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 .
Status of Application/Restriction/Claims
Applicant’s election without traverse of Group I (Claims 1-33) and species (SEQ ID Nos 5, 7, 9, 10 or 22) in the reply filed on 12/1/2025 is acknowledged. Claims 1-34 are pending. Claim 34 is currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-33 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 63/103,471 and 371 of PCT/CN2021/111092 filed on 8/7/2020 and 8/6/2021, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 8/7/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/7/2023, 8/21/2024, 9/26/2024 and 12/3/2024 was received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
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 1-25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gundlach et al. US 2012/0055792, published 3/8/2012 (hereinafter Gundlach).
Claim 1: Gundlach describes the use of bacterial nanopores for detecting nucleic acids and other analytes (Gundlach, abstract). In Example 8, Gundlach describes the use of an artificial poly-a sequence comprising 39 adenines and 1 cytosine as shown below in the sequence search results. Notably, the cytosine Is located in the last 1/3 portion of the poly(a) sequence.
PNG
media_image1.png
126
494
media_image1.png
Greyscale
Seq ID NO: 33 alignment with instant SEQ ID NO: 5
Claims 2-25: The poly-a sequence disclosed by Gundlach comprises 39 adenines and 1 cytosine in which the last nucleotide is not a cytosine. Notably, the cytosine is consecutively grouped (with itself) and locate between the 27-39th nucleotide of the poly-a sequence (Gundlach, example 8).
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.
Claims 1-33 are rejected under 35 U.S.C. 103 as being unpatentable over Gundlach (supra) in view of Schlake et al. US 2022/0233568, published 7/28/2022, priority date 10/19/2017 (hereinafter Schlake).
A description of Gundlach can be found above. Gundlach does not describe an expression cassette, expression vector or host cell comprising the poly-a sequence.
Claims 26-30: Schlake provides various artificial RNA molecules and poly(A) tail embodiments for increased protein expression efficiencies of coding regions operably liked to modified UTR elements (Schlake, para 406-412). Schlake describes the incorporation of these poly-a tail elements into expression constructs comprising multiple cloning sites, promoters, transcription initiation and termination codons (Schlake, para 28, 32, 419-425).
Claims 31-33: Schlake describes expression in a host and RNA polynucleotides which express said cassette comprising the poly-a sequence (Schlake, para 27-28).
It would have been prima facie obvious to one of ordinary skill in the art to use an artificial poly-a sequence like Seq ID NO: 33 disclosed by Gundlach in the methods for improving protein expression described by Schlake. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Schlake shows that incorporating artificial poly-a sequences can increase translation efficiency and mRNA stability (Schlake, para 406-412). Thus, one of ordinary skill would have been motivated to experiment with different adenosine and cytosine combinations in order to optimize for mRNA stability and protein translation since it is recognized that these are result-effective variables, see MPEP § 2144.05. One would have a reasonable expectation of success given that Schlake provides reliable methods for modifying the A/C composition of a given poly-a tail sequence (Schlake, para 406-412). Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 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, Maria Leavitt can be reached on (571)272-1085. 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 https://ppair-my.uspto.gov/pair/PrivatePair. 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.
Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634