Prosecution Insights
Last updated: October 04, 2026
Application No. 17/627,747

SYSTEM AND METHOD FOR PREPARING MRNA

Final Rejection §112
Filed
Jan 17, 2022
Priority
Jul 17, 2019 — CN 201910648409.7 +1 more
Examiner
EDWARDS, LYDIA E
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Academy Of Military Medical Sciences
OA Round
2 (Final)
60%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
66%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allowance Rate
426 granted / 708 resolved
-4.8% vs TC avg
Moderate +6% lift
Without
With
+5.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
24 currently pending
Career history
748
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
52.7%
+12.7% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
21.6%
-18.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 708 resolved cases

Office Action

§112
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 . Information Disclosure Statement The information disclosure statement (IDS) submitted on 05/27/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Response to Arguments Applicant’s arguments filed 05/22/2026 have been fully considered but they are not persuasive in part. In view of the current amendments, the 35 U.S.C. 112(b) regarding the reaction of claims 1, 4, 5 and 6 has been withdrawn. In view of the current amendments and applicant’s remarks, the 35 U.S.C. 112(b) regarding the inclusion of the reaction tube, the solenoid valve assembly, the peristatic pump assembly, the control device and the upper computer control program has been withdrawn. In response to applicant’s argument that the “control device” in the present application is a routine industrial control computer (e.g., a Programmable Logic Controller (PLC) or a microcontroller), and the “upper computer control program” is control software written in a standard language such as C#. The functions performed thereby are merely receiving instructions, opening or closing solenoid valves, and starting, stopping, or adjusting peristaltic pumps. The Applicant submits that these are the most basic and conventional control functions in the field of automated liquid handling. The examiner appreciates applicant’s explanation as to how applicant would like for the claimed “control device” to be interpreted. However, arguments of counsel and/or applicant cannot take the place of evidence in the record. In other words, opinion evidence is not a substitute for applicant’s disclosure. Definitions and interpretations of broadly claimed elements of which applicant intends to be defined and interpreted in a specific manner, should be provided in the instant disclosure i.e., the specification, the drawings and/or the claims as originally filed. It is noted that applicant has not pointed to any portion of the specification as filed to show support for the claimed “control device” and the “upper computer control program”. Furthermore, applicant has not disclosed where support can be found in the specification as filed for a computer readable medium or a computer for which the upper computer control program is stored and executed thereon. In response to applicant’s argument that For routine functions achievable by a person skilled in the art without special algorithms, the specification need not disclose detailed algorithms., the examiner disagrees. MPEP § 2181 discloses In several Federal Circuit cases, the patentees argued that the requirement for the disclosure of an algorithm can be avoided if one of ordinary skill in the art is capable of writing the software to convert a general purpose computer to a special purpose computer to perform the claimed function. Such argument was found to be unpersuasive because the understanding of one skilled in the art does not relieve the patentee of the duty to disclose sufficient structure to support means-plus-function claim terms. The specification must explicitly disclose the algorithm for performing the claimed function, and simply reciting the claimed function in the specification will not be a sufficient disclosure for an algorithm which, by definition, must contain a sequence of steps. Moreover, assuming arguendo that the claimed “control device” is a general purpose computer, to claim a means for performing a specific computer-implemented function (e.g., opening or closing solenoid valves, and starting, stopping, or adjusting peristaltic pumps) and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. The corresponding structure is not simply a general purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Thus, the specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer. Therefore, the rejection is maintained. See MPEP § 2181 and § 2161.01. In response to applicant’s argument that Applicant respectfully submits that both the solenoid valves and peristaltic pumps are driven by electrical signals. Purely mechanical devices cannot achieve programmed control. In the technical context of the present application, a person skilled in the art would readily understand the “control device” to be an electronic controller (e.g., a PLC or an industrial computer), with no ambiguity between mechanical and electrical., the examiner disagrees. The examiner appreciates applicant’s explanation as to how applicant would like for the claimed “control device” to be interpreted. However, arguments of counsel and/or applicant cannot take the place of evidence in the record. In other words, opinion evidence is not a substitute for applicant’s disclosure. Definitions and interpretations of broadly claimed elements of which applicant intends to be defined and interpreted in a specific manner, should be provided in the instant disclosure i.e., the specification, the drawings and/or the claims as originally filed. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 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. The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. Claim limitations “control device” and “upper computer control program” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim 1-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1-16 and 18-20 require specific steps of a control device and “upper computer control program” for controlling a solenoid valve assembly and a peristaltic pump assembly. However, the instant specification fails to teach or suggest an algorithm, a computer or microprocessor that performs that claimed steps. Therefore, the claims are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. Claim 1-16 and 18-20 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 pre-AIA the applicant regards as the invention. The “control device” and “upper computer control program” limitation of claim 1 is indefinite under § 112(b) because the specification fails to adequately disclose structure (e.g., an algorithm that achieves the claimed function in sufficient detail, a computer readable medium, and a computer or microprocessor configured to carry out the algorithm) to perform the claimed function. Additionally, it is unclear as to whether the control device is mechanical and/or electrical. Claims 2-16 and 18-20 depend on independent claim 1 and are therefore, rejected for the same reasons. Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Conclusion THIS ACTION IS MADE FINAL. 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 extension fee 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 LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Wednesday 08:00-18:00 EST. 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, Curtis Mayes can be reached on 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LYDIA EDWARDS/Primary Examiner, Art Unit 1796
Read full office action

Prosecution Timeline

Jan 17, 2022
Application Filed
Feb 23, 2026
Non-Final Rejection mailed — §112
May 22, 2026
Response Filed
Aug 20, 2026
Final Rejection mailed — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
60%
Grant Probability
66%
With Interview (+5.8%)
3y 6m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 708 resolved cases by this examiner. Grant probability derived from career allowance rate.

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