DETAILED ACTION
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 32 and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 recites the limitation "…of the at least part of gantry." (emphasis added) in the third line of the claim. There is insufficient antecedent basis for this limitation in the claim. In this action, it will be assumed the limitation “at least part of gantry” refers to the limitation “at least part of the beamline structure”.
Dependent claim 33 does not cure the deficiencies of claim 32 and is rejected for the same reasons.
Claim Rejections - 35 USC § 102
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 1-11, 14-21, and 26-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamashita et al. (US Pat. 7,372,053, provided in IDS filed 10/24/2024, hereinafter Yamashita).
Regarding claim 1, Yamashita discloses a system (a rotating gantry, see abstract) comprising:
a gantry comprising a beamline structure configured to direct a particle beam from an output of a particle accelerator toward an irradiation target at a treatment position (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67; ions (e.g. protons or carbon ions) generated in the ion source are accelerated by the pre-stage accelerator 7 (e.g. linear accelerator), see col. 4, lines 1-5; through the beam transport 11 to the irradiation device 4 of the patient 14, see col. 4, lines 13-24), the beamline structure comprising magnetic bending elements to bend the particle beam along at least part of a length of the beamline structure (synchrotron 8 comprises magnetic bending elements, see Fig. 1 and col. 4, lines 1-3); and
a mount on which at least part of the beamline structure is held, the mount being configured to enable translational movement of the at least part of the beamline structure relative to the irradiation target (irradiation device 4 mounted to a gantry barrel 18, see Fig. 1-2 and col. 4, lines 13-24; irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54; or couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 2, Yamashita discloses the translational movement comprises movement along a longitudinal dimension of the gantry (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54; or couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 3, Yamashita discloses the translational movement comprises movement toward or away from the particle accelerator (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54; or couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 4, Yamashita discloses the particle accelerator (ions (e.g. protons or carbon ions) generated in the ion source are accelerated by the pre-stage accelerator 7 (e.g. linear accelerator), see col. 4, lines 1-5);
wherein the mount is configured to enable movement of the particle accelerator along with the at least part of the beamline structure (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67).
Regarding claim 5, Yamashita discloses the mount is configured to enable movement of an entirety of the beamline structure relative to the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3 around the patient 14, see Fig. 1 and col. 3, lines 62-67).
Regarding claim 6, Yamashita discloses the mount is configured to enable movement of the entirety of the beamline structure along a longitudinal dimension of the gantry (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54; or couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 7, Yamashita discloses the mount is configured to enable movement of the entirety the beamline structure toward or away from the particle accelerator along at least part of a beamline of the particle beam (particle beam therapy system 1 comprises a rotating gantry 3 around the patient 14, see Fig. 1 and col. 3, lines 62-67).
Regarding claim 8, Yamashita discloses the translational movement causes at least part of the beamline structure to move away from the particle accelerator and to produce an air gap between the at least part of the beamline structure and the particle accelerator, the particle beam to traverse the air gap from the particle accelerator to the at least part of the beamline structure (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54).
Regarding claim 9, Yamashita discloses the at least part of the beamline structure is a first part of the beamline structure, the beamline structure comprising the first part and a second part of the beamline structure (ions (e.g. protons or carbon ions) generated in the ion source are accelerated by the pre-stage accelerator 7 (e.g. linear accelerator), see col. 4, lines 1-5; through the beam transport 11 to the irradiation device 4 of the patient 14, see col. 4, lines 13-24); and
wherein the translational movement causes the first part to move away from the second part and to produce an air gap between the first part and the second part, the particle beam to traverse the air gap from the second part to the first part (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54).
Regarding claim 10, Yamashita discloses the second part is attached to the particle accelerator and is not movable relative to the particle accelerator (ion beam generator 2 includes synchrotron 8 comprises magnetic bending elements, see Fig. 1 and col. 4, lines 1-3).
Regarding claim 11, Yamashita discloses the at least part of the beamline structure comprises an output channel (irradiation device 4, see Fig. 1), the output channel comprising magnetic dipoles arranged in series to bend the particle beam by at least 90 degrees (irradiation device 4 and inverted U shaped beam transport 11, see col. 4, lines 13-19);
wherein the gantry comprises a ring structure on which the output channel is mounted for rotation around the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
wherein the translational movement is parallel to axis of rotation about which the output channel rotates on the ring structure (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54).
Regarding claim 14, Yamashita discloses an imaging system that is movable relative to the irradiation target (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54);
a control system to control the mount or the at least part of the gantry to move the at least part of the beamline structure away from a location proximate to the irradiation target, and to control movement of the imaging system toward the location (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54);
wherein a couch holding the irradiation target is configured to remain stationary during movement of the imaging system and during movement of the mount or the at least part of the beamline structure (movement of couch 13 is controlled by the switch 33 operated by a medical engineer 34, see col. 4 and col. 5, lines 31-58).
Regarding claim 15, Yamashita discloses the mount is a first mount and the system comprises a second mount configured to enable rotational movement of the imaging system relative to the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
wherein the control system is configured to control movement of the imaging system by controlling translational movement of the second mount (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54).
Regarding claim 16, Yamashita discloses the imaging system is rotatable around an axis of rotation defined by the second mount (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
wherein the translational movement of the second mount is parallel to the axis of rotation (couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 17, Yamashita discloses the control system is configured to control movement of the imaging system away from the location and to control the mount or the at least part of the beamline structure to move the at least part of the beamline structure toward the location (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54); and
wherein the couch holding the irradiation target is configured to remain stationary during movement of the imaging system and during movement of the mount or the at least part of the beamline structure (movement of couch 13 is controlled by the switch 33 operated by a medical engineer 34, see col. 4 and col. 5, lines 31-58).
Regarding claim 18, Yamashita discloses the mount is a first mount and the system comprises a second mount configured to enable rotational movement of the imaging system relative to the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
wherein the control system is configured to control movement of the imaging system by controlling translational movement of the second mount (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54).
Regarding claim 19, Yamashita discloses the imaging system is rotatable around an axis of rotation defined by the second mount (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
wherein the translational movement of the second mount is parallel to the axis of rotation (couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 20, Yamashita discloses the mount comprises one or more rails, the one or more rails being moveable or the at least part of the beamline structure being movable along the one or more rails (snout 4a is extendable toward or contractible away from the patient 14, see Fig. 4 and col. 5, lines 47-51).
Regarding claim 21, Yamashita discloses the mount comprises one or more rollers or wheels connected to the at least part of the beamline structure (gantry rotating motors 30 are connected respectively to two of the eight support rollers 22 for rotating the gantry 3, see Fig. 3 and col. 4-5, lines 64-11).
Regarding claim 26, Yamashia discloses a method implemented on a particle therapy system (a rotating gantry of a particle beam therapy system, see Fig. 1 and col. 1, lines 7-10), the method comprising:
receiving data representing a size of a target beam field (the irradiation device is rotated around the patient body with rotation of the rotating gantry, thus enabling the ion beam to be irradiated to the affected part in accordance with the irradiation angle decided in a treatment plan, see col. 1, lines 24-28);
controlling translational movement of at least part of a beamline structure of a gantry in the particle therapy system relative to an irradiation target based on the data (irradiation device 4 mounted to a gantry barrel 18, see Fig. 1-2 and col. 4, lines 13-24; irradiation device 4 comprises a snout 4a which is extendable or contractible in accordance with a treatment plant information, see col. 5, lines 34-54; or couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38), the beamline structure being configured to direct a particle beam from an output of a particle accelerator toward the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67; ions (e.g. protons or carbon ions) generated in the ion source are accelerated by the pre-stage accelerator 7 (e.g. linear accelerator), see col. 4, lines 1-5; through the beam transport 11 to the irradiation device 4 of the patient 14, see col. 4, lines 13-24), the beamline structure comprising magnetic bending elements to bend the particle beam along at least part of a length of the beamline structure (synchrotron 8 comprises magnetic bending elements, see Fig. 1 and col. 4, lines 1-3); and
controlling the particle accelerator to apply particle beam to the irradiation target at different translational positions of the at least part of the beamline structure based on the data (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67; ions (e.g. protons or carbon ions) generated in the ion source are accelerated by the pre-stage accelerator 7 (e.g. linear accelerator), see col. 4, lines 1-5; through the beam transport 11 to the irradiation device 4 of the patient 14, see col. 4, lines 13-24; the irradiation device is rotated around the patient body with rotation of the rotating gantry, thus enabling the ion beam to be irradiated to the affected part in accordance with the irradiation angle decided in a treatment plan, see col. 1, lines 24-28), where a couch holding the irradiation target is to remain stationary during the translational movement of the at least part of the beamline structure and application of the particle beam (movement of couch 13 is controlled by the switch 33 operated by a medical engineer 34, see col. 4 and col. 5, lines 31-58).
Regarding claim 27, Yamashita discloses controlling rotational movement of at least part of the beamline structure relative to the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3 around the patient 14, see Fig. 1 and col. 3, lines 62-67), where the couch is controlled to remain stationary during the rotational movement of the at least part of the beamline structure (movement of couch 13 is controlled by the switch 33 operated by a medical engineer 34, see col. 4 and col. 5, lines 31-58).
Regarding claim 28, Yamashia discloses the translational movement comprises movement along a longitudinal dimension of the gantry to discrete positions along the irradiation target (couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 29, Yamashita discloses the translational movement comprises movement toward or away from the particle accelerator along at least part of a beamline of the particle beam (couch 13 on the treatment bench 5 is moved by a driver such that the patient 14 on the couch 13 is positioned in alignment with an axis of rotation of the rotating gantry 13, see col. 5, lines 35-38).
Regarding claim 30, Yamashita discloses the beamline structure comprises an output channel, the output channel comprising magnetic dipoles arranged in series to bend the particle beam by at least 90 degrees (irradiation device 4 and inverted U shaped beam transport 11, see col. 4, lines 13-19);
wherein the gantry comprises a ring structure on which the output channel is mounted for rotation around the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
wherein the translational movement is parallel to axis of rotation about which the output channel rotates on the ring structure (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54).
Regarding claim 31, Yamashita discloses controlling movement of an imaging system based on the translational movement of the at least part of the beamline structure while the irradiation target is controlled to remain stationary (x-ray CT images of the affected part 15 of the patient 14 are taken in advance at the time of planning the treatment plan, thereby computing deviations of the coordinates, see col. 8, lines 13-29; switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54).
Regarding claim 32, Yamashita discloses the at least part of the beamline structure is controlled to move out of a predefined position and the imaging system is controlled to move to the predefined position following movement of the at least part of the beamline structure (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54).
Regarding claim 33, Yamashita discloses the imaging system is controlled to move out of the predefined position and the beamline structure is controlled to move to the predefined position (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita.
Regarding claim 12, Yamashita discloses a translational movement of the beamline (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54).
Yamashita does not explicitly disclose the movement is for at least 30 centimeters.
However, the amount of movement of the snout 4a is obvious without showing that the claimed range(s) achieve unexpected results relative to the prior art range. In re Woodruff, 16 USPQ2d 1935, 1937 (Fed. Cir. 1990). See also In re Huang, 40 USPQ2d 1685, 1688 (Fed. Cir. 1996) (claimed ranges of a result effective variable, which do not overlap the prior art ranges, are unpatentable unless they produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art). See also In re Boesch, 205 USPQ 215 (CCPA) (discovery of optimum value of result effective variable in known process is ordinarily within skill of art) and In re Aller, 105 USPQ 233 (CCPA 1955) (selection of optimum ranges within prior art general conditions is obvious).
Regarding claim 13, Yamashita discloses a translational movement of the beamline (irradiation device 4 comprises a snout 4a which is extendable or contractible in relation to the patient 14, see col. 5, lines 34-54).
Yamashita does not explicitly disclose the movement is for between at least 30 centimeters and 1 meter.
However, the amount of movement of the snout 4a is obvious without showing that the claimed range(s) achieve unexpected results relative to the prior art range. In re Woodruff, 16 USPQ2d 1935, 1937 (Fed. Cir. 1990). See also In re Huang, 40 USPQ2d 1685, 1688 (Fed. Cir. 1996) (claimed ranges of a result effective variable, which do not overlap the prior art ranges, are unpatentable unless they produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art). See also In re Boesch, 205 USPQ 215 (CCPA) (discovery of optimum value of result effective variable in known process is ordinarily within skill of art) and In re Aller, 105 USPQ 233 (CCPA 1955) (selection of optimum ranges within prior art general conditions is obvious).
Claims 22-25 and 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita in view of Cooley III et al. (US PGPub 2020/0298023, provided from IDS filed 10/24/2024, hereinafter Cooley).
Regarding claim 22, Yamashita discloses the at least part of the beamline structure comprises a nozzle (irradiation device 4 includes snout 4a, which output a particle beam toward patient 14, see Fig. 1).
Yamashita fails to disclose the nozzle comprises at least one of an energy degrader or a collimator.
Cooley discloses an energy degrader and collimator located between the particle accelerator and the patient (see Fig. 4 and paragraph [0008]). Cooley teaches the energy degrader is used to control the change of energy of the particle beam and therefore the depth to which the dose of the particle beam will be deposited in the target (see paragraph [0095]). Cooley further teaches the collimator is used to maintain a more constant spot size (see paragraph [0100]).
Cooley modifies Yamashita by suggesting providing an energy degrader and a collimator between the accelerator and the patient.
Since both inventions are drawn to particle beam therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Yamashita by providing an energy degrader and a collimator between the accelerator and the patient for the purpose of controlling the depth the particle beam dosage is applied to the target as well as providing a constant spot size as taught by Cooley.
Regarding claim 23, Yamashita discloses an imaging system that is movable relative to the irradiation target (particle beam therapy system 1 comprises a rotating gantry 3, see Fig. 1 and col. 3, lines 62-67); and
a control system to control the mount or the nozzle to move the nozzle away from a location proximate to the irradiation target, and to control movement of the imaging system toward the location (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54);
wherein a couch holding the irradiation target is configured to remain stationary during movement of the imaging system and during movement of the mount or the nozzle (switch 33 controls movement of the couch 13, rotation of the rotating gantry, and the extension/contraction of the snout 4a, see Fig. 4 and col. 5, lines 31-54).
Regarding claim 24, Yamashita discloses the mount comprises a rail-mounted drawer (snout 4a is extendable toward or contractible away from the patient 14, see Fig. 4 and col. 5, lines 47-51).
Regarding claim 25, Yamashita discloses the mount is configured to move the nozzle telescopically (snout 4a is extendable toward or contractible away from the patient 14, see Fig. 4 and col. 5, lines 47-51).
Regarding claim 34, Yamashita fails to disclose the target beam field is greater than a size of a predefined beam field defined, at least in part, by the gantry absent the translational movement of the at least part of the gantry.
Cooley teaches the treatment area exceeds the dimensions of the collimator (e.g. the size of the beam) and controls movement and position of the beam to treat the entire area (see paragraph [0159]).
Cooley modifies Yamashita by suggesting applying the beam to targets greater than a size of a beam field.
Since both inventions are drawn to particle beam therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Yamashita by applying the beam to targets greater than a size of a beam field for the purpose of treating the entire target area as taught by Cooley.
Regarding claims 35-37, Yamashita fails to disclose the target beam field is greater than the predefined beam field.
Cooley teaches the treatment area exceeds the dimensions of the collimator (e.g. the size of the beam) and controls movement and position of the beam to treat the entire area (see paragraph [0159]).
Cooley modifies Yamashita by suggesting applying the beam to targets greater than a size of a beam field.
Since both inventions are drawn to particle beam therapy devices, it would have been obvious to the ordinary artisan before the effective filing date to modify Yamashita by applying the beam to targets greater than a size of a beam field for the purpose of treating the entire target area as taught by Cooley.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANWAY CHANG whose telephone number is (571)270-5766. The examiner can normally be reached Monday - Friday 7:30 AM - 4:00 PM EST.
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Hanway Chang
/HC/ Examiner, Art Unit 2878
/GEORGIA Y EPPS/ Supervisory Patent Examiner, Art Unit 2878
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