DETAILED ACTION
This Office Action is responsive to the Amendment filed 1 August 2025. Claims
1-14 are now pending. The Examiner acknowledges the amendments to claims 1, 7, 8,
11, 13 and 14.
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 Objections
Claims 8 and 9 are objected to because of the following informalities: at line 6 of claim 8, the corrective action that” should apparently read –the corrective action, which--; and at line 3 of claim 9, “that identifies the action” should apparently be deleted to avoid an insufficient antecedent basis issue, and as amended in claims 8, 11, 13 and 14 by Applicant. Appropriate correction is required.
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.
Claims 1-14 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 1 at lines 10-12 recites “wherein the treatment plan contains data comprising medical images, anatomical contours, treatment beams, and computed radiation dose.” While it is clear how treatment plan data could comprise medical images, anatomical contours, and computed radiation dose, it is unclear how treatment data could comprise a treatment beam (or beams).
Claim 1 at lines 10-12 recites “the treatment plan contains data comprising medical images, anatomical contours, treatment beams, and computed radiation dose, which produces hundreds of data points”. It is unclear if the limitation “which produces hundreds of data points” applies to just “computed radiation dose” or if it applies to all of the previously recited limitations of “medical images, anatomical contours, treatment beams, and computed radiation dose”.
Claim 1 at line 14 recites “performing a review of the treatment plan before using the treatment plan...”. It is unclear when the step of “performing a review of the treatment plan” would occur as there is no prior recitation of a step of “using the treatment plan”.
Claim 1 at lines 20-21 recites “analyzing the treatment plan that determines a classification for the treatment plan”, wherein “the treatment plan that determines a classification” lacks antecedent basis. A suggested amendment to avoid a rejection under lack of antecedent basis is changing that recitation to –determining a classification for the treatment plan…--.
Claim 1 at lines 21-22 recites “…determines a classification for the treatment plan based on similarities of features based on distance between the treatment plan and predefined treatment classes”. In light of the specification, it is unclear how one would ascertain a distance between a treatment plan and a treatment class when distance is generally regarded to connotate a physical (or virtual) distance between two physical entities. Further, while the specification at [0045] discloses “Classification of the proposed treatment plan, such as classifying the proposed treatment plan, may be based on determining the similarity (e.g., as calculated through distances) of features of the proposed treatment plan to features of known predefined treatment plan classes or characteristics,” this is the only disclosure of “distance” and does not clarify how a distance would be calculated between a treatment plan and a treatment class, or what entities or objects the claimed distance is relative to.
Claim 1 at lines 22-24 recites “determining how well certain technical parameters of the treatment plan match with certain clinical requirements of the treatment plan.” The phrase “how well” is relative, which renders the claim indefinite. The phrase “how well certain…parameters…match with certain…requirements” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph [0047] of the disclosure recites “The analyses may also include determination of how well certain plan features (e.g., technical parameters) match with expected plan characteristics (e.g., clinical requirements) and may include generation of error and/or warnings if the quality estimate is below a certain threshold value,” however this does not clarify how one of ordinary skill in the art would ascertain what would constitute “how well” certain plan features match with plan characteristics, or how one would measure “how well” the features and characteristics match.
Claim 1 at lines 23-24 recites “certain technical parameters” and “certain clinical requirements” however the claim does not identify what those particular (or “certain”) parameters or requirements are.
At line 3 of claim 3, it is unclear if “a plurality of technical parameters” are the same as or different than “certain technical parameters” recited at line 23 of claim 1.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method/system for a process of receiving, reviewing and analyzing information about a patient, which can be considered as a mental process supplemented and implemented with pen/paper. The step of “receiv[ing] a treatment plan comprising a planned radiation therapy treatment for a subject…compris[ing] delivery instructions…wherein the treatment plan contains data comprising medical images, anatomical contours, treatment beams, and computed radiation dose, which produces hundreds of data points” could be interpreted as an individual/surgeon being handed image data on printed matter, with written instructions printed on the piece of paper on how to use the radiation therapy delivery system to deliver the treatment. The printed matter could be medical images showing anatomical contours, treatment beams being utilized (or data for the treatment beams), and/or radiation dosages, all of which would comprise hundreds of data points.
The “identifying” and “analyzing” steps (lines 13 and 17 respectively) could all be performed mentally or on a piece of paper. The “analyzing the treatment plan that determines a classification for the treatment plan based on similarities of features based on distance between the treatment plan and predefined treatment classes” (lines 20-22) is indefinite as outlined above, though it amounts to a practitioner determining a classification in the mind based on observing similarities between the treatment plan and predefined treatment classes which could constitute looking at a printout of the similarities, which could be distance values, and treatment classes and making a judgement based on those.
With respect to the “performing a review of the treatment plan” step, while it is indefinite, the step will be construed as a practitioner looking at a piece of paper/printout of the plan, and visually reviewing such.
The step of “determining how well certain technical parameters of the treatment plan match with certain clinical requirements of the treatment plan” (lines 22-24), while it is indefinite, the step will be construed as a practitioner looking at a piece of paper/printout containing “certain parameters” (or values) of the plan, and visually/mentally comparing/matching those with certain clinical requirements also printed out on the paper.
The step of “determining a quality estimate for the determined classification” (lines 24-25) will be construed as a practitioner making a mental judgement based on the aforementioned step.
Additionally, the step of “performing the action” is likewise non-specific and could be interpreted as a step of the practitioner using pen/paper to “perform a corrective action” on an image, which could also cover “a document related action”. The actions of “configuring a user interface,” “storing results…to a database,” “outputting an alert” or “disabling the treatment plan from clinical use” are all steps which could be implemented on a generic computer, which is addressed below.
Of note, the recitation following “delivery instructions” (“for delivering a radiation therapy treatment to the subject using the radiation therapy delivery system in accordance with the treatment plan”) is a recitation of the intended use of the delivery instructions.
This judicial exception is not integrated into a practical application because the claims, as written, can be performed in a physician or surgeon’s mind, or implemented with pen/paper and further do not positively recite any application of these steps in claims 1-14. While claim 1 recites the additional elements of a processor and memory, these additional elements are not sufficient to amount to significantly more than the judicial exception because the mental steps of “identifying” and “analyzing” are merely being implemented on generic computer elements and thus do not add a meaningful limitation to the abstract idea since they simply amount to implementing the abstract idea on a generic computer and computer component (memory containing an application which is essentially a set of instructions and a user interface in claim 1; and display/input device in claim 6). Claim 1 (and 2) does recite the additional element of a “radiation therapy delivery system,” however such a device for delivering radiation therapy is well-understood and conventional in the art as suggested by U.S. Pub. No. 2020/0101319 and U.S. Pub. No. 2019/0143145.
And while the claim also appears to recite the steps of “using the treatment plan to deliver the radiation treatment” (lines 14-15) and “…using the radiation therapy delivery system in accordance with the treatment plan” (lines 9-10), both of these recitations lack any further specification of the “use” and amount to no more than merely adding a generic step of “apply it” (or equivalent thereof) with respect to the printed treatment plan and the delivery system.
And with respect to the recitation of “using a machine learning model, wherein the machine learning model is trained on historical data” (lines 18-19), and “wherein the analysis of the treatment plan and the at least one clinical requirement using a machine learning model identifies an action” (lines 25-26), these recitations likewise amount to an added generic step of “apply it” (or equivalent thereof) by simply reciting using a machine learning model, which could be implemented using a generic computer application (“a machine learning model”) lacking any further specification. However, such a machine learning model for image analysis is well-understood and conventional in the art as suggested by U.S. Pub. No. 2019/0143145 and U.S. Pub. No. 2013/0188856.
Dependent claims 3-14 merely further limit the generic steps, which can also be performed mentally; or the “identifying at least one clinical requirement” at line 13 of claim 1, which is addressed above.
Response to Arguments
Applicant’s arguments filed 1 August 2025 with respect to the rejection of claims 1-14 under 35 U.S.C. 112(b) have been fully considered, however new grounds of rejection are presented above in light of the amendments. Applicant does contend that one of ordinary skill in the art would understand that the treatment plan is “to be used deliver the treatment” and therefore they would understand that the claim language clarifies the meaning of performing a review of the treatment plan before using the treatment plan to deliver the radiation treatment. However, this argument is not persuasive. The claim recites “performing a review of the treatment plan before using the treatment plan” and Applicant is arguing the treatment plan being “used [to] deliver the treatment”. It is noted that delivery of treatment and use of a treatment plan could potentially be two different steps as argued, which does not clarify the ambiguity.
Applicant’s arguments filed 1 August 2025 with respect to the rejection of claims 1-14 under 35 U.S.C. 101 have been fully considered and are not persuasive. Applicant contends that the recited claim cannot be reasonably performed in a human mind based on the volume and complexity of the data, which is recited in the claim. While this argument does not specifically point out the recited claim language, it is assumed that Applicant is referencing the most recent amendment of “receiv[ing] a treatment plan comprising a planned radiation therapy treatment for a subject…compris[ing] delivery instructions…wherein the treatment plan contains data comprising medical images, anatomical contours, treatment beams, and computed radiation dose, which produces hundreds of data points”. As addressed above, this recitation could be interpreted as an individual/surgeon being handed image data on printed matter, with written instructions printed on the piece of paper on how to use the radiation therapy delivery system to deliver the treatment. The printed matter could be medical images showing anatomical contours, treatment beams being utilized (or data for the treatment beams), and/or radiation dosages, all of which would comprise hundreds of data points. It is well-understood that printed matter containing medical images, anatomical contours, etc. would comprise "hundreds of points of data". Applicant also contends that the claim recited specific details of the machine learning feature by reciting details of an implementation involving distance between features, the use of vectors, and determining how well technical parameters of the treatment plan match requirements of the plan using the machine learning model. It is noted that Applicant appears to be referencing the limitation “…analyzing the treatment plan that determines a classification for the treatment plan based on similarities of features based on distance between the treatment plan and predefined treatment classes” (lines 20-22), which is indefinite as outlined above. However, it amounts to a practitioner determining a classification in the mind based on observing similarities between the treatment plan and predefined treatment classes which could constitute looking at a printout of the similarities, which could be distance values, and treatment classes and making a judgement based on those. The claim merely recites “using a machine learning model” so this would not amount to specific details of the machine learning feature by reciting details of an implementation involving distance between features, or “the use of vectors”. It is likewise noted that no instance of “the use of vectors” occurs in any of the claims. To expedite prosecution, since the delivery system is recited, an amendment along the lines of reciting the steps of actually delivering the plan via the system based on the “determining” steps is suggested.
Applicant’s arguments filed 1 August 2025 with respect to the rejection of claims 1-14 under 35 U.S.C. 103 citing Adler in view of Dempsey have been fully considered and are persuasive in light of the amendments.
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.
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/CHRISTINE H MATTHEWS/ Primary Examiner, Art Unit 3791