DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments, filed 01/06/26, with respect to the rejection of claims under 35 U.S.C. 102 and U.S.C. 103 as being anticipated by or unpatentable over Elizarov et al. (US 2011/0150714) have been fully considered and are persuasive. Applicant has amended claim 2 to recite “a plurality of connectors for providing selective connection between the vessel and a synthesis unit selector via a first line such that a predetermined amount of the received active product from the vessel may be directed to at least one synthesis component of the radiopharmaceutical production system via the synthesis unit selector, wherein the plurality of connectors separate a gas source and the vessel, and wherein the plurality of connectors provide selective connection between the gas source and the vessel via a prime loop” and then argued the highlighted feature(s) are not taught by the cited prior art. See pages 4-5 of Applicant’s Remarks. The Examiner agrees; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2 and 78 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kiselev et al. (US 2003/0007588). Kiselev teaches a method and apparatus for production of a radiocompound.
Regarding claim 2 – As shown in Figure 1, Kiselev teaches a device comprising: a vessel (target box 11) for receiving an active product from a cyclotron; and a plurality of connectors (connectors provided in valve V1) for providing selective connection between the vessel (target box 11) and a synthesis unit selector (valve V2) via a first line such that a predetermined amount of the received active product from the vessel (target box 11) may be directed to at least one synthesis component (cartridges C2, C3) of the radiopharmaceutical production system via the synthesis unit selector (volve V2), wherein the plurality of connectors (connectors provided in valve V1) separate a gas source (helium source 43) and the vessel (target box 11), and wherein the plurality of connectors (connectors provided in valve V1) provide selective connection between the gas (helium source 43) source (via valve V3) and the vessel (target box 11) via a prime loop (L1).
Regarding claim 78 – The Examiner notes that the pump (13) of the device of Kiselev may be disconnected from the loop lines. The term “may be disconnected” as recited in the claim simply requires the capability to disassemble parts of the device.
Inventorship
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kiselev et al. (US 2003/0007588).
Kiselev as disclosed in Paragraphs 5-7 above teaches every element of claim 3 except for the pump positioned between the vessel and synthesis unit selector. Kiselev teaches a pump (13) in the loop (L1) at a location positioned before the vessel (target box 11) and lines connecting the vessel with the synthesis unit selector to pump a predetermined amount of material from the vessel to the synthesis unit selector. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time to determine the optimum location for a pump in the system through routine optimization to deliver fluids given the finite number of locations available for placement of the pump in the system - including directly after the vessel which would place the pump between the vessel and synthesis unit selector. See MPEP 2144.05, Section II, "Routine Optimization" and MPEP 2143, Section I, E, "Obvious to Try".
Claim 76 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kiselev et al. (US 2003/0007588) in view of Van Dam et al. (US 2008/0233018).
Kiselev as disclosed in Paragraphs 5-7 above teaches every element of claim 76 except for a camera. Van Dam teaches an automated system for the synthesis of radioactive compounds. The embodiments or portions of the system most relevant to the instant claims are shown in Figures 1A-10C and described in Paragraphs 0026-0157. As shown in Figures 1A and 2A, Van Dam teaches a synthesis system that includes a vessel for receiving an active product (vial 1010 in Figure 1A/F18 container at top left of Figure 2A), a connection between the vessel (vial 1010 in Figure 1A/F18 container at top left of Figure 2A) and a synthesis unit selector (trap chip 1005/exchange column Figure 2A) such that a predetermined amount of active product may be directed to at least one other synthesis component (chip 1000) of the radiopharmaceutical. Van Dam further discloses an observation camera in Paragraphs 0051 and 0120. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the use of cameras from Van Dam with the system of Kiselev. One of ordinary skill in the art at the time would add the camera to Kiselev to monitor the reaction system as taught by Van Dam.
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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, Charles Capozzi can be reached at 571-270-3638. 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.
/DWAYNE K HANDY/Examiner, Art Unit 1798 May 21, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights