DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments, filed 11 May 2026, with respect to the drawings, the specification, and the claims have been entered. Therefore, the objections to the drawings and the specification have been withdrawn. Claims 8 and 30 are canceled; therefore, the objection to claim 30 and the rejections of claims 8 and 30 under 35 U.S.C. 112(d) and 35 U.S.C. 112(b), respectively, are moot.
Response to Arguments
Applicant’s arguments, filed 11 May 2026, that the previously cited portions of Iio in view of Meng, Chen, and Liu fails to disclose “the neutron shielding plate, the support member and the sliding rail covering member together shield the linear shaft, a driving mechanism of the linear shaft and a mounting part thereof in the irradiation chamber with room-level shielding” have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new interpretation of the previously applied reference(s) and newly found prior art reference(s).
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 “mounting part thereof” (claim 1, last line) must be shown or the feature(s) canceled from the claim(s).
The drawings further fail to show “the neutron shielding plate, the support member and the sliding rail covering member together shield…a driving mechanism of the linear shaft” (claim 1, last three lines). The driving mechanism 73a of the linear shaft is shown only in FIG. 13 (in block diagram form) and FIG. 12. FIG. 12 shows the driving mechanism 73a as being a part of the robotic arm 72a, separated from the linear shaft 71a by the support seat 712a and arm parts 721a. FIGs. 14-15 show that the robotic arm 72a is not shielded by the neutron shielding plate 60, the support member 713b, or the sliding rail covering member 71b, 711b, 712b. Therefore, “the neutron shielding plate, the support member and the sliding rail covering member together shield…a driving mechanism of the linear shaft” (claim 1, last three lines) must be shown or the feature(s) canceled from the claim(s).
No new matter should be entered.
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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 1 recites the limitation “room-level shielding” (claim 1, last line). The specification contains no reference to a “room”, nor to a particular “level” of shielding. Therefore, the specification fails to provide support for how “room-level shielding” is defined in the present application. For the purpose of compact prosecution, the Examiner has interpreted “room-level shielding” to mean that the neutron shielding plate, the support member and the sliding rail covering member are located between the linear shaft, the driving mechanism, and the mounting part thereof, and the remainder of the space inside the irradiation chamber.
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, 6-7, 22-23, 26-29, and 31-32 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 recites the limitation “the linear shaft, a driving mechanism of the linear shaft and a mounting part thereof” (claim 1, last two lines). It is unclear whether the “mounting part thereof” refers to a mounting part of the linear shaft or to a mounting part of the driving mechanism. For the purpose of compact prosecution, the Examiner has interpreted the “mounting part thereof” to mean the “mounting part of the driving mechanism”.
Claims 6-7, 22-23, 26-29, and 31-32 are rejected because of their dependence on 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.
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.
Claims 1 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Iio (EP Patent No. 2921206 A1), hereinafter Iio, in view of Adler et al. (U.S. Patent Application Publication No. 2014/0171725 A1), hereinafter Adler.
Regarding claim 1, Iio discloses a neutron capture therapy system (FIG. 3, element 100), characterized in that the neutron capture therapy system comprises:
a charged particle beam generation part (FIG. 3, element 10a);
a beam transmission part (FIG. 3, element 13);
a neutron beam generation part (FIG. 3, element 10); and
an irradiation chamber (FIG. 3, element 30A), provided with a treatment table (FIG. 3, element 80) and a treatment table positioning device (FIG. 4, element 84), wherein the treatment table positioning device comprises a linear shaft (FIGs. 5 and 6, elements 60, 62), a robotic arm (FIG. 5, element 84) arranged between the linear shaft (FIG. 5, element 60) and the treatment table (FIG. 5, table top portion 83 of treatment table 80) to support and position the treatment table (column 11, lines 53-54), and a shielding device (FIG. 6, element 81);
wherein the neutron capture therapy system is entirely accommodated in a building made of concrete (column 4, lines 55-58; column 8, lines 22-26);
wherein the linear shaft includes a sliding rail (FIG. 6, element 62) fixed to the building (column 17, lines 44-53: the sliding rail 62 is fixed within recessed groove portion 61 in the floor F of the building) and a support seat (FIG. 5, element 82) connected to the robotic arm (FIG. 5: support seat 82 is connected to robotic arm 84 through base 81), the sliding rail is fixed on a fixing surface of the irradiation chamber (column 17, lines 30-53: the sliding rail 62 is fixed within recessed groove portion 61 in the floor F of the irradiation chamber), and the support seat drives the treatment table and the robotic arm to slide along the sliding rail together (column 12, paragraph 0055);
wherein the shielding device includes a sliding rail covering member (FIG. 6, element 81a), the sliding rail covering member is supported by a support member (FIG. 6, element 81b) of the sliding rail covering member (column 12, lines 1-2), and the sliding rail covering member moves together with the support seat (column 12, paragraph 0055) and covers an exposed part of the sliding rail (FIG. 5); and
wherein the support member (FIG. 6, element 81b) and the sliding rail covering member (FIG. 6, element 81a) together shield the linear shaft (FIG. 6, element 62), a driving mechanism of the linear shaft (FIG. 6, driving source 82e) and a mounting part thereof (FIG. 6, element 82c) in the irradiation chamber with room-level shielding (FIGs. 5, 6: elements 62, 82e, and 82c are covered, i.e., shielded, by elements 81a, 81b with respect to the room to the right of wall 31 shown in FIG. 4).
Iio fails to disclose that the fixing surface is provided with a neutron shielding plate, and the sliding rail covering member is arranged between the support seat and the neutron shielding plate; wherein the neutron shielding plate contributes to the room-level shielding.
However, Adler discloses that the fixing surface (paragraph 0060: the sliding rail 64 is fixed on fixing surface 12) is provided with a neutron shielding plate (paragraph 0063: the shielding plates 90 may be coupled to “any of other components in the system 10, or any combination thereof”, such as fixing surface 12), and the sliding rail covering member (FIG. 11F, element 90a) is arranged between the support seat (FIG. 11F, block under element 18 held by arm 602) and the neutron shielding plate (FIG. 11F, element 90b); and
wherein the neutron shielding plate (FIG. 11F, element 90b), the support member (FIG. 13A and paragraph 0161; the sliding rail covering member 90a is supported through coupling to “other components of the system 10”, such as fixing surface 12) and the sliding rail covering member (FIG. 11F, element 90a) together provide the irradiation chamber with room-level shielding (paragraphs 0180-0181).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio to include that the fixing surface is provided with a neutron shielding plate, and the sliding rail covering member is arranged between the support seat and the neutron shielding plate; and wherein the neutron shielding plate, the support member and the sliding rail covering member together provide the irradiation chamber with room-level shielding, based on the teachings of Adler that this simplifies installation of the system by reducing retrofitting requirements for additional shielding (Adler, paragraphs 0180-0181).
Regarding claim 22, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
In addition, Adler discloses that the material of the sliding rail covering member includes a neutron shielding material (paragraph 0181).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler to include that the material of the sliding rail covering member includes a neutron shielding material, based on the additional teachings of Adler that this simplifies installation of the system by reducing retrofitting requirements for additional shielding (Adler, paragraphs 0180-0181).
Regarding claim 23, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
In addition, Iio discloses that an irradiated body (FIG. 4, patient S) is subjected to irradiation treatment by the neutron beam (FIG. 4, neutron beam N) in the irradiation chamber (column 4, lines 44-46).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler as applied to claim 1 above, and further in view of Meng (CN Patent No. 107240428 A), hereinafter Meng (English machine translation provided in a prior office action).
Regarding claim 6, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
In addition, Iio discloses that the robotic arm comprises at least one arm part (FIG. 5, arm parts 84b, 84c).
Iio in view of Adler fails to disclose that the shielding device comprises a robotic arm sheath surrounding the arm part.
However, Meng discloses that the shielding device comprises a robotic arm sheath (FIG. 1, element 2) surrounding the arm part (FIG. 1, element 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler to include that the shielding device comprises a robotic arm sheath surrounding the arm part, based on the teachings of Meng that this prevents radiation from damaging the arm part (Meng, page 3, paragraph beginning “Specifically, the strong radiation area…”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler and Meng as applied to claim 6 above, and further in view of Pinault et al. (U.S. Patent Application Publication No. 2019/0167212 A1), hereinafter Pinault.
Regarding claim 7, Iio in view of Adler and Meng as applied to claim 6 discloses the neutron capture therapy system of claim 6.
Iio in view of Adler and Meng fails to disclose that the robotic arm sheath is provided with an anti-collision protection mechanism.
However, Pinault discloses that the robotic arm sheath is provided with an anti-collision protection mechanism (paragraph 0041).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler and Meng to include that the robotic arm sheath is provided with an anti-collision protection mechanism, based on the teachings of Pinault that this minimizes interference between system components during treatment (Pinault, paragraph 0003).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler as applied to claim 1 above, and further in view of Liu (U.S. Patent No. 10,744,345 B2), hereinafter Liu.
Regarding claim 26, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
Iio in view of Adler fails to disclose that the sliding rail covering member includes a first part and a second part, and each of the first part and the second part includes flat plates connected in sequence.
However, Liu discloses that the sliding rail covering member (FIGs. 9, 10: element 70 (comprising portions 71, 72) covers sliding rail 611 (contained within element 61) with respect to the irradiation area 50 on the inside of the arc) includes a first part and a second part (FIG. 13, elements 71, 72 to the left and right of element 10), and each of the first part and the second part includes plates connected in sequence (paragraph 0081).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler to include that the sliding rail covering member includes a first part and a second part, and each of the first part and the second part includes plates connected in sequence, based on the teachings of Liu that this enables flexibility in terms of movement while still maintaining proper protection (Liu, paragraph 0080).
Liu discloses that the plates connected in sequence are arc-shaped, not flat plates (Liu, paragraph 0083). However, Liu discloses that the plates are arc-shaped because the sliding rail 611 is arc-shaped, and the sliding rail 611 may take other shapes (Liu, paragraph 0065). Liu further discloses that the arc shape may be formed by connecting multiple sections of straight lines (Liu, paragraph 0089). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the teachings of Liu to include that the first and second parts of the sliding rail covering member include flat plates connected in sequence, because such a modification would amount to nothing more than a change in shape (see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Claims 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler and Liu as applied to claim 26 above, and further in view of Yang et al. (CN Patent No. 105682335 B), hereinafter Yang (English machine translation provided in a prior office action).
Regarding claim 27, Iio in view of Adler and Liu as applied to claim 26 discloses the neutron capture therapy system of claim 26.
Iio in view of Adler and Liu fails to disclose that the flat plates are slidably or pivotally connected in sequence.
However, Yang discloses that the flat plates are slidably or pivotally connected in sequence (page 5, paragraph 2, “controllable sliding plate 11”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler and Liu to include that the flat plates are slidably or pivotally connected in sequence, based on the teachings of Yang that this advantageously enables the plates to be adjusted according to different system requirements (Yang, page 5, paragraph 2).
Regarding claim 28, Iio in view of Adler, Liu, and Yang as applied to claim 27 discloses the neutron capture therapy system of claim 27.
In addition, Liu discloses that one end, close to the support seat along a sliding direction of the support seat (FIG. 13, element 10), of each of the first part and the second part is fixedly connected to the support seat, and the other end of each of the first part and the second part is fixedly connected to the support member (paragraph 0080).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler, Liu, and Yang to include that one end, close to the support seat along a sliding direction of the support seat, of each of the first part and the second part is fixedly connected to the support seat, and the other end of each of the first part and the second part is fixedly connected to the support member, based on the additional teachings of Liu that this enables flexibility in terms of movement while still maintaining proper protection (Liu, paragraph 0080).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler as applied to claim 1 above, and further in view of Yamagata et al. (U.S. Patent Application Publication No. 2015/0117584 A1), hereinafter Yamagata.
Regarding claim 29, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
Iio in view of Adler fails to disclose that the material of the support member is a material of which a product after subjecting to neutron irradiation does not have radioactivity or has low radioactivity, or a radioactive isotope generated after subjecting to neutron irradiation has a short half-life period.
However, Yamagata discloses that the material of the support member is a material of which a product after subjecting to neutron irradiation does not have radioactivity or has low radioactivity, or a radioactive isotope generated after subjecting to neutron irradiation has a short half-life period (paragraph 0039).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler to include that the material of the support member is a material of which a product after subjecting to neutron irradiation does not have radioactivity or has low radioactivity, or a radioactive isotope generated after subjecting to neutron irradiation has a short half-life period, based on the teachings of Yamagata that this prolongs the life of the neutron source while making it safe and easy to handle (Yamagata, paragraph 0039).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler as applied to claim 1 above, and further in view of Yamagata and Chen et al. (CN Patent No. 109659061 B), hereinafter Chen (English machine translation provided in a prior office action).
Regarding claim 31, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
Iio in view of Adler fails to disclose that the support member is made of a neutron shielding material, and the neutron shielding plate matches the support member.
However, Yamagata discloses that the support member is made of a neutron shielding material (paragraph 0039).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler to include that the support member is made of a neutron shielding material, based on the teachings of Yamagata that this prolongs the life of the neutron source while making it safe and easy to handle (Yamagata, paragraph 0039).
Iio in view of Adler and Yamagata fails to disclose that the neutron shielding plate matches the support member.
However, Chen discloses that the neutron shielding plate matches the support member (Merriam-Webster.com defines “match” as “to fit together or make suitable for fitting together”; Chen page 3, fifth paragraph from the last, line 7 discloses that the support member 8 fits with neutron shielding plate 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler and Yamagata to include that the neutron shielding plate matches the support member, based on the teachings of Chen that this enables selective motion or fixing in place of system components (Chen, page 7, paragraph beginning “Referring to FIG. 1 and FIG. 3…”).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Iio in view of Adler as applied to claim 1, and further in view of Chen.
Regarding claim 32, Iio in view of Adler as applied to claim 1 discloses the neutron capture therapy system of claim 1.
Iio in view of Adler fails to disclose that the neutron shielding plate covers the support member.
However, Chen discloses that the neutron shielding plate (page 3, last paragraph: housing 1 has a neutron shielding function; therefore, the ceiling of housing 1 is considered to be a neutron shielding plate) covers the support member (FIG. 1: the ceiling of housing 1 covers support member 8).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Iio in view of Adler to include that the neutron shielding plate covers the support member, based on the teachings of Chen that this maintains flexibility of movement while ensuring the neutron irradiation is properly shielded (Chen, page 4, paragraph labeled (3)).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALINA R KALISZEWSKI whose telephone number is (703)756-5581. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/A.K./Examiner, Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881
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