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 .
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 1-6, 8-13, 15-19, and 21-23 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more. Independent claim 1 recites (additional limitations crossed out):
A method comprising:
receiving,
retrieving,
retrieving,
e
calculating,
retrieving,
calculating,
when a difference between the first radiotherapy utility improvement value and the second radiotherapy utility improvement value satisfies a threshold,
instructing,
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people ,as well as mental processes. That is, other than reciting the steps as being performed by a “processor” and “computer models” nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people, or mental processes. For example, but for the “processor” and “computer models” language, the limitations describe iteratively determining a treatment plan and an associated validation score, and halting the iteration if the difference between the associated validation scores satisfies a threshold. The limitations describe the management of personal behavior, as well as mental processes. An analog example of the claims would be continuously evaluating the results of a process until a particular threshold is met. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes steps that may be performed mentally or with pen and paper, the it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims only recite the additional elements of a “processor” and “computer models” to perform the claimed steps. The “processors” are recited at a high level of generality (see at least Paras. [0104]-[0107]) such that it amounts to no more than mere instructions to apply the exception using generic computing components. In regard to the “computer models”, they are considered to be generic computer function and/or field-of-use/”general link” implementations and do not meaningfully limit the claim (See Accenture, 728 F.3d 1336, 108 U.S.P.Q.2d 1173 (Fed. Cir. 2013), citing Cf. Diamond v. Diehr, 450 U.S. 175, 191-192 (1981) ("[I]nsignificant post-solution activity will not transform an unpatentable principle in to a patentable process.”). Moreover, the functionality intended to be performed by the “computer models” appear to be based on very rudimentary constraints (e.g., treatment plan attributes and treatment attributes). Without some prohibition in the claims regarding scalability, computation load, etc., these computer models could reasonably be considered an additional abstract idea in the “mental process” category or in the “mathematical concepts” category, but for which is simply automated (i.e., “apply it”). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a “processor” and “computer models” to perform the claimed steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Therefore, the claims are not found to be patent eligible.
Independent claims 8 and 15 feature limitations similar to those of claim 1, and are therefore also found to be directed to the same abstract idea without significantly more.
Claims 2-6 and 21 are dependent on claim 1, and include all the limitations of claim 1. Claims 9-13 and 22 are dependent on claim 8, and include all the limitations of claim 8. Claims 16-20 are dependent on claim 15, and include all the limitations of claim 15. Therefore, they are also found to be directed to an abstract idea. Claims 21-23 features “in response to instructing the first computer model to stop executing, controlling, by the at least one processor, a radiotherapy machine based on the third treatment plan generated by the first computer model when instructed to stop”. This additional limitation integrates the otherwise abstract operations of the independent claims into a practical application under Step 2A, Prong 2. Specifically , the claim requires the treatment plan produced by the first computer model at the point of termination to be used to control a particular physical machine (i.e., radiotherapy machine). Thus, the result of the claimed computational process is applied to effect an operation of a physical device used to administer radiotherapy. The remaining dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea. Therefore, dependent claims 21-23 are found to be patent eligible, while the remaining dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 112
Claims 22-23 feature limitations similar to those of claim 21 and are therefore rejected using the same rationale.
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.
Claims 1-6, 8-13, 15-19, and 21-23 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.
Regarding claim 1, the limitation ”executing, by the at least one processor, a second computer model to generate, using the first set of treatment attributes, a first validation score for the first treatment plan outputted from the first computer model” is indefinite since the first treatment plan was not positively recited as being output. The Examiner notes that this may be remedied by simply deleting the language “outputted from the first computer model”, or amending it to “generated by the first computer model”.
Claims 8 and 15 feature limitations similar to those of claim 1 and are therefore rejected using the same rationale.
Dependent claims are rejected as well since they inherit the limitations of the independent claims.
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) 1-5, 8-12, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Iterative prescription refinement in fully discretized inverse problems of radiation therapy planning” by Yair Censor, available August 5, 2011, hereinafter referred to as Censor1, in view of Jones (US 2019/0271673)
Regarding claim 1, Censor discloses A method comprising:
receiving, by at least one processor, an indication that a first computer model has initiated an iterative process of generating a radiation therapy treatment plan by ingesting a set of treatment plan attributes;
retrieving, by at least one processor after a first iteration of the first computer model, a first set of treatment attributes associated with a first treatment plan generated during the first iteration;
executing, by the at least one processor, a second computer model to generate a first validation score for the first treatment plan using the first set of treatment attributes;
retrieving, by at least one processor after a second iteration of the first computer model, a second set of treatment attributes associated with a second treatment plan generated during the second iteration;
executing, by the at least one processor, the second computer model to generate a second validation score for the second treatment plan using the second set of treatment attributes;
calculating, by the at least one processor, a first radiotherapy utility improvement value corresponding to a difference between the first validation score and the second validation score;
retrieving, by at least one processor after a third iteration of the first computer model, a third set of treatment attributes associated with a third treatment plan generated during the third iteration;
executing, by the at least one processor, the second computer model to generate a third validation score for the third treatment plan using the third set of treatment attributes;
calculating, by the at least one processor, a second radiotherapy utility improvement value corresponding to a difference between the second validation score and the third validation score;
See at least page 2 – “The method starts out from an ideal dose prescription and repeatedly refines it into a refined dose prescription. This is done computationally without human interaction until a prespecified stopping rule is met, at which point the refined dose vector and the accompanying beamlet intensities vector are evaluated and presented to the planner.”, page 7 – “To circumvent the difficulties mentioned above, we examine here, instead of the traditional approach, an iterative process by which the final refined dose d^ is reached by iteratively refining and steering a given ideal dose prescription vector. Repeated applications of the operator ^R are still used but instead of doing parameter changes inside ^R that require manual intervention and are not always known how to perform, ^R is used without changes and the method itself keeps reducing the discrepancy between the current refinement of the dose vector and the original ideal prescription.”, “The discrepancy vector Δk =dk - µd^k is then added to _d pres, where _ is a user-chosen relaxation parameter, to generate the next refined dose vector d kþ1 and so on, until some predefined stopping rule applies, see the algorithm below.”, and “(3) Calculate the dose discrepancy vector Δk Δk = dk - µd^k. 2” . The Examiner asserts that the discrepancy vector equates to the claimed validation score.
Censor does not explicitly disclose:
when a difference between the first radiotherapy utility improvement value and the second radiotherapy utility improvement value satisfies a threshold,
instructing, by the at least one processor, the first computer model to stop executing a future iteration
(See Jones, Para. [0010] – “generating a set of model performance values based on the set of model predicted values and the set of actual values, wherein the set of overall model performance values comprises of: a first standard error, and a first coefficient of determination”, “( 6) generating a set of overall model performance values based on the set of new predicted model values and the set of actual values, wherein the set of model performance values comprise: a second standard error, and a second coefficient of determination; repeating steps (1)-(6), while substituting the set of new coefficients for the set of coefficients from the previous iteration, unless: a performance termination criteria is satisfied, wherein the performance termination criteria comprises: a standard error termination value and a coefficient of determination termination value, and wherein satisfying the performance termination criteria comprises: the standard error termination value is greater than the difference between the first and second standard error, and the coefficient of determination termination value is greater than the difference between the first and second coefficient of determination; and storing the set of new model predicted values in a computer data medium.” The Examiner asserts that the “standard error” of Jones equates to the “dose discrepancy vector” of Censor. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Censor to utilize the teachings of Censor since both are in the same field of endeavor (i.e., iterative computation with a termination criteria/stopping rule), and all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 2, Censor discloses The method of claim 1, wherein the validation score corresponds to whether a treatment plan is within a clinical boundary. (See page 7 – “To circumvent the difficulties mentioned above, we examine here, instead of the traditional approach, an iterative process by which the final refined dose d^ is reached by iteratively refining and steering a given ideal dose prescription vector. Repeated applications of the operator ^R are still used but instead of doing parameter changes inside ^R that require manual intervention and are not always known how to perform, ^R is used without changes and the method itself keeps reducing the discrepancy between the current refinement of the dose vector and the original ideal prescription.”
Regarding claim 3, Censor discloses The method of claim 2, wherein the clinical boundary corresponds to an organ at risk dose limit, a beam angle constraint, a hot spot attribute, a cold spot attribute, or a planning target volume dose limit. (See page 10 – “The iterative calculation has two parts here: first, for a given set of prescription, the optimization finds the corresponding solution via an iterative process and this typically takes 20–30 iterations. Second, after the above iterative calculation is done, we modify the prescription in such a way that the dose inhomogeneity in the PTV and the high doses in the sensitive structures can be reduced.”
Regarding claim 4, Censor discloses The method of claim 1, wherein the second computer model is configured to generate the validation score based on a different set of criteria than those used by the first computer model, the set of criteria comprising clinical guidelines, historical treatment outcomes, or predictive models for side effects. (See page 7, Equations 6 and 7 which feature different variables used in calculations of the dose vector (i.e., treatment plan) and dose discrepancy vector (i.e., validation score). The Examiner asserts that the language the set of criteria comprising clinical guidelines, historical treatment outcomes, or predictive models for side effects is merely a label for the criteria and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., the particular criteria) which does not explicitly alter or impact the steps of the method (i.e., generating a validation score based on a different set of criteria from the first computer model) does not patentably distinguish the claimed invention from the prior art in terms of patentability. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of invention to have the system of Censor feature the claimed particular criteria because the type of criteria does not functionally alter or relate to the steps of the method and merely labeling the criteria differently from that of the prior art does not patentably distinguish the claimed invention.)
Regarding claim 5, Censor discloses The method of claim 1, further comprising:
adjusting, by at least one processor, the threshold used to determine when to stop the first computer model’s iterative process based on a patient-specific risk profile or physician input. (See page 7 – ““The discrepancy vector Δk =dk - µd^k is then added to µd pres, where µ is a user-chosen relaxation parameter, to generate the next refined dose vector d kþ1 and so on, until some predefined stopping rule applies, see the algorithm below.”, and “(3) Calculate the dose discrepancy vector Δk Δk = dk - µd^k. ”
Claims 8 and 15 feature limitations similar to those of claim 1, and are therefore rejected using the same rationale.
Claims 9 and 16 feature limitations similar to those of claim 2, and are therefore rejected using the same rationale.
Claims 10 and 17 feature limitations similar to those of claim 3, and are therefore rejected using the same rationale.
Claims 11 and 18 feature limitations similar to those of claim 4, and are therefore rejected using the same rationale.
Claims 12 and 19 feature limitations similar to those of claim 5, and are therefore rejected using the same rationale.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Iterative prescription refinement in fully discretized inverse problems of radiation therapy planning” by Yair Censor, available August 5, 2011, hereinafter referred to as Censor, in view of Jones (US 2019/0271673), and in further view of Walters (US 2020/0012900).
Regarding claim 6, Censor and Jones do not explicitly disclose The method of claim 1, wherein the threshold is dynamically adjusted during the iterative process based on real-time analysis of a rate of change in any of the validation scores. (See at least Walters, Para. [0179] – “Step 1804 may include training the predictive model using received model training data, consistent with disclosed embodiments. In some embodiments, training terminates upon satisfaction of one or more termination conditions. Consistent with disclosed embodiments, the termination condition(s) may be based on a performance metric of the predictive model, an elapsed time, a number of models trained, a number of epochs, an accuracy score, or a rate of change of an accuracy score.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Censor and Jones to utilize the teachings of Walters since it may efficiently allocate resources during hyperparameter tuning (Para. [0152]).
Claim 13 feature limitations similar to those of claim 6, and are therefore rejected using the same rationale.
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Iterative prescription refinement in fully discretized inverse problems of radiation therapy planning” by Yair Censor, available August 5, 2011, hereinafter referred to as Censor, in view of Jones (US 2019/0271673), and in further view of Adler (US 2021/0020297
Regarding claim 21, Censor and Jones do not explicitly disclose The method of claim 1, further comprising: in response to instructing the first computer model to stop executing, controlling, by the at least one processor, a radiotherapy machine based on the third treatment plan generated by the first computer model when instructed to stop. (See Adler at least Para. [0031] – “Radiotherapy treatment device parameters, e.g. control points, of a given device can then be determined and generated by the solved radiotherapy treatment plan optimization problem.”, Para. [0065] – “A controller communicatively connected to one or more actuators (not shown) may control the couch 246's movements or rotations in order to properly position the patient in or out of the radiation therapy beam 238, according to a radiation therapy treatment plan.”, and Para. [0081] – “After a certain number of iterations or when a stopping criterion is met, the solution to optimization problem can be output and used to generate a radiotherapy treatment plan.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Censor and Jones to utilize the teachings of Adler since it would provide a means of implementing the generated dose prescription of Censor.
Claims 22-23 feature limitations similar to those of claim 21 and are therefore rejected using the same rationale.
Response to Arguments
Applicant’s arguments, with respect to claims rejected under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that Censor does not feature a second computer model. The Examiner respectfully disagrees. The Examiner points to paragraph [0056] which states, in part, “The models 111 and/or 112 may represent any collection of algorithmic logic and/or artificial intelligence models (e.g., using various machine learning techniques). For instance, the validation model 111 may include various algorithms to monitor and evaluate the performance of the plan optimizer computer model 112.” Based on this, since the calculation of the “dose discrepancy vector” (i.e., the validation score) features a different equation for calculation (i.e., algorithmic logic) than that used to determine the dose prescription vector, that Censor features two models.
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that “a human cannot mentally receive an indication from a computer model, execute a separate computer model to generate a validation score, or instruct a computer model to stop executing iterations”. The Examiner respectfully disagrees. First, receiving an indication is merely receiving data. Further, the execution of the separate computer model is merely applied to the abstract function of generating a validation score. Moreover, instructing a computer model to stop executing iterations is a mental process/decision of determining when an iterative process should terminate and providing an instruction to terminate the process.
Applicant argues that “the validation model may use protocols such as “DVH Compliance, tumor control probability, normal tissue compliance probability, conformity index, homogeneity index, and the like” to calculate the validation score”, and that these calculations cannot practically be performed in the mind without the use of a computer. First, this is not persuasive as it is merely a conclusory statement. Further, the Examiner notes that the specification is devoid of any details indicating the use of such protocols calls for the use of a computer.
Applicant argues that the claims are not directed to organizing human activity. The Examiner respectfully disagrees. As stated in the body of the rejection above, but for the “processor” and “computer models” language, the limitations describe iteratively determining a treatment plan and an associated validation score, and halting the iteration if the difference between the associated validation scores satisfies a threshold.
Based on at least the above, the rejection is maintained. However, the Examiner notes that the 101 rejection may be overcome by incorporating the language of claim 21 into the independent claim.
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 KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://www.tandfonline.com/doi/epdf/10.1080/17415977.2011.603050?needAccess=true
2 Multiple mathematical symbols did not properly translate to Word document
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