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 .
Applicant filed a response dated 10/27/2025 in which claims 1-2, 5-6, 14-16, and 19 have been amended. Thus, the claims 1-20 are pending in the application.
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 of assisting an image-guided therapy procedures without significantly more.
Examiner has identified claim 1 as the claim that represents the claimed invention presented in independent claims 1, 8, and 14-15.
Claim 1 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 is directed to a method reciting a series of steps, e.g., obtaining training data including a set of image-guided therapy images and gaze data corresponding to a clinician enacting the image-guided therapy procedure; for each image in the set of image-guided therapy images; determining a focus area of the image based on the gaze data; and storing the focus area together with actions of the image-guided therapy procedures enacted by the clinician in response to viewing the focus area; and training the machine learning algorithm using the training data comprising determining relationships between the image-guided therapy images, the respective focus area thereof, and the respective actions associated therewith for the image-guided therapy procedure. These limitations (with the exception of italicized limitations) describe the abstract idea of assisting an image-guided therapy procedures which may correspond to a certain method of organizing human activity and thus the claim recites an abstract idea. The additional elements of the machine learning algorithm does not restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the additional element of the machine learning algorithm results in no more than simply applying the abstract idea using generic computer elements. The additional element of the machine learning algorithm is recited at a high level of generality and under their broadest reasonable interpretation comprises a generic computer arrangement. The presence of a generic computer arrangement is nothing more than to implement the claimed invention by applying the exception using a generic computer element (MPEP 2106.05(f)). Therefore, the recitation of additional element does not meaningfully apply the abstract idea and hence do not integrate the abstract idea into a practical application. Thus, the claim 1 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim 1 does not include additional element that is sufficient to amount to significantly more than the judicial exception because the claim recites the additional element of the machine learning algorithm is recited at a high level of generality in that it results in no more than simply applying the abstract idea using generic computer elements. The additional element when considered separately and as an ordered combination does not amount to add significantly more as this element provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 1 is not patent eligible.
Similar arguments can be presented for other independent claims 8 and 14-15 and hence the claims 8 and 14-15 are rejected on similar grounds as claim 1.
Dependent claims 2-7, 9-13, and 16-20 further define the abstract idea that is present in the independent claims 1, 8, and 14-15 thus correspond to a certain method of organizing human activity, and hence are abstract in nature for the reason presented above. Dependent claims 2-7, 9-13, and 16-20 do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Independent claim 8 and dependent claim 18 recite the abstract idea of an acquiring an image-guided therapy image during the image-guided therapy procedure; inferring a first focus area of the image-guided therapy image; and assisting the image-guided therapy procedure based on the inferred first focus area. Therefore, the claims 1-20 are not patent-eligible.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kotian et al., US Patent No. 10,610,307.
Regarding claim 1, Kotian discloses a computer-implemented method of training a machine learning algorithm for assisting an image-guided therapy procedures, the method comprising:
obtaining training data including a set of image-guided therapy images and gaze data corresponding to a clinician enacting the image-guided therapy procedure (col. 1, lines 6-9; col. 7, lines 28-46; col. 11, lines 35-48; col. 12, lines 15-26);
for each image in the set of image-guided therapy images (col. 12, lines 15-50; a clinician’s direction of vision or a current position of the clinician’s body or actions performed by the hands of the clinician);
determining a focus area of the image based on the gaze data (col. 11, lines 35-48; col. 12, lines 15-54); and
storing the focus area together with actions of the image-guided therapy procedures enacted by the clinician in response to viewing the focus area (col. 10, lines 1-7; col. 11, lines 35-48; col. 12, lines 15-50; a clinician’s direction of vision or a current position of the clinician’s body or actions performed by the hands of the clinician); and
training the machine learning algorithm using the training data comprising determining relationships between the image-guided therapy images, the respective focus area thereof, and the respective actions associated therewith for the image-guided therapy procedure (col. 2, lines 43-col. 3, line 3).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine different disclosure of Kotian in order to treat the patient accordingly.
Regarding claim 2, Kotian discloses wherein obtaining the training data comprises displaying a first image-guided therapy image of the set thereof at a first time during a first image-guided therapy procedure performed by a first clinician and estimating a respective first focus area of the first image-guided therapy image of the first clinician using eye tracking (col. 1, lines 6-9; col. 7, lines 28-46; col. 11,lines 41-48; col. 12, lines 15-54).
Regarding claim 3, Kotian discloses wherein the respective actions include image processing (col. 5, lines 55-65, processing of the image).
Regarding claim 4, Kotian discloses wherein the respective actions include image-guided therapy system control (abstract).
Regarding claim 5, Kotian discloses wherein the training data include at least one of speech and/or metadata associated with the image-guided therapy images, the respective focus areas thereof and the respective actions associated therewith from the respective image-guided therapy procedures (col. 8, lines 51-col. 9, lines 21).
Regarding claim 6, Kotian discloses wherein determining the relationships between the image-guided therapy images, the respective focus areas thereof, and the respective actions associated therewith for the image-guided therapy procedures comprises identifying features in the image-guided therapy images and relating the identified features to the respective focus areas (col. 7, lines 28-46).
Regarding claims 7, 17, and 20, it has been held that a wherein clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim (Texas Instruments Inc. v. International Trade Commission 26, USPQ2d 1010 (Fed. Cir. 1993); Griffin v. Bertina, 62 USPQ2d 1431 (Fed. Cir. 2002); Amazon.com Inc. v. Barnesandnoble.com Inc., 57 USPQ2d 1747 (CAFC 2001)), therefore, training the machine learning algorithm using the training data comprises selectively weighting the training data will not differentiate the claims from the prior art.
Regarding claim 8, Kotian discloses a computer-implemented method of assisting an image-guided therapy procedure, the method comprising:
acquiring an image-guided therapy image during the image-guided therapy procedure (col. 1, lines 6-9; col. 7, lines 28-46);
inferring, using a trained machine learning algorithm trained using a method according to claim 1, a first focus area of the image-guided therapy image (col. 3, lines 55-67, zooming in on an area); and
assisting the image-guided therapy procedure based on the inferred first focus area (col. 2, lines 43-col. 3, line 3).
Regarding claim 9, Kotian discloses wherein assisting the image-guided therapy procedure based on the inferred first focus area comprises: displaying the image-guided therapy image including indicating the inferred first focus area (col. 3, lines 55-67).
Regarding claim 10, Kotian discloses wherein assisting the image-guided therapy procedure based on the inferred first focus area comprises: predicting, using the trained machine learning algorithm, an action associated the image- guided therapy image and the inferred first focus area; and enacting the predicted action (claim 9, predicts).
Regarding claim 11, Kotian discloses wherein enacting the action comprises processing the image-guided therapy image (claim 9; col. 5, lines 55-65).
Regarding claim 12, Kotian discloses wherein enacting the action comprises controlling the image-guided therapy procedure (col. 6, lines 57-65).
Regarding claim 13, Kotian discloses inferring, using the trained machine learning algorithm, a second focus area of the image-guided therapy image; and assisting the image-guided therapy procedure based on the inferred second focus area (col. 3, lines 55-67).
Claims 14-16 and 18-19 are substantially similar to claims 1, 6, and 8 and hence rejected on similar grounds.
Response to Arguments
Applicant's arguments filed dated 10/27/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-20 under 35 U.S.C. 101, Applicant states that the claims are directed to a specific, computer-implemented method and system for training and using a machine learning algorithm to assist image-guided procedures. This is not a mere mental process or generic data analysis, but a concrete technological solution to improve the accuracy and efficiency of medical interventions.
Examiner respectfully disagrees and notes that the computer-implemented steps for training and using a machine learning algorithm are considered under Step 2A, Prong 2 and Step 2B to determine if the additional elements integrate the abstract idea into a practical application. Under Step 2A, Prong 1, the claim limitations are initially considered in the absence of additional elements to determine if the claim recites an abstract idea. In this case, it was determined that the claim recites an abstract idea and the additional elements do not restrict the claim from reciting an abstract idea. Thus, these arguments are not persuasive.
With respect to the arguments under step 2A that the claim 1 has been amended, Examiner notes that these amendment are abstract in nature as the additional elements are recited at a high level of generality in that it simply applies the abstract idea without providing any technical improvement. Thus, these arguments are not persuasive.
With respect to the rejection of claims 1-20 under 35 U.S.C. 103, Applicant states that Kotian, however, does not disclose of “determining a focus area” of each image in a set of image-guided therapy images based on the gaze data and “storing the focus area together with actions of the image-guided therapy procedure enacted by the clinician in response to viewing the focus area,” as recited in Applicant’s claims.
Examiner respectfully disagrees and notes that Kotian discloses in col. 12, lines 38-54, that the behavior and intent of the clinicians may be inferred from the observable and detectable actions of the clinicians in the image data processed by the computer vision system 52 or sensing system 66. This may include the determination of a clinician’s direction of vision or a current position of the clinician’s body or actions performed by the hands of clinician. This may be furthered by the audio data processed by the audio system 70 in which the clinicians may provide further context as to behavior or intent either through narration of the surgical procedure or intra-procedure discussion between the clinicians. Thus, the disclosure clearly reads on the argued limitation.
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 RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684