DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding independent claims 1, 10, and 15, the claim limitation “a gantry characterized by an annular rim in mechanical communication with an opposing pair of annular flanges collectively forming a radial cavity and forming a perimeter ring channel, to define a shield zone” is indefinite insofar as the examiner is unclear about the structure of “forming a perimeter ring channel, to define a shield zone” and it is impossible to determine the intending scope of the structure of “forming a perimeter ring channel, to define a shield zone” in claim 1. It is unclear if forming a perimeter ring channel is a specific shape or an abstract definition for some portion which is defining the shield zone. A perimeter ring is an abstract shape which can be defined by a variety of forms, the circumference of a cylinder, sphere, cone, or a non-regular continuous surfaces are all a perimeter ring. A channel can mean a specific shape and structure such as a concave cut-out in a medium which spans from one end to another. A channel can also mean an abstract medium which connects any two objects, such as a communication channel. Therefore, “a perimeter ring channel” could mean: (1) an abstract boundary condition which defines the area to be shielded, i.e. the cavity, or (2) a concave cut-out in the rim which houses the shield. Therefore, it is indefinite.
Claims 2-9, 11-14, and 16-20 are rejected on virtue of their dependency.
For the purpose of examination, forming a perimeter ring channel, to define a shield zone will be interpreted to mean, forming a cavity which is to be shielded.
Claim 7 recites the limitation "the primary collimator.” There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the primary collimator.” There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the primary collimator.” There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dempsey et al. US 2019/0168028.
Regarding claim 1, Dempsey teaches a fast neutron therapy system (figs. 3-4 and 7-9; para. 0023) comprising: a beam delivery subsystem comprising:
a beamline having a first portion (fig. 3 #304 portion prior to entering 312) configured in charged particle communication with a second portion (fig. 3 #304 portion after entering 312), wherein the first portion is characterized by an axled input configured to receive a plurality of particles (fig. 3 input from 302), and wherein the second portion is characterized by a slug converter comprising a primary collimator configured to radiate a plurality of neutrons from a neutron source carried by the slug converter (para. 0046 “attenuating medium” and para. 0052 “collimator”),
a plurality of quadrupoles distributed along the beamline and configured to focus the plurality of particles within the beamline as conveyed between the axled input and the slug converter (fig. 3 shows a series of unnumbered control elements for beamline 304. Quadrupoles are commonly known to be used to control charged beams and one of ordinary skill in the art would understand the control elements in figure 3 to be quadrupoles), and
at least one bend magnet distributed along the second portion and configured to direct the plurality of particles to collide with the neutron source to release the plurality of neutrons (fig. 3 #316; para. 0048); and a beam aiming subsystem comprising:
a gantry (#312) characterized by an annular rim (the cylindrical portions parallel to the patient which connect the flanged head and foot) in mechanical communication with an opposing pair of annular flanges (flanged portions of the head and foot of the gantry) collectively forming a radial cavity (cavity which houses patient) and forming a perimeter ring channel, to define a shield zone (see Claim Rejections - 35 USC §112; cavity), and
including an axially-oriented channel entry in one of the opposing pair of annular flanges (enter channel at the head flange in which beam 304 enters) proximate a radially-oriented slot void in the annular rim extending radially toward an axis of the annular rim of the gantry (slot in rim after bend 316 positioned near 320), and
a secondary collimator received by the radially-oriented slot void (para. 0052) and characterized by a barrel void extending radially toward the axis of the annular rim of the gantry and configured to contour the plurality of neutrons into a neutron beam (fig. 4; shield 420, dosimetry system 416 are all barrel shaped thus the void in the gantry to house such components, and thus the not-shown collimator, would also be barrel shaped);
wherein the shield zone is configured to encase the at least one bend magnet proximate the axially-oriented channel entry (see Claim Rejections - 35 USC §112; shield zone is interpreted to be everything inside the outer perimeter of the gantry) and to receive the slug converter through the radially-oriented slot void and proximate the secondary collimator (para. 0046 “attenuating medium” and para. 0052 “collimator”).
Dempsey fails to teach the first portion being wholly linear and the second portion being wholly curved. However, it has been judiciarily determined that changing in shapes has been obvious to one of ordinary skill in the art (MPEP 2144.04.IV.B). A change in shape is insufficient to establish patentability over the prior art of record unless it changes the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the change of shape is not of patentable significance.
Regarding claim 2, Dempsey teaches a drive configured to rotate the gantry to position the neutron beam at a delivery angle with respect to the axis (para. 0049, 0074); wherein the beam delivery subsystem is configured to define a conical rotation path along the linear portion from the axled input as the drive rotates the gantry to set the delivery angle over approximately 360 degrees about the axis (para. 0049, 0074).
Regarding claim 3, Dempsey teaches wherein the gantry further comprises a patient table positioned in the radial cavity substantially coaxial with the axis of the annular rim of the gantry (fig. 3 #314).
Regarding claim 4, Dempsey teaches wherein the gantry further comprises a platform formed in the annular rim facing radially inward toward the axis and configured for vertical standing support in the gantry at the delivery angle (fig. 3 the floor of the gantry).
Regarding claim 5, Dempsey does not specifically teach wherein the gantry is of a material type selected from the group consisting of prestressed concrete, steel, and hydrogenous material. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have wherein the gantry is of a material type selected from the group consisting of prestressed concrete, steel, and hydrogenous material since it was common knowledge in the art that prestressed concrete, steel, and hydrogenous material are the most common materials used for gantry construction.
Regarding claim 6, Dempsey does not explicitly disclose wherein a distance from the slug converter to the axis of the gantry is approximately 190 centimeters (cm). However, it is well known that the distance a beam travels is directly related to the dispersion of the beam. Therefore, it would have been obvious as a matter of routine optimization for one of ordinary skill in the art at the time of invention to have wherein a distance from the slug converter to the axis of the gantry is approximately 190 centimeters (cm) in order to optimize beam focus.
Regarding claim 7, Dempsey does not specifically teach wherein the primary collimator is of steel material type and the secondary collimator is of at least one of steel material type and hydrogenous material type. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have wherein the primary collimator is of steel material type and the secondary collimator is of at least one of steel material type and hydrogenous material type since it was common knowledge in the art that steel is one of the most common materials for metallic multi-leaf collimators, such as the one of Dempsey (para. 0052).
Regarding claim 8, wherein the neutron beam is of a high linear energy transfer (LET) type (para. 0031).
Regarding claim 9, Dempsey teaches wherein the neutron beam is of a magnitude range of 45 to 90 mega electron-volts (MeV) (para. 0029; <10MeV).
Regarding claim 10, Dempsey teaches a beam delivery subsystem for use with a fast neutron therapy system comprising a beam aiming subsystem comprising (figs. 3-4 and 7-9; para. 0023):
a gantry (#312) characterized by an annular rim (the cylindrical portions parallel to the patient which connect the flanged head and foot) in mechanical communication with an opposing pair of annular flanges (flanged portions of the head and foot of the gantry) collectively forming a radial cavity (cavity which houses patient) and forming a perimeter ring channel, to define a shield zone (see Claim Rejections - 35 USC §112; cavity),
a collimator assembly extending from the radially-oriented slot void of the gantry radially toward an axis of the annular rim of the gantry (para. 0043, 0052; a collimator assembly is interpreted to be the assembly which houses the secondary collimator and is implied in a collimator), and
a secondary collimator received by the radially-oriented slot void (para. 0052) and characterized by a barrel void extending radially toward the axis of the annular rim of the gantry and configured to contour the plurality of neutrons into a neutron beam (fig. 4; shield 420, dosimetry system 416 are all barrel shaped thus the void in the gantry to house such components, and thus the not-shown collimator, would also be barrel shaped); the beam delivery subsystem comprising:
a beamline having a first portion (fig. 3 #304 portion prior to entering 312) configured in charged particle communication with a second portion (fig. 3 #304 portion after entering 312), wherein the first portion is characterized by an axled input configured to receive a plurality of particles (fig. 3 input from 302), and wherein the second portion is characterized by a slug converter comprising a primary collimator configured to radiate a plurality of neutrons from a neutron source carried by the slug converter (para. 0046 “attenuating medium” and para. 0052 “collimator”),
a plurality of quadrupoles distributed along the beamline and configured to focus the plurality of particles within the beamline as conveyed between the axled input and the slug converter (fig. 3 shows a series of unnumbered control elements for beamline 304. Quadrupoles are commonly known to be used to control charged beams and one of ordinary skill in the art would understand the control elements in figure 3 to be quadrupoles),
at least one bend magnet distributed along the second portion and configured to direct the plurality of particles to collide with the neutron source to release the plurality of neutrons (fig. 3 #316; para. 0048);
wherein the at least one bend magnet is configured for positioning within the shield zone proximate the axially-oriented channel entry (fig. 3 #316);
wherein the slug converter is configured for positioning through the radially- oriented slot void and proximate the secondary collimator (fig. 3 slot near #320).
Dempsey fails to teach the first portion being wholly linear and the second portion being wholly curved. However, it has been judiciarily determined that changing in shapes has been obvious to one of ordinary skill in the art (MPEP 2144.04.IV.B). A change in shape is insufficient to establish patentability over the prior art of record unless it changes the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the change of shape is not of patentable significance.
Regarding claim 11, Dempsey teaches wherein secondary collimator are configured to contour the plurality of neutrons into a neutron beam (para. 0052); and further comprising a drive configured to rotate the gantry to position the neutron beam at a delivery angle with respect to the axis (para. 0049, 0074); wherein the beam delivery subsystem is configured to define a conical rotation path along the linear portion from the axled input as the gantry rotates to set the delivery angle over approximately 360 degrees about the axis (para. 0049, 0074).
Dempsey does not explicitly disclose a primary and secondary collimator working together; however, it has been judiciarily determined that duplication of parts has been obvious to one of ordinary skill in the art (MPEP 2144.04.IV.B). Duplication of parts is insufficient to establish patentability over the prior art of record unless it changes the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the duplication of parts is not of patentable significance.
Regarding claim 12, wherein the neutron beam is of a high linear energy transfer (LET) type (para. 0031).
Regarding claim 13, Dempsey teaches wherein the neutron beam is of a magnitude range of 45 to 90 mega electron-volts (MeV) (para. 0029; <10MeV).
Regarding claim 15, Dempsey teaches a beam aiming subsystem for use with a fast neutron therapy system comprising a beam delivery subsystem (figs. 3-4 and 7-9; para. 0023) comprising:
a beamline having a first portion (fig. 3 #304 portion prior to entering 312) configured in charged particle communication with a second portion (fig. 3 #304 portion after entering 312), wherein the first portion is characterized by an axled input configured to receive a plurality of particles (fig. 3 input from 302), and wherein the second portion is characterized by a slug converter comprising a primary collimator configured to radiate a plurality of neutrons from a neutron source carried by the slug converter (para. 0046 “attenuating medium” and para. 0052 “collimator”),
a plurality of quadrupoles distributed along the beamline and configured to focus the plurality of particles within the beamline as conveyed between the axled input and the slug converter (fig. 3 shows a series of unnumbered control elements for beamline 304. Quadrupoles are commonly known to be used to control charged beams and one of ordinary skill in the art would understand the control elements in figure 3 to be quadrupoles), and
at least one bend magnet distributed along the second portion and configured to direct the plurality of particles to collide with the neutron source to release the plurality of neutrons (fig. 3 #316; para. 0048); the beam aiming subsystem comprising:
a gantry (#312) characterized by an annular rim (the cylindrical portions parallel to the patient which connect the flanged head and foot) in mechanical communication with an opposing pair of annular flanges (flanged portions of the head and foot of the gantry) collectively forming a radial cavity (cavity which houses patient) and forming a perimeter ring channel, to define a shield zone (see Claim Rejections - 35 USC §112; cavity), and including an axially-oriented channel entry in one of the opposing pair of annular flanges (enter channel at the head flange in which beam 304 enters) proximate a radially-oriented slot void in the annular rim extending radially toward an axis of the annular rim of the gantry (slot in rim after bend 316 positioned near 320),
a collimator assembly extending from the radially-oriented slot void of the gantry radially toward an axis of the annular rim of the gantry (para. 0043, 0052; a collimator assembly is interpreted to be the assembly which houses the secondary collimator and is implied in a collimator), and
a secondary collimator received by the radially-oriented slot void (para. 0052) and characterized by a barrel void extending radially toward the axis of the annular rim of the gantry and configured to contour the plurality of neutrons into a neutron beam (fig. 4; shield 420, dosimetry system 416 are all barrel shaped thus the void in the gantry to house such components, and thus the not-shown collimator, would also be barrel shaped);
wherein the at least one bend magnet is configured for positioning within the shield zone proximate the axially-oriented channel entry (fig. 3 #316);
wherein the slug converter is configured for positioning through the radially- oriented slot void and proximate the secondary collimator (fig. 3 slot near #320); and
wherein the gantry is configured to rotate the beam delivery subsystem to define a conical rotation path along the linear portion from the axled input and to set a delivery angle with respect to the axis (para. 0049, 0074).
Dempsey fails to teach the first portion being wholly linear and the second portion being wholly curved. However, it has been judiciarily determined that changing in shapes has been obvious to one of ordinary skill in the art (MPEP 2144.04.IV.B). A change in shape is insufficient to establish patentability over the prior art of record unless it changes the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the change of shape is not of patentable significance.
Regarding claim 16, Dempsey teaches wherein the gantry further comprises a patient table positioned in the radial cavity substantially coaxial with the axis of the annular rim of the gantry (fig. 3 #314).
Regarding claim 17, Dempsey teaches wherein the gantry further comprises a platform formed in the annular rim facing radially inward toward the axis and configured for vertical standing support in the gantry at the delivery angle (fig. 3 the floor of the gantry).
Regarding claim 18, Dempsey does not specifically teach wherein the gantry is of a material type selected from the group consisting of prestressed concrete and steel. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have wherein the gantry is of a material type selected from the group consisting of prestressed concrete and steel since it was common knowledge in the art that prestressed concrete and steel are the most common materials used for gantry construction.
Regarding claim 19, Dempsey does not specifically teach wherein the primary collimator is of steel material type and the secondary collimator is of at least one of steel material type and hydrogenous material type. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have wherein the primary collimator is of steel material type and the secondary collimator is of at least one of steel material type and hydrogenous material type since it was common knowledge in the art that steel is one of the most common materials for metallic multi-leaf collimators, such as the one of Dempsey (para. 0052).
Regarding claim 20, Dempsey teaches a drive configured to rotate the gantry to position the neutron beam at the delivery angle (para. 0049, 0074).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dempsey et al. US 2019/0168028 in view of Ota et al. US 2025/0059680.
Regarding claim 14, Dempsey fails to disclose any information regarding the composition of the neutron source, including wherein the neutron source comprises beryllium.
Ota teaches a type of neutron generating material comprising beryllium which prevents generation of blistering (para. 0008-0010).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein the neutron source comprises beryllium as taught by Ota in the system of Dempsey for the purpose of preventing the generation of blistering.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard Toohey whose telephone number is (703)756-5818. The examiner can normally be reached Mon-Fri: 7:30am – 5pm.
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/RICHARD O TOOHEY/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
