DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 7/27/2026 is acknowledged.
Claim Rejections - 35 USC § 112
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 1, 2, 5, 6, 8, 11, 14, 15, 17-23, 26, 28, 31, and 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1:
1. It is unclear what configuration would be required for "performing post-synthesis processing"
2. It is unclear what structure is required to be "configured for solid-phase synethesis of the oligo product"
3. It is unclear what structure is required of a "cleave component" to meet the configured to language
4. It is unclear what "post-synthesis processing" requires and the structure of the "deprotection component"
5. The "oligo column" is not required by the claim. AS such, it is unclear if the ultrafiltration component is required given that the ultrafiltration component is configured to treat products from the solid-phase sythesis which is from the oligo column. It is also unclear what structure is required of the "configured for" language
Claim 6: “external vessel” is indefinite as it is unclear what would be considered “external” as Claim 1 is an open-type claim which envisages other components. It is unclear what would be considered “external”.
Claim 6: “additional pumps” is indefinite as Claim 1 recites “on or more pumps”. It is unclear what would be considered “additional pumps” and how the system would not comprise “additional pumps” when Claim 1 from which Claim 6 depends specifically states a plurality of pumps.
Claim 11: It is unclear what makes a system "certifiable for use in hazardous electrical areas". Further, Claim 11 is said to be canceled but still is presented. It is unclear if Claim 11 is canceled or not.
Claim 14: It is unclear what structure is required for "automatically controlling a temperature within the process vessel". It is also unclear what is considered “automatically” with respect to controlling.
Claim 15:
Is the "deprotection pump" the same thing as the "deprotection component" in Claim 1 or a separate element.
Claim 22:
1. Unclear what a deprotection solution is and requires.
2. There is no positive claim recitation of the oligo product. It is also not part of the system. As such, it is unclear if this is structure.
Claim 23:
Claims 1, 20, and 23 never positively recite an oligo product. As such, “the oligo product” lacks antecedent basis in the claim.
Claims 31 and 32:
It is noted that a claim is only limited by positively recited elements. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). And, therefore, inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.
Claims 31 and 32 recite the process and fluids worked upon by the system. These are not limiting to the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 6, 8, 11, 14, 15, 17-23, 26, 28, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Aemissegger et al. (US Pub No. 2022/0401910) and further in view of Krishnamurthy et al. (WO2022/231661).
Claims 1, 8, 11, 26, 28 : Aemissegger et al. teach a single process vessel [0010, “reaction vessel” or waste container 7], an inline temperature control element [0038, jacketed reactor, 0133 “heat exchanger” 13], one or more pumps [0133, pump], a deprotection component [0069, 0090 “deprotection reagent”].
Aemissegger et al. do not teach an ultrafiltration component or diafiltration component.
Krishnamurthy et al. teach a system comprising an ultrafiltration component (Fig. 6B, Step 1) and diafiltration component (Fig. 6B, Step 2) for removing salts used in the chromatography process required for producing oligo products [0007]. This is provided in a UFDF cartridge [0007].
One of ordinary skill in the art at the time of the invention would have found it obvious to modify Aemissegger et al. to include a UF and a DF component for the benefit of purifying and concentrating the oligo product.
Claim 2: the system comprises an oligo column [0037].
Claim 5: the system comprises a recirculation loop [0037].
Claim 6: there is no disclosure of an external vessel.
Claim 14: the system comprises a temperature controller for automatic control [0038, 0044, 0133].
Claims 15, 21, and 22: the system comprises a feed pump and/or deprotection pump [0048, 0139].
Claims 17-19: the “deprotection component” claimed is a material worked upon by the claimed apparatus. According to MPEP 2115, “A claim is only limited by positively recited elements. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).”
Claims 20 and 23: there are a variety of pumps including a recirculation pump (claim 37).
Claim 26: the nanofiltration and ultrafiltration components comprise membranes (abstract).
Claim 31: the quenching buffer limitation is an optional limitation recited in Claim 21 and, therefore, is not required in Claim 31.
Claim 32: Aemissegger et al. teach a variety of pumps (Claim 37, 0133).
Krishnamurthy et al. teach a circulation pump to control solution flow through the system including the ultrafiltration and diafiltration membranes [0067]. With respect to the process limitations of Claim 32, the claim is a system claim. Process limitations are not limiting to the structure of an apparatus claim. Further, according to MPEP 2115, “A claim is only limited by positively recited elements. Thus, “[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.” In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).” As such, the disclosure of pumps generally and more specifically recirculation pumps meets the structure of the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cedillo et al. (Designing Commercial Scale Oligonucleotide Synthesis, February 2020) teaches the fundamental structure of a oligonucleotide synthesis and processing system including purification, detritylation, column purification, and concentration/diafiltration (i.e. UFDF) (Page 26, Fig. 1).
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ALLISON FITZSIMMONS
Primary Examiner
Art Unit 1773
/ALLISON G FITZSIMMONS/ Primary Examiner, Art Unit 1773
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