Prosecution Insights
Last updated: July 17, 2026
Application No. 18/036,459

OLIGONUCLEOTIDES, REAGENTS, AND PREPARATION THEREOF

Non-Final OA §102§112
Filed
May 11, 2023
Priority
Nov 11, 2020 — provisional 63/112,281 +1 more
Examiner
LEWIS, PATRICK T
Art Unit
1691
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Biogen Ma Inc.
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
88%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
860 granted / 1159 resolved
+14.2% vs TC avg
Moderate +14% lift
Without
With
+14.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
17 currently pending
Career history
1180
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
55.2%
+15.2% vs TC avg
§102
19.9%
-20.1% vs TC avg
§112
12.7%
-27.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1159 resolved cases

Office Action

§102 §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 . Election/Restrictions Applicant’s election without traverse of Group I (claims 1-3, 5-6, 9-10, 12-13, 18-19, 22, and 24) in the reply filed on March 19, 2026 is acknowledged. Claims 27, 54, 56-58, 63, and 84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19, 2026. Claim Objections Claim 24 is objected to because of the following informalities: the claim reads upon “a compound of Table 1”. There are six (6) compounds depicted in Table 1; the compounds could be recited in the claim. Appropriate correction is required. 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 9, 13, and 22 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. Regarding claims 9 and 22, the term “preferably” renders the claim indefinite because it is unclear whether the limitations after the term are part of the claimed invention. See MPEP § 2173.05(d). Claim 13 recites the limitation "W", “Rw”, “V”, “U”, and “U-V” in i), ii), iii), iv), and v). There is insufficient antecedent basis for this limitation in the claim. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 5-6, 9, 12, 22, and 24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. As set forth is claim 1, P1 is bonded to a carbon atom and is NO2 or a silyl hydroxyl protecting group (e.g., TBDPS, TBoDPS, or TBDAS). A moiety containing oxygen such as O-TBDPS, O-TBoDPS, O-TBDAS, or the like is not a silyl hydroxyl protecting group but rather a “silyl protected hydroxy group”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Interpretations For the purposes of applying prior art, the examiner interprets the variable P1 to include moieties containing oxygen (e.g., O-TBDPS). 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 (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 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. Claim(s) 1-2, 5-6, 9, 12, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guerlavais‐Dagland, Typhaine, et al. "Fluoride‐labile protecting groups for the synthesis of base‐sensitive methyl‐SATE oligonucleotide prodrugs." European Journal of Organic Chemistry 2003.12 (2003): 2327-2335 (Guerlavais‐Dagland). Guerlavais‐Dagland discloses the compound PNG media_image1.png 72 154 media_image1.png Greyscale . See Figure 1. The compound of Guerlavais‐Dagland is embraced by a compound instant formula I’ wherein, A = phenyl; Y = H; e = 0; R1 = R2 = H; f =1; and P1 = OTBDPS. Thus, claims 1-2, 5-6, 9, 12, and 19 are anticipated. Claim(s) 1, 3, 10, 12, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mori, Shunji, Shoko Iwamoto, and Satoshi Yamauchi. "Synthesis of a glandular secretion of the civet cat,(2S, 6S)-(6-methyltetrahydropyran-2-yl) acetic acid and its enantiomer, by using the yeast-reduction product and recovered substrate from yeast reduction." Bioscience, biotechnology, and biochemistry 70.3 (2006): 712-717 (Mori). Mori discloses compound 6 (Scheme 2). PNG media_image2.png 186 326 media_image2.png Greyscale Compound 6 is embraced by a compound of instant formula B, wherein A1 = OMOM; e = 4; A2 = A3 = H; and P1 = OTBDPS. Thus, claims 1, 3, 10, 12, and 18-19 are anticipated. Claim(s) 1-2, 5-6, 10, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tobler, Ernst, et al. "On‐column deracemization of an atropisomeric biphenyl by quinine‐based stationary phase and determination of rotational energy barrier by enantioselective stopped‐flow HPLC and CEC." Chirality: The Pharmacological, Biological, and Chemical Consequences of Molecular Asymmetry 13.10 (2001): 641-647 (Tobler). Tobler discloses compound 1 (Fig. 1). PNG media_image3.png 310 332 media_image3.png Greyscale Compound 1 is embraced by a compound of instant formula B, wherein A = phenyl; Y = Ph-O-C12H25; e = f = 0; and P1 = NO2. Thus, claims 1-2, 5-6, 10, and 19 are anticipated. Conclusion Claims 1-3, 5-6, 9-10, 12-13, 18-19, 22, 24, 27, 54, 56-58, 63, and 84 are pending. Claims 27, 54, 56-58, 63, and 84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-3, 5-6, 9-10, 12-13, 18-19, 22, and 24 are rejected. No claims are allowed. Contacts Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex). 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, Renee Claytor can be reached at (571) 272-8394. 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. /PATRICK T LEWIS/Primary Examiner, Art Unit 1691 /PL/
Read full office action

Prosecution Timeline

May 11, 2023
Application Filed
Jun 11, 2026
Non-Final Rejection mailed — §102, §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

1-2
Expected OA Rounds
74%
Grant Probability
88%
With Interview (+14.1%)
2y 3m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1159 resolved cases by this examiner. Grant probability derived from career allowance rate.

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