DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant respectfully traverses the abstract idea rejection because the claims provide a technical improvement to the function of a computer in two ways. First, Applicant argues that there is an improvement in the ability of a computer to perceive and analyze medical images and second that there is an improvement in the ability of a computer to generate an extent of inflammation and/or fibrosis within the one or more intestinal strictures. Examiner respectfully disagrees. It is not clear how the improvement to the function of a computer is achieved. The claims do not contain any details as to how the medical images are analyzed.
Applicant respectfully submits that the prior art fails to explicitly teach inflammation score as recited in the currently amended claims. Applicant’s arguments are moot in view of the new grounds of rejected necessitate by the claim amendments.
Applicant respectfully submits that the prior art fails to explicitly teach Stenosis Therapy and Research (STAR) scoring. Examiner respectfully disagrees. The claim limitation recites “wherein the one or more pathological features comprise one or more features used in Stenosis Therapy and Research (STAR) scoring of the one or more intestinal strictures”, i.e., pathological features that are used in STAR scoring, which is basically an international working group composed of inflammatory bowel disease (IBD) pathologists and gastroenterologists that develop standardized guidelines. The features described in D1 are implicitly used in STAR scoring. Additionally, Examiner provides additional documentary evidence describing the STAR scoring.1 Gordon et al. describes an International consensus to standardize histopathological scoring for small bowel strictures in Crohn’s disease on behalf of the Stenosis Therapy and Anti-Fibrotic Research (STAR) Consortium.
Applicant respectfully submits that the prior art fails to teach morphological features. Applicant admits that the prior art teaches shape features, but argues that the final model only selects texture features. Examiner respectfully disagrees. It is clear that D1 explicitly teach shape features. In an exemplary embodiment, texture features are selected for the model. However, it is clear that shape features may also be used as shown in fig. 2.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 1 recites “identifying a plurality of determinative features from within the one or more intestinal strictures in the one or more radiological images, wherein the plurality of determinative features are associated with one or more pathological features used to identify inflammation or fibrosis within an intestinal stricture” which falls under the grouping of Mental Processes because a person or doctor can mentally observe the images and identify the features for discriminating inflammation or fibrosis by visual inspection. The other limitation “accessing an imaging data set comprising one or more radiological images of a patient having Crohn's disease, wherein the one or more radiological images comprise one or more intestinal strictures” is merely a data gathering step which is an insignificant extra-solution activity. Finally, the limitation “applying a machine learning model to the plurality of determinative features generate an inflammation score and a fibrosis score, wherein the inflammation score has a first numeric value corresponding to an extent of inflammation within the one or more intestinal strictures and the fibrosis score has a second numeric value corresponding to an extent of fibrosis within the one or more intestinal strictures” falls under the grouping of Mental Processes because a person or doctor can mentally observe the images and identify the features for discriminating inflammation or fibrosis by visual inspection and classifying the images. The stipulation of using a machine learning model is nothing more than an instruction to implement an abstract idea on a generic computer. Moreover, applying a machine learning model merely indicates a field of use or technological environment in which the judicial exception is performed, and this type of limitation merely confines the use of the abstract idea to a particular technological environment (machine learning) described at a high level of generality and thus fails to add an inventive concept to the claims.
Dependent claim 2 recites “wherein the one or more pathological features comprise one or more features used in Stenosis Therapy and Research (STAR) scoring of the one or more intestinal strictures” which falls under the grouping of Mental Processes because a person or doctor can mentally inspect and score the features by visual inspection.
Dependent claim 3 recites “extracting a plurality of radiomic features from within the one or more intestinal strictures in the one or more radiological images; and identifying the plurality of determinative features as a subset of the plurality of radiomic features by correlating one or more of the plurality of radiomic features with the one or more pathological features” which fall under the grouping of Mental Processes because a person can mentally observe and extract plurality of features and correlate to pathological features by visual inspection.
Dependent claim 4 recites “identifying a plurality of determinative inflammation features from the plurality of radiomic features by correlating a first set of the plurality of radiomic features with a first set of the one or more pathological features used to identify inflammation within the intestinal stricture; and generating an inflammation score comprising a first numeric value that is indicative of the extent of inflammation within the one or more intestinal strictures” which falls under the grouping of Mental Processes because a person can mentally observe and score plurality of features and correlate to inflammation by visual inspection.
Dependent claim 5 recites “determining a treatment plan for the patient based on the inflammation and/or fibrosis score” ” which falls under the grouping of Mental Processes because a person can mentally determine a treatment plan based on the scores.
Dependent claim 6 recites “wherein the one or more radiological images comprise magnetic resonance enterography (MRE) images” which is merely a data gathering step which is an insignificant extra-solution activity.
Dependent claim 7 recites “wherein the plurality of determinative features comprise a first plurality of determinative inflammation features that are used to determine the extent of inflammation within the one or more intestinal strictures, the first plurality of determinative inflammation features comprising one or more of a median of a Law's feature, a Kurtosis of a Gabor feature, and a skewness of a Law's feature” which falls under the grouping of Mental Processes because a person can mentally observe and score plurality of features and correlate to inflammation by visual inspection. Alternatively, determining a median or statistical measure of Kurtosis can be read as Mathematical calculation.
Dependent claim 8 recites “wherein the plurality of determinative features comprise a first plurality of determinative fibrosis features that are used to determine the extent of fibrosis within the one or more intestinal strictures, the first plurality of determinative fibrosis features comprising one or more of a skewness of a Gabor feature, a skewness of a Law's feature, a kurtosis of a Law's feature, a kurtosis of a Gray mean feature, and a variance of a Gray range” which falls under the grouping of Mental Processes because a person can mentally observe and score plurality of features and correlate to fibrosis by visual inspection. Alternatively, determining a median or statistical measure of Kurtosis can be read as Mathematical calculation.
Dependent claim 9 recites “wherein the one or more radiological images comprise computed tomography enterography (CTE) images” which is merely a data gathering step which is an insignificant extra-solution activity.
Dependent claim 10 recites “wherein the plurality of determinative features comprise a second plurality of determinative inflammation features that are used to determine the extent of inflammation within the one or more intestinal strictures, the second plurality of determinative inflammation features comprising one or more of a median of a Gradient Sobel feature, a skewness of a Law's feature, a variance of a Gradient Sobel feature, a kurtosis of a Gabor feature, a skewness of a Haralick energy feature, a skewness of a Law's feature, a skewness of a Law's feature, a median of a Gabor feature, a median of a Law's feature, and/or a median of a Law's feature”, which falls under the grouping of Mental Processes because a person can mentally observe and score plurality of features and correlate to inflammation by visual inspection. Alternatively, determining a median or statistical measure of Kurtosis can be read as Mathematical calculation.
Dependent claim 11 recites “wherein the plurality of determinative features comprise a second plurality of determinative fibrosis features that are used to determine the extent of fibrosis within the one or more intestinal strictures, the second plurality of determinative fibrosis features comprising one or more of a skewness of a Law's feature, a median of a Gabor feature, a median of a Gray range feature, a median of a Haralick sum variance, a median of a Law's feature, a kurtosis of a Haralick energy feature, a median of a Law's feature, a median of a Gabor feature, a variance of a Law's feature, and/or a median of a Law's feature” which falls under the grouping of Mental Processes because a person can mentally observe and score plurality of features and correlate to fibrosis by visual inspection. Alternatively, determining a median or statistical measure of Kurtosis can be read as Mathematical calculation.
Claims 12-20 are rejected for the same reasons as above. See discussion of corresponding claims.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 16 and 19-20 recite limitations that been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it they use a generic placeholders “feature extraction stage”, “identification stage” and “model stage” coupled with functional language without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, the claim have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 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 1, 3-6, 9, 12-16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over D12 and further in view of D2.3
With regard to claim 1, D1 teach accessing an imaging data set comprising one or more radiological images of a patient having Crohn's disease, wherein the one or more radiological images comprise one or more intestinal strictures (see p. 2306 ¶ 1, fig. 2: radiology images); identifying a plurality of determinative features from within the one or more intestinal strictures in the one or more radiological images, wherein the plurality of determinative features are associated with one or more pathological features used to identify inflammation or fibrosis within an intestinal stricture (see p. 2306 ¶¶ 1-2, fig. 2); and applying a machine learning model to the plurality of determinative features generate an see p. 2306 ¶¶ 1-2, fig. 2: fibrosis score). D1 fails to explicitly teach generating a inflammation score, however D2 teaches the missing features (see ¶¶ 132, 150: inflammation score).
One skilled in the art before the effective filing date would have found it obvious to combine the teachings to arrive at the claimed invention. In particular, it would have been obvious to incorporate known teachings of generating an inflammation score as taught by D2 into the configuration of D1 yielding predictable and enhanced diagnostic results. In particular, it would have been obvious to train the machine learning model in D1 to generate an inflammation score in addition to the fibrosis score in order to improve diagnosis of certain conditions.
With regard to claim 3, D1 teach extracting a plurality of radiomic features from within the one or more intestinal strictures in the one or more radiological images; and identifying the plurality of determinative features as a subset of the plurality of radiomic features by correlating one or more of the plurality of radiomic features with the one or more pathological features (see fig. 2, p. 2307 last ¶: features used to discriminate pathology such as fibrosis or inflammation).
With regard to claim 4, D1 teach identifying a plurality of determinative inflammation features from the plurality of radiomic features by correlating a first set of the plurality of radiomic features with a first set of the one or more pathological features used to identify inflammation within the intestinal stricture; and generating an inflammation score comprising a first numeric value that is indicative of the extent of inflammation within the one or more intestinal strictures (see fig. 2, p. 2309 col 2 ¶ 3: inflammation score). .
With regard to claim 5, D1 teach identifying a plurality of determinative fibrosis features from the plurality of radiomic features by correlating a first set of the plurality of radiomic features with a first set of the one or more pathological features used to identify fibrosis within the intestinal stricture; and generating a fibrosis score comprising a second numeric value that is indicative of the extent of fibrosis within the one or more intestinal strictures (see fig. 2, p. 2305 ¶ 4: inflammation and fibrosis scores).
With regard to claim 6, D1 teach wherein the one or more radiological images comprise magnetic resonance enterography (MRE) images (see p. 2304 ¶ 2).
With regard to claim 9, D1 teach wherein the one or more radiological images comprise computed tomography enterography (CTE) images (see p. 2304 ¶ 3).
With regard to claim 12, see discussion of claim 1.
With regard to claim 13, see discussion of claims 6 and/or 9.
With regard to claim 14, see discussion of claim 3.
With regard to claim 15, D1 teach wherein the plurality of radiomic features comprise texture features and morphological features (see fig. 2: texture features, shape/volume features).
With regard to claim 16, see discussion of claim 1.
With regard to claim 18, see discussion of claim 15.
With regard to claim 19, see discussion of claim 4.
With regard to claim 20, see discussion of claim 5.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over D1 and D2 and further in view of D34.
With regard to claim 7, D1 teach wherein the plurality of determinative features comprise a first plurality of determinative inflammation features that are used to determine the extent of inflammation within the one or more intestinal strictures (see fig. 2, p. 2307 last ¶: features used to discriminate pathology such as fibrosis or inflammation), but fails to explicitly teach wherein the first plurality of determinative inflammation features comprising one or more of a median of a Law's feature, a Kurtosis of a Gabor feature, and a skewness of a Law's feature. However, D2 teach the missing feature (see abstract, p. 434 last ¶: Law’s features, median, kurtosis, skewness measures).
One skilled in the art before the effective filing date would have found it obvious to combine the teachings to arrive at the claimed invention. In particular, it would have been obvious to incorporate known teachings of using Law’s features as taught by D3 into the configuration of D1 to classify the features to discriminate pathologies relating to Crohn’s disease yielding predictable and enhanced results.
With regard to claim 8, D1 teach wherein the plurality of determinative features comprise a first plurality of determinative fibrosis features that are used to determine the extent of fibrosis within the one or more intestinal strictures (see fig. 2, p. 2307 last ¶: features used to discriminate pathology such as fibrosis or inflammation), but fails to explicitly teach the first plurality of determinative fibrosis features comprising one or more of a skewness of a Gabor feature, a skewness of a Law's feature, a kurtosis of a Law's feature, a kurtosis of a Gray mean feature, and a variance of a Gray range. However, D2 teaches the missing features (abstract, p. 434 last ¶: Law’s features, median, kurtosis, skewness measures). The motivation for combining the teachings it the same as stated above.
With regard to claim 10, D1 teach wherein the plurality of determinative features comprise a second plurality of determinative inflammation features that are used to determine the extent of inflammation within the one or more intestinal strictures (see fig. 2, p. 2307 last ¶: features used to discriminate pathology such as fibrosis or inflammation), but fails to explicitly teach the second plurality of determinative inflammation features comprising one or more of a median of a Gradient Sobel feature, a skewness of a Law's feature, a variance of a Gradient Sobel feature, a kurtosis of a Gabor feature, a skewness of a Haralick energy feature, a skewness of a Law's feature, a skewness of a Law's feature, a median of a Gabor feature, a median of a Law's feature, and/or a median of a Law's feature. However, D2 teaches the missing features (abstract, p. 434 last ¶: Law’s features, median, kurtosis, skewness measures). The motivation for combining the teachings it the same as stated above.
With regard to claim 11, D1 teach wherein the plurality of determinative features comprise a second plurality of determinative fibrosis features that are used to determine the extent of fibrosis within the one or more intestinal strictures (see fig. 2, p. 2307 last ¶: features used to discriminate pathology such as fibrosis or inflammation), but fails to explicitly teach the second plurality of determinative fibrosis features comprising one or more of a skewness of a Law's feature, a median of a Gabor feature, a median of a Gray range feature, a median of a Haralick sum variance, a median of a Law's feature, a kurtosis of a Haralick energy feature, a median of a Law's feature, a median of a Gabor feature, a variance of a Law's feature, and/or a median of a Law's feature. However, D2 teaches the missing features (abstract, p. 434 last ¶: Law’s features, median, kurtosis, skewness measures). The motivation for combining the teachings it the same as stated above.
Claims 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over D1 and D2 and further in view of D4.5
With regard to claim 2, D1 teach wherein the one or more pathological features comprise one or more features see p. 2307 last ¶: scoring; see abstract: fribrostenosis). The features described in D1 are implicitly used in STAR scoring. However, D1 fails to explicitly teach STAR scoring, however D4 teaches the missing features (see p. 483 col 2 ¶ 2: STAR consortium and scoring systems).
One skilled in the art before the effective filing date would have found it obvious to combine the teachings to arrive at the claimed invention. In particular, it would have been obvious to incorporate known teachings of using STAR scoring method as taught by D4 into the configuration of D1 yielding predictable and enhanced results because the STAR system is based on an international working group composed of inflammatory bowel disease (IBD) pathologists and gastroenterologists that develop standardized guidelines.
With regard to claim 17, see discussion of claim 2.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVINASH YENTRAPATI whose telephone number is (571)270-7982. The examiner can normally be reached on 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached on (571) 272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVINASH YENTRAPATI/Primary Examiner, Art Unit 2672
1 Gordon, Ilyssa O., et al. "International consensus to standardise histopathological scoring for small bowel strictures in Crohn’s disease." Gut 71.3 (2022): 479-486.
2 Li, Xuehua, et al. "Development and validation of a novel computed-tomography enterography radiomic approach for characterization of intestinal fibrosis in Crohn’s disease." Gastroenterology 160.7 (2021): 2303-2316.
3 US Publication No. 2023/0117179.
4 Kalpathy-Cramer, Jayashree, et al. "Radiomics of lung nodules: a multi-institutional study of robustness and agreement of quantitative imaging features." Tomography 2.4 (2016): 430.
5 Gordon, Ilyssa O., et al. "International consensus to standardise histopathological scoring for small bowel strictures in Crohn’s disease." Gut 71.3 (2022): 479-486.