DETAILED ACTION
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:
“an irradiation unit irradiating an irradiation target with the particle beam in claim 1. (scanning electromagnet –see paragraph [0030])
“a first shielding member” in claims 1 and 11 (material that shields particle beam [0039]).
“a second shielding member” in claims 1 and 11. (material that shields particle beam ([0039])).
“a support member supporting” in claim 3 (a material having a groove ([0040]-[0041]))
“a cooling unit” in claim 8 (tube for passing fluid ([0052])).
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 § 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, 3-7 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toru (JP2014138669) (copy of publication and machine translation submitted with the IDS of 12/05/2025).
Regarding claim 1, Toru teach a particle beam irradiation apparatus (figs. 1-2, 7 and 8) comprising:
an accelerator (fig. 1, 2 upstream of components in figure 7) accelerating a particle so as to generate a particle beam (inherent to an accelerator);
an irradiation unit (irradiation nozzle 18 irradiates the charged particle beam using a scanning method [0023], and paragraph [0056] teaches scanning electromagnet is the scanning means 18a) irradiating an irradiation target with the particle beam (object below nozzle);
a transport path (path through transport line 3 which transports charged particle beam from accelerator to gantry 4 ([0017]), which transports the charged particle beam to nozzle in order for irradiation from nozzle to occur as discussed in paragraph [0023]) provided between the accelerator and the irradiation unit (path through transport line 3 which transports charged particle beam from accelerator to gantry 4 ([0017]), which transports the charged particle beam to nozzle in order for irradiation from nozzle to occur as discussed in paragraph [0023]. Thus 3 between nozzle (i.e. irradiator) and accelerator) and provided so as to be capable of transporting the particle beam ([0017]); and
a collimator device (figs. 7-8, 53A/53B) including a first shielding member (53A) provided in the transport path (53 part of path 3 in figure 7), shielding the particle beam (best seen in figure 8, 53A shields the beam (i.e. inherent to a collimator to shape the beam)), and including a first opening (53a) allowing the particle beam to pass in an advancing direction of the particle beam (best seen in figure 8, beam passing through 53a of 53A) and
a second shielding member (53B) provided in the transport path (53 part of path 3), shielding the particle beam (fig. 8 shows 53B shielding the beam Ra, see paragraph [0050]), and including a second opening (53b) allowing the particle beam to pass in the advancing direction of the particle beam (beam passing through 53b as seen in figure 8),
wherein the second shielding member is spaced from the first shielding member to a downstream side in the advancing direction of the particle beam (figures 7-8 show 53B downstream of 53A in the beam direction as indicated by arrow Ra), and the second opening of the second shielding member is visible on the downstream side in the advancing direction of the particle beam in a case where the first opening of the first shielding member is viewed from an upstream side in the advancing direction of the particle beam (53a and 53b are coaxial thus 53b is viewable from 53a).
Regarding claim 3, Toru teaches wherein the collimator device includes a support member (transport line 52 including first collimator 53A and second collimator 53B ([0045]). Figure 7 shows transport line 52 including transport line 3. Paragraph [0017] teaches transport line is connected to the accelerator. Therefore, since transport line is a physical conduit (see figure 1, 3) that includes the collimators 53A and 53B, the line itself must inherently support 53A and 53B directly or indirectly) supporting at least the first shielding member and the second shielding member (see interpretation discussed above with respect to support member being the transport line 3 supporting 53A and 53B).
Regarding claim 4, Toru teaches wherein the support member includes a first support surface supporting the first shielding member and a second support surface supporting the second shielding member (respective support surfaces to support 53A and 53B in transport line coupled to accelerator, see discussion in claim 3 above), and the first support surface and the second support surface are machined surfaces formed by drilling in the same direction perpendicular to the advancing direction of the particle beam (This machined and formed are product by process limitations. MPEP 2113 recites: “E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." . Here, the production does not provide any structurally distinguishing feature other than a surface, thus it is interpreted that the inherent surfaces to support 53A and 53B in the transport line are not distinguished from the claimed surfaces even if made by a different process).
Regarding claim 5, Toru teaches wherein the support member supports at least one of the first shielding member and the second shielding member from two directions perpendicular to the advancing direction of the particle beam (figures 7 and 8 show 53A and 53B perpendicular to the path of charged particles, in order for the collimators to remain upright and aligned they inherently are supported in two directions perpendicular to the beam, otherwise the collimators would not remain aligned thus fail to block scatter ray Ra as shown in annotated figure below).
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Regarding claim 6, Toru teaches wherein the support member includes a particle beam passage groove portion forming a passage path for the particle beam so as not to interfere with the particle beam (transport line 3 supporting 53A and 53B discussed above in claim 3, wherein passage of particle beam without interfering with transport line is facilitated by second collimator 53B as seen in figure 8).
Regarding claim 7, Toru teaches wherein the particle beam is incident into the first opening of the first shielding member from the upstream side in the advancing direction of the particle beam (figure 8 showing 53A collimating the beam R through opening 53a), passes through the particle beam passage groove portion of the support member (through transport line 3 between 53A and 53B), enters the second opening of the second shielding member (R enters opening 53b in 53B), and exits from a downstream end portion of the second opening in the advancing direction of the particle beam (as indicated by R in figure 8).
Claim 11 is a combination of claims 1 and 3 and is taught as discussed in the citations above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Sasai (US pgPub 2021/0299480) in view of Toru.
Regarding claim 1, Sasai teaches a particle beam irradiation apparatus (fig. 1) comprising:
an accelerator (2) accelerating a particle so as to generate a particle beam (inherent);
an irradiation unit (3) irradiating an irradiation target with the particle beam ([0026], target is a patient);
a transport path (4) provided between the accelerator and the irradiation unit (4 is between 3 and 2) and provided so as to be capable of transporting the particle beam ([0027]); and
a collimator device (44).
Sasi fails to disclose including a first shielding member provided in the transport path, shielding the particle beam, and including a first opening allowing the particle beam to pass in an advancing direction of the particle beam and a second shielding member provided in the transport path, shielding the particle beam, and including a second opening allowing the particle beam to pass in the advancing direction of the particle beam, wherein the second shielding member is spaced from the first shielding member to a downstream side in the advancing direction of the particle beam, and the second opening of the second shielding member is visible on the downstream side in the advancing direction of the particle beam in a case where the first opening of the first shielding member is viewed from an upstream side in the advancing direction of the particle beam.
However Toru teaches these deficiencies as discussed above.
Toru modifies Sasai by suggesting a structure of the collimator.
Since both inventions are directed towards collimators upstream of a gantry, it would have been obvious to one of ordinary skill in the art to include the collimator of Toru in the device of Sasai because it would allow for accurate beam shape adjustment by removing deviating charged particle beams ([0050]).
Regarding claim 2, Sasai teaches a degrader (43) provided on the transport path (4) and attenuating the particle beam (inherent to an energy degrader), wherein the collimator device is provided on a downstream side of the degrader in the advancing direction of the particle beam (44 is downstream of 43 in beam direction).
Claim 5 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Toru (second interpretation).
Regarding claim 5, Toru teaches wherein the support member supports at least one of the first shielding member and the second shielding (see discussion above with respect to claim 3).
Toru fails to expressly teach member from two directions perpendicular to the advancing direction of the particle beam
However, figures 7 and 8 show 53A and 53B perpendicular to the path of charged particles, in order for the collimators to remain upright and aligned it would be obvious for the collimators to be supported in two directions perpendicular to the beam, would remain aligned and thus fail to block scatter ray Ra as shown in figure 8.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Toru in view of KR100309690 (herein ‘690) (copy of publication and machine translation submitted herewith).
Regarding claim 8, Toru fails to disclose wherein a cooling unit is connected to the support member.
However, ‘690 teaches wherein a cooling unit is connected to the support member (figure 4 shows colling passage 11’ in holder 11 of collimator 10).
‘690 modifies Toru by suggesting a cooling passage for the collimator support.
Since both inventions are directed towards collimators, it would have been obvious to one of ordinary skill in the art to have the cooling member 11’ of ‘690 in the device of Toru because the cooling passage allows heat generated by the beam being incident on the collimator to be cooled (page 3, second full paragraph), thus protecting the collimator from detrimental thermal effects (thermal stress).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Toru in view of KR100309690 (herein ‘690) and further in view of KR19990024031. (herein ‘031) (copy of publication and machine translation submitted herewith)..
Regarding claims 9-10, Toru in view of ‘690 teaches cooling passages formed in the holder 11 (see page 4, third paragraph from bottom of the page). Therefore, the combined device fails to disclose wherein the cooling unit includes an outer tube extending in an up-down direction and an inner tube disposed in the outer tube and causes a cooling medium to flow downward from above through the inner tube, wherein the cooling medium is folded back at a lower end of the inner tube and flows upward from below through a gap between the outer tube and the inner tube.
However, ‘031 teaches wherein the cooling unit (fluid moving through passages 60/56) includes an outer tube (fig. 2, hollow shaft 56) extending in an up-down direction (as seen in figure 2) and an inner tube (60) disposed in the outer tube (60 inside hollow shaft 56) and causes a cooling medium to flow downward from above through the inner tube, wherein the cooling medium is folded back at a lower end of the inner tube and flows upward from below through a gap between the outer tube and the inner tube (last paragraph on page 4).
‘031 modifies the combined device by suggesting an exterior cooling mechanism. Specifically, ‘031 teaches that machining to receive a manifold or pipe increases the cost (see paragraph bridging pages 2-3).
Since both inventions are directed towards cooling systems, it would have been obvious to one of ordinary skill in the art to substitute the embedded fluid passage of the combined device co-axial arrangement suggested in ‘031 because the coaxial arrangement would reduce the cost of the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tsutsui (US pgPub 2023/0414970) teaches a passage selection unit 33 in figure 1, figure 3B shows collimator 33B supported in duct 3B.
Nonaka et al. (USPN 6,080,992) teaches a holder 72 comprising grooves 73b for quickly changing out collimator plates (34a-34c).
KR200325713 teaches a holder 51 holding a collimator 49 on one side and a plate 45 with an aperture on the other (see figure 6).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881