Prosecution Insights
Last updated: October 21, 2026
Application No. 18/685,971

ANTI-NECTIN-4 ANTIBODY, DRUG CONJUGATE, AND PREPARATION METHOD THEREFOR AND USE THEREOF

Non-Final OA §112§DP
Filed
Feb 23, 2024
Priority
Aug 27, 2021 — CN 202110999986.8 +1 more
Examiner
SAOUD, CHRISTINE J
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cspc Megalith Biopharmarceutical Co. Ltd.
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
3m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
446 granted / 770 resolved
-2.1% vs TC avg
Strong +38% interview lift
Without
With
+37.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
41 currently pending
Career history
818
Total Applications
across all art units

Statute-Specific Performance

§101
7.7%
-32.3% vs TC avg
§103
19.7%
-20.3% vs TC avg
§102
12.1%
-27.9% vs TC avg
§112
42.3%
+2.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 770 resolved cases

Office Action

§112 §DP
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/Restrictions Applicant’s election without traverse of Group I, claims 1-2, 8-15, 19 and 21-22 in the reply filed on 21 September 2026 is acknowledged. Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 21 September 2026. Information Disclosure Statement The information disclosure statement (IDS) submitted on 21 June 2024, 21 November 2024 and 09 April 2026 have been considered by the examiner. Drawings The drawings are objected to because they do not comply with: 37 CFR 1.84(a)(1) -Black ink. Black and white drawings are normally required. India ink, or its equivalent that secures solid black lines, must be used for drawings; 37 CFR 1.84(l) - Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction; and 37 CFR 1.84(p)(3) - Numbers, letters, and reference characters. Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height. Specific deficiencies of the Drawings can be found in Figure 1 (text is too small), Figure 2 (lines are not solid or sufficiently dense and dark or uniformly think and well-defined). These issues are found in all of the Figures, resulting in an inability to comprehend the information presented in the Figures. See screenshot example below. PNG media_image1.png 234 709 media_image1.png Greyscale 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. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. Required response – Applicant must 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. Specification The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The disclosure is objected to because of the following informalities: reference to SEQ ID NO:5 is confusing because the sequence is “skipped” in the sequence listing. The Sequence listing was filed under ST.26 which does not permit short amino acid sequences (less than 4 amino acids) to be included in the Sequence listing. SEQ ID NO:5 is meant to represent the amino acid sequence “YAS”. However, because the sequence is “skipped” due to the length requirements, reference to SEQ ID NO:5 results in “000” in the Sequence listing. Each instance in which “SEQ ID NO:5” is referenced should be removed from the specification and replaced with the actual amino acid sequence (which appears to be YAS according to Table 2 at page 21). Appropriate correction is required. The use of the term PADCEV®, which is a trade name or a mark used in commerce, has been noted in this application. See at least page 32 (lines 12, 25 and 33), page 33 (lines 7 and 10), page 22 (lines 18 and 24), page 36 (section 10.2) and page 37 (line 3). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The disclosure is objected to because of the following informalities: the text at page 19, line 5 (“BALB/c mice”) is not solid black. The text at page 23, lines 4-5 (“Biointron, Taizhou”), is not black and clear. See 37 CFR 1.52 (a)(1)(iv-v) and screenshots below. PNG media_image2.png 40 354 media_image2.png Greyscale PNG media_image3.png 152 312 media_image3.png Greyscale Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 14 (and dependent claims 15 and 21-22) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 14 is directed to a method of preventing a tumor in a subject by administration of an antibody drug conjugate which binds to Nectin-4. However, the instant claim are not enabled for prevention of tumors by administration of an antibody drug conjugate which binds to Nectin-4. Nectin-4 is a transmembrane receptor which is implicated in migration, adhesion and proliferation of tumors cells and has minimal expression in healthy adult tissue. There is no evidence of record or any teaching or suggestion in the prior art of record that administration of an antibody drug conjugate which binds to nectin-4 will prevent the formation of tumors. There is no teaching that inhibition of nectin-4 in healthy individuals by an antibody that binds to nectin-4 will prevent cancer. There is no teaching that nectin-4 expression leads to tumor formation, such that inhibition of nectin-4 in a subject without a tumor will prevent tumor formation. If nectin-4 was a receptor that was responsible for tumor formation, it might be plausible that inhibition of nectin-4 might be a therapeutic to inhibit tumor formation but there is no evidence of such a role for nectin-4 in tumor formation. While nectin-4 is expressed on tumors and is involved in migration, adhesion and proliferation, this does not support a conclusion that inhibition of nectin-4 or killing of cells that express nectin-4 will result in a prevention of tumors. As nectin-4 has minimal expression in healthy adult tissue, the antibody drug conjugate which binds to Nectin-4 of the instant claims would more likely than not be binding to tumors, and therefore, would not be acting as a preventative. Therefore, the instant claims are not enabled for preventing tumors as currently claimed. In so far as claim 14 is directed to treating a tumor in a subject, the claims are also not enabled for treating any and all tumors as broadly claimed. The antibody drug conjugate of the instant claims binds to nectin-4. If the tumor does not express nectin-4, then the antibody drug conjugate would more likely than not be incapable of treating a tumor in a subject. The instant specification fails to enable the full breadth of the instant claim as there is no evidence to support a conclusion that an antibody drug conjugate which binds to nectin-4 would provide any therapeutic benefit in a subject with a tumor if the tumor did not express nectin-4. 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 1-2, 8-15, 19 and 21-22 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 1 recites “CDR2 comprising SEQ ID NO:5”. However, reference to SEQ ID NO:5 is confusing because the sequence is “skipped” in the Sequence listing. The Sequence listing was filed under ST.26 which does not permit short amino acid sequences (less than 4 amino acids) to be included in the Sequence listing. SEQ ID NO:5 is meant to represent the amino acid sequence “YAS” according to Table 2 of the specification. However, because the sequence is “skipped” due to the length requirements, reference to SEQ ID NO:5 results in “000” in the Sequence listing. Replacement of SEQ ID NO:5 with the actual amino acid sequence it is meant to represent would be remedial. Claims 8-15, 19 and 21-22 are indefinite for depending on an indefinite claim as they do not correct the deficiency which results in claim 1 being indefinite. Claim 1 is also indefinite for the recitation of “wherein the heavy chain variable region comprises CDR1 comprising SEQ ID NO:1, …”. The CDR1 does not “comprise” a sequence identifier and therefore, this recitation is indefinite. The CDR1 is a portion of a protein which has an amino acid sequence which is represented by a Sequence identifier. Therefore, the claim should recite “CDR1 comprising the amino acid sequence of SEQ ID NO:1”. Each instance of “comprising” a sequence identifier should be corrected in the noted manner. Claim 2 is indefinite for the recitation of “wherein the heavy chain variable region sequence of the antibody or the functional fragment thereof is an amino acid sequence shown in SEQ ID NO:9 …”. First, the antibody drug conjugate does not comprise a “heavy chain variable region sequence”. A “sequence” is merely a representation of a characteristic of a protein, which would happen to be the amino acid sequence. The heavy chain variable region is the protein and the heavy chain variable region may comprise an amino acid sequence. Next, the recitation of “an amino acid sequence shown in SEQ ID NO:9” is indefinite because it is not clear which sequence displayed in SEQ ID NO:9 is intended. “An” is an indefinite article and therefore, it is not clear which sequence is intended. It is suggested that the claim recite the following: “…wherein the heavy chain variable region of the antibody or the functional fragment thereof comprise the amino acid sequence of SEQ ID NO:9 or a sequence having at least ….sequence identity thereto, and wherein the light chain variable region comprises an amino acid sequence selected from SEQ ID NO:10-12 or a sequence having at least …. sequence identity thereto. Claims 8, 11, 12 and 15 all recite recitation of “preferably” regarding particular limitations. These claims are indefinite because it is not clear if the items following the “preferably” are actual limitations of the claim or just merely preferred embodiments or if the claims should be limited to the preferred embodiments. Therefore, the metes and bounds of the claim cannot be determined. Claim 10 is directed to an antibody drug conjugate wherein the conjugate has the structure Ab-(L-U)n and wherein “n is an integer or a decimal from 1 to 8”. The recitation of “or a decimal from 1 to 8” is unclear and indefinite. It is not known what a “decimal from 1 to 8” would mean in the context of “n” in the claim. L is the linker and U is the drug and if “n” were decimal, that would mean that there would be fractions of the linker and drug, and that concept is just not clear. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim is directed to a pharmaceutical composition comprising the antibody drug conjugate of claim 1 and optionally a pharmaceutically acceptable carrier. However, if the composition does not contain a pharmaceutically acceptable carrier, it does not further limit the subject matter of the claim from which it depends. The recitation that the claim is to a pharmaceutical composition does not distinguish from the claim to the antibody drug conjugate, which would constitute a pharmaceutical composition by itself. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-2, 8, 11-15, 19 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 11 and 14 of U.S. Patent No. 12,273,100. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are either encompassed by the claims of ‘100 or made obvious by the claims of ‘100. ‘100 claims an anti-Nectin-4 antibody or antigen-binding fragment thereof which comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:15 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:16 (claim 2, part (h)). The CDRs recited in instant claim 1 are found in the heavy and light chains of ‘100. Furthermore, the heavy and light chains of SEQ ID NO:9 and 10, respectively, of the instant application share at least 80% identity with the heavy and light chains of ‘100 (SEQ ID NO:15 and 16, respectively). PNG media_image4.png 263 623 media_image4.png Greyscale PNG media_image5.png 258 620 media_image5.png Greyscale Claim 6 of ‘100 is directed to an anti-Nectin-4 antibody which is conjugated to a cytotoxic agent. Conjugation of an antibody to a cytotoxic agent results in an antibody drug conjugate when the construct is intended to be administered for a therapeutic purpose, which is clearly the case in the claims of ‘100 as the Nectin-4 antibody is used for treating cancer (see claim 14). ‘100 also claims pharmaceutical compositions of the antibody (see claim 11) as well as wherein the antibody is chimeric (claim 4), humanized (claim 5). Regarding instant claim 12 which recites that the antibody is of the IgG isotype, while ‘100 does not specifically claim that the antibody is an IgG isotype, ‘100 discloses that an exemplary antibody is an IgG subtype (see column 9, first paragraph). While limitations from the specification are not read into the claims, the claims are read in light of the specification and the limitation that the claimed antibody is of the IgG isotype would be obvious over the claims in ‘100 as those claims would necessarily encompass antibodies which are of the IgG isotype. Instant claim 19 is directed to a pharmaceutical composition comprising the anti-Nectin-4 antibody drug conjugate and further comprising an anti-proliferative agent. Instant claim 21 is directed to a method of treating a tumor with the anti-Nectin-4 antibody drug conjugate and further comprising administering radiation to the subject. Instant claim 22 is directed to a method of treating a tumor with the anti-Nectin-4 antibody drug conjugate and further comprising administering an anti-proliferative agent to the subject. However, the claims are obvious over claim 14 of ‘100 which is directed to a method of treating a Nectin-4 expressing cancer by administration of anti-Nectin-4 antibody to the subject and claim 6 which is directed to an anti-Nectin-4 antibody conjugated to a cytotoxic agent. One of ordinary skill in the art would have been apprised of the fact that tumors are commonly treated with radiation as well as with anti-proliferative agents. Furthermore, it is routine and conventional for the skilled artisan to treat tumors with a combination of therapies include radiation and anti-proliferative agents in addition to therapeutics which target a particular type of tumor. As such, the instant claims would have been obvious over the claims of ‘100 and therefore, the instant claims are not patentably distinct from those of ‘100. Claims 1-2, 8, 11-15, 19 and 21-22 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 22-25, 27-28, 31-33 of copending Application No. 19/739,298 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are either encompassed by the claims of ‘298 or made obvious by the claims of ‘298. ‘298 claims an anti-Nectin-4 antibody or antigen-binding fragment thereof which comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:15 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:16 (claim 23, part (h)). The CDRs recited in instant claim 1 are found in the heavy and light chains of ‘298. Furthermore, the heavy and light chains of SEQ ID NO:9 and 10, respectively, of the instant application share at least 80% identity with the heavy and light chains of ‘100 (SEQ ID NO:15 and 16, respectively). (see alignments above with regard to ‘100; ‘298 is a CON of ‘100). Claim 27 of ‘298 is directed to an anti-Nectin-4 antibody which is conjugated to a cytotoxic agent. Conjugation of an antibody to a cytotoxic agent results in an antibody drug conjugate when the construct is intended to be administered for a therapeutic purpose, which is clearly the case in the claims of ‘298 as the Nectin-4 antibody is used for treating cancer (see claims 32-33). ‘298 also claims pharmaceutical compositions of the antibody (see claims 28 and 31) as well as wherein the antibody is chimeric or humanized (claim 24). Regarding instant claim 12 which recites that the antibody is of the IgG isotype, while ‘298 does not specifically claim that the antibody is an IgG isotype, ‘298 discloses that an exemplary antibody is an IgG subtype. While limitations from the specification are not read into the claims, the claims are read in light of the specification and the limitation that the claimed antibody is of the IgG isotype would be obvious over the claims in ‘298 as those claims would necessarily encompass antibodies which are of the IgG isotype. Instant claim 19 is directed to a pharmaceutical composition comprising the anti-Nectin-4 antibody drug conjugate and further comprising an anti-proliferative agent. Instant claim 21 is directed to a method of treating a tumor with the anti-Nectin-4 antibody drug conjugate and further comprising administering radiation to the subject. Instant claim 22 is directed to a method of treating a tumor with the anti-Nectin-4 antibody drug conjugate and further comprising administering an anti-proliferative agent to the subject. Claims 32-33 of ‘298 are directed to treating cancer in a subject in need and optionally include treatment in combination with irradiation, antineoplastic agents, chemotherapy and angiogenesis inhibitors, which would encompass the radiation and anti-proliferative agents recited in the instant claims. As such, the instant claims would have been obvious over the claims of ‘298 and therefore, the instant claims are not patentably distinct from those of ‘298. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 8am-4pm. 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, Julie Z Wu can be reached at 571-272-5205. 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. /Christine J Saoud/Primary Examiner, Art Unit 1645
Read full office action

Prosecution Timeline

Feb 23, 2024
Application Filed
Oct 02, 2026
Non-Final Rejection mailed — §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
95%
With Interview (+37.5%)
2y 11m (~3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 770 resolved cases by this examiner. Grant probability derived from career allowance rate.

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