DETAILED ACTION
Claims 71-72, 81-84, and 87 are pending in the instant application.
Claims 73-76 are cancelled.
Claims 77-80 and 85-86 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/11/2026.
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 71-76 and 81-84, drawn to an antibody drug conjugate comprising an anti-Nectin-4 antibody conjugated to a cytotoxic agent, wherein the anti-Nectin-4 antibody binds to the VC1 bridging domain of a human Nectin-4 polypeptide; wherein the cytotoxic agent exatecan conjugated via a linker to an anti-Nectin-4 antibody comprising the Kabat CDR1, CDR2 and/or CDR3 of the heavy chain variable region having the amino acid sequence of SEQ ID NO: 6 and the Kabat CDR1, CDR2 and/or CDR3 of the light chain variable region having the amino acid sequence of SEQ ID NO: 7 in the reply filed on 3/11/2026 is acknowledged.
Claims 71-72, 81-84, and 87 are being examined on the merit.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Amino acid sequences of 4 or more amino acids require a sequence identifier. See pages 18, 20, 69 (multiple linker sequences requiring sequence identifiers), 73, 107-108, 131-132 and 144.
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 sequence identifiers, 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.
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that the linker sequences listed in the pages discussed above are not listed as part of the Sequence Listing received on 2/14/2024. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112(b)
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 71-72, 81-84, and 87 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.
Instant claim 71 recite exemplary language that renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Specifically, the phrase “optionally wherein the ADC is for use in the treatment of a cancer” renders the claim indefinite, because it is unclear whether the limitations are part of the claimed invention. Claim 72 depends on claim 71.
Instant claim 81 recite exemplary language that renders the claim indefinite because it is unclear whether the limitation(s) are part of the claimed invention. Specifically, the phrases “optionally under intracellular conditions”, “optionally a protease-cleavable di-, tri-, tetra-, or penta-peptide”, and “optionally a camptothecin analogue, optionally a five-ring camptothecin analogue, optionally a six-ring camptothecin analogue, optionally exatecan, SN-38 or Dxd” renders the claim indefinite, because it is unclear whether the limitations are part of the claimed invention. See MPEP § 2173.05(d). Claim 87 depends on claim 81.
Claims 82 and 87 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.
Regarding claims 82 and 87, the metes and bounds of three CDRs contained within the HCVR and three CDRs within the LCVR selected from the sequences of SEQ ID NOs:6 and 7, respectively; SEQ ID NOs:24 and 25, respectively; SEQ ID NOs:42 and 43, respectively; and SEQ ID NOs:50 and 51, respectively, are unclear. Throughout the entire instant specification, the disclosure states the CDRs can be identified according to the Kabat antibody numbering scheme, e.g. page 52 of instant specification. However, in claims 82 and 87, part (a) encompasses any known and undescribed methods of identifying CDR sequences on VHs and VLs, while parts (b)-(d) require using the Kabat numbering scheme. Because different methods of identifying CDR sequences will result is varying regions on the VH and VL that are considered CDR sequences, the metes and bounds of the claims are unclear.
Claim Rejections - 35 USC § 112(a)
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.
Claims 83 and 84 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.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation."' (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (A) The nature of the invention; (B) The breadth of the claims; (C) The amount of direction provided by the inventor; (D) The existence of working examples; (E) The state of the prior art; (F) The level of predictability in the art; (G) The quantity of experimentation needed to make or use the invention based on the content of the disclosure and (H) The level of one of ordinary skill. While all of these factors are considered, a sufficient amount for amount for a prima facie case are discussed below.
This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology". Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The nature of the invention
Claims 83 and 84 are drawn to a nucleic acid or set of nucleic acids encoding a heavy and/or light chain of an antibody that binds to a human Nectin-4 polypeptide and a hybridoma or recombinant host cell producing the antibody.
The breadth of the claims
Regarding instant claims 83 and 84, the instant specification discloses an isolated nucleic acid sequence encoding a light chain and/or a heavy chain of an antibody, as well as a recombinant host cell comprising said nucleic acid that are required to produce a functional antibody. The instant claims encompasses a nucleic acid sequence of a VH OR VL, and a host cell comprising said nucleic acid sequence to produce an antibody. One of ordinary skill in the art would agree that this is not biologically possible, since both the VH and VL are required for proper antibody production.
The amount of direction provided by the inventor/the existence of working examples
The examples of the instant disclosure study different clones of antibodies that bind to a human Nectin-4 polypeptide by generating these antibodies from nucleic acids that encode the antibodies. The instant specification provides an exemplary anti-Nectin-4 VH and VL pair through antibody 5E7 comprising amino acid sequences SEQ ID NO:6 for VH and SEQ ID NO:7 for VL, which are characterized by the nucleic acid sequences encoding these arms (Instant Specification, page 51). Other examples are disclosed in pages 54, 55, and 57 of the instant specification. Although the examples provided require production of these antibodies by the nucleic acids encoding the antibody, the disclosure does not teach that the claimed nucleic acid sequence encoding either VH comprising the sequences of SEQ ID NO:6 OR VL comprising the sequence of SEQ ID NO:7 is sufficient to produce a functioning antibody as required by the instant claims.
The state of the art/the level of predictability in the art
It is well documented in the prior art that during B-cell development, the VH genes are rearranged to generate a functional VH polypeptide that pairs with a surrogate light chain comprising VpreB and l5 light chain to form a pre-B receptor (Janeway, Immuno Biology The immune system in Health and Disease, 4 edition, 1999, pages 195-209, of record; figure 6.2 and 6.9 in particular). The association of the VH polypeptide with the surrogate light chain stabilizes the VH polypeptide, which is required for expression on the cell surface. B cells lacking the expression of a surrogate light chain do not produce functional VH polypeptides (Janeway et al., page 205, paragraphs 1 and 2 in particular). Following stable VH expression, the VL genes are rearranged in the developing B cell to generate a functional VL polypeptide, which then replaces the surrogate light chain to form a functional antibody comprising a VH-VL (Janeway et al., figure 6.2 in particular). The teachings of Janeway shows that both the VH and VL polypeptides need to be expressed in the same cell in order to produce stable VH and VL polypeptides to form an antibody.
Furthermore, Wijesuriya et al. (Protein Expression and Purification, 2018, 149:75-83, of record) showed that the expression level of the VH polypeptide is dependent on the expression of the VL in the same cell (see 3.5 Antibody engineering to improve mAB B-c expression in particular). Wijesuriya et al. showed that laboratories have altered the expression levels and sequences of the VL to improve the expression of the VH and overall antibody production (abstract; see discussion in particular). These data shows that similar to antibody production in B cells, expression of an engineered VH polypeptide requires the expression of a VL polypeptide.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
Based on the instant disclosure and prior art, a cell comprising a nucleic acid sequence encoding either a VH sequence or VL sequence will not produce a functional antibody as required by the claims. Therefore, in order to practice the invention as claimed, one of ordinary skill in the art would have to perform undue experimentation to develop a nucleic acid encoding an antibody that binds to human Nectin-4, wherein the nucleic acid comprises sequences encoding both the VH and VL of the antibody.
Conclusion
In view of the Wands factors as discussed above, one of ordinary skill in the art would have to engage in undue experimentation to practice the full scope of the instant claimed invention. As such, instant claims 83 and 84 were determined to not meet the enablement requirement of 35 USC § 112(a).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 81 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Lewis and Liu (WO2021257938 A1, Priority to 6/19/2020; hereinafter Lewis).
Regarding claim 81, Lewis teaches an anti-191P4D12 antibody drug conjugate comprising (i) an antibody or antigen binding fragment thereof that binds to epitopes of 191P4D12 (which is also known as Nectin-4) common among the 191P4D12 variants observed in humans, wherein the antibody or antigen binding fragment thereof binds to the VC1 domain of 191P4D12 (page 2, paragraph [0004]; page 318, paragraph [00601]; pages 338-339, paragraph [00656]; and page 340, paragraph [00657]); (ii) a linker unit between the drug unit and the antibody unit (e.g., the anti-191P4D12 antibody or antigen binding fragment thereof), wherein the linker is cleavable via a protease under intracellular conditions wherein the cleavable linker comprises a peptidyl linker that is at least two amino acids long or at least three amino acids long (pages 346-347, paragraphs [00676]-[00677]); and (iii) a cytotoxic agent comprising a topoisomerase inhibitor, e.g., camptothecin or SN-38 (pages 343-344, paragraph [00669]).
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.
Claim 81 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37, 43-44, and 53-56 of copending Application No. 17/796,707 (PGPUB No. US20230099149 A1, Priority to January 31, 2020, IDS entered on 5/25/2023; hereinafter ‘149). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The copending claims are directed to a method of treating cancer comprised of administering an immunoconjugate that is the same as the instant claimed immunoconjugate.
Claims 37 and 43-44 of ‘149 teach a method of treating a cancer or killing tumor cells in an individual, comprising administering to said individual a therapeutically effective amount of a Nectin-4 binding protein conjugated to a camptothecin analogue, wherein the Nectin-4-binding protein conjugated to a camptothecin analogue is an immunoconjugate represented by Formula (I):
Ab-(X—(Z)) Formula (I)
wherein (i) Ab is an antigen binding protein that specifically binds to a human Nectin-4 polypeptide; (ii) X is a linker molecule which connects Ab and Z, wherein X comprises a moiety that is cleavable under physiological conditions, optionally under intracellular conditions, optionally a protease-cleavable di-, tri-, tetra-, or penta-peptide, optionally wherein X further comprises a self-eliminating spacer positioned between the protease-cleavable peptide and Z; and (iii) Z is an exatecan molecule. Claims 53-56 of ‘149 teach a method for making the immunoconjugate comprising conjugating an exatecan molecule to an antigen binding protein via a linker (X), wherein the antigen binding protein or antibody is capable of inducing intracellular internalization of Nectin-4 in tumor cells that express Nectin-4 at their surface wherein the antigen binding protein or antibody is conjugated to a linker-exatecan moiety comprising (PEG)n-Val-Ala-PAB-exatecan. The immunoconjugate represented by Formula (I) comprising Nectin-4-binding protein conjugated to a camptothecin analogue that is administered is the same as the instantly claimed immunoconjugate comprising Nectin-4-binding protein conjugated to a camptothecin analogue represented by instant Formula (I). Therefore, although the claims at issue are not identical, the instant claims are not patentably distinct from the issue claims.
Allowable Subject Matter
An antibody that binds to a human Nectin-4 polypeptide, wherein the antibody comprises:
a VH comprising the Kabat CDR 1, CDR2, and CDR3 of the heavy chain variable region having the amino acid sequence of SEQ ID NO:6 and a VL comprising the Kabat CDR 1, CDR2, and CDR3 of the light chain variable region having the amino acid sequence of SEQ ID NO:7;
a VH comprising the Kabat CDR 1, CDR2, and CDR3 of the heavy chain variable region having the amino acid sequence of SEQ ID NO:24 and a VL comprising the Kabat CDR 1, CDR2, and CDR3 of the light chain variable region having the amino acid sequence of SEQ ID NO:25;
a VH comprising the Kabat CDR 1, CDR2, and CDR3 of the heavy chain variable region having the amino acid sequence of SEQ ID NO:42 and a VL comprising the Kabat CDR 1, CDR2, and CDR3 of the light chain variable region having the amino acid sequence of SEQ ID NO:43;
a VH comprising the Kabat CDR 1, CDR2, and CDR3 of the heavy chain variable region having the amino acid sequence of SEQ ID NO:50 and a VL comprising the Kabat CDR 1, CDR2, and CDR3 of the light chain variable region having the amino acid sequence of SEQ ID NO:51;
are free of prior art.
Regarding instant claims 71, 82, and 87, the closest prior art for the antibody that binds to a human Nectin-4 polypeptide, wherein the antibody comprises a VH comprising amino acid sequence instant SEQ ID NO:6, is an antibody or fragment thereof that binds to human Trop-2 of SEQ ID NO:12 present in U.S. Patent No. 12,558,577 B2 (Wang et al), which has a 91.1% query match to the claimed sequence.
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Importantly, the binding determinant region of the instantly claimed human Nectin-4 polypeptide does not have an identical match to SEQ ID NO:12 of Wang. Thus, the antibody or fragment thereof of Wang is not prior art and the subject matter is allowable. Instant claims 83 and 84 are dependent on instant claim 82, and also have allowable subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jieun Ham whose telephone number is (571)272-7779. The examiner can normally be reached Monday - Friday 7-2.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie 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.
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/J.H./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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