DETAILED ACTION
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
Receipt is acknowledged of Applicants’ preliminary amendment, filed on 08/21/2025, in which claims 3-10, 26, 30-32, and 34 are cancelled and no claim are amended.
Claims 1-2, 11-25, 27-29, and 33 are pending.
Priority
The instant application is a 371 of PCT/US2020/055053, filed on 10/09/2020, which claims domestic benefit of 62/913,679, filed on 10/10/2019.
Election/Restrictions
Applicant’s election of species in the reply filed on 08/21/2025 is acknowledged. Applicant elected
a. adalimumab as the single Ab species,
b. right hand CON having the below structure:
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and a left hand CON having the below structure in which the triazole in the left hand CON group forms as part of the reaction between an azide on a lysine side chain (NH2 in lysine sidechain converted to N3) in the Ab and an acetylene group, which results in the connection between Ab and the left hand CON as illustrated in Fig 15:
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c. linker having the below structure:
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d. a generic species of CRBM in which R1 is -CH2OH, R2 is -NHC(=O)CH3, and R3 is -O- having the below structure:
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e. a single extracellular protein of TNF-α in claim 20,
f. a single disease of an autoimmune disease and the disease species within the
single disease is rheumatoid arthritis.
Election was made without traverse in the reply filed on 08/21/2025.
Claims 1-2, 11-25, 27-29, and 33 are examined on the merits herein.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/02/2023, 03/08/2024, 08/06/2024, 12/23/2024, 05/08/2025, and 10/09/2025 comply with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where noted. The foreign patent documents 1 and 3-7 and non-patent literature documents 3-50 in one IDS filed 08/03/2022, as well as non-patent literature documents 1-20 in the other IDS filed 08/03/2022, were not considered, as no corresponding foreign reference and non-patent literature documents were submitted.
Objections to the Specification
The disclosure is objected to because of the following informalities: The chemical structures, for example, those on pages 37, 49, 52, 64, 81, the upper figure on page 82, the table on page 88, and 91 are of poor resolution and cannot be easily read. Appropriate correction is required.
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.
Claim Objections
Claims 14 and 18 and objected to because of the following informalities: the chemical structures on pages 4-5, the first two structures on page 6, page 8, the first figure on page 9, the table and figures on page 16, and page 19 are not legible. Appropriate correction is required.
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 14-18, and 20-21 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 14 recites the variable X at least on page 3 in the first set of structures under (b), page 6 in the first set of structures under (c), the second set of structures on page 8, the first set of structures on page 9, and the structures at the top of page 10. Claim 15 recites the variable X at least on page 14 lines 14, 16, and 17, and on page 15 lines 2, 3, and 8. Claim 16 recites the variable X line 1 of the claim. Similarly, the variable R is recited in claim 14 on page 3 in the first set of structures under (b), on page 9 in the structures under (i), in claim 18 on page 17, line 4, and page 18 lines 1 and 2, page 19 line 2, in claim 20 lines 14, 16, and 22. The variable R1 is recited in claim 14 on page 6 in the first set of structures under (c), the first set of structures on page 8, the first set of structures on page 10, page 11 line 13, page 13 line 8, as well as the in structures in claim 17, in claim 18 structures on page 16-17, and in claim 21 lines 6-9. The variable R2 is recited in claim 14 on page 6 in the first set of structures under (c), the first set of structures on page 8, the first set of structures on page 10, page 13 lines 10 and 17, as well as in the structures in claim 17, and in claim 18 structures on page 16-17. The variable R3 is recited in claim 14 on page 10 in the first set of structures under (j), page 13, line 8, the structures in claim 17 and in claim 18 on page 16 line 4. Claims should not use the same variable having multiple different definitions, neither with in the same claim or across different claims, because it renders unclear which structures are further limited at each recitation of the variable. For example, it is not clear which X in claim 14 is being limited in claim 16.
Claim 20 recites X1 on line 20 and X1 on line 22 on page 20. It is not clear whether these are intended to be the same variable.
Claim 18 recites limitations for the ASGPRBM group of claim 14. However, due to the punctuation of the claim, it is not clear what structures are encompassed in the metes and bounds of the claim. For example the two structures in line 2 of claim 18 are separated by a comma and end in a semicolon, but additional structures are introduced on pages 16-19 without any punctuation. It is unclear how the structures limit the claim, whether they are alternatives or whether all recited structures must be included in the ASGPRBM.
Claim 21 recites “the compound of claim 1 wherein the CON comprises...” However, claim 1 recites a compound of the below formula (I).
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This formula includes both [CON]h and [CON]h’ and it is not clear which of these CON groups are being limited in claim 21, and thus the meets and bounds of the claim are unclear. For purposes of compact prosecution, under broadest reasonable interpretation, the claim will be interpreted as encompassing compounds in which either CON meets the recited limitations.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 11-25, 27-29, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Zamora-Atenza et. al (Arthritis Research and Therapy, 2014; PTO-892) in view of Bertozzi et al. (ChemRxiv, 2019; PTO-892), Rensen et. al (Journal of Biological Chemistry, 2001; PTO-892), and Pickens et. al (Bioconjugate Chemistry, 2018; PTO-892), and BroadPharm (Safety Data Sheet for Azido-PEG4-hydrazide HCl Salt, 2018; PTO-892)
Zamora-Atenza teaches methods for treating rheumatoid arthritis (RA) by targeting TNF-α using Adalimumab, which is an anti-TNFα monoclonal antibody that specifically blocks the interaction of TNFα with its receptors and binds both soluble and transmembrane TNFα (abstract). TNFα contributes to joint destruction by attracting leukocytes, inducing inflammatory cytokines, upregulating adhesion molecules on endothelial cells (page 1, paragraph 1).
The teachings of Zamora-Atenza differ from that of the instantly claimed invention in that Zamora-Atenza does not teach a compound of instant claim 1.
Bertozzi teaches that a general strategy for targeting secreted and plasma membrane proteins for degradation is an unmet need that could dramatically impact human health (page 1, paragraph 1). Bertozzi thus discloses lysosome targeting chimeras (LYTACs), which represent a modular strategy for directing secreted and membrane proteins for degradation in the context of both basic research and therapy (abstract). The LYTAC platform enables depletion of both secreted and membrane proteins via a mechanism of action that is orthogonal and complementary to existing technologies (paragraph bridging pages 1-2). LYTACs consist of antibodies fused to ligands targeting the protein for degradation, and Bertozzi discloses a proof-of-principle example in which an antibody fused to agonist glycopeptide ligands for the cation-independent mannose-6-phosphate receptor (abstract). The antibody was conjugated by non-specifically labeling lysines of the antibody with bicyclononyne and subsequently conjugating this modified antibody to azide-terminated glycopolypeptides via Cu-free strain-promoted azide-alkyne cycloaddition (page 3, paragraph 1). Bertozzi concludes that the chemical tunability and modularity of LYTACs will offer new opportunities in targeted protein degradation for both research and translational applications (page 5, paragraph 1).
Rensen teaches that the hepatic asialoglycoprotein receptor (ASGPr) is expressed on the surface of hepatocytes and plays a role in the clearance (endocytosis and lysosomal degradation) of proteins from the serum (page 37577, paragraph 1). Because of its unique localization, abundance, and high internalization capacity, the ASGPr is widely used as a target for the specific delivery of genes and therapeutic agents to hepatocytes (page 37583, paragraph 4). Rensen further discloses ligands that have the structural requirements for proper recognition by the ASGPr and are useful for the design of systems for ASGPr mediated targeting of drugs to hepatocytes (page 37578, paragraph 3). Rensen describes a novel triantennary N-acetylgalactosamine-terminated cluster (Z-Tris(GalNAc)3) that was synthesized and conjugated to a steroid structure via a tyrosine residue (page 37578, paragraph 6). The triantennary ligand is shown below.
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Rensen shows that the Tris(GalNAc)3 ligand successfully targeted liposomes to hepatocytes in vivo through recognition by ASGPr.
Pickens reviews the state of the art in bioconjugation via azide−alkyne cycloaddition. Pickens teaches that the emergence of “click chemistry” has revolutionized bioconjugate chemistry by providing facile reaction conditions amenable to both biologic molecules and small molecule probes such as fluorophores, toxins, or therapeutics (abstract). Of all the bioorthogonal click reactions that have been developed, the most widely applied is the copper-catalyzed azide−alkyne cycloaddition reaction (CuAAC). In order to improve upon the CuAAC reaction, the strain promoted azide−alkyne cycloaddition reaction (SPAAC) was introduced, which mitigated several disadvantages of the CuAAC (page 686, paragraph 2). Pickens provides the following general formula for the outcomes of SPAAC reactions (Table 1).
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In the biopharmaceutical field, click chemistry is an attractive option for antibody-drug conjugates in which click chemistry is being explored for the conjugation of payloads to antibodies, and heterobifunctional linkers have been used to functionalize the payload molecule (page 693, paragraph 1). A large variety of heterobifunctional linkers are commercially available with different of solubilizing moieties like PEG and sulfate groups. PEGylated forms of the heterobifunctional linkers are available in various lengths, which permits precise spacing of the reactive handle. Pickens teaches that including PEG in the linker can improve water solubility and alleviate steric effects between the two molecules (page 692, paragraph 4). Pickens further teaches that NHS esters are among the most popular compounds used to functionalize biomolecules due to their aqueous compatibility, commercial availability, and ability to selectively target primary amines present on lysine residues or the N-terminus (page 688, paragraph 2). As shown below, a primary amine on the biomolecule reacts with the NHS ester to form an azide functionalized protein (Figure 2A).
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Pickens further teaches that linkers employed for installation of a reactive handle include DBCO-COOH, shown below (Figure 3D).
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BroadPharm discloses the compound DBCO-PEG4-acid, which is shown below (section I).
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One of ordinary skill in the art would have been motivated to apply the LYTAC strategy of Bertozzi to the Adalimumab of Zamora-Atenza on order to provide targeted degradation of TNF-α in the treatment of RA because Bertozzi teaches that LYTAC platform enables depletion of both secreted and membrane proteins and Zamora-Atenza teaches that TNFα, which occurs in both soluble and transmembrane forms, contributes to joint destruction in RA.
In order to achieve a LYTAC of Adalimumab, it would have been prima facie obvious to combine the teachings of Zamora-Atenza with that of Bertozzi, Rensen, Pickens, and BroadPharm before the effective filing date of the claimed invention by derivatizing the Adalimumab of Zamora-Atenza using a linker composed of the DBCO-PEG4-acid of BroadPharm joined by SPAAC to an azide modified lysine residue as taught by Pickens in order to provide a linker which can conjugate to the Adalimumab of Zamora-Atenza because Pickens teaches that DBCO-COOH is employed in the installation of a reactive handle and that NHS esters react with a primary amine on a biomolecule to provide an azide functional handle. One of ordinary skill in the art would have been motivated to derivatize Adalimumab using the commercially available DBCO-PEG4-acid heterobifunctional linker of BroadPharm because Pickens teaches that a large variety of heterobifunctional linkers are commercially available and that including PEG in the heterobifunctional linker can improve water solubility and alleviate steric effects between the two molecules. It would have further been prima facie obvious to append the DBCO functionalized linker to the triantennary Tris(GalNAc)3 ligand of Rensen, because Rensen teaches that ASPGr is expressed on the surface of hepatocytes and plays a role in the clearance of proteins from the serum and discloses triantennary ligands for recognition by the ASGPr that are useful for ASGPr mediated targeting of drugs to hepatocytes. One of ordinary skill in the art would have had a reasonable expectation of success because Bertozzi teaches that antibody conjugates, in which the antibody is linked to a targeting ligand via Cu-free strain-promoted azide-alkyne cycloaddition, are useful for targeting secreted and membrane proteins for degradation, and Rensen provides ligands targeting drugs to ASGPr expressed on the surface of hepatocytes, which plays a role in the endocytosis and lysosomal degradation of proteins from the serum.
Regarding instant claim 15, the claim recites further limitations of X in the ASGPRBM. However, claim 15 depends from claim 14, which encompasses the scope of ASGPRBM that do not comprise X. Thus the limitations of instant claim 15 are met by prior art teaching the alternative ASGPRBM of claim 14.
Regarding instant claim 25, it would have been prima facie obvious to combine the Tris(GalNAc)3 conjugated Adalimumab suggested by the combined teachings of Zamora-Atenza, Bertozzi, Rensen, Pickens, and BroadPharm with an excipient because Zamora-Atenza teaches that Adalimumab is administered as an injection, which indicates that the antibody is administered as a solution and suggests a composition comprising the excipient water.
Regarding instant claim 33, it would have been prima facie obvious to treat RA in a human subject using the Tris(GalNAc)3 conjugated Adalimumab suggested by the combined teachings of Zamora-Atenza, Bertozzi, Rensen, Pickens, and BroadPharm because Zamora-Atenza teaches that Adalimumab is used in the treatment of RA patients, who would be understood by one of ordinary skill in the art to be human subjects.
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, 11-25, 27-29, and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 19, 25, 28-29, 31-36, and 38-43 of copending Application No. 17/654,984 (reference application). The claims at issue are not identical because ‘984 recites compounds with a narrower scope of structures. However, they are not patentably distinct from each other because ‘984 is directed to a compound of the below formula (I)
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in which Ab is selected from, among others adalimumab, CRBM has the below structure wherein ZB- may be absent,
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each CON is independently selected from the group consisting of, among others,
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and
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and the linker may be, among others, a polyethylene glycol linker having 2-12 ethylene glycol residues.
Claim 25 of ‘984 recites pharmaceutical composition comprising at least one pharmaceutically acceptable excipient and at least one compound of claim 1. Claim 29 of ‘984 recites a method of threating an autoimmune disease, cancer, or inflammation in a subject comprising administering a compound of claim 1, which may be formulated as a pharmaceutical composition. Claim 31 of ‘984 recites the method of claim 29 wherein the diseases is, among others, rheumatoid arthritis. Claim 36 of ‘984 recites the method of claim 29 wherein the subject is human.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693