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 3/30/20206 in which claims 1-6, 9, 11-12, and 14-20 have been amended, claims 8 and 10 have been canceled. Thus, the claims 1-7, 9, and 11-20 are pending in the application.
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/30/2026 has been entered.
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 1-7, 9, and 11-20 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 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., predicting, using a trained machine learning algorithm, a predicted focus area of an image-guided therapy image acquired during the image-guided therapy procedure, wherein the trained machine learning algorithm has been trained using training data including a set of image-guided therapy images, respective gaze areas thereof, and respective actions associated therewith from at least one clinician performing the same type of image-guided therapy procedure to determine, via eye tracking a focus area within each image in the set if image-guided therapy images and an action associated with the focus area; determining, from the trained machine learning algorithm, a predicted action associated with the predicted focus area; and in response to determining the predicted action from the predicted focus area of the image-guided therapy image, configuring an image-guided therapy system to perform the predicted action. 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 a trained 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 a trained machine learning algorithm results in no more than simply applying the abstract idea using generic computer elements. The additional element of a trained 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 a trained 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 14-15 and hence the claims 14-15 are rejected on similar grounds as claim 1.
Dependent claims 2-7, 9, and 11-20 further define the abstract idea that is present in the independent claims 1 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 1-7, 9, and 11-20 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 1-7, 9, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kotian et al., US Patent No. 10,610,307 in view of Sanchez-Matilla et al., US Patent Application No. 2024/0303984.
Regarding claim 1, Kotian discloses a computer-implemented method for assisting an image-guided therapy procedures, the method comprising:
predicting, using a trained machine learning algorithm, a predicted focus area of an image-guided therapy image acquired during the image-guided therapy procedure, wherein the trained machine learning algorithm has been trained using training data including a set of image-guided therapy images, respective gaze areas thereof, and respective actions associated therewith from at least one clinician performing the same type of image-guided therapy procedure to determine, via eye tracking, a focus area within each image in the set of image-guided therapy images and an action associated with the focus area (col. 1, lines 6-9; col. 2, lines 43-col. 3, line 3; col. 7, lines 28-46; col. 10, lines 1-7; col. 11, lines 35-48; col. 12, lines 15-54, a clinician’s direction of vision or a current position of the clinician’s body or actions performed by the hands of the clinician; claim 9, predicts);
determining, from the trained machine learning algorithm, a predicted action associated with the predicted focus area (claim 9; col. 5, lines 55-65; col. 6, lines 57-65); and
in response to determining the predicted action from the predicted focus area of the image-guided therapy image, configuring an image-guided therapy system to perform the predicted action (claim 9; col. 5, lines 55-65; col. 6, lines 57-65).
Kotian does not specifically disclose
predicting;
to determine, via eye tracking, a focus area within each image in the set of image-guided therapy images and an action associated with the focus area.
However, Sanchez-Matilla discloses
predicting ([0024]);
to determine, via eye tracking, a focus area within each image in the set of image-guided therapy images and an action associated with the focus area ([0024]).
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 above-noted disclosure of Kotian with the above-noted disclosure of Sanchez-Matilla in order to treat the patient accordingly.
Regarding claim 2, Kotian discloses training the machine learning algorithm on 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 (col. 1, lines 6-9; col. 7, lines 28-46; col. 11,lines 41-48; col. 12, lines 15-54).
Sanchez-Matilla discloses
estimating a respective first focus area of the first image-guided therapy image of the first clinician using eye tracking ([0024]).
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 above-noted disclosure of Kotian with the above-noted disclosure of Sanchez-Matilla in order to treat the patient accordingly.
Regarding claim 3, Sanchez-Matilla discloses wherein the actions associated with the focus area comprises an image processing function of the focus area ([0024]).
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 above-noted disclosure of Kotian with the above-noted disclosure of Sanchez-Matilla in order to treat the patient accordingly.
Regarding claim 4, Kotian discloses control action of an image guided therapy system (abstract).
Regarding claim 5, Kotian discloses wherein the trained machine learning algorithm is trained using training data including at least one of speech and/or metadata associated with the image-guided therapy images, the respective gaze 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 the trained machine learning algorithm has been trained on identifying features in the image-guided therapy images and relating the identified features to the respective gaze areas (col. 7, lines 28-46).
Regarding claims 7 and 17, 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, weighted training data and selectively weight the training data will not differentiate the claims from the prior art.
Regarding claim 9, Kotian discloses displaying the image-guided therapy image including (col. 3, lines 55-67).
Sanchez-Matilla discloses
indicating the predicted first focus area ([0024]).
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 above-noted disclosure of Kotian with the above-noted disclosure of Sanchez-Matilla in order to treat the patient accordingly.
Regarding claim 11, Kotian discloses processing the image-guided therapy image (claim 9; col. 5, lines 55-65).
Regarding claim 12, Kotian discloses controlling the image-guided therapy procedure (col. 6, lines 57-65).
Regarding claim 13, Kotian discloses predicting, using the trained machine learning algorithm, a second focus area of the image-guided therapy image; determining, from the trained machine learning algorithm, a predicted second action associated with the predicted second focus area; and in response to determining the predicted second action from the predicted second focus area of the image-guided therapy image, configuring the image-guided therapy system to perform the predicted second action (col. 3, lines 55-67).
Sanchez-Matilla discloses
predicting,
a second focus area,
a predicted second action associated with the predicted second focus area ([0024], obvious to extend the disclosure to predict a second focus are and second action).
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 above-noted disclosure of Kotian with the above-noted disclosure of Sanchez-Matilla in order to treat the patient accordingly.
Claims 14-16 and 18-20 are substantially similar to claims 1, 6, and 11 and hence rejected on similar grounds.
Response to Arguments
Applicant's arguments filed dated 3/30/2026 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 under Step 2A, Prong One, the claims are not directed to abstract idea but instead directed to “configuring an image-guided therapy system” based on “determining… a predicted action associated with [a] predicted focus area.” This is clearly a mechanical configuration of a medical imaging system, and is not related to any organization of human activity.
Examiner respectfully disagrees and notes that under Step 2A, Prong One, the claims are initially considered in the absence of additional elements (i.e., mechanical configuration) to determine if the claim recites an abstract idea. The additional elements are then considered to determine if the additional elements restrict the claim from reciting 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.
With respect to Step 2A, Prong Two, Applicant states that the claims are nevertheless directed towards a technical improvement in medical procedures and interventions.
Examiner respectfully disagrees and notes that the additional elements are recited at a high level of generality in that it amounts to merely applying the abstract idea without integrating the abstract idea into a practical application.
With respect to Step 2B, Applicant states that the claims recite a specific and non-generic arrangement of medical imaging systems components and is configured to performing the predicted action. That is far more than merely invoking a generic computer to automate a human decision.
Examiner respectfully disagrees and notes that the additional elements are present as a tool to implement the abstract idea and training and performing a predicted action is not described with any specificity that may be unique to the claimed invention. The prediction is based on historical data and is within the knowledge of a healthcare professional. In other words, the prediction does not solve a technical problem. Thus, the additional elements do not amount to add significantly more.
With respect to the rejection of claims 1-20 under 35 U.S.C. 103, Applicant states that Kotian broadly references gaze direction in the room. Rather, amended claim 1 uses gaze in a much more specific and technically different manner which Kotian does not disclose not suggest.
Examiner respectfully disagrees and notes that Kotian disclosure of a gaze or clinician attention direction relates to the “focus area within each image in the set of image guided-therapy images,” as Kotian discloses that the data received from the computer vision system 52 indicating the positions of medical equipment, clinicians, and the patient within the surgical suite and the AI enabled controller 62 may use this information to determine and provide operational commands to the interventional imaging system 20 or other medical equipment 76. Kotian also discloses that the AI enable controller 62 operates to automatedly provide inputs to the interventional imaging system 20 based upon the position of the clinicians in the surgical suite, a gaze or clinician attention direction, a position of the imaging system relative to the patient and/or another piece of medical equipment, currently ongoing functions of the interventional imaging system or other medical equipment. The clinician’s gaze “direction” or “line of sight” when present in the surgical suite with imaging system relative to the patient and currently ongoing functions of the interventional imaging customer other medical equipment has to be within the “focus area within each image” based on the context. If the clinician is present in the surgical suite to attend to a patient, then clinician’s gaze “direction” of “line of sight” has to be associated with patient and the images associated with treating the patient. With respect to eye tracking arguments, these arguments are moot in view of the new grounds of rejection presented above in this office action.
Conclusion
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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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684
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