Fig. 21).
Combined/relational modeling of multiple first-level metrics:
[0082]–[0084] and Fig. 5/Table 530; Fig. 10/Table 1080: multivariate general linear models combining PCM(blue) and LAA (and other metrics) to relate them to FEV1—i.e., explicit use of relationships among evaluation values.
Distributional relationships:
[0094]–¶[0096]: center of distribution and principal eigenvector of the voxel distribution provide relational descriptors beyond individual values.
Even if Ross does not present the second value as a literal “ratio of adjacent region diameters,” it nevertheless teaches deriving and using relationship values among region-level first values (e.g., cross-region comparisons, multivariate relationships), satisfying this element.
Claim element: “derive a third evaluation value indicating presence or absence of an abnormality in the entire target organ based on the second evaluation value”
Ross explicitly derives organ-level abnormality indicators from relational/aggregate measures:
[0076]–[0079]: threshold analysis segments presence/non-presence of conditions into voxel classes; outcome measures (relative volumes) are used diagnostically.
[0082]–[0084], [0104]–[0106]: multivariate models (using PCM(blue), LAA, etc.) correlate to and predict organ-level clinical endpoints (FEV1, GOLD status, exacerbation risk)—i.e., determining disease presence/severity for the entire lung based on the relationships/aggregates.
Figs. 5, 7, 10, 12 and Tables 2, 5, 6: show organ-level determinations grounded in the inter-metric relationships.
Direct rebuttal to the “single temporal voxel-change framework” contention
Ross is not confined to per-voxel temporal changes:
It aggregates to region-based metrics (lobes, bronchi) and compares across regions ([0108]–[0109]).
It uses relational modeling among multiple first-level metrics (PCM categories, LAA, GT) to derive organ-level outcomes ([0082]–[0084], [0104]–[0106]).
It explicitly retains and exploits spatial distributions and provides per-region analyses and displays ([0053]–[0054], [0108]–[0109]).
Thus, Ross discloses the same three-tier evaluation paradigm in substance: (i) per-region first values from pixel/voxel data, (ii) relational values across those region metrics (comparisons/statistical relationships), and (iii) organ-level abnormality determination based on those relationships.
Even if minor differences remain, the claimed framework would have been obvious over Ross
To the extent applicant argues the claim requires a specific “cross-sectional” calculation or a particular algebraic ratio between adjacent regions:
Ross’s voxelwise/volume computations are performed over tomographic cross-sections (pixel grids), and its PCM overlays and metrics are computed and displayed per slice and per region ([0045], [0079], Figs. 5, 10, 11). Implementing a per-region metric “based on pixel data in at least one cross-section” is a routine, predictable variant of Ross’s slice-based processing.
Computing explicit relational values (e.g., ratios/differences) between per-region measures such as lobe-wise PCM(blue) percentages is an obvious design choice given Ross’s explicit lobe/branch comparisons ([0108]–[0109]) and multivariate relationships ([0082]–[0084]).
Accordingly, even if not literally disclosed in the precise words used by applicant, Ross at least suggests—and would render obvious to a person of ordinary skill—the recited first/second/third evaluation workflow across spatial regions.
Summary or Examiner’s response to 102/103 Arguments:
Applicant’s argument that Ross is confined to temporal same-voxel analysis and does not disclose or suggest region-level first values, inter-regional relationships, and organ-level determinations is not persuasive. Ross discloses:
region definition and per-region quantitative metrics from pixel/voxel data ([0108]–[0109], [0045], [0079]);
use of relationships among those metrics (comparisons across regions; multivariate models) ([0082]–[0084], [0094]–[0096], [0108]–[0109]);
deriving organ-level abnormality indications based thereon ([0076]–[0079], [0104]–[0106]).
Thus, Ross anticipates or at least renders obvious the challenged limitations of claim 1.
Therefore, with this broad interpretation, Ross in combination with Shim teaches, discloses or suggests the Applicant's invention, an image processing apparatus comprising at least one processor, in which the processor is configured to: extract a target organ from a medical image; set a plurality of small regions in the target organ; derive a first evaluation value representing a physical quantity of each of the plurality of small regions; derive at least one second evaluation value representing a relationship between the first evaluation values in the plurality of small regions; and derive a third evaluation value indicating presence or absence of an abnormality in the entire target organ based on the second evaluation value. Thus, Applicant's invention is not far removed from the art of record. Accordingly, these limitations do not render claims patentably distinct over the prior art of record. As a result, it is respectfully submitted that the present application is not in condition for allowance.
Conclusion
Therefore, the Examiner finds the Applicant’s arguments to be non-persuasive.
The Examiner maintains that limitations as presented and as rejected were properly and adequately met. The rejection as presented in the non-final rejection is maintained regarding to the above limitations. Additional citations and/or modified citations may be present to more concisely address limitations. However, the grounds of rejection remain the same.
Claim Rejections - 35 USC § 101 – Abstract Idea
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In January, 2019 (updated October 2019), the USPTO released new examination guidelines setting forth a two-step inquiry for determining whether a claim is directed to non-statutory subject matter. According to the 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 the claims are directed toward non-statutory subject matter, as shown below:
STEP 1: Do the claims fall within one of the statutory categories? Yes.
Claims 1-15 are directed towards an apparatus, i.e. machine.
Claim 16 is directed towards a method, i.e. process.
Claim 17 is directed towards a non-transitory computer-readable storage medium (non-transitory storage mediums), i.e. machine.
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 to an abstract idea.
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; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
The apparatus in claims 1-15, method in claim 16 and the non-transitory storage mediums (computer program product) in claim 17) is a mathematical concepts and mental processes that can be practicably performed in the human mind and, therefore, an abstract idea.
With regard to independent claim 1: The claimed invention recites:
Extract a target organ from a medical image,
Set a plurality of small regions in the target organ,
Derive a first evaluation value representing a physical quantity of each of the plurality of small regions,
Derive a second evaluation value representing a relationship between the first evaluation values in the plurality of small regions, and
Derive a third evaluation value indicating presence or absence of an abnormality in the entire target organ based on the second evaluation values.
These limitations, under their broadest reasonable interpretation, viewed as a whole, extracting images, setting a plurality of small regions, deriving first, second and third evaluation values and determining abnormalities fall within the abstract idea category of:
“Metal processes” – concepts performed in the human mind or by mathematical analysis, such as observation, evaluation, judgement or opinion, and
“Certain methods of organizing human activity’ such as information collection and classification.
These steps involves data gathering, analysis, and labeling, which are forms of mental processes and mathematical techniques. Such subject matter has been recognized by the court as falling within the abstract idea category, cases such as Electric Power Group v. Alsom S.A. and Digitech Image Technologies, LLC v. Electronics For Imaging, Inc. which similar data processing activities were found to be abstract. Therefore claim 1 is directed to an abstract idea.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the claim discloses do not disclose any structure.
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 effect 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.
With regards to Claim 1: The claim does not recite additional elements that integrate the abstract idea into a practical application. The getting images, detecting and matching objects, analyzing and assigning labels are steps that can be performed in a person's mind and/or by using pen paper.
Thus, the claims fail Step 2A, Prong Two.
With regards to claims 2-15, recites the additional limitation of the apparatus, they do not recite additional elements that integrate the abstract idea into a practical application. The extracting images, setting a plurality of small regions, deriving first, second and third evaluation values and determining abnormalities are steps that can be performed in a person's mind and/or by using pen paper. Therefore, claims 2-15 do not recite additional elements that integrate the judicial exception into a practical application.
With regards to claim 16, recites the additional limitation of a method, they do not recite additional elements that integrate the abstract idea into a practical application. The extracting images, setting a plurality of small regions, deriving first, second and third evaluation values and determining abnormalities are steps that can be performed in a person's mind and/or by using pen paper. Therefore, claim 16 does not recite additional elements that integrate the judicial exception into a practical application.
Claim 17 recites the additional limitation of a “a non-transitory computer-readable medium) comprising instructions, which, when the program is executed on a computer, causes the computer to perform the methods according to claim 16.” This computer program product is simply a computer recited at a high level of generality. The generic computer is used to perform the abstract idea. Using a computer as a tool to perform the abstract idea does not integrate the exception into a practical application. Data gathering is a form of insignificant extra-solution activity. See MPEP 2106.05(g). Therefore, claim 17 does not 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? No, the additional elements do not amount to significantly more and they are well understood, routine and conventional components and rather generic functions. The claim does 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.
The following computer functions have been recognized as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality): receiving or transmitting data over a network. See MPEP 2106.05(d)(II).
The claim elements, individually and in combination, do not recite significantly more than the abstract idea itself.
Extract a target organ from a medical image,
Set a plurality of small regions in the target organ,
Derive a first evaluation value representing a physical quantity of each of the plurality of small regions,
Derive a second evaluation value representing a relationship between the first evaluation values in the plurality of small regions, and
Derive a third evaluation value indicating presence or absence of an abnormality in the entire target organ based on the second evaluation values.
These are routine data processing activities and falls into the abstract idea categories:
“Metal processes” – concepts performed in the human mind or by mathematical analysis, such as observation, evaluation, judgement or opinion, and
“Certain methods of organizing human activity’ such as information collection and classification.
The extracting images, setting a plurality of small regions, deriving first, second and third evaluation values and determining abnormalities are well-known practices in data analysis and curation, even when implemented on a computer. Accordingly, the claim is directed to abstract idea.
Further, the extracting images, setting a plurality of small regions, deriving first, second and third evaluation values and determining abnormalities are steps that can be performed in a person's mind and/or by using pen paper.
Accordingly, the claims do not recite an inventive concept sufficient to transform the abstract idea into patent-eligible subject matter.
Accordingly, claims 1-17 are directed to concepts relating to processes of collecting and comparing data that can be performed mentally, which several court cases have found to be abstract. The claims do not recite any technological improvement or unconventional steps. The operations of detecting, matching, analyzing and labeling objects in sequential images are routine and conventional in the field of computer vision and image analysis.
There is no indication that the claimed extracting images, setting a plurality of small regions, deriving first, second and third evaluation values and determining abnormalities provides any technical solution or enhancement beyond generic data processing. The claims do not include any specific implementation that would amount to significantly more than the abstract idea itself.
CONCLUSION
Thus, since claims 1-17 are (a) directed toward an abstract idea, (b) does not recite additional elements that integrate the judicial exception into a practical application, and (c) does not recite additional elements that amount to significantly more than the judicial exception, it is clear that Independent Claims 1, 16 and 17 are directed towards non-statutory subject matter.
Further, dependent claims 2-15 further limit the abstract idea without integrating the abstract idea into practical application or adding significantly more. Each of the claimed limitations either expand upon or add either 1) new mental process, 2) a new additional element, 3) previously presented mental process, and/or 4) a previously presented additional element. As such, claims 2-15 are similarly rejected as being directed towards non-statutory subject matter.
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)(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) 1-14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ross et al. (US 2013/0004044 A1) here after referred to as Ross.
Regarding claim 1, Ross teaches an image processing apparatus (Ross, Fig 24, computer system, 1000) comprising:
at least one processor (Ross, Fig 24, computer 1010), wherein the processor is configured to: extract a target organ (Ross, sample region) from a medical image (Ross, Paragraphs [0043] {tissue type analyzed can include lung, prostate, breast, colon…In some embodiments, the tissue region is an organ.}, [0118] – [0121]) to generate a target image (Ross, Fig 4, [0046]–[0048], [0056]–[0062], {PCM repeatedly describes segmentation/extraction (lung segmentation, segmentation for registration) and treating segmented/registered volumes as processing targets.});
set a plurality of small regions in the target organ based on values of voxel data constituting the target image (Ross, Paragraph [0122], … such collected image data to produce a co-registered image data comprising a plurality of voxels…determine the presence of the tissue state condition in the sample region, Figs.1,18–21, [0011], [0045]–[0048], [0053]–[0054], [0056], [0092], [0108]–[0112]);
derive a first evaluation value representing a physical quantity of each of the plurality of small regions based on pixel data in at least one cross section corresponding to each of the plurality of small regions (Ross, Figs.6,9,10, Paragraphs [0045]-[0047], These local variations are determined by taking two or more imaged acquired at different phases of movement, which could be acquired over time intervals…, [0050], [0053]–[0054], [0066]–[0068], [0076]–[0079], normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612; PCM computes per-voxel and per-region quantitative measures (HU, ΔHU, relative volume fractions, medians, center of distribution));
derive at least one second evaluation value representing a relationship between the first evaluation values in the plurality of small regions (Ross, Figs.6,9, Paragraphs [0066]–[0068], [0094]–[0096], [0104]–[0106], normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612; PCM analyzes relationships across voxels/regions (scatter plots of inspiration vs expiration, PCA principal eigenvector, center of distribution, relative-volume comparisons, multivariate regressions). ([0094]–[0096]; Fig.6)); and
derive a third evaluation value indicating presence or absence of an abnormality in the entire target organ based on the second evaluation value (Ross, Tables & Figs.5,7,10,12, [0076]–[0079], [0082]–[0084], [0096]–[0106], PCM derives organ-level diagnostic/prognostic outputs (relative volumes of classified voxels, correlation to FEV1 / GOLD, classification of COPD phenotypes, thresholds segmenting presence/absence).
Regarding claim 2, Ross teaches the image processing apparatus according to claim 1, wherein the first evaluation value is a physical quantity related to a size of the small region, and
the second evaluation value is an evaluation value related to a difference in sizes between the small regions (Ross, Figure 2, paragraph [0055]).
Regarding claim 3, Ross teaches the image processing apparatus according to claim 1, wherein the processor is configured to:
set an axis passing through the target organ; and
set the small region along the axis (Ross, Fig 6 and paragraph [0068]).
Regarding claim 4, Ross teaches the image processing apparatus according to claim 2, wherein the processor is configured to:
set an axis passing through the target organ; and
set the small region along the axis (Ross, Fig 6 and paragraph [0068]).
Regarding claim 5, Ross teaches the image processing apparatus according to claim 1, wherein the processor is configured to display an evaluation result based on the third evaluation value on a display (Ross, paragraphs [0051] – [0055]).
Regarding claim 6, Ross teaches the image processing apparatus according to claim 5, wherein the evaluation result based on the third evaluation value is an occurrence probability of a finding representing a feature of a shape of the target organ (Ross, paragraphs [0047], [0051] – [0055]).
Regarding claim 7, Ross teaches the image processing apparatus according to claim 6, wherein the finding includes at least one of atrophy, swelling, stenosis, or dilation that occurs in the target organ (Ross, [0052], …The deformation registration engine provides a set of tissue specific parameters… where these parameters may represent physical characteristics of the tissue (e.g., general shape, position, …swelling due to edema…).
Regarding claim 8, Ross teaches the image processing apparatus according to claim 5, wherein the processor is configured to display a position of the small region having a relatively high contribution to the evaluation result in the target organ on the display as distinguished from a position of the small region having a relatively low contribution (Ross, [0068] normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612).
Regarding claim 9, Ross teaches the image processing apparatus according to claim 6, wherein the processor is configured to display a position of the small region having a relatively high contribution to the evaluation result in the target organ on the display as distinguished from a position of the small region having a relatively low contribution . (Ross, [0068] normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612).
Regarding claim 10, Ross teaches the image processing apparatus according to claim 7, wherein the processor is configured to display a position of the small region having a relatively high contribution to the evaluation result in the target organ on the display as distinguished from a position of the small region having a relatively low contribution (Ross, [0068] normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612).
Regarding claim 11, Ross teaches the image processing apparatus according to claim 8, wherein the processor is configured to display at least one of the first evaluation value or the second evaluation value of the small region having the relatively high contribution to the evaluation result in the target organ on the display (Ross, [0068] normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612).
Regarding claim 12, Ross teaches the image processing apparatus according to claim 9, wherein the processor is configured to display at least one of the first evaluation value or the second evaluation value of the small region having the relatively high contribution to the evaluation result in the target organ on the display (Ross, [0068] normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612).
Regarding claim 13, Ross teaches the image processing apparatus according to claim 10, wherein the processor is configured to display at least one of the first evaluation value or the second evaluation value of the small region having the relatively high contribution to the evaluation result in the target organ on the display (Ross, [0068] normal classified areas 1604 and II 606, diseased by non-emphysematous tissue Classified III 608, Emphysematous classified under areas IV 610 and V 612).
Regarding claim 14, Ross teaches the image processing apparatus according to claim 1, wherein the medical image is a tomographic image of an abdomen including a pancreas, and the target organ is a pancreas (Ross, paragraph [0043]).
Regarding claim 18, Ross teaches the image processing apparatus according to claim 1, wherein the at least one second evaluation value representing the relationship between the first evaluation values in two adjacent small regions among the plurality of small regions (Ross, Fig. 18; Fig. 21; Paragraphs [0108]–[0109]; also [0053]–[0054]; [0083]; Ross computes per-region “first” metrics (e.g., PCM(blue), PCM(yellow), PCM(red) volume fractions) for spatial subregions: “individual lobes of the lung were manually contoured… PCM metrics were calculated over the individual lobe VOI” and “extended to analyze the bronchi… different branches of the bronchi are analyzed separately.” ([0108]–[0109]; Fig. 18 shows per-lobe bars; Fig. 21 shows per-branch bars). Ross then compares those region metrics within the same lung, e.g., “within lungs… higher values of PCM(blue) in the lung posterior than anterior” ([0108])—a relational comparison between adjacent anterior/posterior subregions. Ross also observes adjacency phenomena (regions “bordered” by other regions with different PCM classes) ([0083]).
Claims 16 and 17 are rejected for the same reasons as claim 1.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. (US 2013/0004044 A1) here after referred to as Ross in view of SHIM (US 2021/0219828 A1).
Regarding claim 15, Ross teaches the image processing apparatus according to claim 14, but does not implicitly teach wherein the processor is configured to set the small region by dividing the pancreas into a head portion, a body portion, and a caudal portion.
However, SHIM teaches wherein the processor is configured to set the small region by dividing the pancreas into a head portion, a body portion, and a caudal portion (Kaufman, paragraph [0016,],…when the peripheral organ is a pancreas, the control unit may control the at least one ultrasonic unit to perform imaging of the pancreas by…imaging of a central part of the pancreas and frequency of performing imaging of head and tail parts of the pancreas., [0064], [0097], [0106], …for clos-up imaging, ….the operator may adjust the frequency to perform imaging of the heard, tail and center part of the pancreas.).
These arts are analogous since they are both related to medical imaging devices. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention (AIA ) to modify the invention of Ross with the classification module of SHIM to more easily image and diagnose disease in the pancreas by segmenting as taught by SHIM in paragraph 0075.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/TWYLER L HASKINS/Supervisory Patent Examiner, Art Unit 2639