CTNF 17/612,206 CTNF 100108 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Continued Examination Under 37 CFR 1.114 07-42-04 AIA A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01 April 2026 has been entered. Response to Amendment Applicant’s Amendment filed on 01 April 2026 has been considered. It is acknowledged that claims 1 and 13 have been amended, and claim 11 has been cancelled by Applicant. Accordingly, claims 1-10, 13-15, and 26-27 are under full consideration. Response to Arguments 07-37 AIA Applicant's arguments filed 01 April 2026 have been fully considered but they are not persuasive. The respective arguments are addressed below: Applicant argues that Samper does not disclose a motorized rotation stage that rotates a cassette to provide for dispensing of different reagents or removal of product. Examiner respectfully disagrees. Samper discloses “the transfer element 62, magazine 12, and cassette handling platform 18 or synthesizer 26 may be configured such that one or more may translate and/or rotate to facilitate transfer” (see [0033]), clearly indicated one or more rotation stages, “a radioactive reagent generated by the particle accelerator 32 may be injected into one or more channels on the cassette 14” (see [0027]), “the cassette 14 may be rotated or translated to align with the appropriate reagent reservoirs 66 and/or channels 68 with the entry passage 70” (see [0033]), clearly indicating that the rotation not only supports the dispensing of the cassette into the cassette handling platform and/or synthesizer, but also alignment of the channels of the cassette with the entry passage, therefore enabling the particle accelerator to inject reagent into the channels of the cassette, and, “transfer element 62 or multiple transfer elements 62 or robotic assemblies may facilitate the transfer”, clearly indicating motorization. Regarding Applicant’s argument about the operation of the rotating stage being at the start up vs. during the process, Examiner reminds applicant that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham , 2 USPQ2d 1647 (BPAI 1987). Further, Applicant’s exclamation that the rotation must occur during the reaction process is not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant argues that the motivation to modify Wang by Samper is not valid because it is not applicable to Applicant’s application. Examiner reminds Applicant that the test for obviousness is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller , 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The motivation to combine does not have to solve a problem identified by the Applicant. Applicant argues that the cartridge of Wang does not contain the collection tube or any non-contact dispensers. Examiner finds Applicant’s argument persuasive, and therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Joris (EP-3798640-A1) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (WO-2018067965-A1) in view of Samper et al. (US-20130170931-A1), hereinafter “Samper”, Joris (EP-3798640-A1), and Schultz et al. (US-7442665-B2), hereinafter “Schultz” . Regarding Claim 1 , Wang discloses a radiosynthesis device (microfluidic platforms for performing… in particular radiochemical reactions; see e.g. [0003]) comprising: a thermally controlled support (temperature controlled synthesis platform; see e.g. [0036]) configured to hold a microfluidic chip (see e.g. [0036] part 62) having one or more circular (see Fig. 1 Part 16) reaction sites formed thereon (see e.g. [0036] part 16); a fixture (see e.g. [0041] part 90) configured to hold a plurality of dispensers (see e.g. [0041] part 76) and a collection tube (see e.g. [0042] part 92); a plurality of non-contact dispensers (see e.g. [0024]) installed on the fixture above the support (above the loading sites of the microfluidic chip; see e.g. [0041]) and configured to respectively dispense one or more droplets of a respective reagent into the one or more circular reaction sites of the microfluidic chip (droplets were loaded onto the microfluidic chip 10 at reagent loading sites through miniature… dispensers; see e.g. [0038] and [0029]); a collection tube installed on the fixture (see e.g. [0042] and Fig. 5a, parts 92 and 90) above the support (see e.g. Fig. 5a, parts 92 and 62), a moveable stage (see e.g. [0065]) that controllably moves the support relative to the collection tube to sequentially position the one or more circular reaction sites of the microfluidic chip for removing reaction product from the one or more circular reaction sites of the microfluidic chip via the collection tube (sites may be arranged as an array such that parallel or multiple separate synthesis reactions can take place on a single microfluidic chip 10… whereby fluids may be… unloaded from the various locations; see e.g. [0065]). Wang does not explicitly teach a motorized rotation stage. However, Samper discloses a motorized rotation stage (see e.g. [0032], “robotic assembly”, and [0033]) operatively coupled to the support for controllably rotating the support (the transfer element 62, magazine 12, and cassette handling platform 18 or synthesizer 26 may be configured such that one or more may translate and/or rotate to facilitate transfer; see e.g. [0033]) about an axis of rotation (this is in the nature of rotation), the motorized rotation stage configured to controllably rotate the support relative to the non-contact dispensers to sequentially position the one or more reaction sites for dispensing respective reagent from the non-contact dispensers into the one or more reaction sites (The transfer element, magazine, and cassette handling platform or synthesizer may be configured such that one or more may rotate to facilitate transfer. The cassette may be rotated or translated to align the appropriate reagent reservoirs with the entry passage; see e.g. [0033], [0034], and [0027]). Wang and Samper are both considered to be analogous to the claimed invention because they are in the same field of microfluidic, radiochemical devices. Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Wang by incorporating the teachings of Samper and modifying the movable stage of Wang to be motorized and rotatable. Doing so can prevent the sedimentation or separation of an agent or material (see e.g. Samper [0030]) and align the appropriate reservoirs with the entry passage (see e.g. Samper [0033]). Schultz also discloses a motorized rotation stage operatively coupled to the support for controllably rotating the support (the substrate is placed on a rotating stage driven by a gear rack which is coupled to a micrometer and a stepping motor; see Col. 28 Lines 29-31), the motorized rotation stage configured to controllably rotate the support relative to the dispensers to sequentially position the one or more reaction sites for dispensing respective reagent from the dispensers into the one or more reaction sites (The dispenser is then moved to the appropriate track while the disk substrate rotates. When the appropriate cell is positioned below the dispenser, a droplet of reactant solution is released; see Col. 24 Lines 12-16). Wang and Schultz are both considered to be analogous to the claimed invention because they are in the same field of microfluidic devices. Therefore, it would have been obvious to a person of ordinary skill in the art to modify Wang by incorporating the teachings of Schultz and incorporating the motorized rotation stage. Doing so would enable the dispenser to be aligned with the region of interest (see Schultz, Col. 24 Lines 8-9). Regarding the limitation of the reaction sites being circular, Wang discloses this, as previously exemplified. Further, changes in shape would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention unless the particular shape presents new and unexpected results. See In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In this case, Applicant makes it clear that there are multiple shapes that are suitable, and that these shapes are interchangeable (“Each reaction site may be a circular-shaped hydrophilic region, or other suitable shape, such as a square, rectangle, etc.” see [0010] of instant specification). Regarding the limitation claiming, “a plurality of dispensers and a collection tube in a carousel configuration”, Wang discloses that the dispensers are “above the loading sites of the microfluidic chip” (see [004]). When modifying Wang with the rotatable stage disclosed by Samper, it would naturally follow that the dispensers would be arranged in a carousel configuration to align with the disclosure of “the dispensers being above to the loading sites”. Further, Samper discloses the reagent 72 from the particle accelerator being arranged in a carousel configuration (see Fig. 8 Part 72), which is configured to be dispensed into the cassettes or reaction sites, as previously explained. Samper also discloses the use of cartridges (see e.g. [0027] “cassette”) that are removably mounted to the fixture (see e.g. [0030]) and in which reagents are disposed (see e.g. [0034]). This would have been obvious to a person of ordinary skill in the art because doing this allows for processing complex processes or parallel operation (see e.g. [0034]). Modified Wang does not explicitly teach wherein the one or more of the plurality of non-contact dispensers and the collection tube are disposed in a removeable cartridge or kit. However, Joris discloses a removable cartridge (cartridge to be mounted and removed from the sample processing unit; see [0017]) that contains a regent dispensing device and collection device (microfluidic cartridge… comprising a fluid flow network… The fluid flow network comprises chamber entry orifices and chamber exit orifices arranged on opposed sides of the reaction chamber for flow of reagents through the reaction chamber; see [0028]). Joris and Wang are both considered to be analogous to the claimed invention because they are in the same field of microfluidic devices. Therefore, it would have been obvious to a person of ordinary skill in the art to modify Wang by incorporating the teachings of Joris and providing the dispensers and collection tube in a removeable cartridge. Doing so can enable rapid, efficient, and accurate imaging of samples (see Joris [0012]) Regarding Claim 2 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses the device comprising a computing device (computer; see e.g. [0012]) having software executed thereon (LabView software program running on computer 90; see e.g. [0037]) and configured to control a temperature of the thermally controlled support (the cooling device 66 was… operated through another solid state relay 72 controlled by the LabView software program; see e.g. [0012] and [0037]), and dispensing of reagents by the non-contact dispensers (each dispenser was… controlled via the LabView program; see e.g. [0039]) and removal of reaction product by the collection tube (output of an electronic pressure regulator controlled by the LabView program; see e.g. [0038] and The height of this tube 92 was controlled by mounting it on a single acting pneumatic cylinder. The pneumatic cylinder was activated by applying pressure from an electronic pressure regulator; see e.g. [0042])). Wang does not explicitly teach a computing device controlling a motorized rotation stage. However, Samper discloses a computing device having a software executed thereon and configured to control the motorized rotation stage (see e.g. [0032]). Specifically, Samper discloses the use of a robotic assembly to facilitate transfers, of which occur by the rotational transfer element. A robotic assembly indicates the use of a computer and software. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Wang by including the rotational stage taught by Samper, as explained in section 7 of this office action. The rotational stage taught by Samper is robotically controlled, indicating control by a computing device with software, and Wang discloses a computing device with software to control other elements. So, when modifying Wang with the rotational stage taught by Samper, it would have logically followed that the stage taught by Samper would have been controlled by the computing device with software disclosed by Wang. Regarding Claim 3 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses the thermally controlled support comprising a heater (heating element; see e.g. [0036]) and a thermoelectric cooler (see e.g. [0036]). Regarding Claim 4 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 3. Wang further discloses the device further comprising a heat sink in thermal contact with one or more of the heater and the thermoelectric cooler (see e.g. [0037]). Regarding Claim 5 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 4. Wang further discloses the device further comprising a fan coupled to the fixture (see e.g. [0036]) and configured to move air over the heat sink (see e.g. [0036]). It would have been obvious to a person of ordinary skill in the art that the fan and heatsink were effectively coupled (see e.g. [0036] and Fig. 5B parts 68 and 66) and that the fan was therefore configured to move air over the heat sink because the heatsink is disposed below the fan (see e.g. Fig. 5B parts 68 and 66). Regarding Claim 6 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses the device further comprising a collection vial fluidically coupled to the collection tube (see e.g. [0042] and Fig. 5a, parts 97 and 92) and respective reagent tubes (see e.g. 0038]) fluidically coupled to the plurality of non-contact dispensers (the inlet of each dispenser was connected to a 1 mL glass V-vial; see e.g. [0038]) and to respective reagent containers coupled to the fixture (solution may come directly from the cyclotron… or other dispenser; see e.g. [0039] and [0040]). Regarding Claim 7 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses the microfluidic chip comprising a plurality of separate hydrophilic circular reaction sites formed thereon (multiple hydrophilic reaction or collection sites 16; see e.g. [0065]) and disposed along an arc on a surface of the microfluidic chip (the microfluidic chip includes a central hydrophilic reaction site and plurality of hydrophilic channels… the hydrophilic channels may be curved; see e.g. [0029]). Regarding Claim 8 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 2. Wang further discloses the device further comprising a data acquisition device (see e.g. [0037]) interfacing the computing device with the thermally controlled support (see e.g. [0037]), the motorized rotation stage (please see section 8 of this office action as this follows the same logic), the non-contact dispensers (see e.g. [0039]), and the collection tube (see e.g. [0038] and [0042]). Regarding Claim 9 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses shielding (see e.g. [0064]) and discloses sealing with the use of seal material (see e.g. [0038]) indicating the importance of emission prevention. Samper further discloses the motorized rotation stage and fixture being mounted within a housing (see e.g. [0023]) which provides radiation shielding (see e.g. [0022]). The shielding disclosed by Wang requires some kind of device or product to provide said shielding. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to choose the housing taught by Samper from a finite number of identified, predictable solution, with a reasonable expectation of success, to provide the shielding taught by Wang. Regarding Claim 10 , MPEP 2144.04.IV.A states that “where the only difference between the prior art and the claims is a recitation of the claimed device’s relative dimensions and the claimed device would not perform differently than the prior art device, the claimed invention is not patentably distinct from that of the prior art”. Here, one having ordinary skill in the art would have been able to select the appropriate volume for the radiosynthesizer that would be workable with the device, thereby facilitating device operation. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have made the device less than 750 cm 3 to facilitate device operation. Wang discloses that the volume capacity of the device can be scaled up or down (see e.g. [0063]) and teaches advantages of a smaller device being the requirement of much less shielding (see e.g. [0064]) and potential use on a benchtop (see e.g. [0064]). Based on the motivations taught by Wang, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to perform routine experimentation in efforts to optimize the size of the device. Regarding Claim 13 , the limitations of this claim do not exceed those of claim 1, with the exception of the chip holder. Please see the claim 1 rejection for the associated rationale. Regarding the remaining limitations, Wang discloses a thermally controlled support having a microfluidic chip holder disposed thereon (platform 60 includes a chip holder; see [0036]) and configured to hold a microfluidic chip (chip holder 62 holds the microfluidic chip 10; see [0036]) wherein the microfluidic chip holder maintains the microfluidic chip stationary on the thermally controlled support (chip holder that supports the microfluidic chip…The chip holder holds the microfluidic chip; see [0036]). Regarding Claim 14 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses a radiosynthesis system (see e.g. [0036]) comprising: a radioisotope concentrator (fluoride concentrator; e.g. [0040]) configured to concentrate a radioisotope (this is the definition/design of a radioisotope concentrator) and output the radioisotope to the radiosynthesis device of claim 1 (see e.g. [0040] and [0039]); and a downstream purification and/or formulation module (direct the droplet for further processing such as purification and/or formulation see e.g. [0042]) configured to receive a radiochemical compound synthesized by the radiosynthesis device (see e.g. [0042]). Regarding Claim 15 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis system of claim 14. Wang further discloses the system further comprising a downstream formulation module (see e.g. [0042]) configured to receive a radiochemical compound synthesized by the radiosynthesis device (see e.g. [0042]) . 07-21-aia AIA Claim s 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (WO-2018067965-A1) in view of Samper et al. (US-20130170931-A1), hereinafter “Samper”, Joris (EP-3798640-A1), Schultz et al. (US-7442665-B2), hereinafter “Schultz”, and Desmond et al. (US-20040018117-A1), hereinafter “Desmond” . Regarding Claim 26 , Wang, Samper, Schultz, and Joris together disclose the radiosynthesis device of claim 1. Wang further discloses the thermally controlled support comprising a microfluidic chip holder (platform 60 includes a chip holder; see [0036]) configured to hold the microfluidic chip (chip holder 62 holds the microfluidic chip 10; see [0036]). Wang does not explicitly teach the microfluidic chip being off-center. However, Desmond discloses the microfluidic chip being off-center with respect to the axis of rotation (The processing apparatus can include a rotatable platen having an axis of rotation, a holder capable of holding a microfluidic device on or in the platen and being disposed off-center with respect to the axis of rotation; see [0006]). Wang and Desmond are both considered to be analogous to the claimed invention because they are in the same field of microfluidic devices. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang by incorporating the teachings of Desmond and disposing the microfluidic chip off-center with respect to the axis of rotation. Doing so would determine a direction in which teardrop-shaped chamber is canted (see Desmond [0047]). Regarding Claim 27 , the limitations of this claim do not exceed those of claim 26. Please refer to the rejection of claim 26 for the associated rationale. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA LEE KUYKENDALL whose telephone number is (571)270-3806. The examiner can normally be reached Monday- Friday 9:00am-5:00pm. 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, Claire Wang can be reached at 571-270-1051. 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. /A.L.K./Examiner, Art Unit 1774 /CLAIRE X WANG/Supervisory Patent Examiner, Art Unit 1774 Application/Control Number: 17/612,206 Page 2 Art Unit: 1774 Application/Control Number: 17/612,206 Page 3 Art Unit: 1774 Application/Control Number: 17/612,206 Page 4 Art Unit: 1774 Application/Control Number: 17/612,206 Page 5 Art Unit: 1774 Application/Control Number: 17/612,206 Page 6 Art Unit: 1774 Application/Control Number: 17/612,206 Page 7 Art Unit: 1774 Application/Control Number: 17/612,206 Page 8 Art Unit: 1774 Application/Control Number: 17/612,206 Page 9 Art Unit: 1774 Application/Control Number: 17/612,206 Page 10 Art Unit: 1774 Application/Control Number: 17/612,206 Page 11 Art Unit: 1774 Application/Control Number: 17/612,206 Page 12 Art Unit: 1774 Application/Control Number: 17/612,206 Page 13 Art Unit: 1774 Application/Control Number: 17/612,206 Page 14 Art Unit: 1774 Application/Control Number: 17/612,206 Page 15 Art Unit: 1774
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