NON-FINAL REJECTION
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 .
Election/Restrictions
Applicant's election with traverse of Species I (Fig. 10; claims 1, 2, 4-7, 10, and 12-16) in the reply filed on 2/2/2026 is acknowledged. The traversal is on the ground(s) that all pending claims may be examined with serious search or examination burden. This is not found persuasive because Applicant’s arguments appear to be entirely conclusory with no supporting evidence.
Applicant argues “the identified Species A-K are closely related and share substantially similar structural features and underlying technical concepts, such that a single search would reasonably encompass the subject matter of all species”, but does not provide any evidence or reasoning as to how to arrive at this conclusion. For example, Applicant does not identify the aforementioned “similar structural feature” and “underlying technical concepts”. Furthermore, Applicant does not identify any such search strategy, let alone why/how it would be expected to reasonably encompass the subject matter of all species.
Applicant further argues “the differences among the species represent variations of a common inventive concept rather than distinct inventions requires separate searches”, but again does not provide any evidence or reasoning as to how to arrive at this conclusion. Again, Applicant does not identify the common inventive concept, let alone the variations thereof. Furthermore, Applicant does explain why the differences do not represent distinct inventions requiring separate searches.
The traversal is entirely conclusory as discussed above and therefore not found to be persuasive. The requirement is still deemed proper and is therefore made FINAL.
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, 2, 6, 7, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujii et al., US 2021/0154495 A1 (hereinafter “Fujii”).
Regarding claim 1: Fujii discloses a magnetic resonance imaging guided radiotherapy system, comprising:
a rotating gantry (18, Fig. 2) rotatable about a preset rotation axis [1];
at least one treatment head (irradiation apparatus 21, Fig. 2) rotatable along with rotation of the rotating gantry [2] and configured to emit radiotherapy rays to a target object [3]; and
a magnetic resonance imaging apparatus (MRI apparatus 50, Fig. 2) including two magnet assemblies (61, Fig. 2), the two magnet assemblies being disposed opposite to each other [4] on the rotating gantry [5] in a circumferential direction of the rotating gantry (see right side of Fig. 2) and used to provide a magnetic field for imaging [6], the magnetic field for imaging having an overlapping region with the radiotherapy rays, so as to perform magnetic resonance imaging on the target object [7]; wherein a center axis of the magnet assemblies disposed opposite to each other has a preset included angle with the rotation axis, and closer to the center axis, greater a distance between inner surfaces of the magnet assemblies disposed opposite to each other (see discussion below).
The left-hand portion of Fujii’s Fig 2 illustrates the rotational axis as a horizontal dash/dot line. Further, the center axis (annotated by the examiner above as a vertical dotted line) of the magnet assemblies (coils 61) disposed opposite each other has a present included angle with the rotation axis (the angle annotated by the examiner above as a curved double-headed arrow).
The right-hand portion of Fujii’s Fig. 2 as annotated by the examiner above shows that the closer the to the center axis, the greater the distance between the inner surfaces of the magnet assemblies disposed opposite to each other. The center axis is annotated by the examiner above as a vertical dotted line; the distance between the inner surfaces of the magnet assemblies disposed opposite to each other are annotated by the examiner above as vertical solid double-headed arrows; and centerline closeness thereof (i.e., how close the aforementioned distances are to the center axis). As can be easily seen in the annotated figure above, the distance that is closest to the center axis is the greatest distance, and the distance that is farthest from the center axis is the shortest distance. Compare to Applicant’s Fig. 7 which appears to illustrate the same.
Regarding the limitation of “radiotherapy system” and “radiotherapy rays”: Fujii teaches therapy by way of a charged particle beam as discussed above. More specifically, Fujii discloses at ¶ [0001]: “The present invention relates to a particle therapy system configured to irradiate a target volume with a charged particle beam (hereinafter referred to as a particle beam) of, for example, heavy particle such as carbon and helium, and proton.” The ordinarily skilled artisan would understand that the charged particle beam as disclosed in Fujii reads on the term “radiotherapy” as used throughout the instant Application, because Applicant appears to use the term “radio-” (e.g., “radiation”, etc.) more broadly to also include charged particles (ions). For example, see ¶ [0032] of the Specification which has been reproduced below for the reader’s convenience (with emphasis added):
[0032] A radiation source used by the treatment head 102 may be any radiation source. For example, the radiation source may be a particle accelerator (e.g., an X-ray accelerator) or a radioactive isotope source (e.g., a cobalt 60 radiation source). For example, the rays generated by the radiation source may be gamma rays, X-rays, electron rays, proton rays, helium ion rays, carbon ion rays, other heavy ion rays or neutron rays. For example, the treatment head 102 may be a gamma-ray focused treatment head, a gamma-ray conformal intensity-modulated treatment head, a gamma-ray pencil-shaped beam treatment head, an X-ray conformal intensity-modulated treatment head, an X-ray focused treatment head, or an X-ray pencil-shaped beam treatment head (i.e., an X-knife treatment head).
Regarding claim 2: Fujii further discloses that at least one of the magnet assemblies disposed opposite to each other has a through hole in a direction of the center axis, and correspondingly, the at least one treatment head is located at the through hole, and the radiotherapy rays emitted by the at least one treatment head irradiate the target object (see Fig. 2).
Regarding claim 6: Fujii further discloses that any one of the magnet assemblies disposed opposite to each other includes a plurality of magnets, and the plurality of magnets are arranged in sequence in a direction of the center axis (see Fig. 2).
Regarding claim 7: Fujii further discloses that the plurality of magnets are nested and arranged.
Regarding claim 10: Fujii further discloses that the plurality of magnets of one of the two magnet assemblies are disposed opposite to the plurality of magnets of another of the two magnet assemblies, respectively (see Fig. 2).
Regarding claim 12: Fujii further discloses that inner surface of at least one of the magnet assemblies disposed opposite to each other is a curved surface or has a stepped shape (see Fig. 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Fujii.
Regarding claim 13: Fujii does not disclose that field strength of the magnetic field; however, the ordinarily skilled artisan would understand that the magnetic field strengths of the main magnetic field in MRI are typically on the order of 1-10 Tesla (T). The Office takes OFFICIAL NOTICE that a main magnetic field strength on the order of 1-10 T is considered well-understood, routine, and conventional in the art of magnetic resonance imaging). It is noted that the claimed range (0.2 - 3T) overlaps the prior art range (1-10 T). The strength of the magnetic field is understood as having an effect on the overall signal to noise ratio especially regarding signal bandwidth (e.g., the ability to discern frequency and phase encoding in the of the RF signal and therefore the ability to discern the position from which signals are coming from, and therefore spatial resolution) because the Larmor frequency is proportional to the magnetic field strength. While stronger magnetic field is generally better for the reasons above, the ordinarily skilled artisan would understand that a stronger magnetic field is almost more costly.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujii such that a magnetic field strength generated by the magnet assemblies disposed opposite to each other is within a range of 0.2T to 3T, inclusive, as matter of routine optimization of a result-effective variable (i.e., optimizing magnetic field strength to balance signal to noise ratio with cost) because it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii in view of Fallone et al., US 2019/0217127 A1 (hereinafter “Fallone”).
Regarding claim 4: Fujii teaches the invention of claim 2. Fujii futher teaches the claimed “second treatment head” in the sense that the treatment head in Fujii is located at the through hole and the radiotherapy rays emitted by the treatment head irradiate the target object as discussed above regarding claim 2. However, Fujii does not teach the claimed “first treatment head”, let alone that the first treatment head is located between the two magnet assemblies disposed opposite to each other.
Fallone, teaches the clamed first treatment head in the sense that the Fallone teaches a treatment head located between two magnet assemblies disposed opposite to each other, wherein the radiotherapy rays emitted by the treatment head irradiate the target object (see Figs. 8 and 9).
In this sense, the prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference.
The ordinarily skilled artisan would have recognized that the prior art elements could have been combined my merely adding another treatment head by attaching it to the gantry in Fujii in such a way that the added treatment head is positioned between the two magnet assemblies disposed opposite to each other similar to how the treatment head is positioned in Fallone. Furthermore, such an arrangement would yield treatment beams in orthogonal directions and so the ordinarily skilled artisan would understand that the first and second treatment heads would therefore not interfere with each other. In this sense, it is understood that the in combination, each treatment head would continue to perform the same functions as they did separately.
The combination is predictable in that it would allow the system to emit radiation from multiple positions/angles simultaneously.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Fujii with the claimed “first treatment head” located between two magnet assemblies disposed opposite to each other, wherein the radiotherapy rays emitted by the first treatment head irradiate the target object, as taught by Fallone, because it would have merely involved combining prior art elements according to known methods to yield predictable results. The ordinarily skilled artisan would have been motivated to make this modification in order to emit radiation from multiple position/angles simultaneously such as in a focused manner to increase dosage to the target relative to surrounding tissue.
Regarding claim 5: Claim 5 depends on claim 2. Claim 2 is written such that claim 2 can be infringed by satisfying one or two options. Claim 5 further limits claim 2 by further limiting each of the two options. More specifically, in the case of the first option (i.e., the treatment head is located between the magnet assemblies), the treatment head is a gamma-ray treatment head; however, in the case of the second option (i.e., the treatment head is located at the through hole), the treatment head is a gamma-ray treatment head or an X-ray treatment. In this sense, claim 5 does not require a gamma-ray treatment head disposed between the magnet assemblies as long as a gamma-ray or X-ray treatment head is located at the through hole; likewise, claim 5 does not require a gamma-ray or X-ray treatment head located at the through hole as long as a gamma-ray treatment head is disposed between the magnet assemblies.
In this case, Fujii discloses the second option (i.e., the treatment head located at the through hole; see above regarding claim 2), but does not teach that the treatment head is gamma-ray or X-ray treatment head. Rather, the treatment head in Fujii is charged particles. In this sense, the prior art contains a device which differed from the claimed device by the substitution of some components with other components.
Fallone teaches gamma rays or X-rays as alternatives to charged particles (¶ [0044]). In this sense, the substituted components and their functions were known in the art.
The ordinarily skilled artisan would have substituted one radiation therapy source for another by simply attaching a different radiation therapy source to the gantry and positioning it at the through hole. From another point of view, the ordinarily skilled artisan would have realized that the techniques of Fujii are not necessarily limited to charged particle therapy but could have been applied to other types of radiation therapy.
Further the results of the substitution would have been predictable; i.e., therapy by another type of radiation (in this case, gamma or X-ray therapy). From another point of view, applying Fujii’s technique to a magnetic resonance imaging guided radiotherapy system of a different type of radiation (in this case, gamma or X-ray therapy) would have similarly resulted in reduced magnetic field strength outside the imaging region resulting in reduced interaction (interference) between the imaging and therapy portions of the system.
It would have been obvious to one having ordinary skill in the art to modify the invention of Fujii such that the treatment head is a gamma-ray or X-ray treatment head, as taught by Fallone because it would have merely involved a simple substitution of one known element for another to obtain predictable results; the ordinarily skilled artisan would have been motivated to make this modification in order to provide treatment of another type of radiation (in this case, gamma or X-ray treatment) or otherwise in order to provide improvements of Fujii’s technique to a magnetic resonance imaging guided radiotherapy system of a different type of radiation (in this case, gamma or X-ray therapy).
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al., US 2021/0031055 A1 (hereinafter “Jiang”).
Regarding claim 14: Fujii discloses the invention of claim 1; but does not teach at least one detector, the at least one detector being disposed at a position opposite to the at least one treatment head and configured to receive the radiotherapy rays emitted by the at least one treatment head and generate corresponding image data.
Jiang teaches at least one detector (megavoltage image detectors 330, Fig. 9), the at least one detector being disposed at a position opposite to the at least one treatment head (321, 324, 327, Fig 9) and configured to receive the radiotherapy rays emitted by the at least one treatment head and generate corresponding image data.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Fujii by providing at least one detector, the at least one detector being disposed at a position opposite to the at least one treatment head and configured to receive the radiotherapy rays emitted by the at least one treatment head and generate corresponding image data, as taught by Jiang; and the ordinarily skilled artisan would have been motivated to make this modification in order measure and portray/convey dosage in a visual (2D) manner.
Regarding claim 16: Fujii teaches that the treatment head (21, Fig. 2) is positioned at the through hole (65A, Fig. 2) of the top magnetic assembly. In making the combination discussed above regarding claim 14, the ordinarily skilled artisan would have found it obvious to position the detector such that it is located at the through hole of the bottom magnetic assembly (i.e., 65B, Fig. 2), because Jiang teaches the detector is positioned opposite the treatment head, and the opposite through hole in Fujii (65B) is positioned opposite the treatment head. In other words, the position/location of the opposite through hole in Fujii and the position/location of the detector the Jiang teaches appear to be the same position/location (i.e., opposite the treatment head). It therefore would been obvious to position the detector to be located at the through hole of the bottom magnet assembly as an obvious consequence of making the modification discussed above regarding claim 14.
Claim 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii in view of Fallone as applied to claim 4 above, and further in view of Jiang as applied to claim 14 above; or alternatively over Fujii in view of Jiang as applied to claim 14 above, and further in view of Fallone as applied to claim 4 above.
Regarding claim 15: Claim 15 appears to combine the concept of the detector positioned opposite the treatment head (see above regarding claim 14) with the concept of multiple treatment heads (already discussed above as obvious; claim 4). These concepts are considered obvious for the reasons already discussed above. The concept of the plurality of detectors obviously follows as a natural consequence of combining these conceptions (i.e., since the treatment heads are positioned orthogonally to each other in different directions, they would each need their own detector positioned opposite to the corresponding treatment head). It other words, it would have been obvious to provide another detector for each additional treatment head wherein said another detector is positioned opposite said additional treatment head as an obvious matter of the combining the teachings of Jiang and Fallone with Fujii.
Examiner Remarks
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kruip et al., US 2010/0013418 A1 teaches a magnetic resonance imaging guided radiotherapy system, comprising: a magnetic resonance imaging apparatus including two magnet assemblies, the two magnet assemblies being disposed opposite to each other on the rotating gantry in a circumferential direction of the rotating gantry and used to provide a magnetic field for imaging, the magnetic field for imaging having an overlapping region with the radiotherapy rays, so as to perform magnetic resonance imaging on the target object; wherein a center axis of the magnet assemblies disposed opposite to each other has a preset included angle with the rotation axis, and closer to the center axis, greater a distance between inner surfaces of the magnet assemblies disposed opposite to each other (e.g., see Figs. 6 and 7).
Fahrig et al., US 2010/0239066 A1 teaches a magnetic resonance imaging guided radiotherapy system, comprising: a rotating gantry rotatable about a preset rotation axis; at least one treatment head rotatable along with rotation of the rotating gantry and configured to emit radiotherapy rays to a target object; and a magnetic resonance imaging apparatus including two magnet assemblies, the two magnet assemblies being disposed opposite to each other on the rotating gantry in a circumferential direction of the rotating gantry and used to provide a magnetic field for imaging, the magnetic field for imaging having an overlapping region with the radiotherapy rays, so as to perform magnetic resonance imaging on the target object (e.g., see Fig. 2)
Green, US 6,198,957 B1 teaches a magnetic resonance imaging guided radiotherapy system, comprising: a rotating gantry rotatable about a preset rotation axis; at least one treatment head rotatable along with rotation of the rotating gantry and configured to emit radiotherapy rays to a target object; and a magnetic resonance imaging apparatus including two magnet assemblies, the two magnet assemblies being disposed opposite to each other on the rotating gantry in a circumferential direction of the rotating gantry and used to provide a magnetic field for imaging, the magnetic field for imaging having an overlapping region with the radiotherapy rays, so as to perform magnetic resonance imaging on the target object (see Figs. 4 and 5)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
7 February 2026
1 ¶ [0035]: “As FIG. 2 illustrates, the gantry 18 is made rotatable by a motor 18A.”
2 ¶ [0035]: “[…] the irradiation apparatus 21 […] are rotated in association with a rotation of the gantry 18.”
3 ¶ [0035]: “The rotation of the gantry 18, and accompanying rotations of the respective components allows irradiation of the particle beam to the irradiation target 26 of the irradiation object 25 from an arbitrary direction in a plane perpendicular to a rotation axis of the gantry 18.”
4 See Fig. 2 which illustrates coils 61 disposed on opposite poles 63A and 63B of iron core 60
5 See Fig. 2 which illustrates coils 61 disposed on gantry 18 via iron core 60.
6 See ¶ [0038], [0040], [0045]
7 See Fig. 2 which shows the irradiation target 26 in the imaging magnetic field.