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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 2-6, 8, 12, 14-18, 20 and 24) in the reply filed on July 24, 2026 is acknowledged. The application has pending claims 1–24 (withdrawn claims 9-11 and 21-23 are withdrawn from further consideration).
Response to Arguments
In the remarks filed on July 24, 2026, Applicant respectfully submitted that a restriction under 35 U.S.C. 121 is not proper and that an election of species under 37 C.F.R. § 1.146 would be a more procedurally appropriate course. The Examiner respectfully disagrees.
An election of species under 37 C.F.R. § 1.146 is applicable when claims are drawn to multiple, mutually exclusive alternative embodiments of a single general invention (genus) (see MPEP § 806.04(b)). In the present application, Group I (directed to the planning-time embodiment) and Group II (directed to the treatment-time monitoring embodiment) do NOT represent mutually exclusive alternative variations of a single genus. Rather, they represent distinct, sequential processes that operate at different phases of the overall medical workflow.
Therefore, the groups are properly categorized as related subcombinations disclosed as usable together in a single combination (MPEP § 806.05(d)). Because these subcombinations are distinct, do not overlap in scope, and each possess separate utility (i.e., planning-side boundary determination versus real-time dose reconstruction), a restriction between subcombinations under 35 U.S.C. 121 remains the procedurally correct course
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because FIG. 3 includes reference character 304, which is not mentioned in the description. Appropriate correction is required by submitting a corrected drawing sheet in compliance with 37 CFR 1.121(d), or by amending the specification to identify reference character 304 where supported by the original disclosure.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0021] recites "making a 106 review," in which "106" appears to be an inadvertently retained reference numeral rather than the intended descriptive term.
Paragraph [0025]: The parenthetical expression beginning with “both non-volatile memory…” is unbalanced. The parenthesis opened before “such as read-only memory” is not properly closed.
Paragraph [0046]: “currently-display motion-based image” should grammatically read “currently-displayed motion-based image”.
Paragraph [0063]: there is a grammatical error: "This adverse effect of high doses to OARs can itself leads to dose reductions..." should be corrected to "lead".
Paragraph [0075]: “whether a simulation model and a day-of-treatment model can or are expressing/representing a same motion” contains a malformed verb construction and should be corrected without changing the disclosed substance.
Appropriate correction is required.
Claim Objections
Claims 6 and 18 are objected to because of the informal use of “one motion-based imagery” and “another motion-based imagery”. Applicant should amend the claims to recite, for example, “one motion-based image” and “another motion-based image” or another grammatically correct expression consistent with the intended scope. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 is missing a terminal period. A period must be added at the end of the claim: "...supplemental multi-dimensional information.".
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 4 and 16 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “planning treatment volume” in claims 4 and 16 is used by the claim to mean “as a function of the supplemental boundary and describes Figure 3 as illustrating a target volume 303 added to a “previously-determined planning target volume” [0051]. Figure 3 also separately depicts and labels a PTV and an outer TV”, while Paragraph [0037] defines a “planning target volume (PTV)” as being based upon an internal target volume and an additional margin associated with potential or observed setup errors. Paragraph [0064] similarly refers to “The treatment volume or PTV, --” thereby appearing to equate a treatment volume with the conventional planning target volume. Accordingly, the disclosure uses “planning treatment volume,” “planning target volume,” “treatment volume,” and “target volume” in a manner that does not clearly establish whether the “planning treatment volume” recited in claims 4 and 16 means: (i) the conventional planning target volume (PTV); (ii) a distinct treatment or target volume formed by applying the supplemental boundary outside an already determined PTV; or (iii) either of the foregoing volumes. Because these interpretations define different claimed volumes and different relationships between the claimed supplemental boundary and the PTV, the metes and bounds of claims 4 and 16 cannot be determined with reasonable certainty. The Examiner interpret this term as being disclosed by [0051] for subsequent examinations.
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 1-8, 12-20, and 24 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception without significantly more.
This rejection has been made in accordance with the current USPTO subject matter eligibility framework, including MPEP §§ 2103–2106.07, the 2019 Revised Patent Subject Matter Eligibility Guidance, the October 2019 Patent Eligibility Guidance Update, the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence, the July 2024 AI Subject Matter Eligibility Examples, the August 4, 2025 USPTO memorandum titled "Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. § 101," and the USPTO's guidance concerning Ex parte Desjardins, Appeal No. 2024-000567. The claims have been evaluated under the broadest reasonable interpretation, and the claims have been considered as a whole.
Step 1: Statutory category
Independent claim 1 is directed to a method and therefore falls within the statutory category of a process. Independent claim 13 is directed to an apparatus comprising a control circuit and therefore falls within the statutory category of a machine. The dependent claims remain within the same respective statutory categories. Accordingly, the analysis proceeds to Step 2A.
Step 2A, Prong One (Judicial exception)
Independent claim 1 recites: accessing multi-dimensional information for a particular patient; and automatically determining a supplemental boundary for at least one portion of the particular patient as a function, at least in part, of the multi-dimensional information. These limitations recite an abstract idea in the mental-process grouping, namely collecting patient-motion information and evaluating that information to determine a boundary for a patient portion. The determination is an observation, evaluation, judgment, or opinion of the type that can practically be performed by a person reviewing patient-motion information and selecting or drawing a corresponding boundary, with or without pen, paper, or ordinary graphical aids.
The word "automatically" and the requirement that the steps be performed by a control circuit do not remove the evaluation from the mental-process grouping. A claim may recite a mental process even when the claim requires a computer to perform the process, where the computer is used as a tool to perform an evaluation that the claim otherwise describes at a high level of generality. Claim 1 does not recite a particular algorithm, registration operation, image-processing rule, mathematical relationship, or physical treatment operation by which the supplemental boundary is determined. The claim does NOT recite an improvement to the way medical images are captured, digitized, or generated, nor does it physically apply the determined boundary to shape a radiation beam or treat the patient. Rather, the claim uses generic computer units to obtain data and mathematically calculate a spatial boundary.
Independent claim 13 recites substantially the same abstract information-collection and evaluation process in apparatus form by configuring a control circuit to access the multi-dimensional information and determine the supplemental boundary. Merely drafting the same information-analysis process as a control-circuit apparatus does not avoid the judicial exception.
Claims 2 and 14 further characterize the supplemental boundary as a margin added to an existing boundary. Selecting the magnitude and location of a margin from observed motion information remains an evaluation or judgment. Claims 3 and 15 merely identify the subject of that evaluation as a treatment target or an organ-at-risk and therefore limit the abstract idea to particular medical information.
Claims 4 and 16 further recite determining a planning treatment volume as a function of the supplemental boundary. Under either reasonable interpretation of "planning treatment volume" identified in the separate rejection under 35 U.S.C. § 112(b), the limitation remains the evaluation and derivation of planning-volume information from boundary information. It does not require administering treatment or changing the physical state of a patient or treatment machine.
Claims 5 and 17 limit the information being collected and evaluated to at least two of cardiac-based imagery, respiratory-based imagery, and cyclic gastric motion-based imagery. The content or source of the information does not change the character of the claimed evaluation. The claims do not require capturing the imagery or recite a particular improvement to CT, MRI, PET, fluoroscopy, or other imaging equipment.
Claims 6 and 18 add presenting motion-based imagery and permitting a user, through a user interface, to selectively modify the displayed movement associated with one type of motion imagery separately from another. These limitations add information presentation and user-directed manipulation to the underlying collection and evaluation process. They do not recite a particular graphical layout, image-rendering operation, synchronization algorithm, or improved computer-display mechanism.
Claims 7 and 19 recite generating a patient-motion model as a function of the multi-dimensional information. At the level of generality claimed, generating the model describes analyzing the patient information to form a representation of expected movement. The claims do not recite the structure of the model, a particular model-generation algorithm, or a specific technical training procedure.
Claims 8 and 20 recite assessing efficacy for each of a plurality of therapeutic treatment modalities as a function of the motion model. Assessing efficacy is expressly an evaluation, judgment, or opinion and therefore falls within the mental-process grouping. The claims do not require selecting a modality, controlling a modality, or treating the patient using the assessed modality.
Claims 12 and 24 recite optimizing a radiation-based therapeutic treatment plan as a function of at least two dimensions of movement derived from the multi-dimensional information. Under the broadest reasonable interpretation in light of paragraph [0003], optimization includes adjusting treatment parameters and mathematically calculating a likely treatment result. The limitations therefore recite evaluation and judgment and also encompass mathematical calculations used to obtain an optimized informational plan. No particular objective function, constraint system, calculation, or optimization algorithm is recited.
The claims are similar in character to the claims in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed. Cir. 2016), which were directed to collecting information, analyzing the information, and displaying results, and to the medical-data claims in University of Florida Research Foundation, Inc. v. General Electric Co., 916 F.3d 1363, 1367-69 (Fed. Cir. 2019), which were directed to collecting, analyzing, manipulating, and displaying patient-treatment data using generic computing components. They are also consistent with AI Visualize, Inc. v. Nuance Communications, Inc., 97 F.4th 1371, 1378-82 (Fed. Cir. 2024), where claims concerning medical-scan data were ineligible because their focus remained the manipulation and display of information rather than a claimed technical means for improving the underlying technology.
Accordingly, claims 1-8, 12-20, and 24 recite an abstract idea under Step 2A, Prong One.
Step 2A, Prong Two (Practical Application)
The additional elements, considered individually and in combination with the judicial exception, do not integrate the abstract idea into a practical application.
The recited control circuit merely implements the information collection, evaluation, modeling, and planning functions. Claims 1 and 13 do not recite a radiation source, gantry, patient support, beam-shaping device, imaging apparatus, or other particular machine that is integral to the claimed determination. The specification describes optional coupling to a treatment platform, but that platform and the corresponding physical control operations are not recited in the elected claims.
The preambles state that the method and apparatus are "to facilitate compensating for motion during a therapeutic treatment session". This statement supplies an intended use or technological environment; it does not require that motion actually be compensated for during treatment. Similarly, limiting the information and result to a particular patient, treatment target, organ-at-risk, planning volume, or radiation-treatment plan generally links the abstract analysis to the field of radiation therapy without requiring a physical treatment operation.
The claims do not apply the analysis to effect a particular treatment or prophylaxis. None of the elected claims requires administering radiation to the patient, positioning the patient, moving a gantry, shaping a radiation beam, modifying a delivered dose, or controlling treatment-platform parameters according to the determined boundary or optimized plan. Claims 4, 8, 12, 16, 20, and 24 terminate with a planning volume, efficacy assessment, or optimized plan, each of which is an informational result rather than the performance of treatment.
Claims 6 and 18 do not provide a technological improvement to a user interface or image-display system. They recite only the desired user capability to modify displayed movement for one category of imagery separately from another, without specifying a particular data structure, rendering pipeline, display arrangement, control scheme, or computer operation that produces the capability. Presenting the information and accepting ordinary user input therefore do not meaningfully limit the underlying abstract evaluation.
The specification identifies a technical setting in which patient motion can contribute to target underdosing or overdosing of protected tissue and states that use of multiple motion modalities may produce better treatment plans. However, the claims do not reflect a particular technical mechanism that produces those asserted benefits. They do not specify how different motion sources are registered or synchronized, how motion magnitude is converted into the supplemental boundary, how conflicting motion is resolved, how the motion model is generated, or how treatment-machine parameters are changed. Instead, they claim the desired results of determining a boundary, generating a model, assessing efficacy, or optimizing a plan as a function of patient information.
This case is distinguishable from Ex parte Desjardins, Appeal No. 2024-000567 (PTAB Sept. 26, 2025) (precedential). In Desjardins, the claims themselves reflected a particular improvement in operation of a machine-learning model by optimizing performance on a later task while protecting performance on an earlier task, thereby addressing catastrophic forgetting and associated storage and complexity problems. Here, the claims do not recite a particular algorithm or operational arrangement that improves a computer, model, imaging device, or treatment platform.
The claims are also distinguishable from CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368-71 (Fed. Cir. 2020). The eligible claims there recited a specific cardiac-monitoring device arrangement that detected beat-to-beat timing and ventricular beats and determined relevance to specified arrhythmias while accounting for the detected ventricular beats. The present claims do not recite a comparably specific combination of detectors, processing rules, model structure, or treatment control.
Accordingly, the claims do not integrate the judicial exception into a practical application under Step 2A, Prong Two.
Step 2B: (Inventive Concept)
The additional elements, considered both individually and as an ordered combination, do not amount to significantly more than the abstract idea.
The control circuit is recited only at a high level of generality and performs the ordinary computer functions of accessing information and producing calculated or evaluated information. Paragraph [0023] expressly states that the control circuit may comprise an ASIC, FPGA, microcontroller, or microprocessor; that these architectural options are well known and understood in the art; and that corresponding programming will be well understood by those skilled in the art. This express disclosure supports the finding that the claimed control circuit, when performing the recited generic information-processing functions, is well-understood, routine, and conventional.
For claims 6 and 18, paragraph [0026] describes the user interface generically as conventional keyboards, keypads, cursor-control devices, touch-sensitive displays, visual displays, and similar input and output mechanisms. Paragraphs [0044-0046] describe ordinary cursor selection, submenu selection, and slowing or halting displayed movement. These generic display and input components performing their ordinary functions do not supply an inventive concept.
The patient information, motion imagery, supplemental boundary, margin, planning volume, motion model, efficacy assessment, and optimized treatment plan are the information being collected, analyzed, displayed, or produced. They form part of the abstract analysis itself and cannot provide significantly more merely by being recited in medical or radiation-treatment terminology.
The ordered combination likewise does not provide an inventive concept. The combination follows the abstract information-analysis sequence itself: access patient-motion information; determine a boundary or margin; and, depending on the claim, display and manipulate the information, derive a planning volume, generate a model, assess treatment alternatives, or optimize a plan. The claims recite the functional results of those operations without a nonconventional arrangement of hardware or a particular technical procedure for achieving the results.
Dependent claims 2-8, 12, 14-20, and 24 narrow the data, result, or type of analysis, but do not add a particular machine integral to performance, a physical transformation, a particular treatment step, an improved computer or imaging operation, or another meaningful limitation that amounts to significantly more than the abstract idea.
Accordingly, claims 1-8, 12-20, and 24 are directed to a judicial exception without significantly more and are therefore rejected under 35 U.S.C. § 101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 12-15, 17-20, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-8, 12, 13, 15, 17-20, and 24 of copending Application No. 18/511,326 (a NOA was mailed for these claims on 7/21/2026, but no issue fee has been paid at the time of mailing of this office action, thus the claims are still pending). The claims at issue are identical and/or they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim language in this Application
Application No. 18/511,250
Corresponding claim language in
Application No. 18/511,326 (amended July 13, 2026)
1A
A method to facilitate compensating for motion during a therapeutic treatment session for a particular patient, the method comprising:
1A
A method to facilitate compensating for motion during a cardiac radioablation session for a heart of a particular patient, the method comprising:
18/511,250 > [0065]: -- the present examples reference a cardiac radio ablation application --: A cardiac radioablation session for a heart is a specific type of therapeutic treatment session for a particular patient and therefore falls within the scope of the broader recitation.
Furthermore, the cited reference Sumanaweera et al (US 2009/0257557 A1, 2009) used in the section 102 rejection below also confirm cardiac radioablation session is one type of therapeutic treatment session: [0059] In the case where the target is inside the heart on heart muscle, radiosurgical ablation --.
1B
by a control circuit:
1B
by a control circuit:
1C
accessing multi-dimensional information for the particular patient;
1D
accessing multi-dimensional information for the particular patient;
1D
automatically determining a supplemental boundary for at least one portion of the particular patient as a function, at least in part, of the multi-dimensional information.
1E
automatically determining a supplemental boundary for at least one portion of the particular patient as a function, at least in part, of the multi-dimensional information,
2
The method of claim 1, wherein the supplemental boundary comprises a margin that is added to a boundary of the at least one portion of the particular patient.
wherein the supplemental boundary is an additional margin that is added to the already-established boundary for the at least part of the previously-determined planning target volume for the particular patient;
3
The method of claim 1, wherein the at least one portion of the particular patient comprises at least one of:
a treatment target;
an organ-at-risk.
3
The method of claim 1, wherein the at least one portion of the particular patient comprises at least one of:
a treatment target portion of the heart;
an organ-at-risk.
4
The method of claim 1, further comprising:
determining a planning treatment volume as a function, at least in part, of the supplemental boundary.
1F
Amended claim 1 further requires determining a planning treatment volume as a function, at least in part, of the supplemental boundary.
5
The method of claim 1, wherein the multi-dimensional information includes motion-based imagery comprising at least two of cardiac-based imagery for the particular patient, respiratory-based imagery for the particular patient, and cyclic gastric motion-based imagery for the particular patient.
5
The method of claim 1, wherein the multi-dimensional information includes motion-based imagery comprising cardiac-based imagery for the particular patient and at least one of respiratory-based imagery for the particular patient and cyclic gastric motion-based imagery for the particular patient.
6
The method of claim 5, further comprising:
presenting the motion-based imagery to a user;
providing the user, via a user interface, with an opportunity to selectively modify movement of one motion-based imagery separately from another motion-based imagery.
6
The method of claim 5, further comprising:
presenting the motion-based imagery to a user;
providing the user, via a user interface, with an opportunity to selectively modify movement of one motion-based imagery separately from another motion-based imagery.
7
The method of claim 1, further comprising:
generating a motion model for the particular patient as a function, at least in part, of the multi-dimensional information for the particular patient.
7
The method of claim 1, further comprising:
generating a motion model for the particular patient as a function, at least in part, of the multi-dimensional information for the particular patient.
8
The method of claim 7, further comprising:
assessing efficacy for each of a plurality of different therapeutic treatment modalities for the particular patient as a function, at least in part, of the motion model.
8
The method of claim 7, further comprising:
assessing efficacy for each of a plurality of different therapeutic treatment modalities for the particular patient as a function, at least in part, of the motion model.
12
The method of claim 1, further comprising:
optimizing a radiation-based therapeutic treatment plan for the particular patient as a function of at least two different dimensions of movement as derived, at least in part, from the multi-dimensional information.
12
The method of claim 1, further comprising:
optimizing a cardiac radioablation treatment plan for the particular patient as a function of at least two different dimensions of movement as derived, at least in part, from the multi-dimensional information.
Regarding claims 13, 15, 17-20, and 24, the rationale provided for claims 1, 3, 5-8, and 12 is incorporated herein. The method of claims 1, 3, 5-8, and 12 corresponds to the apparatus of claims 13, 15, 17-20, and 24, and performs the steps disclosed herein. Therefore, the claimed invention of copending Application No. 18/511,326 obviously encompasses the present claimed invention, and claims 1, 3, 5-8, 12, 13, 15, 17-20, and 24 of the instant application are not patentably distinct therefrom.
This is a provisional rejection since the conflicting claims have not in fact been patented. See MPEP § 804. A terminal disclaimer in compliance with 37 CFR 1.321(c) or (d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the conflicting application or patent is commonly owned with this application, or claims common inventorship as required by 37 CFR 1.321.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1–5, 7, 13–17, and 19 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Sumanaweera (Sumanaweera et al, US 2009/0257557 A1, 2009).
Regarding claim 1, Sumanaweera teaches a method to facilitate compensating for motion during a therapeutic treatment session for a particular patient ( [Abstract]; [0008]: Sumanaweera describes planning and delivering radiation treatment to moving target tissue while accounting for tissue motion. ), the method comprising:
by a control circuit:
( [0064], [0085], [0091–0093]: processor modules perform the disclosed imaging, treatment-planning, dose-calculation, tracking, and radiation-delivery operations. )
accessing multi-dimensional information for the particular patient;
( [0044], [0058 and Claim 1A], [0063–0064], [0086–0090], [Fig. 4]: the processor receives and loads sequential three-dimensional CT volumes constituting a volumetric movie or 4-dimensional image dataset representing patient tissue over time. )
automatically determining a supplemental boundary for at least one portion of the particular patient as a function, at least in part, of the multi-dimensional information.
( [0076], [0078–0082]: the system automatically determines tissue motion from the volumetric representations and expands a target or critical-structure volume with a motion-based margin; the margin is calculated from the estimated motion, including by using a three-dimensional probability density function of target position. )
Regarding claim 2, Sumanaweera teaches the method of claim 1, wherein the supplemental boundary comprises a margin that is added to a boundary of the at least one portion of the particular patient.
( [0078–0082]: target and critical-structure volumes are expanded with isotropic or anisotropic margins based on motion; an anisotropic margin may be formed by moving each surface point outward from the original surface. )
Regarding claim 3, Sumanaweera teaches the method of claim 1, wherein the at least one portion of the particular patient comprises at least one of:
a treatment target;
an organ-at-risk.
( [0057], [0065–0066], [0078], [0081], [Figs. 4 and 5]: Sumanaweera defines, contours, and applies motion margins to both target-tissue regions [treatment target] and radiation-sensitive or critical structures. A radiation-sensitive or critical structure is an organ-at-risk. )
Regarding claim 4, Sumanaweera teaches the method of claim 1, further comprising:
determining a planning treatment volume as a function, at least in part, of the supplemental boundary.
( [0068], [0077-0079], [Figs. 5 and 6]: Sumanaweera expressly identifies a Planning Target Volume for Optimization and a Planning Target Volume for Evaluation and uses target volumes in treatment planning and dose calculation. The target volume is expanded using the motion-based margin, and the resulting motion-expanded volume is used to calculate dose and plan radiation treatment. )
Regarding claim 5, Sumanaweera teaches the method of claim 1, wherein the multi-dimensional information includes motion-based imagery comprising at least two of cardiac-based imagery for the particular patient, respiratory-based imagery for the particular patient, and cyclic gastric motion-based imagery for the particular patient.
( [0087-0089]: Sumanaweera teaches acquiring cardiac gated CT volumes based on the EKG cycle, and acquiring respiratory-gated 4-D CT volumes based on a series of respiratory phases; associating each CT volume with the associated phase of the respiration cycle. )
Regarding claim 7, Sumanaweera teaches the method of claim 1, further comprising:
generating a motion model for the particular patient as a function, at least in part, of the multi-dimensional information for the particular patient.
( [0076], [0088], [0091–0093]: the system determines tissue motion using the sequential three-dimensional volumes; Sumanaweera expressly describes a motion model represented by the time sequence of three-dimensional tissue volumes and states that the model is developed during imaging and may be used or revised during treatment tracking; thereby generating a three-dimensional probability density function for the target position to model motion; making use of a motion model represented by the time sequence of 3-D tissue volumes to identify radiation exposure. )
Regarding claims 13–17 and 19, the rationale provided in the rejection of claims 1-5 and 7 is incorporated herein. In addition, the method of claims 1-5 and 7 corresponds to the apparatus of claims 13-17 and 19, and performs the steps disclosed herein. Therefore, the claims are all rejected.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 and 18 are rejected under 35 U.S.C. §103 as being unpatentable over Sumanaweera in view of Wu (Wu et al. Acquisition and visualization of 5D respiratory-resolved cardiac MRI. Journal of Cardiovascular Magnetic Resonance, 14(S1), 2012).
Regarding claim 6, Sumanaweera teaches the method of claim 5, further comprising:
presenting the motion-based imagery to a user;
( [0058], [0064–0065], [0085], and [0091], [Figs. 4 and 6]: Sumanaweera’s volumetric movie captures target motion and is loaded into a visualization-software application coupled to a display. The application displays multi-planar reconstruction and three-dimensional volume-rendered views to a user and provides a treatment-planning user interface. )
Although Sumanaweera presents the motion-based imagery through a user interface, Sumanaweera does not expressly teach using that interface to control for selectively isolating the playback of the different physiological cycles, where Wu teaches:
providing the user, via a user interface, with an opportunity to selectively modify movement of one motion-based imagery separately from another motion-based imagery.
( [Page. 1 > Summary, Methods, and Results], [Page. 2 > Figs. 1–2 with corresponding captions]: Wu acquires cardiac and respiratory signals concurrently and reconstructs a five-dimensional dataset having separate cardiac-cycle and respiratory-cycle dimensions. Wu teaches that the dataset can be redisplayed as a cardiac cine while the respiratory phase is held fixed or as a respiratory cine while the cardiac phase is held fixed. Therefore, one motion dimension is selectively displayed as moving while the other motion dimension remains fixed. )
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate Wu’s fixed-phase cine-display technique into Sumanaweera’s visualization user interface to permit separate evaluation of cardiac and respiratory motion when assessing target and critical-structure movement and establishing motion-based treatment margins. Such a modification constitutes the application of a known visualization technique to a similar motion-analysis system and would have predictably improved the clinician’s ability to isolate and evaluate each source of physiological motion.
Regarding claim 18, the rationale provided in the rejection of claim 6 is incorporated herein. In addition, the method of claim 6 corresponds to the apparatus of claim 18, and performs the steps disclosed herein. Therefore, the claim is rejected.
Claims 8 and 20 are rejected under 35 U.S.C. §103 as being unpatentable over Sumanaweera in view of Trofimov (Trofimov et al. Temporo-spatial IMRT optimization: concepts, implementation and initial results. Physics in Medicine and Biology, 50(12), 2779–2798, 2005).
Regarding claim 8, Sumanaweera teaches the method of claim 7, further comprising:
Sumanaweera does not expressly disclose where Trofimov teaches:
assessing efficacy for each of a plurality of different therapeutic treatment modalities for the particular patient as a function, at least in part, of the motion model.
( [Page. 2779 > Abstract], [Sec. 1 "Introduction"], [Sec. 2.3], [Figs. 7–13], [Sec. 3–4]: using patient-specific 4D-CT motion information to develop and compare treatment plans employing four different motion-management modalities (motion-dependent margins, a motion kernel, respiratory gating, and tracking); and assessing their efficacy by comparing target coverage, dose conformity, healthy-tissue and critical-structure dose, treatment time, and delivery complexity. )
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply Trofimov’s comparative treatment-planning analysis to Sumanaweera’s patient motion model to select among known motion-margin, motion-kernel, gating, and tracking approaches based on predicted target coverage, healthy-tissue dose, and delivery efficiency. Doing so would have predictably provided a patient-specific selection of an effective motion-compensated radiation-treatment approach.
Regarding claim 20, the rationale provided in the rejection of claim 8 is incorporated herein. In addition, the method of claim 8 corresponds to the apparatus of claim 20, and performs the steps disclosed herein. Therefore, the claim is rejected.
Claims 12 and 24 are rejected under 35 U.S.C. §103 as being unpatentable over Sumanaweera in view of Dempsey (Dempsey et al, US 2017/0203126 A1, 2017).
Regarding claim 12, Sumanaweera teaches the method of claim 1, further comprising:
Sumanaweera does not expressly disclose where Dempsey teaches:
optimizing a radiation-based therapeutic treatment plan for the particular patient as a function of at least two different dimensions of movement as derived, at least in part, from the multi-dimensional information.
( [0004], [0014], [0049]: acquiring continuous three-dimensional MRI data sufficiently rapidly to capture and resolve intra-fraction organ motion; determining and updating a displacement from the continuous 3D images; and reoptimizing an IMRT treatment plan using the MRI motion information, including before each radiation delivery, beam-by-beam, or moment-by-moment. Dempsey’s three-dimensional displacement information necessarily represents movement in at least two spatial dimensions. )
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Sumanaweera’s motion-informed treatment-planning method to employ Dempsey’s three-dimensional, motion-responsive IMRT reoptimization because Dempsey teaches that continuously updating the treatment plan using 3D patient-motion images improves treatment-delivery accuracy. The combination would have predictably optimized Sumanaweera’s radiation-treatment plan using patient movement along at least two spatial dimensions.
Regarding claim 24, the rationale provided in the rejection of claim 12 is incorporated herein. In addition, the method of claim 12 corresponds to the apparatus of claim 24, and performs the steps disclosed herein. Therefore, the claim is rejected.
Conclusion
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KEN KUDO
Examiner
Art Unit 2671
/KEN KUDO/Examiner, Art Unit 2671
/VINCENT RUDOLPH/Supervisory Patent Examiner, Art Unit 2671
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