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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-12 in the reply filed on 11/06/25 is acknowledged.
Claim Objections
Claims 1, 3, and 5 are objected to because of the following informalities:
Claims 1, 3, and 5 all refer to the “electron beam accelerator” and should refer to the “electron beam accelerator assembly” as set forth in line 6 of claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawasaki (US 2018/0344884).
Regarding claim 1, Kawasaki (US 2018/0344884) discloses –
A sterilization system for a radiopharmaceutical product (Title, Abstract, par. 2 discloses pharmaceuticals are sterilized with the device; Fig. 4 shows irradiation system 11; the device being well capable of being used with specifically radiopharmaceuticals, see MPEP 2114, II), comprising:
a hot cell (body 20 with walls 21 are for shielding radiation and contain it within, reading on the function of a hot cell and meeting the limitation, more specifically the irradiation chamber 22 reading on this limitation; par. 90) disposed within a clean room environment (par. 2 discloses the room is contained within an aseptic processing room, reading on the limitation of a clean room environment);
a sterilization shaft extending between a first end and a second end and defining an interior (the electron accelerator 52 is in the shape of a tube with a top and bottom end, the tube having components therein, including irradiation window 52a for the transmission of electrons from the tube),
the first end being disposed within the hot cell (fig. 4 shows a lower end of tube 52 being inside the body 20) and the second end being disposed externally to the clean room (the clean room is not positively claimed as part of the invention, and therefore the arrangement of the device within the room is merely a manner in which the device is intended to be deployed or used, and the device disclosed by Kawasaki is well capable of being arranged in this way see MPEP 2114, II); and
an electron beam accelerator assembly disposed within the interior of the sterilization shaft (the tube encompasses the electron accelerator 52, par. 98) so that an emission end of the electron beam accelerator is adjacent the first end of the sterilization shaft (the emission is out of window 52a into the space of irradiation chamber 22; par. 98).
Regarding claim 2, Kawasaki further teaches a sterilization tunnel that is disposed within the hot cell adjacent the first end of the sterilization shaft (the space between electron accelerator 52 and 53 is a tunnel adjacent the emission end and therefore the first end of the accelerators 52 and 53).
Regarding claim 3, Kawasaki further teaches a transmission window at the first end of the sterilization shaft so as to separate the interior of the sterilization shaft from the clean room environment while allowing passage of energy from the emission end of the electronic beam accelerator (irradiation windows 51-53a are at the first end of the shafts and separate the tunnel from an area outside the device 20, which is the aseptic environment – the windows allowing emission of electron; par. 101).
Regarding claim 5, Kawasaki further teaches the electron beam accelerator is vertically mounted in the sterilization shaft (fig. 4 shows the vertical mounting of the tube 52 and the internal components thereof similarly); and the sterilization tunnel is located vertically below the sterilization shaft (fig. 4 shows the tunnel between 53 and 52 being vertically below the tube 52).
Regarding claim 6, Kawasaki further teaches a shuttle assembly operative to move the radiopharmaceutical product into and out of the sterilization tunnel (the tray 61 is conveyed through the tunnel by guide device 70 and is transported away by the pusher 44 and roller conveyor 45, the conveyor and guide device 70 reading on a shuttle assembly as claimed; par. 103).
Regarding claim 7, Kawasaki further teaches the shuttle assembly is operative to move the radiopharmaceutical product into and out of the sterilization tunnel twice, yielding a first sweep and a second sweep (pars. 121-122 discloses the guide device 70 being reciprocated, and therefore being moved back and forth, reasonably so through the space defined as the tunnel in Fig. 4, and the device is at least reasonably capable of performing this function – see MPEP 2114, II).
Regarding claim 8, Kawasaki further teaches the shuttle assembly orients the radiopharmaceutical product in a first orientation during the first sweep and a second orientation during the second sweep (Fig. 12 shows the tray 61 being rotated for additional exposure, par. 135; the device is at least reasonably capable of performing this function – see MPEP 2114, II).
Regarding claim 9, Kawasaki further teaches the second orientation is rotated by 180
°
with respect to the first orientation (pars. 112, 135, the tray 61 is rotatable and therefore reasonably capable of being rotated by 180
°
as claimed, see MPEP 2114, II).
Regarding claim 10, Kawasaki further teaches the shuttle assembly is operative to controllably rotate and oscillate the tray and therefore is well capable of performing the claimed function of rotating automatically the radiopharmaceutical product from the first orientation to the second orientation at a time between the first sweep and the second sweep. The function does not impart any particular structure to the claimed device that is distinct from the prior art, and the prior art could reasonably be deployed to perform the claimed function, and therefore all the limitations of the claim are met. See MPEP 2114, II.
Regarding claim 11, Kawasaki further teaches the shuttle assembly is operative to separate the radiopharmaceutical product from a nest in which the radiopharmaceutical product is carried (the package P and its contents are removed from the holding portion 70 and associated parts, the holding portion 70 and parts reading on the limitation of a nest).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki (US 2018/0344884) in view of Poppi (US 2016/0251099).
Regarding claim 4, Kawasaki further teaches the irradiation transmission windows are made from metal foil (par. 98), but appears to be silent with regards to the specific metal being titanium.
Poppi (US 2016/0251099) discloses irradiation windows preferably being made from materials including metal foils that are titanium (par. 5). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kawasaki to construct the radiation window from titanium to arrive the claimed invention. One would have been motivated to do so in order to use a known appropriate metal suggested by the art for its known appropriate application to arrive at a successful device.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki (US 2018/0344884).
Regarding claim 12, Kawasaki appears to be silent with regards to the electron beam accelerator assembly is vertically removable from the interior of the sterilization shaft. However, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kawasaki such that the electron beam accelerator assembly is vertically removable from the interior of the sterilization shaft. One would have been motivated to do so as this modification is merely making existing components separable, and if it is desirable for any reason to fashion components to be separable then it is obvious to do so. One would benefit from the removability of the components because the components could be cleaned, serviced, and replaced individually which would save time and money for a user. See MPEP 2144.04(V)(C).
Claims 1-3 and 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki (US 2018/0344884) in view of Knott (US 2014/0112826).
Regarding claim 1, should it be found that Kawasaki fails to teach the limitation of the second end of the hot cell being disposed externally to the clean room: Knott (US 2014/0112826) discloses an electron applicator for sterilization (par. 16, abstract) where the application devices 10 and 11 that are located outside of a clean room 12 (par. 45). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Kawasaki such that the sterilization shaft has a second end located externally to the clean room as taught by Knott to arrive at the claimed invention. One would have been motivated to do so to avoid contamination and to conveniently partition parts outside of the clean room as desired to allow more usable space within the clean room.
The remaining claims, 2-3 and 5-12 would be obvious in view of modified Kawasaki in the same manner as the reference is applied to the claims above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kawasaki (US 2018/0344884) in view of Knott (US 2014/0112826) as applied to claim 1 above and further in view of Poppi (US 2016/0251099).
Claim 4 would be obvious in view of modified Kawasaki in the same manner as the reference is applied to the claim above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN A HENSEL whose telephone number is (571)272-6615. The examiner can normally be reached Mon-Thu 8:30 - 7pm;.
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/BRENDAN A HENSEL/ Examiner, Art Unit 1758