DETAILED ACTION
Response to Arguments
Applicant's arguments filed 02 June 2026 have been fully considered but they are not persuasive.
Claim interpretation under 35 USC 112(f):
The remarks do not dispute the interpretation, therefore the claim interpretation stands.
Claim rejections under 35 USC 112(b):
The rejection has been overcome by amendment to claim 3. However, by amendment, claim 1 now has two indefiniteness issues.
Specifically, claim 1 is vague and indefinite for requiring “the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles”. Specifically, it is unclear how a single beam “charged particle beam” can simultaneously exit from a plurality of different angles. As understood from the published specification “The scanning magnet 110 may be configured to diverge the charged particle beam. The divergence refers to a deflection of the charged particle beam that travels in one direction originally to multiple directions, i.e., for deflection at different angles, a point at which the charged particle beam begins to deflect may be set as a deflection start point, a deflection angle may be” ([0039]).
Paragraph [0042] also teaches the change of direction of the charged particle beam occurs at two different time periods (see further discussion below).
That is, like in Mizushima et al. the magnet of the instant specification deflects the charged particle beam to multiple angles.
The only way for the charged particle beam to exit a focusing magnet(s) simultaneously from a plurality of angles would be either if (a) by simultaneously the claim means not actually at the same time but separated by the time to deflect the charged particle beam or (b) the beam is actually divided into a plurality of sub-beams or beamlets or multiple beams. For the purposes of examination, (a) is interpreted as the intended meaning because the instant specification fails to suggest any division or splitting of the beam into beamlets. However, as clear from the remarks filed 02 June 2026, the claim is intended to have the interpretation (b). Therefore, the claim will be additionally rejected under 35 USC 112(a) as discussed below. Claim 26 which requires the beamlet interpretation is rejected under 35 USC § 112(a) as discussed herein below.
Additionally, claim 1 is vague and indefinite for reciting “the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles and converges at a treatment center” because it is not clear how the ions can “simultaneously” exit and converge at the same time. As clear from figure 1 the beams exit the focusing magnet 120 prior to converging at a single point. As above it will be interpretated that by “simultaneously” the claim means not actually simultaneously but occurring at similar time. This allows for the interpretation of Mizushima et al. which has the charged particle beam (see figure 1) converging at isocenter “O” via focusing magnet 10 after deflection by deflector 20.
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Claim rejections under 35 USC 102(a)(1) Mizushima
The remarks take the position that Mizushima teaches that a single particle beam is deflected by a certain angle and after each particle beam is deflected by the bending magnet, it is then incident on the focusing magnet, therefore fails to disclose the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles and converges at a treatment center point.
This has not been found persuasive. Initially, the claim language is indefinite (see above). Moreover, the instant specification does not support this claim limitation. Specifically, paragraph [0038] of the originally filed specification teaches “wherein the charged particle beam may be deflected to multiple angles by a scanning magnet, the charged particle beam may incident from a relatively large angle range to the focusing magnet, and the charged particle beam deflected by the focusing magnet may converge to a focus from different angles”
That is, it appears the instant application like Mizushima teaches that the beam is deflected to multiple angles and focused by the focusing magnet. There is no suggestion that by divergence the claim means a division or splitting the charged particle beam into multiple beamlets. Indeed as discussed by paragraph [0039]:
“The divergence refers to a deflection of the charged particle beam that travels in one direction originally to multiple directions, i.e., for deflection at different angles, a point at which the charged particle beam begins to deflect may be set as a deflection start point, a deflection angle may be.”
That is, as understood by the written description the scanning magnet deflects the beam to multiple directions. This is the same as disclosed by Mizushima. There is no suggestion that the charged particle beam is divided into beamlets, thus such an interpretation cannot be supported by the instant specification.
The remarks then point to paragraph [0041] for reciting deflection in multiple directions to thereby achieve uniform irradiation over a certain range while dispersing the power density of the charged particle beam ([0042]). The remarks then reiterate that claim 1 requires the charged particle beam to be dispersed by the scanning magnet 110.
This has not been found persuasive. Specifically, paragraph [0042] actually recites “In some embodiments, the scanning magnet 110 may scan the charged particle beam at a certain angle in a certain direction at a certain moment (such as a T1 moment), and scan the charged particle beam at a certain angle in a certain direction at a next moment (such as a T2 moment), and the angles may correspond to a magnetic field of the scanning magnet 110, for example, the magnetic field of the scanning magnet 110 may be strengthened, a deflected angle may be relatively large”
That is, paragraph [0042] makes clear that the deflector sequentially deflects the charged particle beam. This is exactly what Mizushima does as admitted by the remarks (see page 10 first paragraph of remarks). Further strengthening not only is the invention as claimed is not distinguishable over Mizushima but fails to meet the written description requirement under 35 USC 112(a).
Therefore the remarks are not persuasive and the rejection stands as reiterated herein below.
Claim 18:
The remarks take the position that Mizushima fails to disclose “wherein a trajectory of the gap from the middle position to the two end positions is an arc”.
This has not found persuasive. As seen in figure 1b of Mizushima the focusing magnets are separated by a gap. In the plan view in figure 1a (annotated below) the gap is in the form of an arc via the shape of the magnets 12a/12b.
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The remarks take the position that this interpretation is not the same concept of the disclosed invention. However, the claim has not been structurally distinguished to preclude such an interpretation.
Applicant is reminded although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Here, since Mizushima teaches an arc as required by the claim and the claim is anticipated by Mizushima. Since there is no structural requirement as to how the arc gap is formed, claim 18 is not distinguished from that of Mitzushima
Rejections under 35 USC 102(a)(1): Kats
Similar to Mizushima, the remarks take the position that Kats teaches sequential irradiation and not simultaneous. However, as discussed above the instant specification does not support a simultaneous irradiation from multiple angles. However, instead the specification like Kats teaches in paragraph [0042] that the charged particles are irradiated at a certain angle at one time period and at the next are irradiated at a different angle. Moreover, like in Kats the instant specification defines diverge to refer to deflected angles (see paragraph [0039]).
Rejections under 35 USC 103
The remarks reiterate the same positions as discussed above. This has not been found persuasive, therefore the rejection stands.
Additional art:
Upon further search and consideration additional art has been found that would anticipate or make obvious claim 1. While not applied herein, the references are discussed in the pertinent art section at the conclusion of this office action.
Election/Restrictions
Newly submitted claims 21-24 and 26 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 21-24 are directed towards previous respective claims 14-15 and 4-6 previously nonelected without traverse. Canceling claims 4-6 and 14-15 and reintroducing the subject matter as new claims does not change that the claimed subject matter has been non-elected without traverse.
Additionally claim 26 is directed towards a previously unclaimed sub-species discussed in paragraph [0041] of the published application. This claim has the mutually exclusive characteristic of changing a point shape to a band shape after deflection by the scanning magnet. This would raise serious search burden as prior art reading on the elected sub-species (iii) would likely not read on the sub-species of paragraph [0041] as evident by the prior art discussed below
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-24 and 26 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A beam generating device configured to generate a charged particle beam in claim 1. (accelerator see paragraph [0040] of the published application)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 8-13, 16, 18, 25 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 fails to meet the written description requirement for reciting:
“wherein the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles and converges at a treatment center point”
MPEP 2163 (I) (B) recites:
“the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) ”
Here, the instant specification clearly defines divergence in paragraph [0039] which recites:
“The divergence refers to a deflection of the charged particle beam that travels in one direction originally to multiple directions, i.e., for deflection at different angles, a point at which the charged particle beam begins to deflect may be set as a deflection start point, a deflection angle may be. The focusing magnet 120 may be configured to converge the charged particle beam deflected by the scanning magnet 110”
Further, paragraph [0042] recites
“the scanning magnet 110 may scan the charged particle beam at a certain angle in a certain direction at a certain moment (such as a T1 moment), and scan the charged particle beam at a certain angle in a certain direction at a next moment (such as a T2 moment), and the angles may correspond to a magnetic field of the scanning magnet 110, for example, the magnetic field of the scanning magnet 110 may be strengthened, a deflected angle may be relatively large.
As clear from above, the focusing magnet sequentially deflects the charged particle beam to multiple directions at different time periods. These beams are converged on a single point ([0044]). However there is no disclosure that the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles as required by claim 1. In other words, as clear from the applicants disclosure a sequential deflection by scanning magnet 110 ([0042]) would not result in a simultaneous exiting of charged particle beams from the magnet 120 as the charged particle beam is deflected sequentially.
Therefore, while the claim supports deflection to multiple locations (i.e. divergence), there is no suggestion that the charge particle beam simultaneously exits the focusing magnet from a plurality of angles.
For the purposes of examination, it will be interpreted that by simultaneously the claim means as delayed via the time to deflect from one angle to the next, in the same manner as Mitzushima discussed below.
Additionally, claim 1 fails to meet the written description requirement for reciting:“wherein the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles and converges at a treatment center point”
As clearly indicated in figure 1 of the instant drawings the charged particle beam first exits than is converged at a treatment point. This cannot occur simultaneously as the charged particle beam has to exit the focusing magnet before converging at a treatment point.
For the purposes of examination, it will be interpreted that simultaneously is intended to mean within the period it takes all beams to be deflected to converge on a point.
All dependent claims fail to meet the written description requirement by virtue of the dependencies on rejected claim 1.
Claim 25 fails to meet the written description requirement for reciting “wherein the charged particle beam is diverged by the scanning magnet into a plurality of beamlets; and the plurality of beamlets of the charged particle beam exit the one or more focusing magnets from the plurality of angles and converge at the treatment center point.”
As discussed above, paragraph [0042] clearly demonstrates that the charged particle beam is selectively directed to different directions at different time periods. The specification is devoid of any suggestion that the beam is diverged into beamlets as required by claim 25.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 8-13, 16, 18, 25 and 27 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 1 is vague and indefinite for requiring “the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles”. Specifically, it is unclear how a single beam “charged particle beam” can simultaneously exit from a plurality of different angles. As understood from the published specification “The scanning magnet 110 may be configured to diverge the charged particle beam. The divergence refers to a deflection of the charged particle beam that travels in one direction originally to multiple directions, i.e., for deflection at different angles, a point at which the charged particle beam begins to deflect may be set as a deflection start point, a deflection angle may be” ([0039]).
Moreover, paragraph [0042] suggests sequentially deflection the charged particle beam (i.e. precluding simultaneous entry and exit to the focusing magnet)
That is, like in Mizushima et al. the magnet of the instant specification deflects the charged particle beam to multiple angles.
The only way for the charged particle beam to exit a focusing manget(s) simultaneously from a plurality of angles would be either if (a) by simultaneously the claim means not actually at the same time but separated by the time to deflect the charged particle beam or (b) the beam is actually divided into a plurality of sub-beams or beamlets or multiple beams. For the purposes of examination, (a) is interpreted as the intended meaning because the instant specification fails to suggest any division or splitting of the beam into beamlets.
Additionally, claim 1 is vague and indefinite for reciting “the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles and converges at a treatment center” because it is not clear how the ions can “simultaneously” exit and converge at the same time. As clear from figure 1 the beams exit the focusing magnet 120 prior to converging at a single point. As above it will be interpretated that by “simultaneously” the claim means not actually simultaneously but occurring at similar time. This allows for the interpretation of Mizushima et al. which has the charged particle beam (see figure 1) converging at isocenter “O” via focusing magnet 10 after deflection by deflector 20.
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All dependent claims are vague and indefinite by virtue of their dependencies on rejected claim 1.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8-11, 13, 16, 18 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mizushima et al. (US pgPub 2019/0311879).
Regarding claim 1, Mizushima et al. teach a radiation therapy device (fig. 1a), comprising:
a beam generating device (upstream accelerator side regarded as the x- axis, thus an accelerator, see paragraph [0099] (note beam generator device invokes 112(f) and the disclosure teaches the structure to be an accelerator)) configured to generate a charged particle beam (accelerator supplies charged particle beam [0099], thus generates from source and accelerates therefrom);
a scanning magnet (20) configured to diverge the charged particle beam (via deflection the charged particle beam is diverged as indicated by ray traces in figure 1a see paragraph [0097] for various angles of deflection. Note this is commensurate as disclosed see paragraphs [0039] and [0042]of the instant application, discussed above); and
one or more focusing magnets (focusing magnet 10 comprising magnetic field regions 15a/15b. Alternatively, Figure 1b shows 15a made up of poles 12a and 15b made up of poles 12b, each pole pair 12a/12b is alternatively interpreted as two focusing magnets) configured to deflect the charged particle beam diverged by the scanning magnet (as seen in figure 1), wherein the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of different angles and converges at a treatment center point (all beams exit from 10 and converge on isocenter O, note paragraph [0103] teaches arbitrary entry point P1 and exit point P2 (see figure 2), thus for each deflection angle ([0097]) all beams converge from exit at O. Here, it is interpreted that simultaneously means during the period of deflection of charged particle beam to the various deflection angles via 10 to reach isocenter O).
Regarding claim 2, Mizushima et al. teach wherein each focusing magnet includes: an entrance configured for injection of the charged particle beam; and an exit configured for emission of the charged particle beam (see annotated figure 1a below).
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Regarding claim 3, Mizushima et al. teach wherein the focusing magnets converge the charged particle beam deflected by the focusing magnets converges at the treatment center point within a range where the treatment center point is taken as a center ([0093] “The focusing magnet 10 is configured to focus the charged particle beam incident from a wide range of deflection angle ϕ with respect to the x-axis on an xy-plane, to an isocenter O”. That is 10 converges (focuses at a treatment center point (i.e. isocenter O)) within a wide range of deflection, wherein the isocenter O is the treatment center point) and a central angle is greater than 180º (O is a point thus having a central angle of 365 degrees).
Regarding claim 8, Mizushima et al. teach wherein a count of the focusing magnets is at least two (fig. 1b, 12a and 12b), the at least two focusing magnets are arranged adjacently or oppositely (as seen in figure 1b); and when the at least two focusing magnets are arranged oppositely, the exits of the at least two focusing magnets are opposite (exits in annotated figure above are arranged opposite of x axis).
Regarding claim 9, Mizushima et al. teach wherein a deflection angle of the charged particle beam is within a range of 0-150º ([0097] teaches max ranges of deflection by bending magnet 20 within this range)
Regarding claim 10, Mizushima et al. teach wherein each focusing magnet bends towards the exit of each focusing magnet (magnet 10 bends towards the exit as seen in figure 1a), and the exit of each focusing magnet is arc (as seen in annotated figure above, exit forms an arc).
Regarding claim 11, Mizushima et al. teach wherein a magnetic field intensity of a magnetic field generated by the focusing magnets is not uniformly distributed ([0107] teaches a non-uniformity in the magnetic field distribution).
Regarding claim 13, Mizushima et al. teach wherein each focusing magnet (interpreting single focusing magnet 10) includes a first portion (fig. 1b, left side 12a/12b interpreted as first portion) and a second portion (right side 12a/12b interpreted as second portion), a gap is arranged between the first portion and the second portion (gap between left and right sides indicated by arrows), and a dimension of a middle position of the gap is greater than a dimension of two ends positions of the gap in a vertical direction (in y direction (vertical dimension) gap between left and right 12a and left and right 12b is smaller than the gap at isocenter “O”).
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Regarding claim 16, Mizushima et al. teach wherein a dimension of the gap gradually decreases from the middle position to the two ends positions (see annotated figure below).
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Regarding claim 18, Mizushima et al. teach wherein a trajectory of the gap from the middle position to the two ends positions is an arc (as seen in figure 1a, a trajectory can be drawn from the middle line along the x axis (i.e. along middle gap in annotated figure 1b above) along an arc).
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Regarding claim 27, Mizushima et al. teach wherein a count of the one or more focusing magnets is at least two (15a/15b), exits of the at least two focusing magnets are opposite each other (charged particle beam vertical exit of 15a is opposite vertical exit 15b), and after the charged particle beam is deflected by the at least two focusing magnets, the range emitted from the exits of the at least two focusing magnets covers 360° (the instant specification teaches at paragraph [0052] “In some embodiments, after treatment for a period of time, the patient 140 (i.e., a treatment bed) may be reversed from head to tail (e.g., reversing an inward direction and an outward direction), which may achieve 360° treatment easily.”—that is it is interpreted that the 360 degrees is achieved by reversing the patient table1,2. Mizushima teaches 180 degree rotation, since the patient inherently lays on a coach/table/bed, by reversing the patient the exit from the two magnets are capable of 380 degree irradiation with the charged particle beam).
Claims 1 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kats (Kats, “gantry free transport line for Proton/Ion therapy”, 2017) (copy of publication submitted herewith).
Regarding claim 1, Kats teaches a radiation therapy device (fig. 5-6), comprising:
a beam generating device (proton beam treatment requires an upstream accelerator) configured to generate a charged particle beam (particle beam entering magnet to deflect by 20 degrees in figures 5 and 6);
a scanning magnet (magnet in figures 5 and 6 deflecting by 20 degrees) configured to diverge the charged particle beam (via deflection the charged particle beam is diverged to either upper path to 30 degree magnets or lower path to 30 degree magnets); and
one or more focusing magnets (30 degree magnets in upper and lower path are interpreted to be focusing magnets because they direct the beam to a point on the patient as illustrated in figures 5 and 6) configured to deflect the charged particle beam diverged by the scanning magnet (30 degree magnets direct diverged beam from 20 degree magnet from respective upper and lower paths to the patient) wherein the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of different angles and converges at a treatment center point (as seen in figures 5-6, same interpretation as discussed above with respect to Mizushima).
Regarding claim 12, Kats teaches a length of each focusing magnet is less than or equal to 4 m (figures 5-6 show 30 degree magnets have a length less than 2 m); and a width of each focusing magnet is less than or equal to 2m (the vertical direction of the magnets is interpreted to be the width, since the magnets are rectangular the width is also less than 2 meters since the length is indicated to be less than 2 meters).
Claims 1 and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Clayton (US pgPub 2023/0319973).
Regarding claim 1, Clayton teaches a radiation therapy device (fig. 2B), comprising:
a beam generating device (210) configured to generate a charged particle beam (as indicated by ray exiting 210);
a scanning magnet (220-221) configured to diverge the charged particle beam ([0028] teaches the particles of the particle beam 271 are diverging when they leave the scan or vacuum port 225 (i.e. diverging as result of magnets 221-220)); and
one or more focusing magnets (250 is an entry angle control component ([0028]), which may be formed of one or more magnets ([0034])) configured to deflect the charged particle beam diverged by the scanning magnet (converge see paragraph [0028]), wherein the charged particle beam simultaneously exits the one or more focusing magnets from a plurality of angles (as seen in figure 2b, particle beam 273 exiting 250, see discussion with respect to paragraph [0055] teaching a plurality of divergent particle beams. Since all beams enter 250 at the same time, they are interpreted to exit at the same time from different angles as seen in figure 2B) and converges at a treatment center point (figure 2B show beams converging towards a target, wherein the target may be repositioned to be at the convergent point. That is, since the beams are converging they will converge at a point, by positioning the target tissue at that point the device is capable of performing the claimed function. MPEP 2114 recites “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Here, Clayton teaches all structural limitations of the claim, since the beams are convergent, the device is capable of operating such that a treatment center point is at the convergence point of the charged particle beams).
Regarding claim 25, Clayton teaches wherein the charged particle beam is diverged by the scanning magnet into a plurality of beamlets ([0055], figures 2b and figure 9); and the plurality of beamlets of the charged particle beam exit the one or more focusing magnets from the plurality of angles and converge at the treatment center point (see discussion with respect to claim 1).
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mizushima et al. as evidenced by Yan et al. (US20230051255) or Mitsumoto (EP3136400) (copy of publication submitted herewith)..
Regarding claim 12, Mizushima teaches the focusing magnet in the irradiation room with a low ceiling ([0126]) and reducing installation space ([0074]) and a width of the magnet much smaller than the length (as evident from figure 1b).
However, Mizushima fails to specifically disclose the length and width of the focusing magnet. Therefore fails to disclose a length of each focusing magnet is less than or equal to 4 m; and a width of each focusing magnet is less than or equal to 2m.
However, Yan et al. is evidence that a conventional radiation treatment room has a height of 3 m ([0036]), similarly Mitsumoto is evidence that an irradiation chamber may measure 3 meters in height ([0025]).
Therefore, it would have been obvious to one of ordinary skill in the art for the length (i.e. height) of the focusing magnet 10 to be less than 4 meters, because a conventional treatment room is known to have a height of 3 meters as evidenced by Yan or Mitsumoto, therefore by having a length (height) less than the height of the room would allow for the focusing magnet to be within the irradiation room as suggested by Mizushima such that the ceiling height may be kept low, thus reducing the space requirement for treatment. Moreover, since it would be obvious for the height to be less than or equal to 4 m, it would further be obvious to one of ordinary skill in the art that the width of the magnet 10 would be less than or equal to 2 m as the width of magnet 10 seen in figures 1b and 4b is less than half of the height (i.e. length) of magnet 10. Alternatively, interpreting the focusing magnets to be 12a/12b, in a room of 3 meters height, the height of 12a/12b would be far less than 3 meters and the width would be far less than 2 meters as the width of 12a/12b is less than the length of each magnet.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US11058899 is similar to Mizushima discussed above and would anticipate at least claim 1. Additionally figure 10 shows an arrangement where the magnets have offset portions that would be sufficient to anticipate claim 13.
CN115569312 anticipates also anticipates claim 1 (see figure 1). Note: deflection occurs greater than 180 degrees (i.e. claim 3) (copy of publication submitted herewith).
CN1139013 (cited in IDS of 07/02/2024) also anticipates at least claim 1, see figure 1.
FR2201523 also anticipates claims 1 and 3 (submitted with IDS of 07/02/2024, see figure 2).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
1 Note if applicant amends the claim to require structure to emit to cover a range of 360 degrees, claim 27 would be considered directed towards a non-elected species. That is species I, figure 1 and sub-species III (fig. 4) does not support 360 degree irradiation at the exit of 120. Specifically, figure 1 clearly shows less than 360 degrees irradiation from exit of 120.
2 It is additionally noted that CN115569312 (cited in the office action of 03/02/2026 and discussed in the pertinent art section below) teaches 360 degree deflection of charged particle beam (see figure 1). While not applied herein ‘312 may anticipate both claims 1 and 27.
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