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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202222621648.3, filed on 09/30/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-14 and 17-20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The instant invention is anticipated by Eshima et al. (US20130102772A1).
Regarding Claim 1, Eshima et al. teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53) comprising a synthesis device (See the synthesis unit 115 or mini cell 203 in [0054]-[0056] in Fig. 1) ,
the synthesis device (See in Claim 1) comprising: a synthesis cassette (See the plurality of modules 204 and modular cassettes 205 comprised in the synthesis unit in [0054]-[0070] in Fig. 1-2) comprising a synthesis cassette body (See the cassette 3010 body in [0164]-[0172] in Fig. 30-32),
the synthesis cassette body comprising a first common pipe extending in a left-right direction (See the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2), the first common pipe being located between three-way valves that are adjacent in the left-right direction (See the 4-way valve 1270 and the check valve 1260 in [0096] in Fig. 12; Also, see the isolation valves 1002 a-1 in [0083] in Fig. 10 and the 12-way selector valve in [0156] in Fig. 23); and
a main synthesis unit comprising a main synthesis unit frame (See how the mini cell 204, i.e. a main synthesis unit, may comprise a plurality of modules 204 and cassettes 205 that are used to formulate the product in [0059] in Fig. 1-2; Also, see the frames and housing in Fig. 30-43), the first common pipe being detachably fixed at a front housing of the main synthesis unit frame by a first fixing assembly (See how each modular cassette synthesis is configured to allow disposable replacement of portions of the subsystem including fluid lines in [0187]-[0196], [0206]-[02112],[0235] in Fig. 39-40 and in Claims 10 and 54).
Regarding Claim(s) 2-7, Eshima et al. teaches the apparatus limitations of claim 1.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein the first fixing assembly (See how mounting versions can vary in [0137]) is one of a mounting sleeve, a snapping hook assembly, and an engagement assembly (See the mounting plates, support structures, and the potential use of springs, pins, clamps, brackets, o-rings, gaskets, etc. in [0094]-[0205] in Fig. 22-27).
wherein: the first fixing assembly is the mounting sleeve, the first common pipe is detachably engaged with and fixed at an inner side of the mounting sleeve; and the mounting sleeve is detachably inserted into and fixed at the front housing (See how each modular cassette synthesis is configured to allow disposable replacement of portions of the subsystem including fluid lines in [0187]-[0196], [0206]-[02112],[0235] in Fig. 22-27 and 39-48 and in Claims 10 and 54).
wherein the mounting sleeve comprises: a vertical plate, the vertical plate and the front housing facing each other; and an engagement base fixed at a rear side surface of the vertical plate, the first common pipe being engaged in the engagement base (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-45; Also, see the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2).
wherein the engagement base comprises an upper engagement base and a lower engagement base, the first common pipe being engaged between the upper engagement base and the lower engagement base (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48; Also, see the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2).
wherein the mounting sleeve further comprises: a three-way valve support fixed at the rear side surface of the vertical plate, the three-way valve support being configured to support a corresponding one of the three-way valves at the first common pipe (See the 4-way valve 1270 and the check valve 1260 in [0096] in Fig. 12; Also, see the isolation valves 1002 a-1 in [0083] in Fig. 10 and the 12-way selector valve in [0156] in Fig. 23).
wherein the mounting sleeve further comprises: a surrounding wall located at a rear side of the vertical plate, the surrounding wall having an end fixed to a periphery of the vertical plate and another end provided with a plurality of insertion portions, the plurality of insertion portions being adaptively inserted into and fixed to the front housing (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48; Also, see the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2).
Note what is discussed in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The claim(s) above recites the limitations of a "first fixing assembly", "mounting sleeve", "snapping hook assembly", "engagement assembly", "vertical plate", "engagement base(s)", "front housing", "three-way valve support", however the arrangement or configuration of these technical component(s) do not change the function of the apparatus in view of the prior art in regards to providing support or mounting tools that allow modules to be detachable.
Regarding Claim(s) 8-9, Eshima et al. teaches the apparatus limitations of claim 7.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein the front housing is provided with a first support, a bottom of the surrounding wail being supported on the first support (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-45; Also, see the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2).
wherein a top of the surrounding wall has a plurality of through holes for passage of respective containers and respective tubes at the synthesis cassette body (See the mounting holes 2530 in [0147], [0162]-[0164] Fig. 25A-B, 30; Also, see the reagents that can be connected in [0194]-[0225] and Claim(s) 10, 23-26).
Regarding Claim 10, Eshima et al. teaches the apparatus limitations of claim 2.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100, 200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein the first fixing assembly is the snapping hook assembly, the snapping hook assembly is disposed at the front housing and configured to hook and snap at the first common pipe in a front-rear direction (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48; Also, see the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2).
Regarding Claim(s) 11-13, Eshima et al. teaches the apparatus limitations of claim 2.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein the snapping hook assembly comprises a snapping hook located at an outer side of the front housing, the snapping hook comprising a hook portion at a front end of the snapping hook, the hook portion being configured to hook and snap at the first common pipe (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48; Also, see the supply line 201, i.e. a first common pipe, in [0057]-[0070] in Fig. 2).
wherein: the snapping hook assembly further comprises a first spring vertically arranged at a rear side of the front housing, the first spring having an end fixed at the front housing and another end fixed at a rear end of the snapping hook, and the first spring being configured to, by means of a restoring force of the first spring, enable the hook portion to hook and snap at the first common pipe (See the mounting plates, support structures, and the potential use of springs, pins, clamps, brackets, o-rings, gaskets, etc. in [0094]-[0205] in Fig. 22-27); and
the snapping hook passes through the front housing and is disposed on the front housing to be rotatable up and down about an axis, wherein the snapping hook is provided with coaxial rotation shafts at a left side and a right side of the snapping hook, respectively, each of the rotation shafts being rotatably mounted at an inner side of the front housing (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48).
wherein the snapping hook assembly further comprises: a protective sleeve (See in [0211]) fixed at a front side of the front housing, the protective sleeve having a space for the snapping hook to rotate up and down, the snapping hook being located in the space, and the hook portion extending out of the protective sleeve (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48).
Regarding Claim 14, Eshima et al. teaches the apparatus limitations of claim 10.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein: the synthesis cassette body further comprises a foundation base located below the synthesis cassette body (See the plurality of modules 204 and modular cassettes 205 comprised in the synthesis unit in [0054]-[0070] in Fig. 1-2) , the synthesis cassette body being fixed at the foundation base (See the foundation base 4210 in [0209] in Fig. 42-43); and
the front housing is provided with a second support, the foundation base being supported on the second support, preferably, a top of the second support has an engagement groove, a lower end of the foundation base being engaged in the engagement groove (See the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48).
Regarding Claim 17, Eshima et al. teaches the apparatus limitations of claim 2.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein the main synthesis unit (See how the mini cell 204, i.e. a main synthesis unit, may comprise a plurality of modules 204 and cassettes 205 that are used to formulate the product in [0059] in Fig. 1-2; Also, see the frames and housing in Fig. 30-43) further comprises: a container fixing module disposed at the front housing and having a plurality of fixing cavities (See the reagents that can be connected in [0194]-[0225] and Claim(s) 10, 23-26), the plurality of fixing cavities being configured to correspondingly accommodate a barrel of a syringe and a container at the synthesis cassette body (See the syringe 4882 in [00232]-[0244] in Fig. 48).
Regarding Claim 18, Eshima et al. teaches the apparatus limitations of claim 2.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), wherein the main synthesis unit (See how each cassette 205 is supported by a corresponding module 204 that provides the necessary connections for required bulk gases or fluids, along with proximity or physical interfaces for heating, cooling, and sensing in [0059] in Fig. 22-28) further comprises: a heating system comprising a heater and a heat insulation plate, the heater being fixed at a front side of the front housing, and the heat insulation plate being arranged between the front housing and the heater (See how the cooling heat exchanger 1255 may be coupled to the target housing 1225 and target cell 1230 to remove accumulated heat and maintain the target housing 1225, target cell 1230 and foil 1250 at or below a selected temperature in [0095] in Fig. 12), preferably,
the main synthesis unit (See how the mini cell 204, i.e. a main synthesis unit, may comprise a plurality of modules 204 and cassettes 205 that are used to formulate the product in [0059] in Fig. 1-2; Also, see the frames and housing in Fig. 30-43) further comprises: a heat dissipation system having a heat dissipation channel and comprising a heat dissipation device, the heat dissipation channel and the heat dissipation device being disposed in the main synthesis unit frame, and the heat dissipation channel having an end connected to the heater and another end connected to the heat dissipation device (See in [0095], [0188], [0200]-[0203] and in Claim 6).
Regarding Claim(s) 19-20, Eshima et al. teaches the apparatus limitations of claim 2.
Eshima et al. further teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the system 100,200, and Claim(s) 1-65 in [0001]-[0019], [0051]-[0271] in Fig. 1-53), further comprising at least one of a purification device or a waste gas treatment device (See how at least one of the plurality of cassettes 205 and/or the plurality of modules 204 may comprise HPLC components for performing product purification in [0061], [0083], [0216]-[0230] in Fig. 10, 45-47 and in Claim(s) 13, 72-73).
wherein the purification device (See the four HPLC columns 4504 in Fig. 10, 45-47) comprises: a purification cassette body comprising a second common pipe extending in the left-right direction (See how at least one of the plurality of cassettes 205 and/or the plurality of modules 204 may comprise HPLC components for performing product purification in [0061], [0083], [0216]-[0230] in Fig. 10, 45-47 and in Claim(s) 13, 72-73),
wherein the purification cassette body and the synthesis cassette body are detachably connected to receive a radiopharmaceutical produced by the synthesis device (See how each modular cassette synthesis is configured to allow disposable replacement of portions of the subsystem including fluid lines in [0187]-[0196], [0206]-[02112],[0235] in Fig. 39-40 and in Claims 10 and 54); and
a main purification unit independently provided and comprising a main purification unit frame, the second common pipe being detachably fixed at the main purification unit frame by a second fixing assembly (See how the mini cell 204, i.e. a main synthesis unit, may comprise a plurality of modules 204 and cassettes 205 that are used to formulate the product in [0059] in Fig. 1-2; Also, see the frames and housing in Fig. 30-43),
the waste gas treatment device (See how fluid recovery may comprise separate compartment for waste and for--water in [0066] and see the waste compartment 2234 and the optional waste collection system 4806 in [0132]-[0237] in Fig. 22, 48) comprises a waste gas treatment device frame, (See the 4-way valve 1270 and the check valve 1260 in [0096] in Fig. 12; Also, see the isolation valves 1002 a-1 in [0083] in Fig. 10 and the 12-way selector valve in [0156] in Fig. 23), the washing bottle, the U-shaped tube (See the reagents that can be connected in [0194]-[0225] and Claim(s) 10, 23-26), and the vacuum pump is mounted in the waste gas treatment device frame (See in [0173]-[0197]),
wherein: the waste gas treatment device frame is independently provided; each of the three-way solenoid valve (See the 4-way valve 1270 and the check valve 1260 in [0096] in Fig. 12; Also, see the isolation valves 1002 a-1 in [0083] in Fig. 10 and the 12-way selector valve in [0156] in Fig. 23), the washing bottle, the U-shaped tube (See the reagents that can be connected in [0194]-[0225] and Claim(s) 10, 23-26), and the vacuum pump is mounted in the waste gas treatment device frame (See in [0173]-[0197]);
the three-way solenoid valve has an end detachably connected to an outlet pipe of a waste gas bottle of the synthesis cassette body and another end connected to the washing bottle; and the U-shaped tube has an end connected to the washing bottle and another end connected to the vacuum pump (See how each modular cassette synthesis is configured to allow disposable replacement of portions of the subsystem including fluid lines in [0187]-[0196], [0206]-[02112],[0235] in Fig. 39-40 and in Claims 10 and 54; Also, see the module front plate assembly and the design discussions in [0194]-[0225] in Fig. 39-48 and Claim(s) 1-65).
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.
Claim(s) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Eshima et al. (US20130102772A1) as applied to claim 2 above, and further in view of Alexoff et al. (US20180250649A1).
Regarding Claim(s) 15-16, Eshima et al. teaches the apparatus limitations of claim 2.
Eshima et al. fails to explicitly teach a full-automatic radiopharmaceutical production apparatus, wherein the main synthesis unit further comprises: a barrel fixing module disposed at the front housing and comprising a first engagement block and a second engagement block, the first engagement block and the second engagement block being arranged to face each other in the left-right direction and configured to tightly clamp a barrel of a syringe at the synthesis cassette body, and a distance between the first engagement block and the second engagement block being adjustable.
However, in the analogous art of radiopharmaceutical labeling device, Alexoff et al. teaches a full-automatic radiopharmaceutical production apparatus (See the Abstract, the device 10, and Claim(s) 1-20 in [0008]-[0019], [0042]-[0140] in Fig. 1-17), wherein the main synthesis unit (See the reaction vessel 310 in Fig. 1 and the radiopharmaceutical generator 300 in Fig. 4-5 in [0042]-[0060] and in Claim 1) further comprises: a barrel fixing module disposed at the front housing (See the syringe barrel restraint members 196 and the housing 100 in [0068] in Fig. 4-5, 12) and comprising a first engagement block and a second engagement block, the first engagement block and the second engagement block being arranged to face each other in the left-right direction and configured to tightly clamp a barrel of a syringe at the synthesis cassette body, and a distance between the first engagement block and the second engagement block being adjustable (See how one of upper manifold adapters 202 and lower manifold adapters 204 can have an elongated shaft 232 for ease of operation and connection of components to upper cassette 301 and lower cassette 303 in [0042]-[0060] in Fig. 1-5, 10-12).
wherein the barrel fixing module further comprises a second spring, wherein: the first engagement block is fixed at the front housing; the second engagement block is arranged at the front housing to be movable in the left-right direction; each of an engagement portion of the first engagement block and an engagement portion of the second engagement block is located at a front side of the front housing; and the second spring has an end connected to the second engagement block and another end fixed to the front housing, the second spring being configured to, by means of a restoring force of the second spring, enable the engagement portion of the second engagement block and the engagement portion of the first engagement block to tightly clamp the barrel of the syringe at the synthesis cassette body (See in [0042]-[0062]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the apparatus of Eshima et al. by incorporating a main synthesis unit comprising a barrel fixing module, a first engagement block, and a second engagement block (as taught by Alexoff et al.) for the benefit of mounting a syringe to the device and housing.
Conclusion
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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