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 .
Election/Restrictions
Applicant's election with traverse of the invention of Group I in the reply filed 5/27/2026, is acknowledged.
Applicant's traversal is on the grounds that the restriction is based on separate classifications and that the search and examination of the entire application can be made without serious burden to the Examiner. Applicant's traversal has been carefully considered, but fails to establish error in the propriety of the present requirement for restriction and election.
As stated in the office action of 3/27/2026, the distinction of the inventions is not based on their classification. And though the Applicant asserts that examination of all pending claims would not pose an undue burden on the Examiner, such is not an accurate assertion in light of the disparate nature of the presently claimed subject matter as noted in the Requirement for Restriction of 3/27/2026.
Consideration of the plurality of inventions that Applicant has claimed would significantly compromise and preclude a quality examination on the merits. Furthermore, execution of a search encompassing the entirety of Applicant's inventions would not only constitute an undue burden on the Examiner, but consideration of the findings of such a search in accordance with the requirements of the law under 35 U.S.C. §§101,102, 103 and 112 would be unduly onerous.
Moreover, it is further noted that a comprehensive search for the presently claimed subject matter is not solely limited to a search of the classes and subclasses in which they are classified. Therefore, it is obvious that a comprehensive search of the copious amounts of patent and non-patent literature for each of the patentably distinct inventions and their permutations presently claimed would necessarily place an undue burden on the Examiner.
Please also note that when all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims will be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
Therefore, for the reasons above and those made of record in the Requirement for Restriction of 3/27/2026, the restriction requirement is deemed proper and is made FINAL.
Claims 14-24 and 26-27 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being to non-elected inventions, there being no allowable generic or linking claim.
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.
Claim 9 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 9 recites the limitation "the clustering" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 1-8, 10-13, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taerum et al. (Pub. No.: US 2020/0085382 A1; hereinafter “Taerum”).
Taerum discloses the following regarding claim 1: a method, comprising: using machine learning, grouping first medical images from a group of patients into two or more groups on the basis of a set of radiomic vessel morphology features extracted from the first medical images or from a vascular segmentation derived from the first medical images (paras. 0142, 0176, 0361-0363, 0386, 0464-0468, 0471-0475); and on the basis of said grouping, defining a phenotypical set of radiomic vessel morphology features (paras. 0361-0363, 0386, 0464-0468, 0471-0475), the phenotypical set of radiomic vessel morphology features being (1) at least a subset of the set of radiomic vessel morphology features extracted from the first medical images (paras. 0214-0218, 0286, 0315-0318, 0361-0363, 0386), and (2) medically predictive of the two or more groups (paras. 0471-0475).
Taerum discloses the following regarding claim 2: the method of claim 1, further comprising: extracting the phenotypical set of radiomic vessel morphology features from a second medical image or images of a patient, or from a vascular segmentation derived from the second medical image or images (paras. 0361, 0386, 0300-0307, 0457, 0471-0475); based on values of the extracted phenotypical set of radiomic vessel morphology features, making a medical prediction concerning the patient (paras. 0361, 0386, 0457, 0471-0475).
Taerum discloses the following regarding claim 3: the method of claim 2, wherein the first set of medical images indicate at least one lesion, and the set of radiomic vessel morphology features are extracted from vasculature associated with the at least one lesion (paras. 0457-0464, 0471-0475).
Taerum discloses the following regarding claim 4: the method of claim 3, wherein the second medical image or images of the patient indicate at least one patient lesion, and the phenotypical set of radiomic vessel morphology features are extracted from vasculature associated with the at least one patient lesion (paras. 0286, 0315-0318, 0361-0363, 0386, 0457-0464, 0471-0475).
Taerum discloses the following regarding claim 5: the method of claim 2, further comprising one or more of: choosing or determining a course of treatment for the patient based on the medical prediction; based on the values of the extracted phenotypical set of radiomic vessel morphology features, determining the efficacy of the course of treatment or another course of treatment; or based on the values of the extracted phenotypical set of radiomic vessel morphology features extracted after a medical treatment has been administered to the patient, determining a mechanism of action of the medical treatment (paras. 0361-0363, 0386, 0457-0468, 0471-0480).
Taerum discloses the following regarding claim 6: the method of claim 2, wherein said making the medical prediction concerning the patient comprises: deriving a vessel morphology score based on the values of the extracted phenotypical set of radiomic vessel morphology features; and outputting the score (paras. 0361-0363, 0386, 0391, 0460-0463).
Taerum discloses the following regarding claim 7: the method of claim 6, wherein said outputting comprises generating a report in which the score is given relative to scores associated with the known outcomes (paras. 0237-0328, 0356-0366, 0386, 0391-0392).
Taerum discloses the following regarding claim 8: the method of claim 1, wherein said using machine learning comprises using unsupervised machine learning (paras. 0295-0296, 0309-0311, 0361, 0386).
Taerum discloses the following regarding claim 10: the method of claim 2, wherein the second medical image or images comprise computed tomography (CT) or magnetic resonance imaging (MRI) scans (paras. 0144, 0149, 0153).
Taerum discloses the following regarding claim 11: the method of claim 1, wherein the phenotypical set of radiomic vessel morphology features comprises one or more categories of radiomic features selected from the group consisting of branching features, torsion features, curvature features, radius features, vessel volume features, inflection point features, features derived from Frenet-Serret frame vectors, and bending energy features (paras. 0024, 0033, 0138-0139, 0214-0218, 0301-0302, 0361, 0386).
Taerum discloses the following regarding claim 12: the method of claim 11, wherein the phenotypical set of radiomic vessel morphology features comprises two or more categories of the radiomic features (paras. 0024, 0033, 0138-0139, 0214-0218, 0301-0302, 0361, 0386).
Taerum discloses the following regarding claim 13: the method of claim 11, wherein the phenotypical set of radiomic vessel morphology features comprises one category of the radiomic features (paras. 0024, 0033, 0138-0139, 0214-0218, 0301-0302, 0361, 0386).
Taerum discloses the following regarding claim 25: the method of claim 2, wherein the medical prediction concerning the patient is a longitudinal medical prediction (paras. 0464-0468, 0477-0480).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taerum in view of Liu et al. (Pub. No.: US 2018/0143199 A1; hereinafter “Liu”).
Taerum discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite using consensus clustering. Liu teaches that it is well known in the art that consensus clustering techniques are used with vascular imaging (paras. 0068-0071, 0099-0100), in order to improve the accuracy and reliability of the image segmentation and anomaly detection of the clustering results. It would have been obvious to one having ordinary skill in the art to modify the analysis method of Taerum to comprise consensus clustering, as taught by Liu, in order to improve the accuracy and reliability of the image segmentation and anomaly detection of the clustering results. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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