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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/28/2026 has been entered.
Claims 50-77, 79-86, and 90-92 are pending.
Claims 53-67, 85, 86, and 90-92 remain withdrawn.
Claim 77 has been amended by Applicant.
Claims 50-52, 68-77, and 79-83 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Office Action contains New Rejections necessitated by both amendments and new considerations.
Rejections Withdrawn
The rejection of claim 77 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn.
Rejections Maintained
Double Patenting
Claims 50-52 and 68-76 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-47 of copending Application No. 19/120485 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because methods of the copending claims require products of instant product claims 50-52 and 68-76.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the Reply of 1/28/26, Applicant states claims of the copending application are directed to methods of treating cancer with an antibody and the instant claims are directed to an antibody and a method of treating RA. Applicant further states the claims do not encompass the prevention or prophylaxis of RA. Applicant further argues the subject matter does not overlap the pending claims of the referenced pending application and concludes the amended claims would not have been obvious in view of the co-pending application. Applicant further argues the present application was the first filed application and should be allowed to proceed to issue without a terminal disclaimer.
The amendments to the claims and the arguments found in the Reply of 1/28/26 have been carefully considered, but are not deemed persuasive. In regards to the statements claims of the copending application are directed to methods of treating cancer with an antibody and the instant claims are directed to an antibody and a method of treating RA and the claims do not encompass the prevention or prophylaxis of RA, claims to treating RA are not part of this rejection.
In regards to the argument the subject matter does not overlap the pending claims of the referenced pending application and conclusion that the amended claims would not have been obvious in view of the co-pending application, the examiner disagrees. Although the claims at issue are not identical, they are not patentably distinct from each other because methods of the copending claims require products of instant product claims 50-52 and 68-76.
In regards to the argument the present application was the first filed application and should be allowed to proceed to issue without a terminal disclaimer, the examiner agrees the present application was the first filed application and should be allowed to proceed to issue without a terminal disclaimer if the provisional rejection is the only rejection remaining. However, instant claims are rejected for the reasons stated below.
Double Patenting
Claims 79-82 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-47 of copending Application No. 19/120485 in view of Queen et al (US Patent 5,693,762; 12/2/97). Copending claims differ from the instant claims in that (i) the instant claims are directed to polynucleotides encoding the antibodies required by the methods of the copending claims and (ii) instant claims are directed to methods of making said antibodies using said polynucleotides. However, Queen et al teaches that antibodies are created by expressing polynucleotide expression vectors encoding antibodies in cultured cells (see column 18 lines 29-31, in particular). Therefore, it would be obvious to generate antibodies for the copending method by expressing polynucleotide expression vectors encoding the antibodies in cultured cells.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
In the Reply of 1/28/26, Applicant repeats arguments addressed above.
Claim Objections
Claim 71 is objected to because of an apparent typographical error. The second line of claim 71 recites “…thereof, hs an isotype….” It is suspected applicant intended the claim to recite “has” in place of “hs.” Proper correction is required.
New Rejections
Claim Rejections - 35 USC § 112
Claims 77, 83, and 84 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 77 recites: “A method for treating rheumatoid arthritis (RA), the method comprises administering a therapeutically effective amount of an isolated antibody, or an antigen-binding fragment thereof, to a subject in need thereof, wherein the isolated antibody, or the antigen-binding fragment thereof, comprising: three complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) (HCDRs); and three CDRs of a light chain variable region (LCVR) (LCDRs), wherein the first HCDR comprises an amino acid sequence according to SEQ ID NO: 7; the second HCDR comprises an amino acid sequence according to SEQ ID NO: 8; the third HCDR comprises an amino acid sequence according to SEQ ID NO: 9; the first LCDR comprises an amino acid sequence according to SEQ ID NO: 10; the second LCDR comprises the amino acid sequence ATS; and the third LCDR comprises an amino acid sequence according to SEQ ID NO: 11.” First, there is insufficient antecedent basis for “the isolated antibody, or the antigen-binding fragment thereof, comprising: three complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) (HCDRs); and three CDRs of a light chain variable region (LCVR) (LCDRs), wherein the first HCDR comprises an amino acid sequence according to SEQ ID NO: 7; the second HCDR comprises an amino acid sequence according to SEQ ID NO: 8; the third HCDR comprises an amino acid sequence according to SEQ ID NO: 9; the first LCDR comprises an amino acid sequence according to SEQ ID NO: 10; the second LCDR comprises the amino acid sequence ATS; and the third LCDR comprises an amino acid sequence according to SEQ ID NO: 11” in the claim. Second, the metes-and-bounds of the claim are unclear because it is unclear as to what is “wherein” the isolated antibody, or the antigen-binding fragment thereof.
In an effort to expedite prosecution, the following amendment to claim 77 is suggested to obviate this rejection: “A method for treating rheumatoid arthritis (RA), the method comprises administering to a subject in need thereof a therapeutically effective amount of an isolated antibody, or an antigen-binding fragment thereof, comprising: three complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) (HCDRs); and three CDRs of a light chain variable region (LCVR) (LCDRs), wherein the first HCDR comprises an amino acid sequence according to SEQ ID NO: 7; the second HCDR comprises an amino acid sequence according to SEQ ID NO: 8; the third HCDR comprises an amino acid sequence according to SEQ ID NO: 9; the first LCDR comprises an amino acid sequence according to SEQ ID NO: 10; the second LCDR comprises the amino acid sequence ATS; and the third LCDR comprises an amino acid sequence according to SEQ ID NO: 11.”
Claims 83-84 both recite: “…to BSSL, wherein the isolated antibody, or the antigen-binding fragment thereof, specifically binding to BSSL, and comprising: three complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) (HCDRs); and three CDRs of a light chain variable region (LCVR) (LCDRs), wherein the first HCDR comprises an amino acid sequence according to SEQ ID NO: 7, or an amino acid sequence having at least 87% identity to SEQ ID NO: 7; the second HCDR comprises an amino acid sequence according to SEQ ID NO: 8, or an amino acid sequence having at least 75% identity to SEQ ID NO: 8; the third HCDR comprises an amino acid sequence according to SEQ ID NO: 9, or an amino acid sequence having at least 83% identity to SEQ ID NO: 9; the first LCDR comprises an amino acid sequence according to SEQ ID NO: 10, or an amino acid sequence having at least 80% identity to SEQ ID NO: 10; the second LCDR comprises the amino acid sequence ATS, or an amino acid sequence having at least 66% identity to the amino acid sequence ATS; and the third LCDR comprises an amino acid sequence according to SEQ ID NO: 11, or an amino acid sequence having at least 87% identity to SEQ ID NO: 11.” First, there is insufficient antecedent basis for “the isolated antibody, or the antigen-binding fragment thereof, specifically binding to BSSL, and comprising: three complementarity determining regions (CDRs) of a heavy chain variable region (HCVR) (HCDRs); and three CDRs of a light chain variable region (LCVR) (LCDRs), wherein the first HCDR comprises an amino acid sequence according to SEQ ID NO: 7, or an amino acid sequence having at least 87% identity to SEQ ID NO: 7; the second HCDR comprises an amino acid sequence according to SEQ ID NO: 8, or an amino acid sequence having at least 75% identity to SEQ ID NO: 8; the third HCDR comprises an amino acid sequence according to SEQ ID NO: 9, or an amino acid sequence having at least 83% identity to SEQ ID NO: 9; the first LCDR comprises an amino acid sequence according to SEQ ID NO: 10, or an amino acid sequence having at least 80% identity to SEQ ID NO: 10; the second LCDR comprises the amino acid sequence ATS, or an amino acid sequence having at least 66% identity to the amino acid sequence ATS; and the third LCDR comprises an amino acid sequence according to SEQ ID NO: 11, or an amino acid sequence having at least 87% identity to SEQ ID NO: 11” in the claims. Second, the metes-and-bounds of the claims are unclear because it is unclear as to what is “wherein” the isolated antibody, or the antigen-binding fragment thereof.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642