SYSTEMS AND METHODS FOR AUTOMATIC NORMAL TISSUE OBJECTIVES IN STEREOTACTIC BODY RADIOTHERAPY

Application No. 18/129,364

• Filed: Mar 31, 2023
• Examiner: LEE, SHUN K
• Art Unit: 2884
• Tech Center: 2800 — Semiconductors & Electrical Systems
• Assignee: Siemens Healthineers International AG
• OA Round: 1 (Non-Final)

Office Action

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 .
Information Disclosure Statement
The information disclosure statement filed on 23 August 2024 does not fully comply with the requirements of 37 CFR 1.98 because: it lacks a legible copy of each foreign patent and each publication or that portion which caused it to be listed (e.g., foreign patent cite no. A4). Since the submission appears to be bona fide, applicant is given ONE (1) MONTH from the date of this notice to supply the above mentioned omissions or corrections in the information disclosure statement. NO EXTENSION OF THIS TIME LIMIT MAY BE GRANTED UNDER EITHER 37 CFR 1.136(a) OR (b). Failure to timely comply with this notice will result in the above mentioned information disclosure statement being placed in the application file with the noncomplying information not being considered. See 37 CFR 1.97(i).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 124. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 4, 9, 15, 17, and 18 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation “the first and second virtual shell structures”. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the second radiation dose level” the last line. There is insufficient antecedent basis for this limitation in the claim.
Claim(s) 15, 17, and 18 is/are dependent on itself. Therefore, the claims are incomplete and fail to particularly point out and distinctly claim the subject matter.
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 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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
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.
Claim(s) 1, 4-9, 11, 14-18, and 20 is/are rejected under U.S.C. 102(a)(1) as being anticipated by Nordström et al. (US 2019/0255354).
In regard to claim 1, Nordström et al. disclose a method of radiation treatment planning comprising:
(a) determining, by one or more processors (e.g., “… steps of the methods according to the present invention, as well as preferred embodiments thereof, are suitable to realize as computer program or as a computer readable medium …” in paragraph 49), a first shell structure defined around a planning target volume (PTV) and having a first thickness (e.g., see “… targets T1 … inner … set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by S1T1 …” in Fig. 7 and paragraph 87);
(b) determining, by the one or more processors, a second shell structure defined around the first shell structure and having a second thickness (e.g., see “… outer set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S2T1 …” in Fig. 7 and paragraph 87);
(c) generating, by the one or more processors, a first objective term of an objective function for optimizing a radiotherapy treatment plan, the first objective term penalizing radiation dose values in the first shell structure exceeding a first dose level specific to the first shell structure (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … second term penalizes overdosing of the inner shell …” in paragraphs 73 and 75);
(d) generating, by the one or more processors, a second objective term of the objective function, the second objective term penalizing radiation dose values in the second shell structure exceeding a second dose level of the PTV specific to the second shell structure, the second dose level smaller than the first dose level (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

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i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … third term penalizes dose in the outer shell that exceeds DT/2 …” in paragraphs 73 and 75);
(e) generating, by the one or more processors, a third objective term of the objective function, the third objective term penalizing radiation dose values in a region (e.g., see “… a fixed low dose ring, R as shown in FIG. 7, of voxels can be created in the volume surrounding at least one target (T1 …” in Fig. 7 and paragraph 90), different from the first and second shell structures, deviating from a predefined dose distribution (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … Dad is the dose at which adverse effects are significant … such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem … it may be in the following form:

w

l
r

N

r

*

D

a
d

∑

i
=
l

N

l
r

m
a
x

ϕ
x

i

-

D

a
d

,
0

where the sum runs over voxels in the low dose ring and wtr is the optimization weight …” in paragraphs 73 and 90); and
(f) optimizing, by the one or more processors, the objective function to determine the radiotherapy treatment plan (e.g., “… This ring is treated in the same way as the outer ring(s) in the optimization …” in paragraph 90).
In regard to claim 4 which is dependent on claim 1 in so far as understood, Nordström et al. also disclose that the region different from the first and second shell structures includes a normal tissue region outside a third shell structure defined around the PTV (e.g., “… direction and shape of the radiation beam should be accurately controlled to ensure that the tumour receives the prescribed radiation dose, and the radiation from the beam should minimize damage to the surrounding healthy tissue, often called the organ(s) at risk (OARs). Treatment planning can be used to control radiation beam parameters, and a radiotherapy device effectuates a treatment by delivering a spatially varying dose distribution to the patient … clinical evidence suggesting an increased risk of radionecrosis if the volume receiving more than 10 Gy exceeds 13 cc, but the user could specify other values. According to the present invention, such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem …” in paragraphs 18 and 90).
In regard to claim 5 which is dependent on claim 1, Nordström et al. also disclose that the third objective term penalizes the radiation dose values in the region different from the first and second shell structures exceeding a parameter of the predefined dose distribution (e.g., “… clinical evidence suggesting an increased risk of radionecrosis if the volume receiving more than 10 Gy exceeds 13 cc, but the user could specify other values. According to the present invention, such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem …” in paragraph 90).
In regard to claim 6 which is dependent on claim 5, Nordström et al. also disclose that the parameter of the predefined distribution includes: a mean of the predefined distribution; or a specific parameter of the predefined distribution (e.g., “… clinical evidence suggesting an increased risk of radionecrosis if the volume receiving more than 10 Gy exceeds 13 cc, but the user could specify other values. According to the present invention, such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem …” in paragraph 90).
In regard to claim 7 which is dependent on claim 1, Nordström et al. also disclose that the PTV is a first PTV and the method further comprising: determining, by the one or more processors, a third shell structure defined around a second PTV and having a third thickness; determining, by the one or more processors (e.g., see “… targets … T2 … inner … set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S1T2 …” in Fig. 7 and paragraph 87), a fourth shell structure defined around the third shell structure and having a fourth thickness (e.g., see “… outer set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S2T2 …” in Fig. 7 and paragraph 87); generating, by the one or more processors, a fourth objective term of the objective function, the fourth objective term penalizing radiation dose values in the third shell structure exceeding a third radiation dose level specific to the third shell structure (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … second term penalizes overdosing of the inner shell …” in paragraphs 73 and 75); and generating, by the one or more processors, a fifth objective term of the objective function, the fifth objective term penalizing radiation dose values in the fourth shell structure exceeding a fourth radiation dose level specific to the fourth shell structure, the fourth radiation dose level smaller than the third radiation dose level (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … third term penalizes dose in the outer shell that exceeds DT/2 …” in paragraphs 73 and 75).
In regard to claim 8 which is dependent on claim 7, the cited prior art is applied as in claim 7 above. Nordström et al. also disclose that the region includes a region outside a fifth shell structure defined around the first PTV (e.g., see a first voxel subset in a region around target T1 in Fig. 7 that can be labeled as a fifth shell structure) and outside a sixth shell structure defined around the second PTV (e.g., see a second voxel subset in a region around target T2 in Fig. 7 that can be labeled as a sixth shell structure), and the third objective term penalizes radiation dose values in the region deviating from the predefined dose distribution (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … Dad is the dose at which adverse effects are significant … such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem … it may be in the following form:

w

l
r

N

r

*

D

a
d

∑

i
=
l

N

l
r

m
a
x

ϕ
x

i

-

D

a
d

,
0

where the sum runs over voxels in the low dose ring and wtr is the optimization weight …” in paragraphs 73 and 90), and wherein the predefined dose distribution over the first voxel subset can be labeled as a first dose distribution, wherein the predefined dose distribution over the second voxel subset can be labeled as a second dose distribution.
In regard to claim 9 which is dependent on claim 7 in so far as understood, the cited prior art is applied as in claim 7 above. Nordström et al. also disclose that at least the second shell structure and the fourth shell structure are overlapping (e.g., see an overlapping region of S2T1 and S2T2 in Fig. 7) and the method further comprising: determining, by the one or more processors, an overlapping region of the second and fourth shell structures; penalizing, by the one or more processors, radiation dose values in the overlapping region exceeding a maximum of the second radiation dose level and the fourth radiation dose level (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … DT is the prescription dose … third term penalizes dose in the outer shell that exceeds DT/2 …” in paragraphs 73 and 78).
In regard to claim 11, Nordström et al. disclose a radiation treatment planning system comprising: one or more processors; and a memory to store computer code instructions (e.g., “… steps of the methods according to the present invention, as well as preferred embodiments thereof, are suitable to realize as computer program or as a computer readable medium …” in paragraph 49 and a computer readable medium can be labeled as a memory to store computer code instructions), the computer code instructions when executed cause the one or more processors to:
(a) determine a first shell structure defined around a planning target volume (PTV) and having a first thickness (e.g., see “… targets T1 … inner … set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by S1T1 …” in Fig. 7 and paragraph 87);
(b) determine a second shell structure defined around the first shell structure and having a second thickness (e.g., see “… outer set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S2T1 …” in Fig. 7 and paragraph 87);
(c) generate a first objective term of an objective function for optimizing a radiotherapy treatment plan, the first objective term penalizing radiation dose values in the first shell structure exceeding a first radiation dose level specific to the first shell structure (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … second term penalizes overdosing of the inner shell …” in paragraphs 73 and 75);
(d) generate a second objective term of the objective function, the second objective term penalizing radiation dose values in the second shell structure exceeding a second radiation dose level specific to the second shell structure, the second radiation dose level smaller than the first radiation dose level (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … third term penalizes dose in the outer shell that exceeds DT/2 …” in paragraphs 73 and 75);
(e) generate a third objective term of the objective function, the third objective term penalizing radiation dose values in a region (e.g., see “… a fixed low dose ring, R as shown in FIG. 7, of voxels can be created in the volume surrounding at least one target (T1 …” in Fig. 7 and paragraph 90), different from the first and second shell structures, deviating from a predefined dose distribution (e.g., see “… a fixed low dose ring, R as shown in FIG. 7, of voxels can be created in the volume surrounding at least one target (T1 …” in Fig. 7 and paragraph 90), different from the first and second shell structures, deviating from a predefined dose distribution (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … Dad is the dose at which adverse effects are significant … such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem … it may be in the following form:

w

l
r

N

r

*

D

a
d

∑

i
=
l

N

l
r

m
a
x

ϕ
x

i

-

D

a
d

,
0

where the sum runs over voxels in the low dose ring and wtr is the optimization weight …” in paragraphs 73 and 90); and
(f) optimize the objective function to determine the radiotherapy treatment plan (e.g., “… This ring is treated in the same way as the outer ring(s) in the optimization …” in paragraph 90).
In regard to claim 14 which is dependent on claim 11, Nordström et al. also disclose that the third objective term penalizes the radiation dose values in the region different from the first and second shell structures exceeding a parameter of the predefined dose distribution (e.g., “… clinical evidence suggesting an increased risk of radionecrosis if the volume receiving more than 10 Gy exceeds 13 cc, but the user could specify other values. According to the present invention, such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem …” in paragraph 90).
In regard to dependent claim 15 in so far as understood, Nordström et al. also disclose that the parameter of the predefined distribution includes: a mean of the predefined distribution; or a specific parameter of the predefined distribution (e.g., “… clinical evidence suggesting an increased risk of radionecrosis if the volume receiving more than 10 Gy exceeds 13 cc, but the user could specify other values. According to the present invention, such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem …” in paragraph 90).
In regard to claim 16 which is dependent on claim 11, Nordström et al. also disclose that the PTV is a first PTV and wherein the one or more processors are further configured to: determine a third shell structure defined around a second PTV and having a third thickness (e.g., see “… targets … T2 … inner … set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S1T2 …” in Fig. 7 and paragraph 87); determine a fourth shell structure defined around the third shell structure and having a fourth thickness (e.g., see “… outer set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S2T2 …” in Fig. 7 and paragraph 87); generate a fourth objective term of the objective function to penalize radiation dose values in the third shell structure exceeding a third radiation dose level specific to the third shell structure (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … second term penalizes overdosing of the inner shell …” in paragraphs 73 and 75); and generate a fifth objective term of the objective function, the fifth objective term penalizing radiation dose values in the fourth shell structure exceeding a fourth radiation dose level specific to the fourth shell structure, the fourth radiation dose level smaller than the third radiation dose level (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … third term penalizes dose in the outer shell that exceeds DT/2 …” in paragraphs 73 and 75).
In regard to dependent claim 17 in so far as understood, the cited prior art is applied as in claim 16 above. Nordström et al. also disclose that the region includes a region outside a fifth shell structure defined around the first PTV (e.g., see a first voxel subset in a region around target T1 in Fig. 7 that can be labeled as a fifth shell structure) and outside a sixth shell structure defined around the second PTV(e.g., see a second voxel subset in a region around target T2 in Fig. 7 that can be labeled as a sixth shell structure), wherein the predefined dose distribution over the first voxel subset can be labeled as a first dose distribution, wherein the predefined dose distribution over the second voxel subset can be labeled as a second dose distribution.
In regard to dependent claim 18 in so far as understood, the cited prior art is applied as in claim 16 above. Nordström et al. also disclose that the PTV is a first PTV and wherein the third objective term penalizes radiation dose values in the region deviating from the predefined dose distribution (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … Dad is the dose at which adverse effects are significant … such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem … it may be in the following form:

w

l
r

N

r

*

D

a
d

∑

i
=
l

N

l
r

m
a
x

ϕ
x

i

-

D

a
d

,
0

where the sum runs over voxels in the low dose ring and wtr is the optimization weight …” in paragraphs 73 and 90).
In regard to claim 20, Nordström et al. disclose a non-transitory computer-readable medium including computer code instructions stored thereon (e.g., “… steps of the methods according to the present invention, as well as preferred embodiments thereof, are suitable to realize as computer program or as a computer readable medium …” in paragraph 49), the computer code instructions when executed cause one or more processors to:
(a) determine a first shell structure defined around a planning target volume (PTV) and having a first thickness (e.g., see “… targets T1 … inner … set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by S1T1 …” in Fig. 7 and paragraph 87);
(b) determine a second shell structure defined around the first shell structure and having a second thickness (e.g., see “… outer set of voxels, called rings below but since the targets are three­dimensional they are shells in reality, are denoted by … S2T1 …” in Fig. 7 and paragraph 87);
(c) generate a first objective term of an objective function for optimizing a radiotherapy treatment plan, the first objective term penalizing radiation dose values in the first shell structure exceeding a first radiation dose level specific to the first shell structure (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … second term penalizes overdosing of the inner shell …” in paragraphs 73 and 75);
(d) generate a second objective term of the objective function, the second objective term penalizing radiation dose values in the second shell structure exceeding a second radiation dose level specific to the first shell structure, the second radiation dose level smaller than the first radiation dose level (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … third term penalizes dose in the outer shell that exceeds DT/2 …” in paragraphs 73 and 75);
(e) generate a third objective term of the objective function, the third objective term penalizing radiation dose values in a region (e.g., see “… a fixed low dose ring, R as shown in FIG. 7, of voxels can be created in the volume surrounding at least one target (T1 …” in Fig. 7 and paragraph 90), different from the first and second shell structures, deviating from a predefined dose distribution (e.g., see “… a fixed low dose ring, R as shown in FIG. 7, of voxels can be created in the volume surrounding at least one target (T1 …” in Fig. 7 and paragraph 90), different from the first and second shell structures, deviating from a predefined dose distribution (e.g., “… may be given by:

1

M

∑

j
=
1

M

1

D

r

N

j

∑

i
=
1

N

j

w

i
j

m
a
x

φ

j

x

i

-
D

r

,
0

where x is the irradiation times for each isocenter, sector, and collimator setting, φj is the dose rate matrix for voxels at distance rj, D(r) is a function describing the desired dose as a function of the distance from the target surface, Nj is the number of voxels at distance r is the vector of all target distances and wij is a scalar weight, which in embodiments can be varied voxel-by-voxel … Dad is the dose at which adverse effects are significant … such adverse effects can be significantly reduced or eliminated by introducing a penalty term in the optimization problem … it may be in the following form:

w

l
r

N

r

*

D

a
d

∑

i
=
l

N

l
r

m
a
x

ϕ
x

i

-

D

a
d

,
0

where the sum runs over voxels in the low dose ring and wtr is the optimization weight …” in paragraphs 73 and 90); and
(f) optimize the objective function to determine the radiotherapy treatment plan (e.g., “… This ring is treated in the same way as the outer ring(s) in the optimization …” in paragraph 90).
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 of this title, 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) 2, 3, 12, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nordström et al. (US 2019/0255354) in view of Ollila et al. (US 2018/0078792).
In regard to claim 2 which is dependent on claim 1, while Nordström et al. also disclose (paragraph 72) that “… shells are illustrated as having a uniform thickness measured in number of voxels or in distance, for example, in mm between inner and outer boundary or surface but the inner and outer set of voxels may instead have a non-uniform thickness measured in voxels or in distance, for example, in mm between inner and outer boundary or surface …”, the method of Nordström et al. lacks an explicit description of details of the “… thickness …” such as the second thickness is greater than the first thickness. However, “… thickness …” details are known to one of ordinary skill in the art (e.g., see “… dose distribution may be substantially homogeneous within the target volume 610 at a dose level slightly higher than the prescribed minimum dose value, and falls off to about 100% of the prescribed minimum dose value in the region 620 immediately outside the target volume, and falls off to about 60% of the prescribed minimum dose value at the outer boundary of the virtual ring 630 of healthy tissue. The thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610 …” in Fig. 6 and paragraph 45 of Ollila et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional thickness (e.g., comprising details such as “thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610”, in order to achieve a desired “dose distribution”) for the unspecified thickness of Nordström et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional thickness (e.g., comprising details such as the second thickness is greater than the first thickness) as the unspecified thickness of Nordström et al.
In regard to claim 3 which is dependent on claim 1, while Nordström et al. also disclose (paragraph 72) that “… shells are illustrated as having a uniform thickness measured in number of voxels or in distance, for example, in mm between inner and outer boundary or surface but the inner and outer set of voxels may instead have a non-uniform thickness measured in voxels or in distance, for example, in mm between inner and outer boundary or surface …”, the method of Nordström et al. lacks an explicit description of details of the “… thickness …” such as at least one of the following applies: the first thickness is equal to about 3 millimeters; or the second thickness is equal to about 1.7 centimeters. However, “… thickness …” details are known to one of ordinary skill in the art (e.g., see “… dose distribution may be substantially homogeneous within the target volume 610 at a dose level slightly higher than the prescribed minimum dose value, and falls off to about 100% of the prescribed minimum dose value in the region 620 immediately outside the target volume, and falls off to about 60% of the prescribed minimum dose value at the outer boundary of the virtual ring 630 of healthy tissue. The thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610 …” in Fig. 6 and paragraph 45 of Ollila et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional thickness (e.g., comprising details such as “thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610”, in order to achieve a desired “dose distribution”) for the unspecified thickness of Nordström et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional thickness (e.g., comprising details such as at least one of the following applies: the first thickness is equal to about 3 millimeters; or the second thickness is equal to about 1.7 centimeters) as the unspecified thickness of Nordström et al.
In regard to claim 12 which is dependent on claim 11, while Nordström et al. also disclose (paragraph 72) that “… shells are illustrated as having a uniform thickness measured in number of voxels or in distance, for example, in mm between inner and outer boundary or surface but the inner and outer set of voxels may instead have a non-uniform thickness measured in voxels or in distance, for example, in mm between inner and outer boundary or surface …”, the system of Nordström et al. lacks an explicit description of details of the “… thickness …” such as the second thickness is greater than the first thickness. However, “… thickness …” details are known to one of ordinary skill in the art (e.g., see “… dose distribution may be substantially homogeneous within the target volume 610 at a dose level slightly higher than the prescribed minimum dose value, and falls off to about 100% of the prescribed minimum dose value in the region 620 immediately outside the target volume, and falls off to about 60% of the prescribed minimum dose value at the outer boundary of the virtual ring 630 of healthy tissue. The thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610 …” in Fig. 6 and paragraph 45 of Ollila et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional thickness (e.g., comprising details such as “thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610”, in order to achieve a desired “dose distribution”) for the unspecified thickness of Nordström et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional thickness (e.g., comprising details such as the second thickness is greater than the first thickness) as the unspecified thickness of Nordström et al.
In regard to claim 13 which is dependent on claim 11, while Nordström et al. also disclose (paragraph 72) that “… shells are illustrated as having a uniform thickness measured in number of voxels or in distance, for example, in mm between inner and outer boundary or surface but the inner and outer set of voxels may instead have a non-uniform thickness measured in voxels or in distance, for example, in mm between inner and outer boundary or surface …”, the system of Nordström et al. lacks an explicit description of details of the “… thickness …” such as at least one of the following applies: the first thickness is equal to about 3 millimeters; or the second thickness is equal to about 1.7 centimeters. However, “… thickness …” details are known to one of ordinary skill in the art (e.g., see “… dose distribution may be substantially homogeneous within the target volume 610 at a dose level slightly higher than the prescribed minimum dose value, and falls off to about 100% of the prescribed minimum dose value in the region 620 immediately outside the target volume, and falls off to about 60% of the prescribed minimum dose value at the outer boundary of the virtual ring 630 of healthy tissue. The thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610 …” in Fig. 6 and paragraph 45 of Ollila et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional thickness (e.g., comprising details such as “thinner the virtual ring 630, the steeper the dose gradient outside the target volume 610”, in order to achieve a desired “dose distribution”) for the unspecified thickness of Nordström et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional thickness (e.g., comprising details such as at least one of the following applies: the first thickness is equal to about 3 millimeters; or the second thickness is equal to about 1.7 centimeters) as the unspecified thickness of Nordström et al.
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nordström et al. (US 2019/0255354) in view of Nordström et al. (US 2019/0255355).
In regard to claim 10 which is dependent on claim 1, while Nordström et al. also disclose (paragraphs 88 and 89) that “… set of voxels, with volume equal to V ad, depends on the dose distribution and will change during the optimization, leading to a non­convex optimization problem which is in general difficult to solve. To achieve a convex formulation it is therefore necessary to have a fixed geometry in which dose is penalized. According to the present invention, a volume filling procedure or fill algorithm is applied … One example of a suitable fill algorithm is described in a co-pending, not yet published, patent application by the same applicant …”, the method of Nordström et al. lacks an explicit description of details of the “… fill algorithm is described in a co-pending, not yet published, patent application by the same applicant …” such as the objective function is optimized iteratively, and wherein generating the third objective term of the objective function includes, at each iteration: calculating radiation dose values within the region different from the first and second shell structures; and calculating a metric of the predefined dose distribution using the radiation dose values within the region different from the first and second shell structures, the metric of the predefined dose distribution used to determine which radiation dose values to be penalized. However, “… thickness …” details are known to one of ordinary skill in the art (e.g., see “… a first estimate of the low dose volume is determined in step 620 … penalizing voxels with dose exceeding a threshold dose, Dir … in step 650, it determined whether the iterative process is finished or not. For example, after a predetermined number of iterations. If yes, a final treatment plan optimization can be performed using the low dose volume in step 680. If no, the procedure 600 proceeds to step 660, where, based on the optimized dose distribution in the preceding optimization step, an updated low dose volume is defined as the volume between two dose levels, possibly the same as in step 620. The term in the objective function is modified accordingly in step 670 …” in Fig. 6 and US 2019/0255355 paragraphs 89, 90, and 93 of Nordström et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional fill algorithm (e.g., comprising details such as “objective function is modified” by an “iterative process”, in order to achieve an “optimized” “low dose volume”) for the unspecified fill algorithm of Nordström et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional fill algorithm (e.g., comprising details such as the objective function is optimized iteratively, and wherein generating the third objective term of the objective function includes, at each iteration: calculating radiation dose values within the region different from the first and second shell structures; and calculating a metric of the predefined dose distribution using the radiation dose values within the region different from the first and second shell structures, the metric of the predefined dose distribution used to determine which radiation dose values to be penalized) as the unspecified fill algorithm of Nordström et al.
In regard to claim 19 which is dependent on claim 11, while Nordström et al. also disclose (paragraphs 88 and 89) that “… set of voxels, with volume equal to V ad, depends on the dose distribution and will change during the optimization, leading to a non­convex optimization problem which is in general difficult to solve. To achieve a convex formulation it is therefore necessary to have a fixed geometry in which dose is penalized. According to the present invention, a volume filling procedure or fill algorithm is applied … One example of a suitable fill algorithm is described in a co-pending, not yet published, patent application by the same applicant …”, the system of Nordström et al. lacks an explicit description of details of the “… fill algorithm is described in a co-pending, not yet published, patent application by the same applicant …” such as the objective function is optimized iteratively, and wherein in generating the third objective term of the objective function the one or more processors are configured to, at each iteration: calculate radiation dose values within the region different from the first and second shell structures; and calculate a metric of the predefined dose distribution using the radiation dose values within the region different from the first and second shell structures, the metric of the predefined dose distribution used to determine which radiation dose values to be penalized. However, “… thickness …” details are known to one of ordinary skill in the art (e.g., see “… a first estimate of the low dose volume is determined in step 620 … penalizing voxels with dose exceeding a threshold dose, Dir … in step 650, it determined whether the iterative process is finished or not. For example, after a predetermined number of iterations. If yes, a final treatment plan optimization can be performed using the low dose volume in step 680. If no, the procedure 600 proceeds to step 660, where, based on the optimized dose distribution in the preceding optimization step, an updated low dose volume is defined as the volume between two dose levels, possibly the same as in step 620. The term in the objective function is modified accordingly in step 670 …” in Fig. 6 and US 2019/0255355 paragraphs 89, 90, and 93 of Nordström et al.). It should be noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable results”. KSR International Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 (2007) at 1395 (citing United States v. Adams, 383 U.S. 39, 40 [148 USPQ 479] (1966)). See MPEP § 2143. In this case, one of ordinary skill in the art could have substituted a known conventional fill algorithm (e.g., comprising details such as “objective function is modified” by an “iterative process”, in order to achieve an “optimized” “low dose volume”) for the unspecified fill algorithm of Nordström et al. and the results of the substitution would have been predictable. Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a known conventional fill algorithm (e.g., comprising details such as the objective function is optimized iteratively, and wherein in generating the third objective term of the objective function the one or more processors are configured to, at each iteration: calculate radiation dose values within the region different from the first and second shell structures; and calculate a metric of the predefined dose distribution using the radiation dose values within the region different from the first and second shell structures, the metric of the predefined dose distribution used to determine which radiation dose values to be penalized) as the unspecified fill algorithm of Nordström et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0154177 teaches a radiation therapy planning system.
US 2019/0388708 teaches a radiation therapy planning system.
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/SL/
Examiner, Art Unit 2884

/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884

Prosecution Timeline

• Mar 31, 2023: Application Filed
• Mar 10, 2026: Non-Final Rejection — §102, §103, §112 (current)