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 .
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(s) 16-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haskell (US 5550383).
Regarding claim 16, Haskell teaches a radiation shield for superficial radiation therapy treatment, the radiation shield comprising:
a rigid shield body 10 having a first surface and a second surface opposite the first surface, the first surface being nonflat (figure 4) and contouring an exterior surface of a portion of a patient adjacent a region of interest that is to receive superficial radiation therapy, the exterior surface of the patient including skin of the patient (figures 3-4);
an aperture 22 directed through the rigid shield body that corresponds to the shape and the size of the region of interest 26 that is to receive radiation therapy, the aperture aligning with at least a portion of the region of interest when the radiation shield is interfaced with the exterior surface of the patient (figures 3-4), and
a material of the radiation shield body comprising at least one of: copper, tin, or iron (col 7 line 3).
However Haskell fails to teach the first surface and the second surface defining a thickness of the radiation shield, the thickness of the radiation shield being larger than 10 mm.
It would have been an obvious to one having ordinary skill in the art at the time the invention was made to adapt the thickness, since such a modification would have involved a mere change in the size (thickness) of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Accordingly, one would be motivated to adapt the thickness in order to further project the patient from the radiation.
Regarding claim 17, Haskell teaches the radiation shield is constructed from a three-dimensional (3D) printer (note: the process limitations are given no patentable weight in device claim. The final structure of claimed invention is identical to the prior art. This is a product by process limitation. “Even 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 claims in the same as or obvious from a product of the prior art, the claim is unpatenable even though the prior product was made by a different process”).
Regarding claim 19, Haskell teaches when the radiation shield is disposed on the exterior surface of the patient and is configured to receive a radiation therapy beam, the radiation therapy beam including an electron beam for superficial radiation therapy (col 1 lines 20+).
Claim(s) 16-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fishman (US 20170326385) in view of Haskell and Bermuth (US 20210151212).
Regarding claim 16, Fishman teaches a radiation shield comprising:
A rigid shield body 752 composed of a rigid material, the shield body having a first surface and a second surface opposite the first surface, the first surface contouring an exterior surface (any planar surface of the patient) of a portion of a patient adjacent a region of interest 704, the exterior surface of the patient including skin of the patient (figure 7 para 2);
an aperture 754 directed through the shield body that corresponds to the shape and the size of the region of interest 704 that is to receive radiation (figure 7), the aperture aligning with at least a portion of the region of interest when the radiation shield is interfaced with the exterior surface of the patient (figure 7), and the first surface and the second surface defining a thickness of the radiation shield (figure 7) (note: “for superficial radiation therapy treatment” and “the radiation shield that is to receive superficial radiation therapy” are intended used and does not structurally distinguish the apparatus over the prior art).
However Fishman fails to teach the thickness of the radiation shield being larger than 10 mm.
It would have been an obvious to one having ordinary skill in the art at the time the invention was made to adapt the thickness, since such a modification would have involved a mere change in the size (thickness) of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. Accordingly, one would be motivated to adapt the thickness in order to further project the patient from the radiation.
Further Fishman fails to teach the first surface being nonflat.
Haskell teaches a surface being nonflat (figure 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the surface of Fishman with the surface as taught by Haskell, since it would provide better beam/target positioning,
Further Fishman fails to teach the rigid of the radiation shield body comprising at least one of copper, tin, or iron.
Bermuth teaches a radiation shield comprising at least one of copper, tin, or iron (para 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the shield of Fishman with the material as taught by Bermuth, since it would provide sufficient/safer radiation shielding.
Regarding claim 17, Fishman teaches the radiation shield is constructed from a three-dimensional (3D) printer. (note: the process limitations are given no patentable weight in device claim. The final structure of claimed invention is identical to the prior art. This is a product by process limitation. “Even 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 claims in the same as or obvious from a product of the prior art, the claim is unpatenable even though the prior product was made by a different process”).
Regarding claim 19, Fishman teaches the radiation shield is disposed on the exterior surface of the patient (figure 11) (note: “receive a radiation therapy beam, the radiation therapy beam including an electron beam for superficial radiation therapy” is intended use).
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-17 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 HOON K SONG whose telephone number is (571)272-2494. The examiner can normally be reached M to Th 10am to 7pm.
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/HOON K SONG/Primary Examiner, Art Unit 2884