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 .
Status of Claims / Response to Amendments
The Amendments and Remarks filed 08/08/2025 in response to the Office Action of 05/08/2025 are acknowledged and have been entered.
Claim 63 has been added by Applicant.
Claims 1, 2, 8, 9, 18, 20, 21, 27, 30, 32, 41-43, 45, 47, 59 and 60-63 are pending.
Claims 1, 8, 9 and 18 are amended.
Claims 18, 20, 27, 30, 32, 42, 43, 45, 47 and 60-62 remain withdrawn.
Claims 1, 2, 8, 9, 21,41, 59 and 63 are currently under examination in the instant Office Action.
The non-elected species in claim 1 of VH (SEQ ID NOs: 6, 8, 9, 10 and 11) and VL (SEQ ID NOs: 17, 19 and 20) have been rejoined.
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 Amendments.
Objections – Withdrawn
The objection to the drawings and Nucleotide and/or Amino Acid Sequence Disclosures for Figure 9A (Pg. 23/53) are withdrawn because Applicant has included amino acid sequence identifiers (SEQ ID NOs) for the described STEAP1 proteins in this figure.
Claim Objections - Withdrawn
The objection of claim 9 is withdrawn because Applicant has corrected the typographical error.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second paragraph has been withdrawn because Applicant has amended claim 8.
Claim Rejections 35 U.S.C.112(a) - Withdrawn
The written description rejection of claims 8 and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph has been withdrawn because Applicant has amended the claims by deleting the sentence “or a variant thereof having one or more conservative amino acid substitutions”.
Claim Rejections - 35 USC § 102 - Withdrawn
The rejection of claims 1, 2 and 21 under 35 U.S.C. 102(a)(1) has been withdrawn because Applicant has amended the claims.
Claim Rejections - 35 USC § 112 - Maintained
Claims 9, 41 and 59 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second paragraph.
Amended claim 9 recites “The antibody of claim 1, comprising…… a LC amino acid sequence selected from the group consisting of …. SEQ ID NO: 24;…… SEQ ID NO: 27;……. SEQ ID NO: 28….”. Upon close examination of the specification and drawings (Figures 11 to 13 and Paragraphs [0058] to [0060]), it is noted that only SEQ ID NO: 21, consisting of 220 amino acids, corresponds to the length and sequence of an LC, as is correctly described on Fig. 11A as Light chain sequence (LC) (SEQ ID NO: 21. However, SEQ ID NO; 24, 27 and 28 are each at 512, 515 and 515 amino acid residues long and have the following descriptions in the corresponding figures:
SEQ ID NO: 24 (FIG. 12A): signal peptide- VL-2 – CL – linker-hOKT3 VH – linker-hOKT3 VL
SEQ ID NO: 27 (FIG. 13A): huX120-VL-CL-(G4S)3-mouse C825-VH-(G4S)6-VL
SEQ ID NO: 28 (FIG. 13B): huX120-VL-CL-(G4S)3-huC825-VH-(G4S)6-VL
As such SEQ ID NOs: 24, 27 and 28 comprise not only the LC (VL-CL) of the anti-STEAP1 antibody, but also comprise the VH and VL of hKOT3 antibody in SEQ ID NO: 24, the VH and VL of mouse C825 antibody in SEQ ID NO: 27, and the VH and VL of human C825 antibody in SEQ ID NO; 28.
With regards to claim 9, a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of antibodies for SEQ ID NOs: 24, 27 and 28 that comprises the anti-STEAP1 “LC and the VH and VL of a second binding domain”, and the claim also recites antibodies which only comprises the anti-STEAP1 "LC” which is the narrower limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such broader language is a required feature of the claims.
Response to Arguments
Applicant’s Argument: In the Reply of 01/15/2026, Applicant cites that “claim 9 is amended to be dependent upon claim 1 and to delete all instances of the phrase "SEQ ID NO: 21," thus obviating the foregoing indefiniteness rejections under 35 U.S.C. § 112(b)”.
Examiner’s Response: The amendments to claim 9 and the arguments found in the Reply of 01/15/2026 have been carefully considered. However, even though Applicant addressed the indefiniteness issue in claim 8, Applicant has not addressed the same issue in the previously dependent claim 9. Therefore, claim 9 and dependent claims 41 and 59 remain rejected above.
Double Patenting – Maintained
Application No. 17/920539 (First NSDP)
Claims 1, 8, 9, 21 and 59 remain and claim 63 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 17/920,539.
Copending application 17/920,539 claim 9 is drawn in part to an antibody comprising a heavy chain (HC) amino acid sequence comprising SEQ ID NO: 112 and a light chain (LC) amino acid sequence comprising SEQ ID NO: 128.
Sequence alignment of copending SEQ ID NO: 112 shows that it is an exact match to instant HC SEQ ID NO: 26, while copending SEQ ID NO: 128 is an exact match to instant LC SEQ ID NO: 28. In addition, copending SEQ ID NO: 112 comprises instant VH SEQ ID NO: 7 while copending SEQ ID NO: 128 comprises instant VL SEQ ID NO: 18.
Regarding instant claim 21, it would be obvious to generate a composition comprising the antibody and a pharmaceutically acceptable carrier because copending specification discloses claimed antibodies are prepared with a pharmaceutically acceptable carrier to protect against rapid elimination from the body (Paragraphs[0020] and [0327], in particular).
Regarding instant claim 63, copending claim 9 recites an antibody comprising a (HC) amino acid sequence comprising SEQ ID NO: 112 and a light chain LC amino acid sequence comprising SEQ ID NO: 128, wherein the multi-specific antibody or antigen binding fragment binds to T cells, B-cells, myeloid cells, plasma cells, mast-cells, CD3, CD4, CD8, CD20,CD19, CD21, CD23, CD46, CD80, HLA-DR, CD74, CD22, CD14, CD15,CD16, CD123, TCR gamma/delta, NKp46, STEAP1 or a small molecule DOTA hapten.
Therefore, copending 17/920,539 claim 9 anticipates the above instant claims.
This is a provisional nonstatutory double patenting rejection.
Application No. 18/007,292 (Second NSDP)
Claims 1, 8, 9 ,21 and 59 remain and claim 63 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 18/007,292.
Copending application 18/007,292 claim 21 is drawn in part to an ex vivo armed T cell that is coated with an anti-CD3 multi-specific antibody comprising a heavy chain (HC) amino acid sequence comprising SEQ ID NO: 88, or a variant thereof having one or more conservative amino acid substitutions, and/or a light chain (LC) amino acid sequence comprising SEQ ID NO: 136, or a variant thereof having one or more conservative amino acid substitutions.
Sequence alignment of copending HC SEQ ID NO: 88 shows that it is an exact match to instant HC SEQ ID NO: 22, while copending LC SEQ ID NO: 136 is a 100% local match to instant LC SEQ ID NO: 28 from amino acid residues 20 to 515, wherein amino acid residues 1 to 19 is a signal peptide consisting of the sequence MGWSCIILFLVATATGVHS. In addition, copending SEQ ID NO: 88 comprises instant VH SEQ ID NO: 7 while copending SEQ ID NO: 136 comprises instant VL SEQ ID NO: 18.
Regarding instant claim 21, it would be obvious to generate a composition comprising the ex vivo armed T cell that is coated with the antibody and a pharmaceutically-acceptable carrier because compositions comprising the ex vivo armed T cell that is coated with the antibody of the copending claims are to be administered (see Paragraph [0021]) and the specification discloses such products are administered in compositions comprising a pharmaceutically-acceptable carrier (Paragraph [0157], in particular).
Regarding instant claim 63, copending claim 21 recites that the antibody coating the armed T cell is an anti-CD3 multi-specific antibody. In addition, copending specification discloses that the anti-CD3 multi-specific antibody on the armed T cell can bind additional target antigens including STEAP1 (paragraph [0011]).
Therefore, copending 18/007,292 claim 21 anticipates the above instant claims.
This is a provisional nonstatutory double patenting rejection.
Application No. 18/554,184 (Third NSDP)
Claims 1, 8, 9, 21 and 59 remain and claim 63 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23 and 24 of copending Application No. 18/554,184.
Copending application 18/554,184 claim 23 is drawn in part to anti-CD3 multi-specific antibody that is to be administered (see claim 1) comprising a heavy chain (HC) amino acid sequence comprising SEQ ID NO: 88, or a variant thereof having one or more conservative amino acid substitutions, and/or a light chain (LC) amino acid sequence comprising SEQ ID NO: 87, SEQ ID NO: 119, or a variant thereof having one or more conservative amino acid substitutions.
Copending claim 24 is drawn in part to anti-CD3 multi-specific antibody comprising a HC amino acid sequence and a LC amino acid sequence selected from the group consisting of: SEQ ID NO: 88 and SEQ ID NO: 87 respectively
Sequence alignment of copending HC SEQ ID NO: 88 shows that it is an exact match to instant HC SEQ ID NO: 22, while copending LC SEQ ID NO: 87 and 119 both have 100% local match to instant LC SEQ ID NO: 24 from amino acid residues 20 to 512, wherein amino acid residues 1 to 19 is a signal peptide consisting of the sequence MGWSCIILFLVATATGVHS. In addition, copending SEQ ID NO: 88 comprises instant VH SEQ ID NO: 7 while copending SEQ ID NO: 87 and 119 both comprise instant VL SEQ ID NO: 18. It is also noted that copending SEQ ID NO: 87 and 119 are both 493 amino acid residues long and have 100% identity match.
Regarding instant claim 21, it would be obvious to generate a composition comprising the antibody and a pharmaceutically acceptable carrier because the antibody of the copending claims is to be administered (see claim 1) and the specification discloses antibodies are administered in compositions comprising a pharmaceutically acceptable carrier (Paragraph [0140], in particular).
Regarding instant claim 63, copending claim 23 recites that the antibody is an anti-CD3 multi-specific antibody. In addition, copending specification discloses that the anti-CD3 multi-specific antibody can bind one or more target antigens including STEAP1 (paragraph [0132]).
Therefore, copending 18/554,184 claims 23 and 24 anticipate the above instant claims.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s Argument: In the Reply of 01/15/26, Applicant cites the following:
The effective filing date of the instant application is September 5, 2019, whereas the effective filing date of the '539, '292, and '184 applications are April 24, 2020, July 28, 2020, and April 6, 2021, respectively. As such, the instant application is the earlier filed application, and Applicant respectfully requests withdrawal of the foregoing provisional ODP rejections. If an ODP rejection is issued in the later-filed co-pending application, Applicant will address the rejection at that time."
Examiner’s Response: The amendments to the claims and the arguments found in the Reply of 01/15/26 have been carefully considered but are not deemed persuasive. The examiner maintains the above non-statutory double patenting rejections of amended claims because there are rejections that are maintained as well as new rejections that are necessitated by amendments (See below).
New Objections Necessitated by Amendments
Claim Objections – New or Necessitated by Amendments
Claim 63 appears to have three typographical errors. Firstly, the word “that” should be inserted in line 8 between “binding fragment” and “binds to T cells” to read “binding fragment that binds to T cells”. Secondly, there should be a punctuation comma “,” after the word “hapten” (or before the word “or”). Thirdly, the word “comprises” in line 11 should be amended to “comprising”.
Appropriate correction is required.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112(b) – Necessitated by Amendments
Claims 41 and 59 recite "The bispecific antibody or antigen binding fragment of claim 9 or the bispecific antibody or antigen binding fragment comprising…wherein the bispecific antibody binds….” or “The bispecific antibody or antigen binding fragment of claim 9….. wherein the bispecific antibody binds….”. There is insufficient antecedent basis for "The bispecific antibody or antigen binding fragment of claim 9”, “the bispecific antibody or antigen binding fragment comprising”, and “the bispecific antibody” in the claims.
Allowable Subject Matter
Antibodies comprising the VH sequence as set forth in SEQ ID NOs: 6-11 and the VL sequences as set forth in SEQ ID NOs: 17-20 are free of prior art. The HC sequence as set for in SEQ ID NO: 22, SEQ ID NO: 26 and the LC sequence as set forth in SEQ ID NO: 21, as well as amino acid sequences of SEQ ID NO: 24, SEQ ID NO: 27 and SEQ ID NO: 28 which comprise the LC sequence as set forth in SEQ ID NO: 21 are free of prior art. The bispecific antibody sequence as set forth in SEQ ID NOs: 29-40 and 61-64 are free of prior art.
Conclusion
Claim 2 is objected to as being dependent on a rejected claim (claim 1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Yie-Chia (Tonya) Lee (Tonya) whose telephone number is (571)272-0123. The examiner can normally be reached Monday - Friday 8.30a - 5.30p Eastern Time Zone.
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, Samira Jean-Louis can be reached on 571-270-3503. 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.
/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642