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 .
Response to Arguments
Applicant’s argument on Pages 14-15 regarding the objections to the drawings has been fully considered. The objections to the drawings are withdrawn in view of the amendments.
Applicant’s argument on Page 16 regarding the objections to the specification has been fully considered. The objections to the specification are withdrawn in view of the amendments.
Applicant’s argument on Page 17 regarding the interpretation of Claims 1, 5-6, and 18 under 35 U.S.C. 112(f) has been fully considered. The interpretation is withdrawn in view of the amendments and cancelation of Claim 5.
Applicant’s argument on Pages 18-19 regarding the interpretation of Claims 1-11, 13-16, 18, and 20-21 under 35 U.S.C. 112(a) has been fully considered. The interpretation is withdrawn in view of the amendments and cancelation of Claims 2, 4-5, 7, 13-16, and 21.
Applicant’s argument on Pages 19-21 regarding the interpretation of Claims 1-11, 13-16, 18, and 20-21 under 35 U.S.C. 112(b) has been fully considered. The interpretation is withdrawn in view of the amendments and cancelation of Claims 2, 4-5, 7, 13-16, and 21.
Applicant’s argument on Pages 22-25 regarding the rejection of Claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Wang has been fully considered but is not persuasive under new grounds of rejection as below.
Applicant’s argument on Pages 25-28 regarding the rejection of Claim 6 under 35 U.S.C. 103 over Wang in view of Harper has been fully considered but is not persuasive under new grounds of rejection as below.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Pages 25 and 28 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
The rejection of Claims 2, 4-5,13-16, and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Wang and Claim 7 under 35 U.S.C. 103 over Wang in view of Harper is withdrawn in view of the cancelation of the claims.
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.
Claim 31 is 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.
The term “high” in Claim 31 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of applying prior art, the limitation “high” is interpreted as materials that may be classified as ferromagnetic.
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 1, 3, 8-10, 18, 23-24, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Kruip (US 20140135615).
Regarding Claim 1, Kruip teaches a radiation therapy system, (Fig. 2) comprising:
a) a magnetic resonance imaging (MRI) device configured to acquire MRI data with respect to a region of interest (ROI), (Fig. 2 and [0037] “Main magnet 10 is provided with "Letterbox" slots 100 through the cryostat and between coils of the main magnet to allow the radiation beam to reach a patient P at the irradiation center B.”), the MRI device including: a main magnet, ([0037] “Main magnet 10”), that is around a longitudinal axis, (Fig. 2), and configured to generate a magnetic field, ([0041] “the magnetic field of the main magnet 10”), the main magnet including a plurality of main magnetic coils, ([0066] “main magnet coils 104”), a plurality of shielding magnetic coils, ([0042] “Shield coils 102”), and a cryostat, ([0068] “inner cryostat 106 […] outer cryostat 108”), the plurality of main magnetic coils and the plurality of shielding magnetic coils being accommodated in the cryostat ([0068] “The main magnet coils are located within an inner cryostat 106, while the shield coils are located within an outer cryostat 108.”);
b) a radiation therapy device, (Abstract “radiation therapy system”), configured to perform a treatment on at least one portion of the ROI by delivering, based on the MRI data, therapeutic radiation to the at least one portion of the ROI by delivering, based on the MRI data, therapeutic radiation to the at least one portion of the ROI, the radiation therapy device being rotatable around the longitudinal axis ([0029] “the LINAC required for generating an electron beam, which is in turn required for generating a radiation beam” and [0051]-[0055] “define centerline of LINAC and set a maximum tolerable deviation of field strength experienced by the LINAC; constrain imaging volume; constrain stray field to ensure that the shielding coils remain effective; constrain the geometry of the coils according to the design parameters of the system; perform computer-aided optimization based on well-known linear optimization or linear current density optimizer methods.”); and
c) wherein the radiation therapy device further includes:
i) a radiation source configured to provide the therapeutic radiation, ([0016] “electron source 11” and Fig. 2), the radiation source including at least one of:
1) a linear accelerator configured to accelerate electrons in an electron beam to produce a radiation beam of the therapeutic radiation, ([0037] “LINAC 9”),
2) a target configured to receive the accelerated electron beam to produce the radiation beam for the therapeutic radiation, ([0037] “allow the radiation beam to reach a patient P at the irradiation center B.”), or
3) a collimator configured to collimate the radiation beam of the therapeutic radiation ([0037] “[0021] “The collimator 23 is arranged in an annular slot between the distanced partial gradient coils 21A, 21B in the beam path after the target anode 19.”); and
ii) a gantry configured to support the radiation source, the radiation source being rotatable with the gantry ([0037] “Gantry 8 is able to rotate about axis 15, enabling the radiation beam to be applied to the irradiation center B from an arbitrary angle” and Claim 5 “a rotatable gantry in which said LINAC assembly is mounted, said gantry being configured to rotate said LINAC assembly around said main magnet coils”).
However, the first embodiment of Kruip does not have a first shielding structure configured to provide electromagnetic interference shielding for the MRI device or the radiation therapy device, the first shielding structure being around the longitudinal axis and located outside the cryostat of the main magnet during the treatment, the first shielding structure being configured to be non-rotatable around the longitudinal axis, at least a portion of the radiation therapy device being configured to rotate around the longitudinal axis and relative to the first shielding structure during the treatment.
A second embodiment of Kruip teaches a first shielding structure configured to provide electromagnetic interference shielding for the MRI device or the radiation therapy device, ([0073] “ferromagnetic tube 110 […]. This ferromagnetic tube prevents the high-frequency intermittent electron beam of the LINAC from interfering with the imaging system. It also isolates the LINAC assembly 5 from the magnetic field of the main magnet 10 to ensure that the residual field of the main magnet will not impair proper operation of the LINAC” and [0076] “Shielding arrangements other than the particular active and passive shielding arrangements described and illustrated can be used.”), the first shielding structure being around the longitudinal axis and located outside the cryostat of the main magnet during the treatment, (Fig. 6), the first shielding structure being configured to be non-rotatable around the longitudinal axis, (Claim 8 “identical ferromagnetic tubes being respectively located at selected circumferential locations around said main magnet coils” and [0074] “For symmetry, all ferromagnetic tubes 110, 112 may have holes 114 that are similar to that provided to accommodate the target and related equipment in ferromagnetic tube 110. The holes 114 are preferably aligned with the axial position of the radiation path 26, and the axial center plane of the magnet.”), at least a portion of the radiation therapy device being configured to rotate around the longitudinal axis and relative to the first shielding structure during the treatment (Claim 5 “a rotatable gantry in which said LINAC assembly is mounted, said gantry being configured to rotate said LINAC assembly around said main magnet coils”);
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to combine the first and second embodiments of Kruip because the combination of using active and passive shielding arrangements together is highly desirable in order to control the treatment environment.
Regarding Claim 3, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches wherein at least a portion of the radiation therapy device is surrounded by the first shielding structure ([0073] “a ferromagnetic tube 110 arranged around the LINAC assembly 5, with a radial hole cut into it to accommodate the target and related equipment.”).
Regarding Claim 8, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches one or more second shielding structures mounted on the gantry (Claim 5 “a rotatable gantry in which said LINAC assembly is mounted, said gantry being configured to rotate said LINAC assembly around said main magnet coils” and [0073] “to provide effective shielding of the stray field, similar ferromagnetic tubes 112 are placed at selected symmetrical circumferential locations about the main magnet coils.”).
Regarding Claim 9, Kruip teaches all limitations of Claim 8, as discussed above. Furthermore, Kruip teaches wherein the one or more second shielding structures are respectively located at one or more circumferential locations on the gantry ([0073] “to provide effective shielding of the stray field, similar ferromagnetic tubes 112 are placed at selected symmetrical circumferential locations about the main magnet coils.”).
Regarding Claim 10, Kruip teaches all limitations of Claim 9, as discussed above. Furthermore, Kruip teaches wherein the radiation source and the one or more second shielding structures are evenly distributed on the gantry (Fig. 6, [0030] “the LINAC is arranged parallel to the axis of the main magnet, radially positioned between the radially outer surface of the main magnet coils and the radially inner surface of the shield coils,” and [0073] “to provide effective shielding of the stray field, similar ferromagnetic tubes 112 are placed at selected symmetrical circumferential locations about the main magnet coils.”).
Regarding Claim 18, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches wherein the radiation therapy device further includes:
a) a multi-leaf collimator (MLC) configured to make the radiation beam approximate the at least one portion of the ROI ([0044] “More space is available for positioning of a multi-leaf collimator 23, which may accordingly be a better collimator with more leaves than could be accommodated in the arrangement of the prior art.” It is understood by one of ordinary skill in the art the MLC is installed and works below the primary collimator.);
b) wherein at least a portion of at least one of the linear accelerator, the target, the collimator, or the MLC is surrounded by the first shielding structure ([0073] “a ferromagnetic tube 110 arranged around the LINAC assembly 5, with a radial hole cut into it to accommodate the target and related equipment.”).
Regarding Claim 23, Kruip teaches all limitations of Claim 9, as discussed above. Furthermore, Kruip teaches wherein one of the one or more second shielding structures has shape of a plate, or includes one or more parallel strips or rods ([0075] “the additional ferromagnetic tubes 112 are placed with simple ferromagnetic rods”).
Regarding Claim 24, Kruip teaches all limitations of Claim 9, as discussed above. Furthermore, Kruip teaches wherein the one or more slots are respectively located at one or more circumferential locations on a wall of the first shielding structure (Fig. 6 and [0074] “all ferromagnetic tubes 110, 112 may have holes 114”); and when the radiation source is located at an initial location, each of the one or more slots is disposed between the radiation source and one of the one or more second shielding structures, ([0074] “The holes 114 are preferably aligned with the axial position of the radiation path 26, and the axial center plane of the magnet.”), or between two adjacent second shielding structures of the one or more second shielding structures; or the one or more slots extend along the longitudinal axis, and when the radiation source is located at an initial location, for each of the one or more slots, the slot is located corresponding to one of the one or more second shielding structures, and the circumferential location of the slot and the circumferential location of the corresponding second shielding structure are at a same radial direction (Fig. 6).
Regarding Claim 25, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches wherein the first shielding structure has a shape of an annulus around an entire circumference of the main magnet (Fig. 6 and [0073] “to provide effective shielding of the stray field, similar ferromagnetic tubes 112 are placed at selected symmetrical circumferential locations about the main magnet coils.”).
Regarding Claim 27, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches wherein a location of the first shielding structure is adjustable to cover a rotation pathway of the radiation therapy device during the treatment, ([0069] “associated equipment in LINAC assembly 5, should be able to rotate about axis 15”), and the first shielding structure includes a first opening configured to allow the therapeutic radiation from the radiation therapy device to pass through (Fig. 6 and [0074] “all ferromagnetic tubes 110, 112 may have holes 114 […]. The holes 114 are preferably aligned with the axial position of the radiation path 26, and the axial center plane of the magnet.”).
Regarding Claim 28, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches wherein the first shielding structure includes a plurality of shielding layers, at least one first shielding layer of the plurality of shielding layers is used to reduce magnetic interference between the MRI device and the radiation therapy device, ([0073] “This ferromagnetic tube prevents the high-frequency intermittent electron beam of the LINAC from interfering with the imaging system.”), at least one second shielding layer of the plurality of shielding layers is used to reduce radiofrequency (RF) and/or microwave interference between the MRI device and the radiation therapy device ([0043] “RF shielding may be provided around the LINAC to reduce its interference with the operation of magnetic resonance imaging.”).
Regarding Claim 30, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Kruip teaches wherein the first shielding structure is made of magnetic susceptibility and permeability material ([0073] “ferromagnetic tube 110”).
Regarding Claim 31, Kruip teaches all limitations of Claim 30, as discussed above. Furthermore, Kruip teaches wherein the first shielding structure is made of high magnetic susceptibility and permeability material ([0073] “ferromagnetic tube 110”).
Claims 6, 11, 22, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kruip (US 20140135615) in view of Calvert (US 20140107468).
Regarding Claim 6, Kruip teaches all limitations of Claim 1, as discussed above. However, Kruip does not explicitly teach wherein the radiation therapy device further includes: a connection component configured to operably connect the gantry and the first shielding structure, the gantry being rotatably around the longitudinal axis and supported on the first shielding structure through the connection component; wherein the connection component includes one or more bearings. In an analogous combined MRI and radiation therapy field of endeavor, Calvert teaches a radiation device, (Abstract “combined MRI and radiation therapy system”), wherein the radiation therapy device further includes:
a) a connection component, (Fig. 1 and [0025] “bearings 208 [sic], such as ball bearings or rollers”), configured to operably connect the gantry, ([0025] “pivoting gimbal ring 212 which retains the radiation source 202”), and the first shielding structure, ([0019] “outer vacuum container (OVC) 122”), the gantry being rotatably around the longitudinal axis, ([0021] “a gimbal arrangement 203 which allows the source 202 to rotate about axis A-A” and Fig. 1), and supported on the first shielding structure through the connection component (Fig. 1 and [0025] “An outer fixed gimbal ring 216 is in a fixed relative position compared to the OVC, and bearings 208, such as ball bearings or rollers, are provided between the outer fixed gimbal ring 218 and the rotating gimbal ring 214 to allow the latter to rotate within the former.”);
b) wherein the connection component includes one or more bearings ([0025] “bearings 208 [sic], such as ball bearings or rollers”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the radiation therapy device of Kruip with the connection component of Calvert because the modification of including one or more bearings as a connection component allow for minimized friction of components, essentially silent movement, and the bearings are low-maintenance.
Regarding Claim 11, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Calvert teaches wherein the gantry is located within the first shielding structure (Fig. 1, where pivoting gimbal ring 212 is within OVC 122).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the radiation therapy device of Kruip with the location of the gantry of Calvert because it allows for super-controlled environment for the radiation source, see Calvert [0019].
Regarding Claim 22, Kruip teaches all limitations of Claim 8, as discussed above. Furthermore, Calvert teaches wherein the one or more second shielding structures, ([0025] “pivoting gimbal ring 212 which retains the radiation source 202”), are located inside the first shielding structure (Fig. 1, where pivoting gimbal ring 212 is within OVC 122).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the radiation therapy device of Kruip with the location of the gantry of Calvert because it allows for super-controlled environment for the radiation source, see Calvert [0019].
Regarding Claim 26, Kruip teaches all limitations of Claim 1, as discussed above. Furthermore, Calvert teaches wherein the first shielding structure has a shape of one or more arcs covering a rotation range of the radiation source ([0022] “the gamma source 202 may be constrained to rotate only in a lower semicircular arc,” which would mean that the first shielding structure, OVC 122 has a shape of one or more arcs.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the radiation therapy device of Kruip with the shape of the first shielding structure of Calvert because the curve is the most efficient geometry for uniform magnetic fields containment and provides optimal special alignment with the patient’s anatomy.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kruip (US 20140135615) in view of Harper et al. (US 20180133518).
Regarding Claim 20, Kruip teaches all limitations of Claim 1, as discussed above. However, Kruip does not explicitly teach wherein the first shielding structure includes one or more slots configured to dissipate heat produced by the MRI device or the radiation therapy device, or facilitate cable layout of the radiation therapy system.
In an analogous emission-guided high-energy photon delivery field of endeavor, Harper teaches a radiation therapy system (Abstract “radiation therapy systems”), wherein the first shielding structure includes one or more slots configured to dissipate heat produced by the MRI device or the radiation therapy device, ([0106] “A temperature management assembly may comprise a first heat exchange interface comprising one or more exhaust components (504) mounted on the rotatable ring (502) and a stationary duct (506) located within the enclosure of the housing (501).”), or facilitate cable layout of the radiation therapy system.
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the radiation therapy device of Kruip with the slots of Harper because the modification maintains the system temperature within an operable range, as taught by Harper in [0104].
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Kruip (US 20140135615) in view of Uhlemann (US 20130261430).
Regarding Claim 29, Kruip teaches all limitations of Claim 1, as discussed above. However, Kruip does not explicitly teach wherein the collimator includes a primary collimator, a flattening filter, and at least one secondary collimator.
In an analogous radiotherapy field of endeavor, Uhlemann teaches a radiation therapy system, (Abstract “A therapeutic apparatus (400, 500) comprising a radiotherapy apparatus (402)”), wherein the collimator includes a primary collimator, ([0089] “primary collimator 304”), a flattening filter, ([0088] “flattening filter 208”), and at least one secondary collimator ([0089] “second collimator 306”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the radiation therapy device of Kruip with the collimator of Uhlemann because it allows an operator to effectively steer the radiation path in a minimal design.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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