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 the Application
The amendment of 29 November 2023 is entered.
The election of 15 June 2026 is entered.
Claims 4, 16, 17, 19, 20, 25-45, and 47-65 have been canceled. Claims 1-3, 5-15, 18, 21-24, and 46 are pending. Claims 14, 15, 18, and 21 are withdrawn without traverse. Claims 1-3, 5-13, 23, 24, and 46 are being examined on the merits.
Election/Restrictions
Applicant’s election of Group I (claims 1-3, 5-13, 22-24, and 46) and BT7480/BCY11863 in the reply filed on 15 June 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14, 15, 18, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 15 June 2026.
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 – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See claim 7, 8, 11, and corresponding occurrences of same sequences in specification. Any sequence appending amino acids to an existing peptide must have its own SEQ ID NO (see e.g. sequences such as “Ac-A-(SEQ ID NO: 5)-Dap (herein referred toa s BCY7732)” in claim 7, “[PYA]-(SEQ ID NO: 1) (herein referred to as BCY11015) in claim 11).
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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 5 and 7-13 are objected to because of the following informalities: informal names should not be utilized to identify compounds (i.e. “herein referred to as BY12353”). 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.
Claims 1-3, 5-13, 22-24, and 46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating colon cancer in a patient comprising administering to said patient a therapeutically effective amount of a heterotandem bicyclic peptide complex BT7480 or BCY11864 or pharmaceutically acceptable salt thereof and an immuno-oncology agent, does not reasonably provide enablement for a method of treating a cancer in a patient with the same heterotandem bicyclic peptide complex and immuno-oncology agent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to treatment of a cancer in a patient, achieved through administration of a heterotandem bicyclic peptide complex in conjunction with an immuno-oncology agent. The heterotandem bicyclic peptide complex comprises a first bicyclic peptide ligand binding to Nectin-4 on a cancer cell surface that is conjugated via a linker to a CD137 binding bicyclic peptide ligand, where each ligand contains at least three reactive groups separated by loop sequences and a scaffold to form covalent bonds to the reactive groups in order to form at least two polypeptide loops on the molecular scaffold.
Breadth of the Claims
The claims are broad. They encompass treatment of any cancer. At their broadest, the heterotandem bicyclic peptide complex is defined largely by the targets of the peptide ligands rather than by structure. The linker is broadly defined. The molecular scaffold is broadly defined. The immuno-oncology agent as claimed is broad. The broadest reasonable interpretation of the claims is that their breadth is extremely wide.
State of the Prior Art
BT7480 is discussed as being a potential therapeutic utilizing a bispecific targeting approach towards Nectin-4 and CD137 in multiple cancers, with data suggesting efficacy in a mouse model utilizing MC38 colorectal cancer cell tumors (see e.g. Hurov et al. Cancer Res. 80:5552, published 15 August 2020). Notably, the Hurov art does not disclose a specific structure of BT7480, although the associated poster does illustrate a linker connecting a Nectin-4 bicycle peptide having two loops to a CD137 bicycle having two loops (see e.g. Figure 2).
The ability of the skilled artisan to predict a clinical response to a cancer therapeutic is considered to be a major challenge (see e.g. Sakellaropoulos et al. Cell Reports 29:3367-3373.e4, published 2019). Sakellaropoulos also notes that well-validated algorithms for prediction of therapeutic response are lacking (see e.g. Introduction). Sakellaropoulos also notes that while their direct neural network approach offers some advantages, it still requires large amounts of additional data on drug response and genomic data for accurate training, as well as extensive clinical validation (see e.g. Discussion).
Relative Skill of those in the Art
The relative skill of those in the art is high.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Cancer treatment is inherently unpredictable. Treatment options for one form of cancer are not readily predictable with respect to their efficacy in other forms of cancer, i.e. what works in treatment of cervical cancer has no reasonable assurance it would work in any other form of cancer.
Amount of Direction or Guidance Given
Nectin-4 binding ligands are discussed in [0052]-[0058]. CD137 binding ligands are discussed in [0229]-[0237]. The linker is discussed in [00240]-[0245]. Molecular scaffolds are discussed in [00320]-[00328]. A phage library-based combinatorial approach to ligand development is discussed in [0005], and more generic peptides are discussed in [00291]. Extensive lists of cancers are discussed in [0362]-[0393].
Presence/Absence of Working Examples
The working examples do not utilize any cancer models beyond those based upon colorectal cancer cells, in particular MC38#13 cells overexpressing Nectin-4 (see e.g. [0478]). BCY12491 is also administered in conjunction with pembrolizumab, again in a MC38 model system (see e.g. Example 2). Notably, BCY12491 targets EphA2 and CD137, not Nectin-4 and CD137. BCY11864 is administered to mice with CD26#7 cells overexpressing Nectin-4 alone or in combination with anti-PD-1 antibodies (see e.g. Example 3). BT7480 is also administered to mice with MC38#13 cells alone or in combination with anti-PD-1 or anti-Ctla-4 antibodies (see e.g. Example 4). Transcriptional profiling is made of cells after BT7455 administration, but this targets EphA2 instead of Nectin-4 (see e.g. Example 5).
Quantity of Experimentation Necessary
Extensive and undue experimentation is required to make and use the invention as claimed. While three separate heterotandem bicyclic peptides are utilized in studies of colorectal cancer, the claims themselves at their broadest do not limit the peptide complex outside of targets, nor do the claims limit the form of cancer. The ability to treat colorectal cancer does not translate to the ability to treat glioblastoma, lung cancer, pancreatic cancer, and so forth. Given that the bicyclic peptides at their broadest are defined largely by their target rather than by structure, his leads to a significant level of experimentation to prepare the necessary heterotandem bicyclic peptide complex. This is complicated by the claim to treatment of “a cancer”, which requires the skilled artisan to not only prepare representative species from the genus as claimed, but also to test them in model systems against sufficient cancers to establish an expectation of efficacy across cancer types. This level of experimentation is undue.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
Claims 1-3, 5-12, 22-24, and 46 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
At issue is the highly generic nature of the claimed heterotandem bicyclic peptide complex. Claim 1 largely defines the peptide ligands in terms of their target rather than by any actual structure, for instance the first ligand is claimed as one that “binds to a component present on a cancer cell, wherein the component present on the cancer cell is Nectin-4, and the first peptide ligand comprises an Nectin-4 binding bicyclic peptide ligand”. This does not indicate to the skilled artisan anything about what structure the peptide ligand should take other than it must be bicyclic. The CD137 binding ligand is only defined by target and needing to be bicyclic. The claim does include language on the presence of reactive groups separated by loop sequences, as well as a molecular scaffold to form said loops via bonding between the scaffold and the reactive groups. However, this does not lead the skilled artisan to an understanding of what structure is necessary to be a Nectin-4 binding peptide or a CD137 binding peptide. Later claims refine one of the elements, but leave the other peptide ligand as defined by target rather than by structure. The molecular scaffold is only found in claim 22.
Nectin-4 binding ligands are discussed in [0052]-[0058]. CD137 binding ligands are discussed in [0229]-[0237]. The linker is discussed in [00240]-[0245]. Molecular scaffolds are discussed in [00320]-[00328].
The precise method to achieve the claimed Nectin-4 binding ligands or CD137 binding ligands is not explicitly discussed in the Examples. Reference is made to using phage display-based combinatorial approaches to develop and screen large libraries of bicyclic peptides binding to targets of interest, utilizing CX6CX6C motifs where the cysteines are linked to tris-(bromomethyl)benzene (see e.g. [0005]). Such combinatorial approaches generally imply low hit levels and rely upon the skilled artisan for extensive experimentation to achieve bicyclic peptides with acceptable binding activity, disregarding the need for use of different molecular scaffolds and linker molecules.
Collectively, while combinations of Nectin-4 bicyclic peptide ligands and CD137 bicyclic peptide ligands are present within the specification, they represent only a small subset of species possible given the open-ended claiming of the ligands within the claims based largely upon targets rather than structure. One of ordinary skill in the art might recognize possession of particular species of heterotandem bicyclic peptide complexes, but the genus is so diverse given the claim language that there is no reasonable conclusion that a representative number of species were possessed by Applicants to indicate possession of the genus. This is especially true given that there are few limitations of the peptide sequences necessary for Nectin-4 or CD137 binding. The situation is akin to antibody claiming through description of a target rather than by a specific structure as in Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378, 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). See MPEP 2163 II. 3. (a) as well as MPEP 2163 II. A. 2. (a) ii).
Even in the cases where one element is defined, such as in claim 5, the remainder of the heterotandem bicyclic peptide complex is left as a generic structure including the molecular scaffold, the linker, and the Nectin-4 bicyclic peptide.
The skilled artisan would recognize possession of species of heterotandem bicyclic peptide complexes targeting Nectin-4 and CD137, but not the genus as claimed.
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.
Claim 13 is 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 claim 13, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Also regarding claim 13, reference to the specification is generally unacceptable unless there is no way to reasonably convey the information through text within a claim. Where possible, claims are to be complete in themselves unless exceptional circumstances are present such that the invention cannot be defined by words. See MPEP 2173.05(s). Such is not the case with reference to the claimed compounds.
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.
1. Claims 1-3, 5-13, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 15, and 19 of copending Application No. 18/710,083 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘083 application claims an overlapping method.
The ’083 application claims a method of treating a Nectin-4 associated advanced malignancy in a subject by administering a pharmaceutical composition comprising BT7480 or a salt thereof, Tris base, mannitol, sodium hydroxide, and water (see e.g. claim 14). A malignancy is further noted to include a variety of cancers (see e.g. claim 15). ‘083 further claims administration with nivolumab (see e.g. claim 19). This overlaps with claim 1 as it treats a cancer (malignancy) through administration of a heterotandem bicyclic peptide complex BT7480 with an immuno-oncology agent nivolumab.
With respect to claims 2 and 3, BT7480 of ‘083 reads upon these sub-genera.
With respect to claims 5-13 and 22, again BT7480 reads upon these sub-genera as indicated by the species election of 15 June 2026.
With respect to claims 23 and 24, nivolumab is a checkpoint inhibitor targeting PD-1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1-3, 5-13, 22-24, and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 12 of U.S. Patent No. 11,970,553 B2 in view of Beswick et al. (WO 2019/243833 A1, published 26 December 2019, hereafter referred to as ‘833)
The ‘553 patent claims a method of treating cancer in a patient by administering a heterotandem bicyclic peptide complex (see e.g. claim 1). The ‘553 patent further claims a complex matching BT7480 (see e.g. claims 2 and 12).
The difference between ‘553 and the claimed invention is that ‘553 does not claim an immuno-oncology agent.
The ‘833 application discloses Nectin-4 bicyclic peptides as well as inclusion of immuno-oncology agents (See e.g. p.2, 41-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ‘553 patent by including an immuno-oncology agent as utilized in ‘833 to provide an additional anti-cancer effect in treatment. The rationale comes from the overlapping Nectin-4 targeting of ‘553 and ‘833. There would have been a reasonable expectation of success because both the ‘553 complex and the immuno-oncology agents of ‘833 target are useful in cancer treatment. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 2, 3, 5-13, 21, and 22 as noted above BT7480 reads upon each of these claims.
With respect to claims 23 and 24, ‘833 provides for checkpoint inhibitors and the other immuno-oncology agents.
With respect to claim 46, ‘553 claims carcinomas of the colon, which are a type of solid tumor (see e.g. claims 3 and 4).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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