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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the couch and controller of claims 17-20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Figure 10 does not sufficiently aide the understanding of the structure of the couch or controller, or their relationship with each other or the medical device.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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 11 and 15 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 11 recites the limitation "the second support member and the third support member" (Line 7). There is insufficient antecedent basis for this limitation in the claim. The second and third support members and their positions are described in Claim 2, on which Claim 11 does not depend; therefore, for examination purposes, the limitations will be read as “a second support member and a third support member”. Any item(s) which could be considered a “support member” rotatably mounted on the connecting portion around the second rotation axis will be treated as reading on the second and third support members.
Regarding claim 15, it is unclear how the final two limitations (“an emission period of the first scanning rays…” and “an emission period of the second scanning rays…”) further limit the structure of the claimed device. These limitations appear to be a method of using the device, as the user is able to configure the emission periods of the first and second scanning rays by simply activating the first and second scanning ray emitters as desired. MPEP 2173.05(p)II explains that “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b)”. Therefore, claim 15 is rejected under 35 U.S.C. 112(b) as being indefinite.
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, 5, 6, 8, 9, 10, 11, 12, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Humber et al. (US 2018/0304098 A1).
Regarding claim 1, Humber teaches a medical device (Abstract) comprising:
a gantry (Fig. 1B: first support 102 and second support 104);
a first support member (Paragraph [0042] and Fig. 1B: stages 144 connected to circular rail bearings 146) rotatably mounted on the gantry around a first rotation axis (Paragraph [0042]: “the drive system 142 may move stages 144 along circular rail bearings 146 mounted on the first support 102, causing the first and second ring structures 110a, 110b of the first gantry 110 coupled to the stages 144 to rotate about the first axis 114”; implicitly, the stages to which the ring structures are coupled are rotating about the first axis along the circular rail bearings); and
a treatment device including a treatment ray emitter configured to emit treatment rays (paragraph [0037]: treatment head 130) and a treatment ray receiver configured to receive the treatment rays (paragraph [0037]: electronic portal imaging device (EPID) 126), the treatment ray emitter and the treatment ray receiver being rotatably mounted on the first support member around a second rotation axis synchronously (Paragraph [0062]: the EPID 126 and the treatment head 130 can be moved together with the second gantry 120 about the second axis 116 using a single drive; paragraph [0037] explains the second gantry rides on the first gantry and paragraph [0042] explains the first gantry is coupled to the rotating stages; altogether, the emitter and receiver are mounted on the stages, the stages being analogous to the claimed “first support member”), wherein the first rotation axis intersects with the second rotation axis (Fig. 1A: axes 114 and 116 intersect at the isocenter 112).
Regarding claim 5, Humber teaches that during a rotation process of the treatment ray emitter, a distance between the treatment ray emitter and an isocenter of the treatment device remains constant (Figures 2A, 2B: The treatment head 130 is mounted on the second gantry 120. Since the second gantry 120 is mounted on the circular rings 110a-b and the isocenter is at the center of the rings, the treatment ray emitter (treatment head) rotates in a circle around the isocenter, thus keeping a constant distance).
Regarding claim 6, Humber teaches
a first scanning device (Paragraph [0056]: first imaging system 122) including a first scanning ray emitter (Fig. 1A-B: imaging source 122a) configured to emit first scanning rays and a first scanning ray receiver configured to receive the first scanning rays (Fig. 1A-B: imager 122b), wherein the first scanning ray emitter and the first scanning ray receiver are rotationally mounted on the first support member around the second rotation axis synchronously (Paragraph [0056]: “Alternatively or additionally, an imaging system may be coupled to the second gantry 120 and is thus further rotatable about the second axis 116”. Note the second gantry is coupled to the first gantry, which is rotationally mounted on the first support member; thus, the emitter and receiver are rotationally mounted on the first support member), and
an isocenter of the treatment device coincides with an isocenter of the first scanning device (Fig. 1B).
Regarding claim 8, Humber teaches a second scanning device (Paragraph [0056]: second imaging system 124) including a second scanning ray emitter (Fig. 1A: imaging source 124a) configured to emit second scanning rays and a second scanning ray receiver configured to receive the second scanning rays (Fig. 1A: imager 124b), wherein the second scanning ray emitter and the second scanning ray receiver are fixedly mounted on the first support member (Fig. 1A: the second imaging system 124a-b is fixedly mounted on the first gantry 110, which is coupled to the stages 144 considered analogous to the “first support member”).
Regarding claim 9, Humber teaches the second scanning ray emitter and the second scanning ray receiver being mounted on different sides of a plane defined by the first rotation axis and the second rotation axis (Fig. 1A: imaging source 124a is above the plane formed by the axes 114 and 116; imager 124b is below said plane).
Regarding claim 10, Humber teaches the gantry including a first gantry component and a second gantry component (Fig. 1A: first support 102 and second support 104), and the first gantry component and the second gantry component are spaced apart from each other along an extension direction of the first rotation axis (see Fig. 1A, where 114 is the first rotation axis), and
two ends of the first support member along the extension direction of the first rotation axis are rotationally connected with the first gantry component and the second gantry component, respectively (Paragraph [0069]: “By way of example, rail bearings 146 may be mounted on the first and/or second supports 102, 104, allowing the first gantry 110… to rotate about the first axis 114”. The stages 144, rail bearings 146, first gantry 110, and connecting members 111, 113 can be considered in combination to be the “first support member”, extended along the length of the first axis 114 and rotationally connected at its ends with the first and second supports 102, 104).
Regarding claim 11, as best understood, Humber teaches the first support member including a first support end portion (Paragraph [0042] and Figures 1A-B: members 111), a second support end portion (Paragraph [0042] and Figure 1A: plate members 113), and a connecting portion (Fig. 1A: first gantry 110),
the connecting portion is located between and connects the first support end portion and the second support end portion (Fig. 1A), the first support end portion is rotationally connected with the first gantry component (Fig. 1B: members 111 rotated via stages 144 along the circular rail bearings 146 within the first support 102), the second support end portion is rotationally connected with the second gantry component (Paragraph [0042] discloses the same structure being applied to the other end: “a drive system may move stages along circular rail bearings on the second support 104, causing the first and second ring structures 110a, 110b to rotate about the first axis 114”),
[a] second support member (Fig. 1A: second gantry 120 is rotatably mounted on the rings around the second axis 116) and [a] third support member (Paragraph [0062] and Fig. 1B: separate truck 152 may be used to carry and position the EPID) are rotatably mounted on the connecting portion around the second rotation axis, and
the second scanning ray emitter and the second scanning ray receiver are fixed on the connecting portion (Fig. 1A: imaging source 124a and imager 124b fixed on the rings 110a,b).
Regarding claim 12, Humber teaches the first rotation axis being perpendicular to the second rotation axis, and an intersection point between the first rotation axis and the second rotation axis coincides with an isocenter of the medical device (Fig. 1A and Abstract).
Regarding claim 13, Humber teaches
the medical device further comprises a slide rail arranged along a circumferential direction of the gantry (Fig. 1B: circular rail bearings 146), an axial direction of the slide rail coincides with the first rotation axis (Fig. 1A-B: first axis 114 is through the center of the first support 102, which is also the central axis of the rail 146),
the first support member includes a first sliding device and a second sliding device, the first sliding device is configured to slidably mount the treatment ray emitter in the slide rail (Fig. 1A-B: the treatment head 130 is mounted on the second gantry 120, which is mounted on the first gantry 110; since the first gantry is slidably mounted in the slide rail 146 via the stages 144, it can be said that the combination of the stages 144, first gantry 110, and second gantry 120 are a “sliding device” that slidably mounts the treatment ray emitter in the slide rail), the second sliding device is configured to slidably mount the treatment ray receiver in the slide rail (Fig. 1B: the EPID 126 is carried on the truck 152, which is mounted on the first gantry 110; since the first gantry is slidably mounted in the slide rail 146 via the stages 144, it can be said that the combination of the stages 144, first gantry 110, and truck 152 are a “sliding device” that that slidably mounts the treatment ray emitter in the slide rail), and
the first sliding device and the second sliding device are symmetrically arranged on two sides of the first rotation axis (Fig. 1A-B: the truck 152 and second gantry 120 are on opposite sides of and equidistant from the first axis 114).
Regarding claim 15, as best understood, Humber teaches
a first scanning device (Paragraph [0056]: first imaging system 122) including a first scanning ray emitter (Fig. 1A-B: imaging source 122a) configured to emit first scanning rays and a first scanning ray receiver configured to receive the first scanning rays (Fig. 1A-B: imager 122b), the first scanning ray emitter and the first scanning ray receiver being rotatably mounted on the first support member around the second rotation axis synchronously (Paragraph [0056]: “Alternatively or additionally, an imaging system may be coupled to the second gantry 120 and is thus further rotatable about the second axis 116”. Note the second gantry is coupled to the first gantry, which is rotationally mounted on the first support member; thus, the emitter and receiver are rotationally mounted on the first support member); and
a second scanning device (Paragraph [0056]: second imaging system 124) including a second scanning ray emitter (Fig. 1A: imaging source 124a) configured to emit second scanning rays and a second scanning ray receiver configured to receive the second scanning rays (Fig. 1A: imager 124b), the second scanning ray emitter and the second scanning ray receiver being fixedly mounted on the first support member (Fig. 1A: the second imaging system 124a-b is fixedly mounted on the first gantry 110, which is coupled to the stages 144 considered analogous to the “first support member”); wherein
an emission period of the first scanning rays at least partially coincides with an emission period of the treatment rays (Paragraph [0057]: “the first and/or second imaging systems 122, 124 may be configured to acquire imaging data during treatment”); and
and emission period of the second scanning rays does not coincide with the emission period of the treatment rays (Paragraph [0057]: “The first and/or second imaging systems 122, 124 can also be used to acquire projection radiographs or digital tomosynthesis data before treatment”).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Humber in view of Chen et al. (US 10716956 B2).
Regarding claim 14, Humber does not teach the first sliding device including a first pulley mounted in the slide rail and a first connecting rod configured to connect the first pulley and the treatment ray emitter, a length of the first connecting rod is adjustable for adjusting a distance from the treatment ray emitter to the gantry, and
the second sliding device includes a second pulley mounted in the slide rail and a second connecting rod configured to connect the second pulley and the treatment ray receiver, a length of the second connecting rod is adjustable for adjusting a distance from the treatment ray receiver to the gantry.
In the same field of endeavor, Chen teaches a sliding device including a pulley (Fig. 3: pulley 28) mounted in a slide rail (Fig. 3: sliding rail 29) and a connecting rod configured to connect the second pulley and the treatment ray receiver (Fig. 3: moveable block 15 and cover plate 151 with detector 16 on it), a length of the rod being adjustable for adjusting a distance from the treatment ray receiver to the gantry (Paragraph (40): Detector mounted on the moveable block by a moving mechanism, such as a jack device, to move along a radial direction of the gantry, to increase or decrease the distance from the movable block to the center of the gantry).
In light of the teachings of Chen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Humber such that the stages slide on the rail bearings (146 and/or 138 in Humber) via pulleys, and the pulleys are connected to an adjustable block/rod that moves the EPID (treatment ray receiver) relative to the gantry. This allows the user to adjust the dose of the treatment beam on the receiver and/or control the accuracy of the receiver. Applying the same structure to the sliding mechanism controlling the position of the treatment ray emitter as well is an obvious duplication of parts, providing the benefit of allowing the user to adjust the position of the emitter to control the dose and/or accuracy.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Humber.
Regarding claim 16, Humber does not teach a dose of the second scanning rays being higher than a dose of the first scanning rays.
However, Humber teaches that one of the two imaging systems can be used for patient set-up and/or adaptive treatment planning, while the other may additionally be used to acquire imaging data during treatment for intrafraction motion management (Paragraph [0057]). A person having ordinary skill in the art would recognize that pre-treatment imaging requires one or a small number of high-quality scans, whereas intrafraction imaging during treatment requires frequent periodic or continuous imaging. As a result, the pre-treatment imaging would require a higher radiation dose, while the intrafraction imaging would require a lower dose to manage cumulative radiation exposure. It therefore would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to set the dose of the pre-treatment scanning rays lower than those during treatment, as a result of routine optimization of the device of Humber.
Claims 17, 18, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Humber in view of Wang et al. (US 20210077828 A1).
Regarding claim 17, Humber teaches a medical system, comprising a couch (Fig. 1A: table 108), a controller (Paragraph [0037]: “The radiation system 100 may be controlled by a control (not shown), which may be programmed or configured to provide control signals for operation of the first and second gantries 110, 120, treatment head 130, imaging systems 122, 124, and the EPID 126, etc.”), and the medical device of claim 1, wherein the couch is configured to support a patient (Fig. 1A), and the controller is configured to: determine a region to be treated for the patient (Paragraph [0057] describes the imaging systems, which may be controlled by the control according to [0037], being used for patient set-up and treatment planning);
control the treatment device to rotate around the second rotation axis to adjust an irradiation angle of the treatment rays to be emitted by the treatment ray emitter (Paragraph [0037] describes the control providing signals for operation of the second gantry and treatment head, which rotate around the second axis as explained above, thus controlling the irradiation angle of the treatment rays);
control the first support member to rotate around the first rotation axis (Paragraph [0037] describes the control providing signals for operation of the first gantry which rotates around the first axis, and thus implicitly controls the drive system 142 and stages 144, which rotate the first gantry) while controlling the treatment device to emit the treatment rays for performing radiotherapy (Paragraph [0037] describes the treatment head being operated by the control).
Humber does not explicitly teach the controller being configured to control the couch to move such that an isocenter of the medical device is located in the region to be treated. However, it should be noted that Paragraph [0037] describes the table being positioned such that the target volume to be irradiated is located at the isocenter of the radiation system; due to the necessity of precision, one could reasonably assume that the table is also operated by the control rather than by hand, as is conventional in the art.
In the same field of endeavor, Wang explicitly teaches a control being configured to control the couch to move such that an isocenter of the medical device is located in the region to be treated (Paragraph [0085]). In light of the teachings of Wang, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Humber so that the couch/table is also operated by the control, providing the benefit of precise positioning not achievable by hand.
Regarding claim 18, Humber teaches the medical device further including a first scanning device and/or a second scanning device (Fig. 1A-B: imaging systems 122a-b, 124a-b);
the first scanning device includes a first scanning ray emitter configured to emit first scanning rays and a first scanning ray receiver configured to receive the first scanning rays, the first scanning ray emitter and the first scanning ray receiver are rotatably mounted on the first support member around the second rotation axis synchronously (see rejection of claim 15 above),
the second scanning device includes a second scanning ray emitter configured to emit second scanning rays and a second scanning ray receiver configured to receive the second scanning rays, the second scanning ray emitter and the second scanning ray receiver are fixedly mounted on the first support member (see rejection of claim 15 above), and
to determine the region to be treated for the patient, the controller is further configured to control the first scanning device and/or the second scanning device to acquire a planning image of the patient, and determine the region to be treated based on the planning image (Paragraph [0057] describes the imaging systems, which may be controlled by the control according to [0037], being used for patient set-up and treatment planning).
Regarding claim 19, Humber teaches the treatment device being controlled to emit the treatment rays for performing radiotherapy (Paragraph [0037]), the controller being further configured to control the first scanning device and/or the second scanning device to acquire a treatment image of the patient (Paragraph [0057]: “the first and/or second imaging systems 122, 124 may be configured to acquire imaging data during treatment for intrafraction motion management”), and determine whether the treatment rays emitted by the treatment device need to be adjusted based on the treatment image (Paragraph [0057]: imaging guided radiotherapy).
Regarding claim 20, Humber teaches the medical device including the first scanning device and the second scanning device (see rejection of claim 15 above), the planning image being acquired by the second scanning device (Paragraph [0057] allows the planning image to be acquired by either imaging system 122 or 124, so the planning image may be acquired by the scanning device fixed relative to the second axis), and the treatment image is acquired by the first scanning device (Paragraph [0057] allows the treatment image to be acquired by either imaging system, so the treatment image may be acquired by the scanning device rotatable about the second axis).
Allowable Subject Matter
Claims 2, 3, 4, and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 2, the closest prior art, Humber, teaches the medical device of claim 1, further comprising a second support member and a third support member (Fig. 1A: first ring structure 110a and second ring structure 110b of the first gantry 110), wherein
the second support member and the third support member are spaced apart from each other along an extension direction of the second rotation axis (Fig. 1A: ring structures 110a, 110b spaced apart along second axis 116),
the treatment ray receiver is mounted on a transmission path of the treatment rays emitted by the treatment ray emitter (Paragraph [0062]: “In operation, an EPID 126 is positioned 180 degrees from the treatment head 130”).
Humber does not teach the second support member and the third support member being rotatably mounted on the first support member around the second rotation axis synchronously. Rather, the rings 110a-b are only synchronously rotatably about the first axis, and it is not simple or obvious over the prior art to modify Humber such that the rings are rotatable about the second axis. Furthermore, the treatment head and the EPID each appear to be (Fig. 1B) mounted between and on both of the rings, rather than the treatment head being mounted on one and the EPID on the other.
Alternatively, if the “second support member” is mapped to the second gantry 120 carrying the treatment head and the “third support member” is mapped to the truck 152 carrying the EPID, then the second and third support members are indeed rotatably mounted on the first support member around the second rotation axis synchronously. However, in this case, the second and third support members fail to be spaced apart from each other along an extension direction of the second rotation axis.
The prior art thus fails to teach or suggest the combination of elements of claim 2.
Claims 3 and 4 are allowable because they are dependent on claim 2.
Claim 7 discloses an identical structure to claim 2, albeit replacing the treatment ray emitter with a scanning ray emitter and the treatment ray receiver with a scanning ray receiver. As the allowability of claim 2 does not depend on the type of radiation emitter/receiver, claim 7 is considered allowable according to the same reasoning.
Conclusion
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/WILLIAM LAURENCE TAYLOR/Examiner, Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884