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 Status
The Amendment filed on 09Feb2026 is acknowledged in which claim(s) 1-77 were canceled, and claim(s) 78-97 are new.
Applicant’s election without traverse of Group I which is drawn to an antibody that binds to BMP9 and the species of anti-BMP9 antibody comprising (1) a VH of SEQ ID NO: 77 comprising Kabat HCDR1-3 of SEQ ID NOs: 90, 76, 26, and (2) a VL of SEQ ID NO: 74 comprising Kabat LCDR1-3 of SEQ ID NOs: 73, 20, 67, in the reply filed on 09Feb2026 is acknowledged.
Claim(s) 79 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09Feb2026.
Claim(s) 78, 80-97 is/are currently pending and presented for examination on the merits.
Specification
The use of trade name(s) or mark(s) used in commerce (e.g., ATCC), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
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 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.
Claim(s) 78, 80-81, 83-86, 88-97 is/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.
Regarding instant claim(s) 78, 81, 83-86, 88-97, recites “a VH CDR1, a VH CDR2, and a VH CDR3 of a heavy chain variable region (VH)…SEQ ID NO: 77” in lines 2-3, and “a VL CDR1, a VL CDR2, and a VL CDR3 of a light chain variable region (VL)…SEQ ID NO: 74” in lines 4-5, rendering the claim indefinite. The instant disclosure provides that for CDR definitions “Examples of such methods include, but are not limited to, the Kabat definition, the Chothia definition, the AbM definition, the contact definition, the extended definition, and the conformational definition” and “CDR may refer to CDRs defined by any approach known in the art, including combinations of approaches…CDRs may defined in accordance with any one or more of Kabat, Chothia, extended, AbM, contact, and/or conformational definitions” [e.g., pgs. 47-48], and also discloses CDRs of an unidentified scheme (e.g., Kabat, Chothia, etc.) in Table 3. As the claim does not recite the CDR definition scheme, and the instant disclosure teaches one set of CDRs in table 3 but also that CDRs may comprise any one or more of the non-limiting examples of CDR definitions in the specification, it is unclear if the phrases reciting CDRs in claim 78 (1) use Kabat definition, (2) Chothia definition, (3) AbM definition, (4) contact definition, (5) extended definition, (6) conformational definition, (7) a mixture of definitions, (8) the CDRs recited in Table 3 for VH of SEQ ID NO: 77 and VL of SEQ ID NO: 74, or (9) something else. For the purposes of compact prosecution, the CDRs are considered to be the elected species of HCDR1-3 (SEQ ID NOs: : 90, 76, 26) and LCDR1-3 (SEQ ID NOs: 73, 20, 67). Applicant may overcome this rejection by amending claim(s) 78 to recite (I) the SEQ ID NOs of the 6 CDRs (e.g., HCDR1-3 and LCD1-3) of the anti-BMP9 antibody, without variability in the CDR sequences thereof, (II) recite the SEQ ID NOs for each of the 6 CDR sets for each definition (e.g., a) Kabat HCDR1-3 and LCDR1-3; b) Chothia HCDR1-3 and LCDR1-3; c) IMGT HCDR1-3 and LCDR1-3; etc.), without variability in the CDR sequences thereof, or (III) to otherwise clearly recite the limitations of the instant invention. Dependent claim(s) 81, 83-86, and 88-97 can overcome this rejection by amending claim(s) 78 as described above.
Regarding instant claim(s) 80, the limitation “SEQ ID NO: 26” corresponds to a skip sequence (e.g., less than 4 residues) and therefore shows “000” in the instant sequence listing, rendering the claimed limitation indefinite. For the purposes of compact prosecution, “SEQ ID NO: 26” is considered to mean residues “GTY”, as provided in the instant disclosure [e.g., pg. 113]. This rejection may be overcome by amending claim 80 to replace “SEQ ID NO: 26” with the specific sequence residues (e.g., “GTY”).
Regarding instant claim(s) 81, referencing of ATCC accession numbers renders the claim indefinite. Specifically, sequences associated with ATCC accession numbers are subject to changes, updates, and revisions and therefore the claim scope is uncertain and may change over time. This rejection may be overcome by removing reference to ATCC accession numbers.
Instant claim(s) 81 contain(s) the trademark/trade name “ATCC”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify and/or describe a/an repository and, accordingly, the identification/description is indefinite. This rejection can be overcome by amending claim(s) 81 to remove reference(s) to “ATCC”.
Allowable Subject Matter
Claim(s) 82 and 87 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Specifically, claims 82 and 87 require the CDRs, VH/VL, and/or HC/LC, of Ab1076. During the course of examination, the Ab1076 anti-BMP9 antibody comprising (1) HCDR1-3 of SEQ ID NOs: 90, 76, 26, and LCDR1-3 or SEQ ID NOs: 73, 20, 67; (2) a VH/VL of SEQ ID NOs: 77/74; and (3) a HC/LC of SEQ ID NOs: 75/72 were found to nonobvious over the prior art. Briefly, a sequence search of the prior art returned no 100% matches to the instant claimed HCDR1-3, VH, or HC (see closest prior art alignments below).
Alignment of anti-BMP9 HCDR1-3 (SEQ ID NOs: 90, 76, 26) with WO2012170438-A2 (Human antibody light chain variable region mutant #230):
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207
554
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Greyscale
Alignment of anti-BMP9 VH (SEQ ID NO: 77) with WO2021211775-A1 (Anti-surface glycoprotein mAb VH S2H14-v3, SEQ 64):
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314
624
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Greyscale
Alignment of anti-BMP9 HCD (SEQ ID NOs:75) with WO2020167668-A1 (Anti-CLEC2D antibody heavy chain, SEQ 1486):
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662
555
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Greyscale
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643