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
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Status of Claims
Claims 18-43 are currently pending. Claims 18-25, 27-39 and 41-43 have been amended by Applicants’ amendment filed 03-13-2026. No claims have been added or canceled by Applicant’s amendment filed 03-13-2026.
Election-Restriction Requirement
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
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 was previously acknowledged.
Claims 21, 23 and 42 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.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.
A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
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.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed March 13, 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or
objection not specifically addressed below are herein withdrawn.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 40 is withdrawn 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 due to Applicant’s amendment of the claim, in the reply filed 03-13-2026.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Claim Rejections - 35 USC § 102
The rejection of claims 18, 20, 22 and 40 is withdrawn 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; of record) as evidenced by Chemspeed (Chemspeed, 2013, 1-8; of record); and Chemspeed Technologies (Chemspeed Technologies, 2014, 1-3; of record).
Tu does not specifically exemplify polymer synthesis.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Claim Rejections - 35 USC § 103
The rejection of claims 18, 20, 22 and 40 is withdrawn 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 combined references of Tu and Eshima do not teach polymer synthesis.
In view of the withdrawn rejection, Applicant’s arguments are rendered moot.
Maintained Objections/Rejections
Claim Interpretation: The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 18, 20, 22 and 40 are maintained 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 terms “may” and “can” such as recited in claim 18, lines 11, 18, 24 and 41 because the claims are required to particularly point out and distinctly claim the subject matter which the applicant regards as his invention, where the terms “may” and “can” express a possibility, such that it is unclear whether the steps and/or components are used in the manner that “can” happen or that “may” be the outcome and, thus, the metes and bounds of the claim cannot be determined.
Claim 18 is indefinite for the recitation of the terms “any other specific storage vessel,” “any one storage vessel” and “specific storage vessel” such as recited in claim 18, lines 10, 12, 13 and 27 because it is unclear whether the terms “any other specific storage vessel,” “any one storage vessel” and “specific storage vessel” refer to one of the “plurality of movable, closable storage vessels,” or whether the term refers to a different storage vessel and/or a different type of storage vessel and, thus, the metes and bounds of the claim cannot be determined.
Claim 18 is indefinite for the recitation of the term “the dissolved building block B” such as recited in claim 18, line 47. There is insufficient antecedent basis for the term “the dissolved building block B” in the claim.
Claim 18 is indefinite for the recitation of the term “purging a liquid” such as recited in claim 18, line 48 because the origin of the liquid is unclear. Claim 18 does not recite the presence of a liquid, such that it is unclear whether the term “purging a liquid” refers to the previously recited solution, suitable solvent, some previously unrecited liquid added in step (9), or whether the term refers to something else and, thus, the metes and bounds of the claim cannot be determined.
Claims 20, 22 and 40 are indefinite insofar as they ultimately depend from instant claim 18.
New Objections/Rejections
Claim Objection
Claim 18 is objected to because of the following informalities: Claim 18 recites:
“material can pass through the second transfer port in solid form when the first transfer port and the second transfer port are in connected state, but not in disconnected state,” which is recited twice in lines 22-26;
“second transfer pot” in line 28, wherein the term “port” might be more appropriate.
Appropriate correction is required.
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 may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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 negatived 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 Barstow et al. (hereinafter “Barstow”) (US Patent No. 5064940, issued November 12, 1991) in view of Barton et. al. (hereinafter “Barton”) (US Patent No. 8740187, issued June 3, 2014); and further in view of Lehtonen et al. (hereinafter “Lehtonen”) (US Patent 10578634, issued March 3, 2020; previously published as US20180080952, published March 22, 2018). This is a new rejection necessitated by amendment of the claims in the response filed 03-13-2026.
Regarding claims 18 (in part) and 40, Barstow teaches a method for combining highly reactive dry solids in a manner which makes them unreactive and shelf stable at room temperature for extended periods of time, such that once the solids are dissolved in solvent, a highly reactive amino acid ester that can readily be used in solid phase peptide synthesis is formed; and a method of delivering reagents to an automated peptide synthesizer, which allows a very simplified instrument to be constructed using fewer and less expensive components and significantly reducing the associated software required (interpreted as solid form of building block B; automated; and automated transfer, claim 18) (Abstract). Barstow teaches that dry solid protected amino acids can be packaged and stored with dry solid BOP activating reagent, such that quantities of each reagent (protected amino acid and activating reagent) sufficient for a single amino acid coupling can be provided in a single disposable vial (interpreted as providing a plurality of movable, closable storage vessels, shaped to enable transport by automated means; interpreting amino acids are a monomeric unit; as a solid form of building block B; and synthesizing a peptide, claims 18 and 40) (col 5, lines 49-54). Barstow teaches that the dry reagent of this invention comprises a predetermined amount of each of a protected amino acid and an activating agent for the protected amino acid (interpreted as a predetermined amount, claim 18) (col 5, lines 65-67). Barstow teaches that the reagent of this invention is prepared by dry mixing the selected protected amino acid and activating agent by known dry blending techniques; and since these ingredients are anhydrous, the mixing must be under anhydrous conditions, such that the resulting mixture is then charged to a vial or other moisture or solvent impermeable container and the container is sealed (col 6, lines 30-37). Barstow teaches that at the time of use, the container is opened, and the reagent is dissolved in an appropriate reaction solvent, such that in the case of an FMOC-protected amino acid and a BOP activating agent, the solvent typically is a solution of N-methyl-morpholine in dimethylformamide, wherein dissolution is preferably achieved by adding solvent directly to the container (interpreted as dissolving building block B by addition of a solvent, claim 18) (col 6, lines 38-45). Barstow teaches that the resulting solution is then mixed with a deprotected solid-phase peptide substrate, such as a Merrifield-type resin, and the coupling reaction is allowed to occur (interpreted as transferring the solution to a second reaction vessel containing molecule C tethered to a carrier, claim 18) (col 6, lines 47-51). Barstow teaches that most laboratory scale synthesizers commonly use either 0.5 millimole or 2 millimole of amino acid for each reaction step, while industrial-scale synthesizers use approximately one kilogram of protected amino acid, such that the amount of activating agent is adjusted to provide the desired molar ratio (col 6, lines 24-29). Barstow teaches that a 1.398 gram (0.5 mMole) portion of FMOC-leucine p-benzyloxy-benzyl alcohol resin was placed in the reaction vessel of an automated peptide synthesizer; the resin was mixed with 15 ml of dimethylformamide for 1 minute; and the solvent wash was performed three times; the FMOC amino acid resin was then deprotected; and washed 6 times (interpreted as molecule C tethered to a resin carrier, claim 18) (col 7, lines 12-21). Barstow teaches that a previously prepared dry mixture of FMOC-glutamic acid (1.0 mM 369 mg) and benzotriazole-1-yl-oxy-tris-(dimethyl-amino)phosphonium hexafluorophosphate (BOP 1.2 mM, 532 mg) was dissolved in 8.0 ml DMF. 2.0 ml of 10% NMM (N-methyl morpholine) was added, and the solution mixed with the resin for 1 hour, then the resin was washed 3 times with DMF (interpreted as transferring the solution of building block B to a second reaction vessel; automated transport of the solution; and incubating the reaction mixture to allow for coupling with tethered molecule C to form molecule C’; and purging a liquid comprising by-products and residual educts of the coupling reaction, claim 18) (col 7, lines 22-30). Barstow teaches that this procedure was repeated, using a dry pre-mixed FMOC amino acid/BOP activating reagent for each amino acid until the following sequence was complete: Val-Glu-Glu-Asp-Thr-Lys-Ser-Glu-Asp-Glu-Leu-Resin (interpreted as repeating the iterative steps, claim 18) (col 7, lines 30-33). Barstow teaches a pre-packaged reagent kit for solid phase peptide synthesis comprising a dry, shelf stable, and pre-mixed two component reagent consisting essentially of a protected amino acid and an activating agent for the protected amino acid for said synthesis, wherein the mole ratio of activating agent to protected amino acid is at least 1:1, said reagent being free of reaction solvent, and a container for said reagent (interpreted as a plurality of movable, closable storage vessels, claim 18) (col 8, lines 27-34, claim 7).
Regarding claim 22, Barstow teaches that a previously prepared dry mixture of FMOC-glutamic acid (1.0 mM 369 mg) and benzotriazole-1-yl-oxy-tris-(dimethyl-amino)phosphonium hexafluoro-phosphate (BOP 1.2 mM, 532 mg) was dissolved in 8.0 ml DMF. 2.0 ml of 10% NMM (N-methyl morpholine) was added, and the solution mixed with the resin for 1 hour, then the resin was washed 3 times with DMF (interpreted as adding an activating agent, claim 18) (col 7, lines 22-30).
Barstow does not specifically exemplify using an automated transport means to transport the storage vessel; a first transport port releasably docked to a second transport port; undocking and removing the storage vessel; and cleaning the first reaction vessel (claim 18, in part); or a split valve (claim 20).
Regarding claims 18 (in part) and 20, Barton teaches a split valve apparatus for the control, charging, discharging and/or regulating the flow of powders, liquids, slurries and/or fluids, wherein the valve has two valve portions complementarily shaped such that the first can sealingly engage with and
cooperate with the second to allow the flow of material there through (interpreted as a split valve, claims 18 and 20) (Abstract). Barton teaches that valves, such as split butterfly valves, are available in many designs and used widely for processes where product containment is required to prevent product exposure to environment and personnel working in close proximity of the product, wherein the split valves are designed pre-dominantly for handling and contained transfer of solid state powders and granular material alike (interpreting split butterfly valves as comprising releasable docking, claims 18 and 20) (col 1, lines 7-13). Barton teaches that the split valve design allows the valve to be split open into two halves, commonly called alpha and beta halves, or active and passive halves, where the valve design is such that when split, the two halves keep the contents on either side sealed and contained (interpreting split butterfly valves as comprising a first transport port and a second transport port; split valve; and releasable docking, claims 18 and 20) (col 1, lines 14-18). Barton teaches that split valves can be sterilized via a number of known methods, which include autoclaving, passing steam through the open valve, or passing other gases, such as vaporized hydrogen peroxide, through them prior to any product coming in contact with the internal surfaces or product contact parts (interpreted as cleaning the first reaction vessel and second transfer port, by rinsing with solvent, claim 18) (col 1, lines 30-35). Barton teaches that in the manufacture of pharmaceuticals, chemicals, biological material and food, effective containment is essential for the safe and hygienic handling of such compounds and materials, wherein handling must be controlled and managed to provide optimum protection for the operator and for maintaining the integrity of the product (col 1, lines 35-42). Barton teaches that the locking means can comprise a locking pair, one member of which is moveable relative to the other and capable of selectively engaging with the other member to lock and unlock portions together (interpreted as and first and second transport port; aligning; and locking and unlocking, claim 18) (col 2, lines 28-31).
Barstow does not specifically exemplify using an automated transport means to transport the storage vessel (claim 18, in part).
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 method of pre-packaging dry solid protected amino acids and dry solid activating agents within individual vials as exemplified by Barstow, to include the use of containers comprising split butterfly valves as disclosed by Barton, with a reasonable expectation of success in effectively containing and transferring the solids; and/or in safely and hygienically handling the reagents, while providing optimum protection for the operator, while maintaining the integrity of the product.
Regarding claim 18 (in part), Lehtonen teaches that a number of laboratory tasks that can be involved in solution preparation, including measuring, dispensing, mixing, adjusting the pH, adjusting the temperature, degassing, filtering, bottling, labeling, and cleaning before or after solution preparation is mostly done manually requiring a lot of time from laboratory workers, such that consistent handling of a wide range of solids, including fine powders, clumpy powders and crystalline solids in an accurate manner is currently often achieved manually, wherein automation can reduce the time spent by the individual workers for these routine tasks and allow them the use of their time in other tasks; and can also enable for reproducibility and consistency within and among laboratories, while allowing for consistent and accurate monitoring of key parameters of the solution (col 1, lines 14-28). Lehtonen teaches a solution dispenser that can accurately dose, mix, pH, heat, cool, degas, filter, and bottle solutions with minimal human intervention, wherein the automated solution dispenser that can handle solids of various physical properties, such as fine powder, clumpy powder, and crystalline solids, accurately and consistently (col 1, lines 43-49). Lehtonen teaches that the system can comprise (a) a mixing chamber; (b) an automated solution dispenser that directs at least one solid selected from a plurality of solids and at least one liquid selected from a plurality of liquids in the mixing chamber to form the solution; (c) one or more containers having an internal volume that is sufficient to accommodate at least a portion of the solution; (d) a bottle handling sub-system, wherein the bottle handling sub-system is configured to manipulate the one or more containers; and (e) a controller that is operably coupled to the automated solution dispenser and the bottle handling sub system, wherein the controller can be programmed to (i) direct mixing of the at least one solid and the at least one liquid in the mixing chamber to form the solution having at least one target characteristic, (ii) direct the bottle handling sub-system to manipulate at least a subset of the one or more containers to a dispensing position, and (iii) dispense at least a portion of the solution from the mixing chamber into the one or more containers when the one or more containers are at the dispensing position (col 1, lines 55-67; and col 2, lines 1-7). Lehtonen teaches that the sensor can be a weight sensor, a pressure sensor, an optical sensor, an ultrasonic sensor, an infrared sensor, a barcode sensor, an apriltag sensor, a material composition sensor, or any combination thereof; and/or the sensor can detect an emission of light, a reflection of light, an absorption of light, a sound emission, or any combination thereof to determine the internal volume of the one or more containers (col 2, lines 51-58). Lehtonen teaches that the one or more containers can include two or more containers, and wherein at least two of the two or more containers can have a different external container shape; and the bottle handling sub-system can comprise a conveyor belt; a roller conveyor; an adhesive conveyor; an automated arm, hand, or gripper; a robotic arm, hand, or gripper; a mechanical arm, hand, or gripper; a programmable arm, hand, or gripper; or any combination thereof, such that during use, the bottle handling sub-system can select a number of the one or more containers to receive the solution (interpreted as an automated transport means, claim 18) (col 4, lines 47-57).
“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 automating tasks in a laboratory environment as exemplified by Lehtonen, 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 method of transferring dry solid protected amino acids and activators into individual containers for use in an automated peptide synthesizer as disclosed by Barstow; and the method of using a split butterfly valve for the transfer of solids and powders as taught by Barton, to include the automation methods including the bottle handling subsystem, solution dispensers, solid dispensers, mixing chamber, sensors, conveyor systems, and/or robotic arms as taught by Lehtonen with a reasonable expectation of success in further automating solid phase and/or solution chemistries including solid-phase peptide synthesis; in reducing the amount of time spent by individual workers in repetitive tasks, while reducing their exposure to harmful reagents; and/or in using automated devices for the safe and hygienic to reliably transfer and/or combine solid and/or liquid reagents including for the production of premixed dry reagents within individual containers, as well as, during their use in chemical synthesis reaction including solid-phase peptide synthesis.
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 remain rejected.
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 AMY M BUNKER whose telephone number is (313) 446-4833. The examiner can normally be reached on Monday-Friday (6am-2:30pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571) 272-2876. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684
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