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 .
Priority
This application is a 371 PCT of US2022/032068 filed 06/03/2022 which claims priority to application 63/197,106 filed 06/04/2021.
Information Disclosure Statement
The information disclosure statement filed 11/30/2023 has been considered.
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 1-8, 11, 13, 15-23 and 25 is 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 recites “a first portion” in line 5. It is unclear what “first portion” means. It is unclear if it means a first set of transcripts, a first percentage, the first “x” number of nucleotides, etc. The specification does not describe “first portion” therefore the metes and bounds of this limitation is unclear.
Claim 1 recites “analyzing” the cleaved RNA fragment to determine the first portion of mRNA transcripts comprising the Cap 1 structure in the mRNA sample (i.e., quantify capping efficiency) in a method for determining capping efficiency. However, the claim fails to specify the analytical process by which the determination is made. The specification describes multiple analytical techniques capable of analyzing the cleavage products; however, the claims are read in light of the specification. Therefore, because the claim does not positively recite the analytical technique or otherwise define the analytical step with sufficiency specificity, it is unclear what acts or methods constitute the claimed “analyzing” step.
Those claims identified in the statement of rejection but not explicitly referenced in the rejection are also rejected for depending from a rejected claim but failing to remedy the indefiniteness therein.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest art is Heartlein (wo2014152659). Heartlein teaches methods of quantifying mRNA capping efficiency by hybridizing a DNA oligonucleotide to the 5′ untranslated region of an mRNA transcript, cleaving the resulting DNA/RNA hybrid with RNase H to generate short cap-containing fragments, and chromatographically analyzing the resulting fragments to determine capping characteristics. Heartlein further teaches positioning a probe adjacent the 5′ cap and generating short cleavage products for analytical evaluation. Although Tcherepanova (Tcherepanova et al. BMC Molecular Biology 2008, 9:90) teaches a method for measuring the percentage of capped mRNA in a population by oligonucleotide-directed RNAse H cleavage (page 7 col 2 para 4-page 8 col 2 para 1, Fig. 7 A, page 12 col 1 para 1). The DNA oligonucleotide used anneals in the proximity to the 5' end of the RNA such that digested products are 19 nucleotides long if the RNA was not capped and 20 nucleotides long if the RNA was capped (page 7 col 2 para 4-page 8 col 2 para 1) and teaches improved translation resulting from Cap 1 [abstract], thereby providing a motivation for wanting to know how much Cap 1 is present; the prior art fails to teach or suggest hybridizing the oligonucleotide specifically between nucleotides 2–5, 3–6, or 4–7 of the mRNA transcript so as to release the first five, six, or seven nucleotides of the transcript for analysis, as presently claimed. The prior art likewise does not provide a teaching or suggestion that these specific probe positions and corresponding cleavage products should be selected for determining the proportion of Cap 1-containing transcripts. Accordingly, it was found that the claimed probe placement and resulting cleavage-fragment configuration distinguish the presently claimed invention from the prior art of record. Therefore, the presently claimed probe geometry and resulting cleavage products are considered to define a patentably distinct analytical method.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
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, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
Prosecution Insights