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 2, 6-44, 53-65, 69, and 78-85 have been cancelled.
Specification
The replacement sequence listing submitted 10/22/2025 has been entered. The new sequence listing adds SEQ ID NOS: 277-433.
The substitute specification filed 10/22/2025 has been entered.
Drawings
The replacement drawings (42 sheets) were received on 10/22/2025. These drawings are acceptable. The new drawings contain appropriate sequence identifiers.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: Independent claims 1 and 3 should identify the acronym “S-HBs” as small hepatitis B virus surface antigens. See for example page 1 of the specification. Appropriate correction is required.
Claim 74 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The antibody of claim 3 does not differ in scope from the antibody of claim 74.
Sequence Compliance
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The consensus sequence (i.e. “Sequence logo”) found in Figure 15A (see replacement sheet 32/42 submitted 10/22/2025) below SEQ ID NOS: 255-258, 254, 262, 260, 259, and 261 is a sequence that must be in sequence compliance and be referenced by a sequence identifier.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
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 45, 47, and 50 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 45 is directed to the antibody of claim 3 which is cross-reactive against each of the HBV proteins of SEQ ID NO: 254-262. The claim is confusing and indefinite as the specification does not specifically disclose that the Bcl.187 antibody having the CDRs recited in claim 3 is cross-reactive to each of these sequences. Furthermore, if Bcl.187 does bind to each of these sequences, then this claim would not further limit the subject matter of claim 3 as each antibody encompassed would have this activity. If they do not have this activity, then the specification does not identify those structural features responsible for the activity. Clarification is requested.
Claim 47 is directed to the antibody of claim 3 which has a neutralizing IC50 value against HBV genome D of less than or equal to 1 ng/ml, measured in vitro. The claim is confusing and indefinite as the specification does not specifically disclose that the Bcl.187 antibody having the CDRs recited in claim 3 has this IC50 value. Furthermore, if Bcl.187 does have this IC50 value, then this claim would not further limit the subject matter of claim 3 as each antibody encompassed would have this activity. If they do not all have this activity, then the specification does not identify those structural features responsible for the activity. Clarification is requested.
Claim 50 is dependent upon claim 3. Claim 50 is confusing and indefinite as claim 3 does not include antibody fragments and claim 50 is directed to antibody fragments. Clarification is requested.
Claim 1 and 3 are free of the prior art. The prior art does not disclose or suggest antibodies having the recited CDR sequences. These claims are objected to for informalities as set forth above.
Claims 4-5 are free of the prior. The prior art does not disclose or suggest having the recited VH/VL retaining the CDRs of independent claim 3. These claims depend upon an objected claim.
Claims 52 and 67-68 are free of the prior art. The prior art does not disclose or suggest having the recited heavy chain and light chain sequences retaining the CDRs of independent claim 3. These claims depend upon an objected claim.
Claims 46, 48-49, 51, 66, 70-73, 75-77, and 86-89 depend upon an objected claim.
With respect to claims 86 and 89, the specification examples demonstrate decreased circulating HBsAg levels in viremic mice by administering antibody Bcl.187 having the CDRs as recited in instant claim 3. The prior art was aware that HBV (acute and chronic) could be treated by administering antibodies against HBV surface antigens. See at least claims of U.S. Patent Nos. 12,509,504; 12,410,239; 11,390,664; and 10,689,434.
The prior art was aware that HBV could be treated by additional therapeutic agents as recited in claims 87-88. See at least claims of U.S. Patent Nos. 12,404,318 and 11,382,969.
Claims 86-89 depend upon an objected claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa