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 .
This communication is responsive to the Application No. 18/634,413 filed on 04/12/2024.
Claims 1-12 are presented for examination.
Drawing/Specification Objections
The drawing is objected to because of the following informalities:
a. The drawings, Figs. 5, 7 and 8 are not of sufficient quality because of the blurry and small font of the text.
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.
Examiner's Note
Examiner has cited particular paragraphs/ columns and line numbers or figures in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching
all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. Applicant is reminded that the Examiner is entitled to give the broadest reasonable interpretation to the language of the claims. Furthermore, the Examiner is not limited to Applicants' definition which is not specifically set forth in the claims.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang Satyamurthy et al. (US 2012/0107175) (hereinafter Satyamurthy) in view of Knopp et al. (US 2012/0305813) (hereinafter Knopp).
Claim 1. Satyamurthy teaches an automated radiochemical reaction system (See Para. [0002], [0011], disclose “automated chemical synthesis apparatus suitable for the preparation of small quantities of chemicals, particularly radio pharmaceuticals”, and/or see Para. [0045], discloses “robotic device to a provide a broad range of synthesis capability and address a broad range of reaction complexity”, and/or see Para. [0123], discloses “a multi-module radiochemical synthesis platform”), comprising:
a hot cell including a plurality of chemicals and components required for performing a radiochemical reaction (See Para. [0004], “High dose (curies) synthesis must be conducted in a hot cell with considerably higher shielding and safety requirements”, and/or see Para. [0049], [0232], discloses “"remote control" unit for an operation within a hot cell”, and Para. [0068], discloses “a series of reaction events”. Additionally, see Para. [0056]-[0057], discloses “robotic arm including heating unit”);
a robot positioned within and coupled to an interior of the hot cell (See Para. [0049], “remote control" unit that is not limited to operation within a fume hood or hot cell. This unit allows streamlined control of each robotic actuator”), the robot comprising a robot arm (See Para. [0054]-[0055], discloses “robotic arm 12 and 14”); and
a chemical reaction unit that includes at least one element for the radiochemical reaction to be performed (See Para. [0007], [0010], “Automated radiochemistry units are available, and several devices referred to as "automated synthesis modules" exist for specific types of reactions that are routinely and repeatedly conducted”, and see Para. [0092], “chemical reaction is performed”);
Satyamurthy fails to teach, an end effector coupled to a distal free end of the robot arm, the end effector being adapted to grasp, release, and actuate a syringe within the hot cell; and wherein the robot is adapted to complete an automated radiochemical reaction within the hot cell without human interaction.
However, Knopp teaches, an end effector coupled to a distal free end of the robot arm, the end effector being adapted to grasp, release, and actuate a syringe within the hot cell (See Para. [0037], “one or several syringes 206 are attached to holders 208, 210 disposed inside the shielding 202”);
wherein the robot is adapted to complete an automated radiochemical reaction within the hot cell without human interaction (See Para. [0004], “Fully automatic systems (e.g. synthesis modules, dispensers, robots) are operated inside the shielding (see FIG. 1)”, and see Para. [0012], “the at least one shielding unit is preferably constructed as a so-called "hot cell.", and Para. [0032], “Synthesis modules 100 for processing radioactive materials automatically or fully automatically are typically operated for radiation protection entirely inside shielding 102 ("hot cell") which is shielded in all spatial directions”).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a robot that would be placed within a holt cell and would hold/grasp container/syringes as taught by Knopp in order to safely handle radioactive materials with high activities.
Claim 2. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 1, wherein a controller is communicatively coupled to the robot, the chemical reaction unit to send movement and operation instructions to the robot (See Satyamurthy, Para. [0049], “Utilization of a "remote control" unit that is not limited to operation within a fume hood or hot cell. This unit allows streamlined control of each robotic actuator”, and see Para. [0054], “FIGS. 1-4 comprises a remote controlled assembly 10, which includes robotic arms (two shown) 12,14 that can be moved up and down and forward and backward under remote control in order to perform pressurized reactions, solvent evaporation and product transfer (e.g. to another SPE unit)”).
Claim 3. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 1, wherein the robot includes at least one force sensor coupled to the robot arm or the end effector, the at least one force sensor adapted to identify when the robot collides with a wall or an object within the hot cell (See Satyamurthy, Para. [0050], “Utilization of remote sensing, including video, that limits the actuation range of the robotic arms for safety purposes as well as providing to the chemist a remote visual monitoring capability. This enables the chemist to either utilize the remote control at a position distant from the fume hood/hot cell (e.g., out of viewing range) or to integrate the control functions of the "remote control" with a more visual environment outside of the hot cell (e.g. video monitors, personal computers, etc.)”).
Claim 4. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 2, wherein the robot includes at least one camera or vision system, the at least one camera or vision system being communicatively coupled to the controller (See Satyamurthy, Para. [0070], “the streamlined utilization of modular remote control assemblies 10, it is also contemplated that the system includes a digital capture of video information. A small video camera (not shown) can be focused on the reaction vessel or vial 16. A "ceiling" view camera (not shown) for observing each robotic arm 12, 14 as well additional video cameras (not shown) for viewing other components of the system can also be included”).
Claim 5. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 1, wherein the end effector includes an actuatable and axially translatable body, and an end effector is adapted to be coupled to the syringe (See Knopp, Fig. 5, “a syringe 206 and four containers 502 via a hose connection 504”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 6. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 5, wherein the end effector further includes a first grip, a second grip, a third grip, and a fourth grip (See Knopp, Fig. 5, “four containers 502 are conned via hose connection 504”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 7. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 6, wherein the first grip and the second grip are adapted to be positioned on opposite sides of a plunger grip of the syringe, securely coupling the end effector to the syringe (See Knopp, Fig. 5, syringe 206 and grip of 502 via 504). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 8. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 7, wherein the third grip and the fourth grip are adapted to be positioned on opposite sides of a base grip of the syringe, securely coupling the end effector to the syringe (See Knopp, Fig. 5, syringe 206 and grip of 502 via 504). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 9. The teaching of Satyamurthy as modified by the teaching of Knopp teaches the automated radiochemical reaction system of claim 8, wherein the robot can axially translate the body of the end effector along a central axis of the body, causing the syringe to draw a liquid into the syringe or expel a liquid from the syringe (See Knopp, Fig. 5, discloses this claimed invention). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 10. The automated radiochemical reaction system of claim 5, wherein the end effector includes a generally C-shaped cross-sectional shape viewing axially along an axial direction of the body (See Knob, Fig. 4, “one or several syringes 206 are attached to holders 208, 210 disposed inside the shielding 202”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 11. The automated radiochemical reaction system of claim 5, wherein the end effector is actuatable in a radial direction with respect to a central axis of the body (See Knopp, Fig. 6). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have modified the teaching of Satyamurthy with a setting arrangement of the robot arm and mechanism of robot as presented by Knopp in order to safely handle radioactive materials with high activities.
Claim 12. The automated radiochemical reaction system of claim 1, wherein the at least one element includes a heater (See Satyamurthy, Para. [0057], [0094], [0098], discloses “heater 22”, and/or see Para. [0111], “Typical components are a temperature controller 212 connected to a gas heater 214 as well as a vacuum pump 216, the operation of each controlled by a module controller 218. Methods contemplated of heating the vial content include the use of a heating block, the use of microwave energy, etc.”), compressed air cooler, magnetic stirrer, vacuum, inert gases, radiation detector for reaction monitoring, and/or ultraviolet (UV)-vis detector for chemical analysis (See Satyamurthy, Para. [0101], “The cavity 172 has a control unit 174 that may include microwave power control, temperature control, cooling gas, temperature monitoring, and stir bar control.”, and see Para. [0232], “a 254 nm UV detector”, and/or see Para. [0290], “analytical probes (i.e., IR, UV, specialty probes for various chemical constituents, etc) for conducting process analysis during a reaction in the system”. Furthermore, see Para. [0055], [0097], “The assembly of components also allows for the application of pressure or vacuum to vessels from an external gas supply if desirable”, and see Para. [0119], [0292], discloses “A flow rate sensor 232 in combination with a calibrated radiation sensor 222 is monitored to integrate the total radioactivity passing the detection point and arrive at the total radioactivity”. Furthermore, see Para. [0117], “a radiation detector to measure the radioactivity of the sample”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to B M M HANNAN whose telephone number is (571)270-0237. The examiner can normally be reached MONDAY-FRIDAY at 8:30AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Mott can be reached at 5712705376. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B M M HANNAN/Primary Examiner, Art Unit 3657