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 .
Election/Restriction
The response filed on 12/16/25 to the restriction requirement of 11/26/25 has been received. With traverse, Applicant has elected a species comprising SEQ ID NOs:40, 48, 65, 113, 126, 142, 27, and 105. The traversal is based on the CDRs set-forth as SEQ ID NOs:40, 48, 65, 113, 126, and 142 of claim 56 are of a non-obvious antibody C1.851.hu12 that is a single general “inventive concept” and the two additional SEQ ID NOs recited by claim 56 differ by only one amino acid of SEQ ID NO:142 and would not pose undue burden to search. In an effort to expedite prosecution, the examiner rejoins all species encompassed by instant claim 56.
Status of Claims
Claims 56-75 are pending.
Claims 56-75 are new.
Claims 56 and 58-75 are under consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/073,826, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. There is lack of support for the antibody that specifically binds to ATP Binding Cassette Subfamily C Member 1 (ABCC1) on surface of a mammalian cell, the antibody comprising: a variable heavy chain (VH) region comprising: a heavy chain complementarity determining region (HCDR 1) comprising the amino acid sequence: NNGVS (SEQ ID NO:40),a HCDR 2 comprising the amino acid sequence: AISSGGNIYYNSAFKS (SEQ ID NO:48), and a HCDR 3 comprising the amino acid sequence: HRGYYGYNWGYFDY (SEQ ID NO:65); and a variable light chain (VL) region comprising: a light chain complementarity determining region (LCDR 1) comprising the amino acid sequences: KGSQNINNYLA (SEQ ID NO:113),a LCDR 2 comprising the amino acid sequence: KTNSLQT (SEQ ID NO:126), and a LCDR 3 comprising the amino acid sequence: YQYNNGYT (SEQ ID NO:142) or CQYNNGYT (SEQ ID NO:143) or YQYNQGYT (SEQ ID NO:148). Accordingly, claims 56-75 are not entitled to the benefit of the prior provisional application of 63/073,826.
Therefore, the U.S. effective filing date of all claims under examination is set at 09/01/2021 based on the PCT/US2021/048701 application (filed 09/01/2021).
Information Disclosure Statement
The information disclosure statements (IDS) submitted are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because:
In FIG. 11C, the table at the bottom of the page shows rows 3 to 5 to have exactly the same results for cC1 Kd(nM), hKT9 Kd(nM) and cKT9 Kd(nM) for the four bispecific antibodies that were tested. Please verify if these identical results are correct. Also, it is noted that on Pg. 3 of the specification, KT9 stands for atezolizumab, an anti-PD-L1 monoclonal antibody. As such, hKT9 and cKT9 in rows 3 and 4 respectively would be interpreted as cell lines that overexpress the anti-PD-L1 monoclonal antibody KT9, while it appears Applicant may have intended to describe cells as overexpressing PD-L1. Appropriate correction is required if this were not the fact.
In FIG. 12C, the table at the bottom of the page shows rows 3 and 4 labeled with the same cells of 293T.cKT1 Kd(nM) but have different results for the four tested bispecific antibodies. Please verify if these are results from the same cells. Also, it is noted that on Pg. 3 of the specification, KT1 stands for trastuzumab, an anti-ErbB2 (anti-HER2) monoclonal antibody. As such, 293T.cKT1 would be interpreted as 293T cells that express the anti-ErbB2 monoclonal antibody KT1, while it appears Applicant may have intended to describe cells as overexpressing HER2. Appropriate correction is required if this were not the fact.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
On Pg. 3, the description for FIGS. 11A-11C recites in line 2 “C6 cell lines, overexpressing ABCC1 and KT9, respectively” and in lines 3-4 “KT9 stands for atezolizumab, an anti-PD-L1 monoclonal antibody”. If KT9 stands for atezolizumab which is an anti-PD-L1 monoclonal antibody, then as recited, the cell line would be interpreted as overexpressing ABCC1 and the monoclonal antibody KT9 which binds to PD-L1, respectively. It appears Applicant may have intended to disclose the cell lines as overexpressing ABCC1 and PD-L1 (as opposed to “KT9”), respectively. If that is the case, it is suggested that line 2 be amended to recite “C6 cell lines, overexpressing ABCC1 and PD-L1, respectively”. Amendments should also be made in the Drawings if appropriate (see above).
On Pg. 3, the description for FIGS. 12A-12C recites in line 2 “293T cells expressing human or cynomolgus KT1” and in line 3 “KT1 stands for trastuzumab, an anti-ErbB2 (anti-HER2) monoclonal antibody”. If KT1 stands for trastuzumab which is an anti-ErbB2 (anti-HER2) monoclonal antibody, then as recited, the 293T cells would be interpreted as expressing human or cynomolgus anti-ErbB2 (anti-HER2) monoclonal antibody KT1. It appears Applicant may have intended to disclose that the 293T cells express human or cynomolgus ErbB2 (HER2). If that is the case, it is suggested that line 2 be amended to recite “293T cells expressing human or cynomolgus ErbB2 (HER2)”. Amendments should also be made in the Drawings if appropriate (see above).
Appropriate correction is required.
Claim Objections
Claims 56, 67, and 72 are objected to because of the following informalities:
Claim 56 appears to be missing the word “the” in line 2 before the phrase “surface of a mammalian cell”.
Claim 56 on line 11 recites the term “(LCDR) 1”. For consistency with line 4 which recites the term “(HCDR 1)”, it is suggested that the term in line 11 be amended to “(LCDR 1)”.
Claim 56 on line 13 recites the term “LCDR2” and line 14 the term “LCDR3”. For consistency throughout the claim set, it is suggested that recitation of these terms include a space between the abbreviation “LCDR” and the numeral “2” or “3” to recite “LCDR 2” in line 13 and “LCDR 3” in line 14.
Claim 67 appears to be missing the word “the” in line 2 before the phrase “surface of a mammalian cell”.
Claim 72 recites “the LCDR2 comprises the sequence and the LCDR3 comprises the sequence” in lines 9 to 10, between the sentence “LCDR 1 comprising the amino acid sequence: RASQDVNTAVA (SEQ ID NO:180)” and the sentence “LCDR 2 comprising the amino acid sequence: SASFLYS (SEQ ID NO:172)”. It is suggested that the sentence “the LCDR2 comprises the sequence and the LCDR3 comprises the sequence” be deleted since it appears to be a typographical error.
Appropriate correction is required.
Claims 58-66, 68-71 and 73-75 are objected to for being dependent upon an objected claim.
Allowable Subject Matter
The antibody that specifically binds to ATP Binding Cassette Subfamily C Member 1 (ABCC1) on the surface of a mammalian cell, the antibody comprising: a variable heavy chain (VH) region comprising: a heavy chain complementarity determining region (HCDR 1) comprising the amino acid sequence: NNGVS (SEQ ID NO:40), a HCDR 2 comprising the amino acid sequence: AISSGGNIYYNSAFKS (SEQ ID NO:48), and a HCDR 3 comprising the amino acid sequence: HRGYYGYNWGYFDY (SEQ ID NO:65); and a variable light chain (VL) region comprising: a light chain complementarity determining region (LCDR) 1 comprising the amino acid sequences: KGSQNINNYLA (SEQ ID NO:113), a LCDR2 comprising the amino acid sequence: KTNSLQT (SEQ ID NO:126), and a LCDR3 comprising the amino acid sequence: YQYNNGYT (SEQ ID NO:142) or CQYNNGYT (SEQ ID NO:143) or YQYNQGYT (SEQ ID NO:148) is free of prior art. The prior art does not teach or suggest any antibody with a combination of recited CDR sequences encompassed by instant claim 56.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yie-Chia Lee (Tonya) whose telephone number is (571)272-0123. The examiner can normally be reached Monday - Friday 7.30a - 3.30p 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