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 .
Applicant’s remarks filed 11-26-25 are acknowledged.
Claims 1-3, 7, 8, 13, 23, 31-36 and 38 are pending.
Claims 1-3, 7, 8, 13, 31-36 are under examination.
Claims 23 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6-24-25.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The prior provisionally rejection on the ground of nonstatutory double patenting over claims 35-37 of copending Application No. 19/225896 has been withdrawn in view of the claim amendments filed in connection with the ‘896 on 12-11-25.
Claims 1-3, 7, 8, 13 and 31-36 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11186639 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Applicant traverses on the grounds that,
“The Office bears the burden of establishing a prima facie case of unpatentability. In re Oetiker, 997 F.2d 1443, 1446 (Fed. Cir. 1992). Only if this burden is met does the burden of coming forward with evidence or arguments shift to the applicant. Id. To meet its prima facie burden of production, the Office is required to set forth the statutory basis of the rejection and the references relied upon in a sufficiently articulated and informative manner as the meet the notice requirement of 35 U.S.C. §132. In re Jung 637 F.9d 1356, 1364 (Fed. Cir. 2011).
…the Office has not established a prima facie case of unpatentability, at least, because the instant rejection fails to sufficiently articulate a basis for the conclusion that the ‘reference claims anticipate the instant claims.’ Accordingly, reconsideration and withdrawal of this ground of rejection is respectfully requested.” (page 4 of the remarks).
Applicant's argument has been considered but has not been found convincing essentially for the reasons of record as described below.
As set forth in MPEP § 2131, “A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.”
Here the reference claims anticipate the claimed invention because they disclose an antibody that binds to, inter alia, human BCMA, said antibody comprising either SEQ ID NO: 58 or 76, and these sequences anticipate the sequences of the instant claims.
Stated another way, where the prior Office Action asserted that “[a]lthough the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims,” (see section 3 on page 4) this means that the reference clams contain all the limitations of claims 1-3, 7, 8, 13 and 31-36, i.e., the reference claims anticipate the rejected claims.
Thus, the undersigned disagrees that the prior Office Action failed to establish a prima facie case of unpatentability.
Claims 1-3, 7, 8, 13 and 31-36 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11421027 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Applicant traverses on the grounds that “…the Office has not established a prima facie case of unpatentability, at least, because the instant rejection fails to sufficiently articulate a basis for the
conclusion that the "reference claims anticipate the instant claims." Accordingly, reconsideration
and withdrawal of this ground of rejection is respectfully requested.
Applicant's argument has been considered but has not been found convincing essentially for the reasons of record as described below.
As set forth in MPEP § 2131, “A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation.”
Here the reference claims anticipate the claimed invention because they disclose an antibody that binds to, inter alia, human BCMA, said antibody comprising either SEQ ID NO: 20 or 21, including claims drawn to antibodies having the CDRs contained within SEQ ID NOs: 20 and 21, and these sequences anticipate the sequences of the instant claims.
Stated another way, where the prior Office Action asserted that “[a]lthough the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims,” (see section 4 on page 4) this means that the reference clams contain all the limitations of claims 1-3, 7, 8, 13 and 31-36, i.e., the reference claims anticipate the rejected claims.
Thus, the undersigned disagrees that the prior Office Action failed to establish a prima facie case of unpatentability.
Claims 1-3, 7, 8, 13 and 31-36 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-61 of copending Application No. 19/088689 (reference application). Insofar as the nucleic acids, vectors and cell comprising said nucleic acids and vectors of the reference claims are not explicitly drawn to the polypeptides of the instant claims, given the reference nucleic acids, vectors and cell comprising said nucleic acids and vectors of the reference claims it would have been obvious to one of ordinary skill in the art to make the polypeptides encoded by said reference nucleic acids, vectors and cell comprising said nucleic acids and vectors since the polypeptide products of said nucleic acids are useful, e.g., to redirect the cytotoxicity of CD3 expressing T-cells to BCMA expressing cancer cells for treatment purposes. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant traverses on the grounds that “…claims 39-61 of the '689 Application are directed to polynucleotides encoding a bispecific antibody, whereas instant 1-3, 7, 8, 13, and 31-36 are directed to bispecific antibodies (i.e., proteins). Accordingly, Applicant respectfully submits that the instant claims are structurally and functionally distinct from claims 39-61 of the '689 Application because an antibody (protein) is composed of amino acids while polynucleotides are composed of mononucleotides, and they are not generally usable in the same methods. As such, the instant claims are patentably distinct from claims 39-61 of the '689 Application.”
Applicant's argument has been considered but has not been found convincing essentially for the reasons of record as described below.
Applicant’s assertion that “…the instant claims are structurally and functionally distinct from claims 39-61 of the '689 Application because an antibody (protein) is composed of amino acids while polynucleotides are composed of mononucleotides, and they are not generally usable in the same methods” is acknowledged but is not material to the rejection of record because the rejection is based on the obviousness of making the polypeptides encoded by said reference nucleic acids, vectors and cell comprising said nucleic acids and vectors (see above) and, in so doing, making polypeptides that anticipate the claimed polypeptides. In other words, the provisional ODP rejection does not depend on any comparative relationship between the structures of the instant claims (polypeptides) and the structure of the structures of the reference claims (polynucleotides), and applicant’s argument based on such is not found convincing.
Claims 1-3, 7, 8, 13 and 31-36 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 87-126 of copending Application No. 18/393099 (reference application). Insofar as the nucleic acids, vectors and cell comprising said nucleic acids and vectors of the reference claims are not explicitly drawn to the polypeptides of the instant claims, given the reference nucleic acids, vectors and cell comprising said nucleic acids and vectors of the reference claims it would have been obvious to one of ordinary skill in the art to make the polypeptides encoded by said reference nucleic acids, vectors and cell comprising said nucleic acids and vectors since the polypeptide products of said nucleic acids are useful, e.g., to redirect the cytotoxicity of CD3 expressing T-cells to BCMA expressing cancer cells for treatment purposes. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pointing to MPEP § 804(I)(B)(1), Applicant traverses on the grounds that: “…the subject application has an earlier effective U.S. filing date than the '099 application, and in light of the remarks herein, Applicant respectfully submits that the present claims are now in condition for allowance. Accordingly, reconsideration and withdrawal of this ground of rejection is respectfully requested.”
Applicant's argument has been considered but has not been found convincing essentially for the reasons of record as described below.
As set forth above several non-provisional non-statutory double patenting rejections are still outstanding, and thus the provisional rejection on the ground of nonstatutory double patenting over claims 87-126 of copending Application No. 18/393099 stands.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644