DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 9/15/0226 has been entered.
Information Disclosure Statement
The references cited in the Information Disclosure Statement (IDS) filed on 9/15/2026 has/have been considered. However, based on the extensive number and the length of references cited, only a cursory review was made. Applicant is advised to provide which of the cited references and/or contents thereof are most pertinent to the instant application, if a detailed consideration is desired.
The information disclosure statement (IDS) submitted on 9/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, it is noted that All Non-Patent Literature (NPL) citations need at least a month and year of publication: MPEP 609.04(a): The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. NPL cited without at least the month and year of publication has been labeled with “no date available”.
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 7 and 19 is/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 7 recites “wherein a relative characteristic is a center of mass of the lesion and a center of mass of the ablation region”. It is unclear how the center of mass of the lesion and the center of mass of the ablation region themselves constitute the recited “relative characteristic”. In particular, it is unclear whether the claimed relative characteristic is the respective positions of the center of mass, a distance between the center of mass, or another relationship between the centers of mass.
The specification describes evaluating the risk of reoccurrence based on a distance between a center of mass of the lesion and a center of mass of the ablation region. However, claim 7 does not recite such a distance or otherwise specify the relationship between the two centers of mass that constitutes the claimed relative characteristic. Accordingly, the scope of the claimed “relative characteristic” cannot be determined with reasonable certainty.
Claim 19 recites that “each post-operative image is acquired using the same image acquisition technique”. The claim does not clearly identify the point of comparison for “the same image acquisition technique”.
In particular, it is unclear whether the limitation requires the post-operative medical image acquired from the individual to be acquired using the same image acquisition technique as the post-operative medical images of the training databased, whether the post-operative medical images within the training database are merely required to be acquired using the same technique as one another, or both.
Accordingly, the scope of the limitation “the same image acquisition technique” cannot be determined with reasonable certainty.
Allowable Subject Matter
Claims 7 and 19 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.
Claims 1, 3, and 5-6, 8-18, 20-21 are allowed.
The following is an examiner’s statement of reasons for allowance: Regarding claim 1, the prior art of record, alone or in combination, fails to teach at least “automatically determining an outline of the ablation region via a machine learning method, of neural network type, analyzing the post-treatment image of the anatomical structure of interest of the individual, said machine learning method being trained beforehand in a training phase using a database comprising a plurality of post-operative medical images of an identical anatomical structure of interest of a set of patients, each medical image in the database being associated with an ablation region for the anatomical structure of interest of said patient, wherein the training phase comprises a prior step of training using medical images of an identical anatomical structure of interest comprising an unablated lesion; and evaluating, based on the determined outline of the ablation region, a risk of recurrence according to a relative characteristic between the ablation region and the lesion, between the ablation region and the anatomical structure of interest, or between the lesion and the anatomical structure of interest.”
At best, Steffen et al (NPL: Automatic Segmentation of Necrosis Zones after Radiofrequency Ablation of Spinal Metastases) teaches in pg. 96 Introduction: evaluate the congruence of both the ablation zone and the former metastasis via distance and volume overlap measures; the segmentation of the necrosis zone is among others a pivotal step towards an automatised, quantitative and objective treatment outcome validation of RFAs of spinal metastases; such segmentations could yield additional insights for a better understanding in tumor reoccurrence and to further improve ablation protocols and procedures.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN KY whose telephone number is (571)272-7648. The examiner can normally be reached Monday-Friday 9-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vincent Rudolph can be reached at 571-272-8243. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN KY/Primary Examiner, Art Unit 2671
