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 12/16/2025 in which claims 1, 6, 11, 16, and 19 have been amended. Thus, the claims 1-19 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
Claim Interpretation
In claim 1 (and elsewhere, where applicable), line 3, the term “the target object” is generally referred to a patient who needs radiation therapy, or a part (such as a tumor region or a region of interest) of the patient as per Applicant’s specification in paragraph [0058] of the specification. When a first image of a target object is obtained, a patient with a tumor region or a region of interest is known. If the first image is focused on a tumor region or a region of interest, then even if the image does not specifically contain positioning information, it is clear that the positioning image contain a tumor region or a region of interest. Regarding “the target object is not positioned by a positioning apparatus as in line 6, Examiner interprets this limitation to be a target object (i.e., a patient) is positioned by a human (physician/nurse or a patient) which reads on the term “not positioned by a positioning apparatus”. Moreover, when acquiring a first image of a target object by scanning the target object by an imaging apparatus, the positioning information of the target object is inherent to the process of acquiring an image. This is also consistent with Applicant’s disclosure in paragraph [0029] that defines diagnostic image of the patient to be an image taken for a not positioned patient. With this interpretation, Examiner relies on Yan for disclosing an image of the target object in the pre-treatment plan stage to read on the acquiring a first image of a target object. If the first image is a diagnostic image and generating a first treatment plant for the target object, then the target object is well-positioned.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of generating a treatment plan without significantly more.
Examiner has identified claim 1 as the claim that represents the claimed invention presented in independent claims 1, 11, and 19.
Claim 1 is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
The claim 1 describes a method for generating a treatment plan comprising: acquiring a first image of a target object by scanning the target object by an imaging apparatus, wherein the first image does not contain positioning information of the target object, and the first image is a diagnostic image acquired in a case where the target object is not positioned by a positioning apparatus; generating a first treatment plan for the target object based on the first image; acquiring a second image of the target object by scanning the target object by an image guidance apparatus of a radiation delivery apparatus, wherein the second image contains the positioning information of the target object, and the second image is a positioning image acquired in a case where the target object is positioned by the positioning apparatus; registering the first image and the second image; and generating a second treatment plan for controlling radiation delivery by a radiation device for the target object by updating the first treatment plan in response to a registration result, wherein the second treatment plan comprises second treatment parameters, and the radiation device comprises the radiation delivery apparatus. These limitations (with the exception of italicized limitations), under their broadest reasonable interpretation, describe the abstract idea of generating a treatment plan. Furthermore, if a claim limitation, under its broadest reasonable interpretation, covers interactions between people, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The additional element of an imaging apparatus, a positioning apparatus, an image guidance apparatus, a radiation delivery apparatus, and a radiation device do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 1 recites an abstract idea (Step 2A-Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of an imaging apparatus, a positioning apparatus, an image guidance apparatus, a radiation delivery apparatus, and a radiation device result in no more than simply applying the abstract idea using generic computer elements. The additional elements of an imaging apparatus, a positioning apparatus, an image guidance apparatus, a radiation delivery apparatus, and a radiation device are recited at a high level of generality, and under their broadest reasonable interpretation comprises a generic computing device. The presence of a generic computing device does nothing more than to implement the claimed invention (MPRP 2106.05(f)). The additional elements of an imaging apparatus, a positioning apparatus, an image guidance apparatus, a radiation delivery apparatus, and a radiation device are no more than mere instructions to apply the exception using a generic computer element. Therefore, the recitation of additional elements do 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 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of an imaging apparatus, a positioning apparatus, an image guidance apparatus, a radiation delivery apparatus, and a radiation device are recited at a high level of generality in that it result in no more than simply applying the abstract idea using generic computer elements. The additional elements when considered separately and as an ordered combination do not amount to add significantly more as the additional elements 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 extended to other independent claims 11 and 19, however, claims 11 and 19 recite additional elements of one or more processors; a memory; and one or more applications stored in the memory. These additional elements do not restrict the claim from reciting an abstract idea under Step 2A, Prong 1 or integrate the abstract idea into a practical application under Step 2A, Prong 2 because the additional elements merely apply the abstract idea without offering any technical/technology improvement or amount to add significantly more under Step 2B since the additional elements are present as a tool to apply the abstract idea. Thus, the claims 11 and 19 are rejected on similar grounds as claim 1.
Dependent claims 2-10 and 12-18 further define the abstract idea that is present in their respective independent claims 1 and 11 and thus correspond to Certain Methods of Organizing Human Activity and hence are abstract in nature for the reasons presented above. Dependent claims 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. Therefore, the claims 2-10 and 12-18 are directed to an abstract idea. Thus, the claims 1-19 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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yan, CN-113573776-A.
Regarding claim 1, Yan discloses a method for generating a treatment plan in a computer-implemented treatment planning system (TPS), comprising:
acquiring a first image of a target object by scanning the target object by an imaging apparatus, wherein the first image does not contain positioning information of the target object, and the first image is a diagnostic image acquired in a case where the target object is not positioned by a positioning apparatus (pages 2-8, planned image … using a diagnostic imaging device; planned image serves as a diagnostic image; CT, MRI, PET, Applicant’s specification in [0029] defines diagnostic image of the patient to be an image taken for a not positioned patient; page 3, when the patient is placed (patient can placed by a human/patient itself);
generating a first treatment plan for the target object based on the first image (abstract, pages 2-10, pre-treatment plan);
acquiring a second image of the target object by scanning the target object by an image guidance apparatus of a radiation delivery apparatus, wherein the second image contains the positioning information of the target object, and the second image is a positioning image acquired in a case where the target object is positioned by the positioning apparatus (abstract, real-time image/treating stage; pages 4-6, an image guide device/patient fixing mechanism serve as the positioning apparatus; radiation treatment device);
registering the first image and the second image (page 3-4 registering the two real-time compensation images and two reconstruction images); and
generating a second treatment plan for controlling radiation delivery by a radiation device for the target object by updating the first treatment plan in response to a registration result (abstract, improve the treatment precision of the patient, pages 2-3, accurate location of the tumor in the treatment process), wherein the second treatment plan comprises second treatment parameters, and the radiation device comprises the radiation delivery apparatus (page 5, radiation treatment device, pages 6-7, shooting angle serves as treatment parameters).
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 Yan in order to treat the patient accordingly.
Regarding claim 2, Yan discloses wherein the registration result comprises a rotation offset amount and a translation offset amount (pages 2-8, rotation offset).
Regarding claim 3, Yan discloses wherein generating the second treatment plan for the target object by updating the first treatment plan in response to the registration result comprises: generating the second treatment plan for the target object by modifying corresponding treatment parameters in the first treatment plan based on the rotation offset amount and the translation offset amount (page 2-10).
Regarding claim 4, Yan discloses wherein both the first image and the second image are images of the target object acquired prior to a treatment stage (pages 2-10).
Regarding claim 5, Yan discloses wherein the first image is an image of the target object acquired prior to a treatment stage; and the second image is an image of the target object acquired in the treatment stage (pages 2-10).
Regarding claim 6, Yan discloses wherein the first treatment plan comprises an image guidance parameter and first treatment parameters; and prior to acquiring the second image of the target object, the method further comprises: instructing, by outputting the first treatment plan only containing the image guidance parameter, the radiation device to perform image guidance on the target object to generate the second image of the target object (pages 2-10).
Regarding claim 7, Yan discloses wherein the second image is a cone beam computed tomography (CBCT) image of the target object acquired in the treatment stage (page 8, CBCT).
Regarding claim 8, Yan discloses wherein registering the first image and the second image comprises: registering the first image and the second image by taking the second image as a fixed image and the first image as a floating image (pages 2-10).
Regarding claim 9, Yan discloses wherein the registration result comprises a rotation offset amount or a translation offset amount (pages 2-10).
Regarding claim 10, Yan discloses wherein generating the second treatment plan for the target object by updating the first treatment plan in response to the registration result comprises: generating the second treatment plan for the target object by modifying corresponding treatment parameters in the first treatment plan based on the rotation offset amount or the translation offset amount (pages 2-10).
Claims 11-19 are substantially similar to claims 1-8 and hence rejected on similar grounds.
Response to Arguments
Applicant's arguments filed dated 12/16/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-19 under 35 U.S.C. 101, Applicant states that the claims are patent eligible under the Streamlined Eligibility Analysis.
Examiner respectfully disagrees and notes that when the claim clearly recites an abstract idea then the streamlined analysis is not applicable.
With respect to Step 2A Prong 1, Applicant states that the claims do not recite a judicial exception.
Examiner respectfully disagrees and notes that the claim clearly recites an abstract idea of generating a treatment plan which corresponds to a method of organizing human activity. This is supported by various steps of acquiring, registering, and generating treatment plan. The additional elements do not restrict the claim from reciting an abstract idea.
With respect to Step 2A, Prong 2, Applicant states that the claims are directed to a specific and real-world technical application of radiation therapy. The claims include using the imaging apparatus to obtain medical images with different clinical and technical attributes, diagnostic images and positioning images. The claims recite image registration which is a specialized technique in medical image processing. The claims further include updating the treatment plan to control the radiation equipment which directly links the data processing results with the physical treatment actions. The recited practical applications further achieve improvement in the field of radiation therapy. The claimed practical applications allows for omission of the conventional radiation therapy step of collecting the positioning image before the treatment. The omission of this step reduces time and processes required for radiation therapy.
Examiner respectfully disagrees and notes that the additional elements integrate the abstract idea when there is a technical improvement. In this case, the additional elements are recited at a high level of generality in that it simply amounts to applying the abstract idea without integrating the abstract idea into a practical application. Moreover, the additional elements do not provide any technical solution to a technical problem. In fact, the specification does not identify any technical problem to which a technical solution is sought. The method of collecting diagnostic images and providing a treatment plan do not provide any technical improvement and thus are not sufficient to integrate the abstract idea into a practical application. Thus, these arguments are not persuasive.
With respect to Step 2B, Applicant states that the claims recite a process which is different from and specifically addresses problems of conventional radiation therapy and therefore, the claims provide significantly more than conventional techniques.
Examiner respectfully disagrees and notes that the claim does not present an “inventive concept”. The claimed invention may provide a different approach to providing a treatment based on the diagnostic image than conventional techniques. Moreover, the more efficient radiation therapy process resulting from the ordered combination of the claims provides an improvement to an abstract idea and not to technology. However, this cannot be the basis for additional elements to amount to significantly more.
Applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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