Prosecution Insights
Last updated: April 19, 2026
Application No. 18/245,563

BINDING PROTEINS AND ANTIGEN BINDING FRAGMENTS THEREOF THAT BIND ABETA

Non-Final OA §112
Filed
Mar 16, 2023
Examiner
ALLEN, MARIANNE P
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Merck Sharpe & Dohme LLC
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
78%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
588 granted / 981 resolved
At TC average
Strong +18% interview lift
Without
With
+18.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
56 currently pending
Career history
1037
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
18.6%
-21.4% vs TC avg
§102
16.1%
-23.9% vs TC avg
§112
44.2%
+4.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 981 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. Claims 1-7, 9, 11, 13-50, 52, 54, 56, 60-64, 66-67, 70-71, 73-74, 78-79, and 82-90 have been cancelled. Claims 8, 10, 12, 51, 53, 55, 57-59, 65, 68-69, 72, 75-77, and 80-81 are under consideration. Election/Restrictions Applicant’s election without traverse of Group I and the species having the CDRs of SEQ ID NOS: 130,131, and 132 (claim 8, part (gg)) in the reply filed on 1/26/2026 is acknowledged. Claims 69, 76-77, and 80-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/26/2026. Upon further consideration of the claims as amended, the species requirement set forth in the restriction requirement mailed 11/25/2025 is withdrawn. Specification The disclosure is objected to because of the following informalities: Applicant is again advised that the CDR3 sequences of SEQ ID NOS: 145, 149, and 153 are 31 amino acids, 27 amino acids, and 31 amino acids, respectively. This is significantly longer than the description of CDR3 sequences as discussed in Table 2 at pages 37-38 of the specification. See at least page 3, lines 4-21. Applicant’s 1/26/2026 response did not address this. The disclosure is objected to because of the following informalities: The incorporation of sequence listing on page 1 of the specification should reference the size of the file in bytes not kilobytes (KB). See MPEP 2422.03(I). See 3/16/2023 specification amendment. 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 appl icant regards as his invention. Claim s 8, 10, 12 , 51, 53, 55, 57- 59 , 65, 68, 72, and 75 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 8 is directed to a binding protein or antigen binding fragment thereof. A binding protein is defined on page 26 of the specification as meaning any protein or peptide that binds to a ligand. However, a ll of the antibodies in claim 8 are clearly VHH antibodies . They do not correspond to any other type of binding protein. See at least abstract and Table 4. Claim 8 and all claims dependent upon claim 8 should reference VHH. In addition, c laim 8, part (dd), is directed to the CDR2 of SEQ ID NO: 119. The CDR 2 sequence of SEQ ID NOS: 1 19 is 84 amino acids in length. This sequence appears to be an error. It is significantly longer than the description of CDR 2 sequences as discussed in Table 2 at pages 37-38 of the specification. It is also noted that amino acids 51-134 of SEQ ID NO: 121 correspond to SEQ ID NO: 121. See vhhLib05-25 in Table 4. Claim 12 is confusing as none of SEQ ID NOS: 142, 146, or 150 contain any of the sets of CDRs recited in claim 8, parts (a)-(z) and (aa)-(ii). The claim does not appear to be properly dependent. Claim 51 is confusing in reciting “binds to human Abeta or inhibits formulation of a plaque comprising Abeta.” All of the VHH in claim 8 have been disclosed as binding to human Abeta. See page 11, lines 8-10, of the specification. None of the VHH in claim 8 have been identified as inhibiting formulation of a plaque comprising Abeta. If all of the VHH in claim 8 have this property, then the claim does not further limit the subject matter of claim 8. If only some of the VHH in claim 8 have this property, then the specification has failed to provide adequate written description with respect to the features of VHH having this property. The claim is confusing. Claim 53 is confusing in reciting a “K D of 5 nM or less.” None of the VHH of claim 8 have been disclosed as meeting this limitation. See at least Table 5. Only the VHH of claim 8, parts (s), (v), (z), (bb), (dd), and (gg) have been disclosed as meeting the limitations of this claim. See VhhLib05-49, vhhLib05-25, vhhLib05-8, vhhLib05-14, vhhLib02-5 3 , and vhhLib02-91 of Table 5. Claim 59 is confusing in reciting “ wherein the binding protein or antigen binding fragment thereof comprises a VHH or antigen binding fragment thereof or an antibody or antigen binding fragment thereof. ” An antibody is defined on page 23 of the specification as including conventional four chain antibodies. A s set forth above, a ll of the antibodies in claim 8 are clearly VHH. See at least abstract and Table 4. At least for example, they are not CDRs for conventional four chain antibodies. The claim is unclear. 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. Claim 55 is 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 . Claim 55 depends upon claim 8. All of the VHH in claim 8 have been disclosed as binding to human Abeta. See page 11, lines 8-10, of the specification. This would include the in vitro or in vivo limitations in claim 55. Claim 55 doesn’t further limit the subject matter of claim 8. 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. The VHH having the CDRs in claim 8 and the sequences in claim 10 are free of the art . The VHH of claim 10 must retain the CDRs of claim 8 for proper dependency. In addition, each of the sequences in claim 10 has a six histidine tag at the C-terminal end. See at least Table 4. The prior art of record does not disclose VHH with the recited sequences that specifically bind Abeta. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MARIANNE P ALLEN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0712 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 7:00-3:30 EST Monday-Friday . 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, FILLIN "SPE Name?" \* MERGEFORMAT Joanne Hama can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-2911 . 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. /Marianne P Allen/ Primary Examiner, Art Unit 1647 mpa
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Prosecution Timeline

Mar 16, 2023
Application Filed
Mar 27, 2026
Non-Final Rejection — §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
60%
Grant Probability
78%
With Interview (+18.0%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 981 resolved cases by this examiner. Grant probability derived from career allow rate.

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