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 .
DETAILED ACTION
Pursuant to a preliminary amendment, claims 18-43 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election without traverse of Group I, claims 18-23, 36 and 38-43, directed to a method of iterative polymer synthesis, in the reply filed July 9, 2025 was previously acknowledged.
Supplemental Election-Restriction Requirement
Applicant's election with traverse of Group I, claims 18, 20-23, 40 and 42, directed to a method of iterative polymer synthesis; and the election of Species without traverse as follows:
Species (A): the method according to claim 18, further comprising a step of adding reagent to a solution of step 5) in at least one synthetic cycle (claim 22);
Species (B): the method according to claim 19, further comprising a step of adding an activating reagent to a solution of step vi) in at least one synthetic cycle (claim 39); and
Species (C): wherein a peptide, a peptide derivative or a peptide analog is synthesized (claim 40), in the reply filed on October 22, 2025 is acknowledged.
Response to Traversals:
The traversal of is on the grounds that: (a) with respect to Groups I and II, Pohl fails to teach that the transfer ports are suitable for the transfer of solid material (1); that each storage vessel contains a defined amount of a building block B in solid form (2); that building block B is transferred from the storage vessel into the first reaction vessel (3); and that building block B is dissolved by addition of a suitable solvent, thereby forming a solution of building block B inside the first reaction vessel RV1 (4) (Applicant Remarks, pg. 2, last partial paragraph); (b) Pohl fails to teach transferring building blocks into the reaction vessel in solid form (Applicant Remarks, pg. 3, first partial paragraph); (c) the claimed invention requires storage and transfer of building blocks in solid form into the first reaction vessel where dissolution occurs which solves the issue of limited scalability of the other approaches known in the art (Applicant Remarks, pg. 3, first full paragraph); and (d) the International Preliminary Report on Patentability in International PCT Application No. PCT/EP2020/082036 (the PCT application of which the present application is a national phase application) found that PCT claims 1-6 (which correspond to present claims 18-23, 36, and 38-39) possessed unity of invention (Applicant Remarks, pg. 3, second full paragraph).
Regarding (a), Applicant is reminded that 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, 26USPQ2d 1057 (Fed. Cir. 1993). As an initial matter, instant claims 18 and 19 do not recite any specific structure of the transfer ports, which makes them suitable for the transfer of solid material. Additionally, instant claims 18 and 19 do not recite a specific identity of building block B and/or any specific order of steps (e.g., dissolving building block B before transfer or after transfer). Pohl teaches solid support containers that are can be used in the devices of the present invention; as well as, handling systems, reaction blocks, wells, or other reaction vessels to dispense or extract reagents, wherein the handling systems regulate the quantities of reagents dispensed (interpreted as a transport ports suitable for the transfer of solid materials) (paragraphs [0041]; and [0043]-[0044]). Additionally, Pohl teaches that the building block monomer units can be immobilized on a solid support, wherein the handling system segregates or distributes the solid supports into selected reaction wells or other vessels (interpreted as solid building block B immobilized on a solid support; the transfer port is suitable for the transfer of solid materials; building block B is transferred from the storage vessel into the first reaction vessel; and that building block B is dissolved by addition of a suitable solvent) (paragraphs [0035]; [0044], lines 1-5; and [0048]). Moreover, Pohl teaches that the donor molecule (265.4mg) and acceptor molecule (43.7mg) were dissolved in DCE in conical vials and placed on the stock solution rack (Donor 1) or the reagent rack, which are connected to the transfer ports, wherein acceptor molecule solution was transferred to the reaction vial 1 (interpreted as defined amount of solid building block B; suitable for the transfer of solid materials; transferred from a storage vessel into a first reaction vessel; block B dissolved in a solvent; and a solution in a first reaction vessel) (paragraphs [0074]; and [0077]). Pohl also teaches the complete extraction of loaded resin from the cartridges (interpreted as solid building block B, the transfer port that is suitable for the transfer of solid materials; building block B is transferred from the storage vessel into the first reaction vessel; and building block B is dissolved by addition of a suitable solvent) (pg. 9, col 1, claim 12). Thus, Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2 because they lack the same or corresponding special technical features, wherein the technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Pohl et al.
Regarding (b), as an initial matter, Groups I and II do not recite transferring building blocks into the reaction vessel in solid form. Moreover, please see the discussion supra regarding what is recited in Groups I and II, and the teachings of Pohl.
Regarding (c), please see the discussion supra regarding what is recited in Groups I and II, and the teachings of Pohl. 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, 26USPQ2d 1057 (Fed. Cir. 1993). It is noted that Groups I and II do not recite any particular scale for the iterative polymer synthesis. Moreover, the claims do not recite that a polymer has been synthesized.
Regarding (d), it is noted that WO2021094518 recites claims 1-17 (and not claims 18-23, 36, and 38-39 as suggested by Applicant). With regard to Applicant’s assertion that the claims possess unity of invention according to the Written Opinion, the Examiner is not persuaded. On the international level, all written opinions are non-binding and a patent does not issue; what does issue is an international preliminary examination report (IPER), which is non-binding on the Elected States. See MPEP § 1878.01(V). Thus, the Written Opinion has no binding opinion on the pending claims.
Claims 19, 24-39, 41 and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 22, 2025.
Claims 21, 23 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 18, 20, 22 and 40 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed May 11, 2022 is a 35 U.S.C. 371 national stage filing of
International Application No. PCT/EP2020/082036, filed November 13, 2020, which claims the benefit of European Applications EP19208979.5, filed November 13, 2019; and EP19209105, filed November 14, 2019.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on May 11, 2022; March 14, 2024 and February 20, 2025 have been considered. Initialed copies of the IDSs accompany this Office Action.
Claim Objections/Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18, 20, 22 and 40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 18 is indefinite for the recitation of the term “a method of iterative polymer synthesis” such as recited in claim 18, line 1 because steps (1)-(11) do not appear to result in the synthesis of a polymer, such that the method is unclear and, thus, the metes and bounds of the claim cannot be determined.
Claims 18 and 20 are indefinite due to the use of use parentheses to comments on or qualify part of the sentences including, for example, “(1)”, “(3)”, “(26)”, “(4)”, etc.). It is unclear whether the limitations in parentheses are meant to be limitations in the claims, whether they are only suggestions, examples of a preferred embodiment, reference notes, or whether they refer to something else. Accordingly, the metes and bounds of the claim are not clear.
Claim 18 is indefinite for the recitation of the term “the transfer” such as recited in claim 18, lines 4-5. There is insufficient antecedent basis for the term “the transfer” in the claim because claim 18, line 4 recites the term “enable transport”.
Claim 18 is indefinite for the recitation of the term “the iterative polymer synthesis process” such as recited in claim 18, line 6. There is insufficient antecedent basis for the term “the iterative polymer synthesis process” in the claim because claim 18, line 1 recites the term “a method of iterative polymer synthesis”.
Claim 18 is indefinite for the recitation of the terms “specific storage vessel” and “each storage vessel” such as recited in claim 18, lines 7 and 10. There is insufficient antecedent basis for the terms “specific storage vessel” and “each storage vessel” in the claim because claim 18, line 3 recites the term “a plurality of movable, closable storage vessels”.
Claim 18 is indefinite for the recitation of the term “the plurality of y storage vessels” such as recited in claim 18, line 8. There is insufficient antecedent basis for the term “the plurality of y storage vessels” in the claim because claim 18, line 3 recites the term “a plurality of movable, closable storage vessels”.
Claim 18 is indefinite for the recitation of the term “both vessels” such as recited in claim 18, line 12. There is insufficient antecedent basis for the term “both vessels” in the claim because claim 18, line 3 recites the term “a plurality of movable, closable storage vessels” and claim 18, line 8 recites a first reaction vessel RV1”.
Claim 18 is indefinite for the recitation of the terms “the transfer ports” or “the transfer port” such as recited in claim 18, lines 13 and 24. There is insufficient antecedent basis for the terms “the transfer ports” or “the transfer port” in the claim because claim 18, lines 4 and 8-9 recites the term “a first transfer port” and “a second transfer port”.
Claim 18 is indefinite for the recitation of the term “the storage vessel” such as recited in claim 18, lines 15 and 17-18. There is insufficient antecedent basis for the term “the storage vessel” in the claim because claim 18, line 3 recites the term “a plurality of movable, closable storage vessels”.
Claim 18 is indefinite for the recitation of the term “the docked transfer ports” such as recited in claim 18, line 17. There is insufficient antecedent basis for the term “the docked transfer ports” in the claim because claim 18, lines 4 and 8-9 recites the term “a first transfer port” and “a second transfer port”.
Claim 18 is indefinite for the recitation of the term “the building block Bi” such as recited in claim 18, lines 22-23 and 27. There is insufficient antecedent basis for the term “the building block Bi” in the claim because claim 18, lines 5-6 recites the term “a building block B”.
Claim 18 is indefinite for the recitation of the term “the formation” such as recited in claim 18, lines 26-27. There is insufficient antecedent basis for the term “the formation” in the claim.
Claim 18 is indefinite for the recitation of the term “the coupling reaction” such as recited in claim 18, line 30. There is insufficient antecedent basis for the term “the coupling reaction” in the claim.
Claim 18 is indefinite for the recitation of the term “the next synthetic cycle” such as recited in claim 18, line 32. There is insufficient antecedent basis for the term “the next synthetic cycle” in the claim because claim 18, line 6 recites the term “one cycle”.
Claim 18 is indefinite for the recitation of the term “conditioning the carrier with the extended molecule C’…extended molecule C’ as molecule C” such as recited in claim 18, lines 32-33 because step (10) is unclear regarding what the term “extend molecule C’ as molecule C” and, thus, the metes and bounds of the claim cannot be determined.
Claim 18 is indefinite for the recitation of the term “the empty storage vessel” such as recited in claim 18, line 34. There is insufficient antecedent basis for the term “the empty storage vessel” in the claim because claim 18, line 3 recites the term “a plurality of movable, closable storage vessels”.
Claim 20 is indefinite for the recitation of the term “the passive part” such as recited in claim 20, line 2. There is insufficient antecedent basis for the term “the passive part” in the claim.
Claim 20 is indefinite for the recitation of the term “the active part” such as recited in claim 20, line 3. There is insufficient antecedent basis for the term “the active part” in the claim.
Claim 22 is indefinite for the recitation of the term “at least one synthetic cycle” such as recited in claim 22, line 2. There is insufficient antecedent basis for the term “at least one synthetic cycle” in the claim because claim 18, line 6 recites the term “one cycle” and claim 18, line 32 recites the term “the next synthetic cycle”.
Claim 40 is indefinite for the recitation of the term “wherein a peptide, a peptide derivative…is synthesized” such as recited in claim 40, lines 1-2 because claim 40 depends from instant claim 18, wherein the body of claim 18 does not recite the synthesis of a peptide, peptide derivative, or a peptide analog. Moreover, it is unclear what structures and/or molecules are encompassed by the term peptide derivative and peptide analog and, thus, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 40 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 40 recites (in part): “wherein a peptide, a peptide derivative, or a peptide analog is synthesized” in lines 1-2 because claims 40 depends from claim 18, wherein claim 18 does not recite the synthesis of a polymer and/or a peptide of any kind. Thus, claim 40 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 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.
Claims 18, 20, 22 and 40 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Tu et al. (hereinafter “Tu”) (Journal of Laboratory Automation, 2016, 21(3), 459-469) as evidenced by Chemspeed (Chemspeed, 2013, 1-8); and Chemspeed Technologies (Chemspeed Technologies, 2014, 1-3).
Regarding claims 18 and 22, Tue teaches a microwave reactor with an integrated high-performance liquid chromatography-mass spectrometry (HPLC-MS) system that uses a fully automated synthesizer with a microwave as energy source and robotic components for weighing and dispensing of solid reagents, handling liquid reagents, capper/crimper of microwave reaction tube assemblies and transportation (interpreted as automated transport; and movable, closable storage vessels shaped to enable transport by automated means, claim 18(1)) (Abstract, lines 2-5). Tu teaches in Figure 4, an integrated robotic instrument for synthesis and purification that is based on the Chemspeed SWAVE (pg. 463, Figure 4). Figure 4 is shown below:
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Tu teaches two different reactions including Sonogashira coupling for C-C bond formation and Buchwald-Hartwig amination for C-N bond formation (Figure 1A), such that for multistep synthesis, a three-step synthetic sequence was designed involving a sulfonylation reaction followed by a nucleophilic substitution and a Suzuki-Miyaura coupling reaction to yield the final product with good yield (Figure 1B) (interpreted as forming chemical bonds between building block B1 and molecule C, to form C’, which is extended by one building block, claim 18(8)) (pg. 460, col 1, first full paragraph). Tu teaches that core, reagents, and monomers (in either 4-mL or 40-mL vials) were dissolved while resin/solid reagents were placed inside the solid dispensing bottle, wherein experimental design was created using the AutoSuite software (Chemspeed Technologies, Augst, Switzerland), which controlled various components in assembling the reaction mixture according to a predetermined amount of each reagent (interpreted as a plurality of storage vessels suitable for solid material; and containing a defined amount of a building block B, claim 18(2)) (pg. 460, col 1; second full paragraph, lines 1-7). Tu teaches Buchwald-Hartwig aminations library as shown in Figure 2A, wherein bromide 1 (700 mg) in a 40-mL vial was added to dioxane (23 mL), and the solution was capped; and a powder mixture of XPhos (242 mg), tris(dibenzylideneacetone) dipalladium(0) (233 mg), and sodium tert-butoxide (367 mg) was placed inside the solid dispensing vial, and the reagents were transported to the synthesizer’s deck; and a bottle of dry dioxane in a 40-mL capped vial and 23 amine monomers (0.6 mmol each) in 4-mL vials without caps were placed on the deck of the synthesizer (interpreted as a plurality of storage vessels suitable for solid material; and containing a defined amount of a building block B, claim 18(2)) (pg. 460, col 2; first full paragraph, lines 1-15). Tu teaches that the synthetic process started with adding dry dioxane (1.0 mL) to the amine monomers with five aspirate/dispense (1.3 mL) cycles to ensure monomer dissolutions, wherein the monomer solution (0.202 mL each) was transferred to a microwave tube, such that to each microwave tube was added the solid mixture (36.62 mg) via the solid dispensing unit, wherein the vials were capped, crimped, and transported to the microwave oven and heated to 120°C for 20 min (interpreted as dissolving building block B in a suitable solvent to form a solution; a plurality of storage vessels that can be releasably docked to a transfer port of a reaction vessel; aligning and docking the transfer port on the storage vessel and the first reaction vessel; opening the docked transfer ports; material passes through in a connected state; cycles; and forming molecule B1, claim 18(2-5)) (pg. 460, col 2; first full paragraph, lines 17-22). Tu teaches that after the heating step, the content from each microwave vial was transferred to the SPE station and passed through cartridges containing celite and the filtrates were collected, wherein the filtrate of each reaction was aspirated and injected into the HPLC injector for purification (interpreted as transferring the solution obtained in step 5 to a second reaction vessel containing a carrier to which molecule C is tethered; and obtaining a reaction mixture containing building block B1, claim 18(6)) (pg. 460, col 2; first full paragraph, lines 22-27). Tu teaches a Sonogashira library as shown in Figure 2B, where an application was created using AutoSuite where 1-fluoro-3-iodobenzene 3 (20 mg, 0.09 mol), alkyne monomer (0.108 mol), triethylamine (0.18 mol), Pd(dppf)Cl2 (0.018 mol), and copper iodide (0.018 mol) were added to each microwave tube, the vials were capped, crimped, transported to the microwave oven, and heated to 100°C for 45 minutes (interpreted as transferring the solution obtained in step 5 to a second reaction vessel containing a carrier to which molecule C is tethered; obtaining a reaction mixture containing building block B1; and interpreting the alkyne monomers as activating reagents, claims 18(6) and 22) (pg. 460, col 2; last partial paragraph; and pg. 461, col 1, first partial paragraph; and Figure 2B). Tu teaches a three-step matrix library as shown in Figure 3A using the following stock solutions, reagents, and reaction microwave reaction vessels were prepared and placed on the deck of SWAVE: (1) three 4-mL vials with a stir bar each containing core 5 (200 mg in DMA (dimethylacetamide); (2) three 4-mL vials, each containing one of the three amines (200 mg in DMA); (3) three 4-mL vials, each containing one of the three phenols (200 mg in DMSO); (4) four 4-mL vials, each containing one of the four boronic acids (100 mg in EtOH); (5) diisopropylamine in a 4-mL vial (2.0 mL); (6) isocyanate resin (2.0 g, 1.5 mmol/g loading) in solid dispensing bottle 1; (7) cesium carbonate (2.0 g) in solid dispensing bottle 2; (8) nine empty microwave tubes (set 1) for step 2 synthesis and 36 empty microwave tubes (set 2) for step 3 synthesis, wherein a script was created in AutoSuite to carry out the entire three-step matrix library synthesis, wherein the hotplate was preheated to 60°C, and the amines were added separately to the three vials containing core with the liquid handler; a programmed pause of 30 min in the script allowed the reaction of step 1 to take place, such that after the 30 min, the content from each 4-mL vial was transferred to the SPE station and passed through cartridges containing isocyanate resin, and the filtrates were collected, such that the filtrate of each reaction was aspirated and dispensed into three empty microwave vessels in equal portion to create nine reaction vessels for step 2 synthesis (set 1), wherein solid cesium carbonate was added to each of the nine reaction vessels using the solid dispensing unit, followed by the addition of phenols (phenol 1 to MW tubes 1, 4, and 7; phenol 2 to MW tubes 2, 5, and 8; phenol 3 to MW tubes 3, 6, and 9); all MW tubes were capped and crimped by the capper/crimper tool, the assembled MW tubes were transported to the microwave oven for heating (100°C, 10 min); and after the heating was done, the contents of each MW tube from step 2 (set 1) synthesis was dispensed into four empty MW tubes (set 2) in equal portions to create 36 tubes for step 3 synthesis, such that four boronic acids were added to the 36 tubes created for step 3 synthesis (boronic acid 1 to MW tubes 1, 5, 9, 13, 17, 21, 25, 29, and 33; boronic acid 2 to MW tubes 2, 6, 10, 14, 18, 22, 26, 30, and 34; boronic 3 to MW tubes 3, 7, 11, 15, 19, 23, 27, 31, and 35; boronic acid 4 to MW tubes 4, 8, 12, 16, 20, 24, 28, 32, and 36), such that all microwave tubes were capped and crimped by the capper/crimper tool, the assembled MW tubes were transported to the microwave oven for heating (120°C, 20 min), wherein the system aspirated and dispensed the crude reaction material from the previous microwave tube through the SPE cartridge and the filtrate was injected into the HPLC injector for purification (interpreted as steps 2-11 including automated transport; aligning and docking; opening; dissolving; transfer to a second reaction vessel containing a carrier; cleaning by rinsing; incubating the reaction mixture; purging a liquid comprising by-product; conditioning the carrier; and undocking and removing the empty storage vessel; and interpreting amines, isocyanate, phenols, and boronic acids as activating reagents, claims 18(steps 2-11) and 22) (pg. 461, last partial paragraph through pg. 462, first partial paragraph). Tu teaches that to ensure minimum retention of material inside the cartridge, a rinse step was incorporated followed by positive air pressure push created by dispensing air with the needle through the air-tight cartridge cap (also interpreted as cleaning by rinsing solvent, claim 17(step 7)) (pg. 464, col 2, last partial paragraph; and pg. 465, col 1, first partial paragraph).
Regarding claim 20, Tu teaches in Figure 4 that the integrated robotic instrument comprises a solid reagent dispenser, a liquid dispenser, robotic arm, liquid reagent dispenser, liquid reagent rack, hot plate reaction rack, microwave rack, HPLC Sample Injector, solid reagent bottle, solid phase extraction, microwave oven, vial storage, vial capper, etc. (pg. 463, Figure 4). Tu teaches that the HPLC-MS system is configured to introduce crude reaction mixtures directly from the HPLC injection valve onto the preparative HPLC column; wherein an active flow splitter and makeup pump are used to deliver a 4000:1 split of the column eluent to the mass spectrometer (interpreted as a split valve device, claim 20) (pg. 465, col 2, first full paragraph). Tu teaches that one of the main advantages of the SWAVE system is the ability to accurately dispense solid materials, wherein the overhead gravimetric solid dispensing module incorporates an overhead balance and a solid dispensing bottle housing an extruder screw that rotates within the cap to dispense solid material to targeted container, such that during the solid dispensing step, the overhead balance monitors the weight of material dispensed and stops rotating the extruder screw once the targeted weight is achieved (interpreted as inherently comprising a split valve device suitable for solid material transfer comprising an active and passive part, claim 20) (pg. 464, col 1, last full paragraph), where it is known that Chemspeed gravimetric dispensing units dispense a wide-range of powders in the milligram to multigram scale; and that the powder dispensing container cartridge comprises a self-closing feature with a closed position and an open position
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as evidenced by Chemspeed (pg. 4, entire page); and that the liquid handling robot comprises 2 way-6 port ceramic valves as evidenced by Chemspeed Technologies (pg. 3, col 1, Technological Data – Liquid Handling).
Regarding claim 40, Tu teaches that in Figure 2, the synthesis of a Buchwald-Hartwig cross-coupling library (Fig. 2A) and a Sonogashira cross-coupling library (Fig. 2B) as shown below:
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(interpreted as peptide analogs, claim 40) (pg. 461, Figure 2).
Tu meets all of the limitations of the claims and, therefore, anticipates the claimed invention.
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 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.
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.
Claims 18, 20, 22 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al. (hereinafter “Tu”) (Journal of Laboratory Automation, 2016, 21(3), 459-469) in view of Eshima et al. (hereinafter “Eshima”) (US Patent No. 10906020, issued February 2, 2021; published September 15, 2016) as evidenced by Chemspeed (Chemspeed, 2013, 1-8); and Chemspeed Technologies (Chemspeed Technologies, 2014, 1-3); and Barton et al. (hereinafter “Barton”) (US Patent No. 8740187, issued June 3, 2014); and Precision Polymer Engineering (European Pharmaceutical Manufacture, 2018, 1-4).
The teachings of Tu as applied to claims 18, 20, 22 and 40 are described supra.
Tu does not specifically exemplify additional types of split valve devices (claim 20, in part).
Regarding claim 20 (in part), Eshima teaches systems, methods, and devices for generating radionuclides for use in production of radiopharmaceuticals; synthesizing the radionuclides generated and removing any unwanted products; measuring the quantity and activity level of the synthesized radionuclides; distributively delivering the radionuclides in appropriate quantities to modular cassette synthesis units in a modular cassette subsystem for contemporaneous/parallel production of radio-pharmaceutical output and that allow reuse and/or quick, safe, and disposable replacement of portions of the subsystem; and delivering non-radionuclide components to the modular cassette synthesis units as part of production of radiopharmaceutical output (Abstract). Eshima teaches the field of fully or partially automated production of radiopharmaceuticals, and the systems, methods and devices for safe, secure, reusable, and flexible production of radionucleotides (col 2, lines 8-13). Eshima teaches implementation for reagent and synthesis operation, wherein internal related art shielded openings used for components for a single product run are replaced with multiple subsystems that two or more contemporaneous parallel production operations, and cooperation among other system components allows increased production by allowing increased efficiency of feed and accuracy of both characteristics and volume of radionuclide and other raw material input to the production process (col 4, lines 28-36). Eshima teaches that the increase in automation of portions of operation, as well as improvement, reduction of size and cost, and advancement of operation of cooperating portions of reagent and synthesis operations results in the both increased speed and accuracy of production and decreased human exposure during the process (col 4, lines 41-46). Eshima teaches that the chamber 3350 can also have one or more input lines such as input lines 3352 and 3354, through which additional reagents, or ingredients, can be provided, for example during a second stage of a manufacturing or reaction process, after or before the fluid has been transferred from chamber 3310 into chamber 3350; as well as, the mixing of various additional ingredients with the fluid transferred from the chamber 3310 to the chamber 3350 may take place inside the chamber 3350, wherein a subsequent transfer of the fluid now present in chamber 3350 to chamber 3390 can be accomplished in a similar process to the process described above with respect to the transfer of fluid between chambers 3310 and 3350 (col 33, lines 7-20). Eshima teaches that with respect to the valves used to open and close the various gas, vacuum and input lines, many types of valves can be used such as, for example, ball valves, butterfly valves, globe valves, gate valves, diaphragm valves, check valves, and the like (interpreted as butterfly valves including split butterfly valves, claim 18) (col 33, lines 45-49), wherein butterfly valves include split butterfly valves designed for the handling and the contained transfer of solid state powders and granular materials as evidenced by Barton (col 1, lines 7-13; and col 3, lines 1-3), wherein SBVs are known to provide an effective containment seal between the active and passive halves once docked together as evidenced by Precision Polymer Engineering (pg. 3, first full paragraph).
“It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of increasing automation and system cooperation between system components as exemplified by Eshima, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microwave-assisted synthesis system for the generation of library compounds including the solid dispensing module as disclosed by Tu to include the modular system including the solid dispensing modules comprising different valve assemblies such as butterfly valves, ball valves, check valves, and the like as taught by Eshima with a reasonable expectation of success in the contemporaneous/parallel production of synthetic library members including the reuse and/or quick, safe, and disposable replacement of portions of the modular cassette subsystem; as well as, delivering components to the modular cassette synthesis units; in increasing the precision and efficiency of dispensing individual and/or discrete reagents including reactive and/or hazardous monomers and/or reagents; and/or in providing an sterile environment that decreases human exposure to reagents during the automated synthesis process.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Conclusion
Claims 18, 20, 22 and 40 are rejected.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684