DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Invention I-B, claims 1, 9-17, in the reply filed on 29 June 2026 is acknowledged.
Claims 2-8, 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions II, III, and I-A, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 June 2026.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 9-16 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.
Claims 9-16 define a physical product (sintered particles) by the process used to make them. The structural characteristics imparted by the process cannot be distinguished from standard sintered particles, and one of ordinary skill in the art cannot reasonably ascertain the boundaries and structural implications of the claim.
Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6. 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.
7. Claims 1, 9-17 are rejected under 35 U.S.C 103 as being unpatentable over Huttner (US 20110271451) in view of Daizo (JP 2018015148A), further in view of Hieronimi (US 8387187).
8. Regarding claim 1:
Huttner teaches a radiation shielding jig ([0011] fig. 1 teaches a vacuum patient positioning cushion 10) comprising a tare filled with shielding material particles (the tare is interpreted as a hollow container as taught in [0036] of the instant application. [0011] teaches that the cushion has an enclosure defined by the outer covering. The enclosure is provided with a filler material 18 formed of a plurality of polymeric beads);
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the shielding material particles comprising resin particles having a predetermined particle diameter ([0011] teaches that the enclosure is provided with a filler material 18 formed of a plurality of polymeric beads. Such polymeric beads is a type of resin particles and have predetermined particle diameter).
Huttner does not specifically note that the tare has a hollow three-dimensional shape with a radiation pathway portion, the shielding material particles comprising a mixture of sintered particles ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight) having a predetermined particle diameter with radiation shielding performance and resin particles having a predetermined particle diameter.
Daizo teaches a shield jig with an irradiation path through which a particle beam pass ([0009]). Daizo further teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together. The particle beam R is absorbed when colliding with the inorganic compound ([0041]). Such inorganic compound particles have a predetermined particle diameter ([0090] teaches average primary particle diameter of 1.5 mm. Such particles are fluid particles).
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 Huttner in view of Daizo to include a radiation pathway in Huttner’s cushion and introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure. One of ordinary skill in the art would be motivated to make such modification to allow the passage of particle beam to target tumor while protecting delicate organ (Daizo [0035], [0009]). The mixture of the inorganic compound particles and resin particles would allow for the property of repelling the particle beam R to be relaxed and the absorption performance of the particle beam can be enhanced (Daizo [0041]).
Huttner in view of Daizo does not specifically note that the tare is made of a resin fabric.
Hieronimi teaches that the exterior of the cushion is made of a coated nylon material, which is a type of resin fabric.
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 Huttner to include that the cushion is made of nylon material as taught by Hieronimi. One of ordinary skill in the art would be motivated to make such modification to allow for smooth mould definition, comfortable patient positioning and ease of cleaning (Hieronimi col 1 lines 49-51).
9. Regarding claim 9:
The modified invention above teaches radiation shielding jig according to Claim 1. Huttner does not specifically note that wherein: the sintered particles are collected by fracturing and abrasion fracturing and sieving sintered body with a relative density of 70-90% ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight. "[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure. One of ordinary skill in the art would be motivated to make such modification since the mixture of the inorganic compound particles and resin particles would allow for the property of repelling the particle beam R to be relaxed and the absorption performance of the particle beam can be enhanced (Daizo [0041]).
10. Regarding claim 10:
The modified invention above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles are collected from LiF sintered body ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight. "[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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]). The inorganic compound is a lithium compound, and it is preferable to use lithium fluoride ([0043]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure, wherein the inorganic compound is lithium fluoride. One of ordinary skill in the art would be motivated to make such modification so that the particle beam is more slowly decelerated to make it easier to absorb (Daizo [0043]).
11. Regarding claim 11:
The modified inventive above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles are collected from a mixed system sintered body consisting of LiF with a boron compound 0.1-5 wt.% as boron isotope ¹⁰B wherein a boron compound is selected from B₂O₃, B(OH)₃, BF₃, LiB₃O₅ or Li₂B₄O⁷ ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]). The inorganic compound is a lithium compound, and it is preferable to use lithium fluoride ([0043]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure, wherein the inorganic compound is lithium fluoride. One of ordinary skill in the art would be motivated to make such modification so that the particle beam is more slowly decelerated to make it easier to absorb (Daizo [0043]).
12. Regarding claim 12:
The modified invention above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles are collected from multicomponent system fluoride sintered body with LiF as a main phase, wherein: multicomponent system fluoride sintered body containing 99wt.% to 5wt.% of LiF and 1wt.% to 95wt.% of one or more fluorides selected from MgF₂, CaF₂, A1F₃, KF, NaF and/or YF₃ ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]). The inorganic compound is a lithium compound, and it is preferable to use lithium fluoride ([0043]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure, wherein the inorganic compound is lithium fluoride. One of ordinary skill in the art would be motivated to make such modification so that the particle beam is more slowly decelerated to make it easier to absorb (Daizo [0043]).
13. Regarding claim 13:
The modified invention above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles are collected from a mixed system sintered body consisting of multicomponent system fluoride with LiF as a main phase and boron compounds selected from B₂O₃, B(OH)₃, BF₃, LiB₃O₅ or Li₂B₄O₇, with 0.1 to 5 wt.% as boron isotope ¹⁰B added ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]). The inorganic compound is a lithium compound, and it is preferable to use lithium fluoride ([0043]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure, wherein the inorganic compound is lithium fluoride. One of ordinary skill in the art would be motivated to make such modification so that the particle beam is more slowly decelerated to make it easier to absorb (Daizo [0043]).
14. Regarding claim 14:
The modified invention above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles are collected from a mixed system sintered body consisting of multicomponent system fluoride with LiF as a main phase and a gadolinium compound selected from Gd₂O₃,Gd(OH)₃ or GdF₃, with 0.1 to 2 wt.% as gadolinium isotope ¹⁵⁷Gd added ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]). The inorganic compound is a lithium compound, and it is preferable to use lithium fluoride ([0043]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure, wherein the inorganic compound is lithium fluoride. One of ordinary skill in the art would be motivated to make such modification so that the particle beam is more slowly decelerated to make it easier to absorb (Daizo [0043]).
15. Regarding claim 15:
The modified invention above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles are collected from a mixed system sintered body consisting of multicomponent system fluoride with LiF as a main phase, and boron compounds selected from B₂O₃, B(OH)₃, BF₃, LiB₃O₅ or Li₂B₄O₇, with 0.1 to 5 wt.% as boron isotope ¹⁰B added, and a gadolinium compound selected from Gd₂O₃,Gd(OH)₃ or GdF₃, with 0.1 to 2 wt.% as gadolinium isotope ¹⁵⁷Gd added ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]). The inorganic compound is a lithium compound, and it is preferable to use lithium fluoride ([0043]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure, wherein the inorganic compound is lithium fluoride. One of ordinary skill in the art would be motivated to make such modification so that the particle beam is more slowly decelerated to make it easier to absorb (Daizo [0043]).
16. Regarding claim 16:
The modified invention above teaches radiation shielding jig according to Claim 9. Huttner does not teach that wherein: the sintered particles of which are formed by fracturing, abrasion fracturing, and sieving the sintered body, are not collected particles, using the not collected particles, the sintered particles are formed by re- pulverizing, mixing with the raw powder, and re-sintering ([0041] of the instant application defines sintered particles as fluid particles having rounded shape. The process of how the sintered particles are made are given no patentable weight).
Daizo teaches that in the shielding jig, the inorganic compound particles and the thermoplastic resin particles are mixed together ([0041]).
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 Huttner in view of Daizo to introduce a mixture of inorganic compound particles and resin particles into Huttner’s enclosure. One of ordinary skill in the art would be motivated to make such modification since the mixture of the inorganic compound particles and resin particles would allow for the property of repelling the particle beam R to be relaxed and the absorption performance of the particle beam can be enhanced (Daizo [0041]).
17. Regarding claim 17:
The modified invention above teaches radiation shielding jig according to Claim 1. Huttner does not specifically teach that wherein: the mixing ratio of the sintered particles and the resin particles in the shielding material particles is set between 10 wt.% and 90 wt.%, the angle of repose of the shielding material particles is from 8 to 45 degrees of fluidity.
Daizo does not specify that the mixing ratio of the sintered particles and the resin particles in the shielding material particles is set between 10 wt.% and 90 wt.%. However, Daizo does teach that the composition containing 50% by mass of polyethylene and 50% by mass of lithium fluoride ([0090]). 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). As such, Daizo’s teaching of a composition containing 50% by mass of polyethylene and 50% by mass of lithium fluoride makes the claimed range between 10wt.% and 90 wt.% obvious.
Daizo does not specifically note that the angle of repose of the shielding material particles is from 8 to 45 degrees of fluidity. However, Daizo does teach average primary particle diameter of 1.5mm is used ([0090]). It is obvious to use particles within the claimed particle size range at 0.5 to 7mm that have an angle of repose function, because this functional range overlaps and contains the disclosed range around 1.5mm taught by Daizo.
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 Huttner to use average primary particle diameter of 1.5mm, as taught by Daizo. One of ordinary skill in the art would be motivated to make such modification to allow for highly fluid particles and uniform particle distribution.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY LI whose telephone number is (571) 272-5043. The examiner can normally be reached 8:30am-4:30pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LARRY LI/
Examiner, Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881
Prosecution Insights