DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment of 4/15/26 has been entered in full. Claims 46 and 62 are amended. Claims 45-65 are pending.
The elections without traverse of (1) para-azidomethylphenylalanine as the species of non-natural amino acid and (2) hemiasterlin as the species of payload moiety in the reply filed on 4/15/26 are acknowledged. Claim 50 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of non-natural amino acid, there being no allowable generic or linking claim.
Claims 45-49 and 51-65 are under consideration.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive for the following reasons: (1) the title is limited to anti-CD74 antibody conjugates, but the claims encompass any type of antibody; (2) the title encompasses any kind of antibody conjugates, but the claims are limited to antibody conjugates comprising a non-natural amino acid at position 42 of the light chain; and (3) the tile in part is directed to methods, but the pending claims do not include any methods. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Antibody Conjugates Comprising a Non-Natural Amino Acid at Position 42 of the Light Chain and Compositions Thereof”.
Appropriate correction is required.
Claim Objections
Claims 46, 53 and 60 are objected to because of the following informalities:
In claim 46, line 2, “-3-(2-naphthyl)alanine” should be “L-3-(2-naphthyl)alanine”; see the specification at page 138 (¶ 438). Furthermore, the article “an” before this term should be removed as no other element in the group includes an article.
In claim 53, the acronyms MMAF and MMAE should be accompanied by the full terminology; i.e., “monomethyl auristatin F (MMAF)” and “monomethyl auristatin E (MMAE)” (page 52, ¶ 161).
In claim 60, line 2, “F(ab’)2” should be “F(ab’)2”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), written description
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 54 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Per MPEP 2163, 35 U.S.C. 112(a) requires, “separate and distinct from the enablement requirement”, that the “specification shall contain a written description of the invention…” (Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010)). In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a), it is necessary to understand what Applicants are claiming and what Applicants have possession of.
Instant claim 54 is directed to a product that is limited functionally to specifically binding to the protein CD74, and structurally to an antibody conjugate comprising a payload moiety linked to an antibody, wherein the antibody comprises a light chain, wherein said light chain comprises a non-natural amino acid at position LC-K42 according to the Kabat or Chothia numbering scheme. The specification teaches that CD74 is also known as “[h]uman leukocyte antigen (HLA) class II histocompatibility antigen gamma chain” or “HLA-DR antigens-associated invariant chain” and “is involved in the formation and transport of major histocompatibility complex (MHC) class II protein” (¶ 4). The specification further teaches that expression of CD74 “has been observed in cancers and autoimmune disease”, with “expression at moderate to high levels on a variety of hematological tumors including B-cell lymphoma, leukemia, and multiple myeloma” (¶ 6). The specification further teaches that “given the upregulation of CD74 in several diseases … therapeutics that specifically target cells and tissues overexpressing CD74 … could be used to deliver therapeutic or diagnostic payload moieties to target cells expressing CD74 for the treatment or diagnosis of such diseases” (¶ 7).
The prior art recognizes that antibodies bind to epitopes of 5-7 amino acids (Benjamini et al, 1991. Immunology: A Short Course, 2nd edition, page 40 only). The human CD74 protein has an extracellular domain of 224 amino acids (see page 1 of Wu et al, 2016. Scientific Reports. 6: 30067, 20 pages as printed). Thus, even considering only continuous epitopes, the region of CD74 expressed on the surface of tumor cells that is targeted by the claimed antibody comprises many different regions of five amino acids that can serve as epitopes (e.g., residues 1-5, 2-6, 3-7, up to residues 219-224). While the general structure of an antibody was well-known in the prior art, it is the structure of the complementarity-determining regions (CDRs) that determines the specificity of a particular antibody, and said CDR structure is not predictable based on the epitope to which it binds. Thus, even knowing the structure (CDRs) of one antibody does not allow the skilled artisan to predict the structure of other antibodies that bind to the same epitope or to the other epitopes in the same protein. The relevant art, Ferrara et al (2015. mAbs. 7(1): 32-41) teaches that there is substantial variation in the structure of antibodies that bind to a single protein, on the order of hundreds of different sequences; specifically, see page 36: "The number of different HCDR3s selected against the test antigens ranges from 74 to 460 (Table 3), with the actual number of different antibodies likely to be significantly higher when different VL chains and additional VH mutations are taken into account” (pg 36). Thus, there are at least hundreds of different antibody structures that bind to the ECD of the human CD74 protein.
Thus, the claims are genus claims because they encompass use of a genus of antibodies with the required functionality, i.e., binding to human CD74. However, a product defined by function is not in and of itself sufficient to describe the product because it is only an indication of what the product does, rather than what it is; i.e., the specific structure of the product. It is only a definition of a useful result rather than a definition of what achieves that result. Per MPEP 2124, "describing a composition by its function alone typically will not suffice to sufficiently describe the composition". Furthermore, in the instant case the specification does not establish a correlation between structure and function; i.e., the structure of one anti-CD74 antibody does not provide predictability regarding other antibody structures having the same functionality. Furthermore, the decision of the Federal Circuit in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Circ. 2017) held that a claim directed to an antibody requires written description of the antibody itself rather than being satisfied solely by a written description of the antigen to which it binds (the so-called "newly characterized antigen" test). Thus, a description of the target protein (e.g. CD74) is not in and of itself sufficient to provide a description of the genus of antibodies binding to said target.
Written description for a genus may also be satisfied through sufficient description of a relevant number of species. This is dependent on whether one of skill in the art would recognize necessary common attributes or features possessed by the members of the genus. Generally, in an unpredictable art, adequate description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Also, “[w]hen a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)). “[A] sufficient description of a genus … requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69).
In support of the genus of antibodies binding to CD74, the specification provides examples of antibodies that are defined by the sequences of their CDRs. The specification provides a list of 32 HCDR3s (SEQ ID NO: 129-160) at ¶ 239 (published application) and also in Table 9. However, several of these CDRs are identical to each other (e.g., SEQ ID NO: 137/138 and 159/160) and at least half of them are related sequences that match a consensus sequence disclosed in the specification (section 5.8.1; ¶ 380). As such, what is disclosed (30 unique sequences, half of which are related in sequence) does not correspond in scope to that which is claimed (the genus of anti-CD74 antibodies, which includes at least hundreds of sequences). Per MPEP 2163, "A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). As such, in the instant case the specification does not provide a representative number of species of the genus of antibodies that can bind to CD74.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (pg 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (pg 1116).
For these reasons, only an antibody conjugate of claim 45, wherein the antibody specifically binds to CD74 and comprises a set of six CDRs each defined by sequence (i.e., SEQ ID NO), but not the full breadth of claim 54 meets the written description provision of 35 U.S.C. §112(a). Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (pg 1115).
Claim Rejections
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(1) Claims 45-49 and 51-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,708,413, issued 7/25/23 (cited on the 4/15/26 IDS), and which shares the same applicant and inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The instant application claims priority as a continuation to application 16/702,778, which issued as the ‘413 patent.
Instant independent claim 45 encompasses an antibody conjugate comprising a payload moiety linked to an antibody, wherein the antibody comprises a light chain, wherein said light chain comprises a non-natural amino acid at position LC-K42 according to the Kabat or Chothia numbering scheme. Dependent claim 47 encompasses the antibody conjugate of claim 45 wherein the payload moiety is linked to the antibody via a non-natural amino acid. Dependent claim 54 encompasses an antibody conjugate of claim 45 wherein the antibody specifically binds to CD74.
Each of instant claims 45, 47 and 54 fully encompass claim 1 of the ‘413 patent, which is directed to an antibody conjugate comprising an antibody the specifically binds to CD74 linked site-specifically to at least one payload moiety, wherein the antibody comprises a non-natural amino acid at a site selected from a group including LC-K42, wherein the payload moiety is covalently linked to the non-natural amino acid directly or via a linker. As instant claims 45, 47 and 54 each fully encompass claim 1 of ‘413, each is anticipated by claim 1 of ‘413, and the two set of claims are not patentably distinct.
Instant claims 46, 48-49, 51-53 and 55-60 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the dependent claims of ‘413 as follows:
Instant Claim
Claim of ‘413
46
2
48
3
49
4
51
6
52
6
53
7
55
17
56
18
57
19
58
20
59
21
60
22
As such, the antibody conjugate of instant dependent claims 46, 48-49, 51-53 and 55-60 are anticipated by the corresponding claims of the ‘413 patent, and as such these instant claims are also not patentably distinct from the claims of ‘413.
Instant claims 61-62 and 64 directed to a kit comprising the antibody the conjugate of claim 45 and instructions for how to use the antibody conjugate in a diagnostic assay or a therapeutic procedure (claim 61) and further wherein the diagnostic assay is used to diagnose cancer, an infection or an autoimmune disease (claim 62) or further wherein the therapeutic procedure is used to treat cancer (claim 63). Claim 27 of ‘413 is directed to an antibody conjugate of claim 1 of ‘413 and instructions for use of the antibody conjugate. While the instructions for use of the antibody conjugate of claim 27 of ‘413 do not specify what the conjugate is to be used for, such instructions for usage are not sufficient to render the claims patentably distinct from the kit of instant claim 45 because, in accord with MPEP 2111.05, said instructions do not perform any function with respect to the antibody conjugate and thus are not functionally related to the associated antibody conjugate. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the kit of claim 27 of ‘413.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in dependent claim 7 of ‘413 is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘413.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 28 of ‘413, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘413.
(2) Claims 45-49, 51-53 and 55-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No 10,596,270, issued 3/24/20 (cited on the 4/15/26 IDS), and which shares the same applicant and several inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The scope of the instant independent claim 45 is set forth above. Claim 1 of ‘270 encompasses an antibody conjugate comprising an antibody that specifically binds to folate receptor alpha (FOLR1) linked site specifically to at least one payload moiety, wherein the antibody is defined by its CDR sequences, and wherein the antibody comprises one or more non-natural amino acids at a site selected from a group including LC-K42 (light chain amino acid lysine 42) according to Kabat. As such, instant claim 45 fully encompasses claim 1 of the ‘413 patent, and the two set of claims are therefore not patentably distinct.
Instant claims 46-47, 49, 51-53 and 55-60 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the dependent claims of ‘270 as follows:
Instant Claim
Claim(s) of ‘270
46
2, 12, 13
47
4
49
4
51
5
52
5
53
6
55
17
56
17
57
18
58
19
59
20
60
20
As such, the antibody conjugate of each of these instant claims is anticipated by the corresponding claims of the ‘270 patent, and as such these instant claims are also not patentably distinct from the claims of ‘270.
Claim 48 encompasses an antibody conjugate of claim 46 wherein the antibody is linked to the payload moiety via a linker that hydrolytically stable. The portion of the specification of ‘270 informing the claimed invention indicates that a primary form of the linkage of the antibody to the payload moiety (as recited in claim 1 of ‘270) is a hydrolytically stable linker (col 39, starting at line 60). As such, the claims of the 270 are properly construed as encompassing an embodiment wherein the linker is hydrolytically stable. As such, claim 48 is also not patentably distinct from the claims of ‘270.
Instant claims 61-62 and 64 directed to a kit as described above. The term “kit” is not provided with a limiting definition in the instant specification, and furthermore the kit of the instant claims does not require any components beyond the antibody conjugate and instructions for use. As set forth above, such instructions are not sufficient to render the claims patentably distinct because they do not perform any function with respect to the antibody conjugate. As such, the limitations of the instant kit are met by the antibody conjugate in and of itself. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the antibody conjugate of claim 1 of ‘270.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in a dependent claim of ‘270 (see above) is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘270.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 21 of ‘270, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘270.
(3) Claims 45-49, 51-53 and 55-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,071,477, issued 8/27/24 (cited on the 4/15/26 IDS), and which shares the same applicant and several inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The scope of the instant independent claim 45 is set forth above. Claim 1 of ‘477 encompasses an antibody conjugate comprising an antibody that specifically binds to folate receptor alpha (FOLR1) linked site-specifically to at least one payload moiety, wherein the antibody is defined by its CDR sequences, and wherein the antibody is linked site-specifically to at least one payload moiety by one or more non-natural amino acids. Furthermore, this claim encompasses a linkage at LC-K42 (light chain amino acid lysine 42) according to Kabat or Chothia, which is expressly recited in dependent claim 16 of ‘477. As such, instant claim 45 is not patentably distinct from the claims of ‘477.
Instant claims 46-49, 51-53 and 55-60 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the claims of ‘477 as follows:
Instant Claim
Claim(s) of ‘477
46
4, 11
47
1
48
1
49
1
51
1
52
1
53
1
55
7
56
7
57
8
58
9
59
10
60
10
As such, the antibody conjugate of each of these instant claims is also not patentably distinct from the claims of ‘477.
Instant claims 61-62 and 64 directed to a kit as described above. The term “kit” is not provided with a limiting definition in the instant specification, and furthermore the kit of the instant claims does not require any components beyond the antibody conjugate and instructions for use. As set forth above, such instructions are not sufficient to render the claims patentably distinct because they do not perform any function with respect to the antibody conjugate. As such, the limitations of the instant kit are met by the antibody conjugate in and of itself. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the antibody conjugate of claim 1 of ‘477.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in a dependent claim of ‘477 (see above) is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘477.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 21 of ‘477, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘477.
(4) Claims 45-49, 51-53 and 55-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No 12,427,201, issued 9/30/25 (cited on the 4/15/26 IDS), and which shares the same applicant and several inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The scope of the instant independent claim 45 is set forth above. Claim 1 of ‘201 encompasses an antibody conjugate comprising an antibody of the Ig1 class that specifically binds to folate receptor alpha (FOLR1) linked site-specifically to at least one payload moiety, wherein the antibody is defined by its CDR sequences. Furthermore, this claim encompasses a linkage wherein the antibody comprises a non-natural amino acid (dependent claim 3 of ‘201), wherein the payload moiety is linked via the non-natural amino acid (dependent claim 4 of ‘201), and wherein the non-natural amino acid is at LC-K42 (light chain amino acid lysine 42) according to Kabat or Chothia, which is expressly recited (dependent claim 12 of ‘201). As such, instant claim 45 is not patentably distinct from the claims of ‘201.
Instant claims 46-49, 51-53 and 55-60 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the claims of ‘201 as follows:
Instant Claim
Claim(s) of ‘201
46
3, 13
47
4
48
16
49
4
51
6
52
6
53
7
55
1
56
1
57
19
58
20
59
21
60
21
As such, the antibody conjugate of each of these instant claims is also not patentably distinct from the claims of ‘201.
Instant claims 61-62 and 64 directed to a kit as described above. The term “kit” is not provided with a limiting definition in the instant specification, and furthermore the kit of the instant claims does not require any components beyond the antibody conjugate and instructions for use. As set forth above, such instructions are not sufficient to render the claims patentably distinct because they do not perform any function with respect to the antibody conjugate. As such, the limitations of the instant kit are met by the antibody conjugate in and of itself. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the antibody conjugate of claim 1 of ‘201.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in a dependent claim of ‘201 (see above) is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘201.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 22 of ‘201, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘201.
(5) Claims 45-49, 51-53 and 55-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No 11,744,876, issued 9/5/23 (cited on the 4/15/26 IDS), and which shares the same applicant and several inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The scope of the instant independent claim 45 is set forth above. Claim 1 of ‘201 encompasses an antibody conjugate comprising an antibody covalently linked to a drug payload, wherein the antibody comprises a non-natural amino acid at position K42 (which is disclosed as LC-K42 in the corresponding portion of disclosure), which has the payload covalently linked. As such, instant claim 45 is not patentably distinct from the claims of ‘876.
Instant claims 46-47, 49, 51-53, 55 and 59 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the claims of ‘876 as follows:
Instant Claim
Claim(s) of ‘876
46
4
47
1
48
40
49
2
51
16
52
16
53
16
55
40, 41
59
1
As such, the antibody conjugate of each of these instant claims is also not patentably distinct from the claims of ‘876.
Claims 56-58 and 60 encompass an antibody conjugate of claim 45 that is an IgG antibody (claim 56), or humanized (claim 57), or aglycosylated (claim 58) or an Fv fragment (claim 60). While these further features of the antibody of the conjugate are not expressly recited in the claims of ‘876, each is a primary feature of said antibody as disclosed in the portion of the specification informing the claimed invention of ‘876. See col 20, starting at line 66 (IgG and Fv fragments); col 77, starting at line 16 (aglycosylated); and col 8, starting at line 52 (humanized). As such, the claims of ‘876 are properly construed as encompassing such embodiments, and claims 56-58 and 60 are therefore not patentably distinct from the claims of ‘876.
Instant claims 61-62 and 64 directed to a kit as described above. The term “kit” is not provided with a limiting definition in the instant specification, and furthermore the kit of the instant claims does not require any components beyond the antibody conjugate and instructions for use. As set forth above, such instructions are not sufficient to render the claims patentably distinct because they do not perform any function with respect to the antibody conjugate. As such, the limitations of the instant kit are met by the antibody conjugate in and of itself. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the antibody conjugate of claim 1 of ‘876.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in a dependent claim of ‘876 (see above) is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘876.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 33 of ‘876, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘876.
(6) Claims 45-49, 51-53 and 55-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No 12,144,869, issued 11/19/24 (cited on the 4/15/26 IDS), and which shares the same applicant and several inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The scope of the instant independent claim 45 is set forth above. Claim 1 of ‘869 encompasses a conjugate comprising an antibody that specifically binds to receptor tyrosine kinase orphan receptor 1 (ROR1) defined by CDRs, the antibody being linked site-specifically to at least one payload moiety and comprising one or more non-natural amino acids. Dependent claim 3 of ‘869 further limits the non-natural amino acid to a site selected from a group including LC-K42. As such, instant claim 45 is not patentably distinct from the claims of ‘869.
Instant claims 46-47, 49, 51-53 and 55-60 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the claims of ‘869 as follows:
Instant Claim
Claim(s) of ‘869
46
7
47
1
49
5
51
8
52
8
53
8
55
16
56
17
57
18
58
19
59
20
60
21
As such, the antibody conjugate of each of these instant claims is also not patentably distinct from the claims of ‘869.
Claim 48 encompasses an antibody conjugate of claim 46 wherein the antibody is linked to the payload moiety via a linker that hydrolytically stable. The portion of the specification of ‘869 informing the claimed invention indicates that a primary form of the linkage of the antibody to the payload moiety (as recited in claim 1 of ‘869) is a hydrolytically stable linker (col 219, starting at line 37). As such, the claims of ‘869 are properly construed as encompassing an embodiment wherein the linker is hydrolytically stable. As such, claim 48 is also not patentably distinct from the claims of ‘869.
Instant claims 61-62 and 64 directed to a kit as described above. The term “kit” is not provided with a limiting definition in the instant specification, and furthermore the kit of the instant claims does not require any components beyond the antibody conjugate and instructions for use. As set forth above, such instructions are not sufficient to render the claims patentably distinct because they do not perform any function with respect to the antibody conjugate. As such, the limitations of the instant kit are met by the antibody conjugate in and of itself. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the antibody conjugate of claim 1 of ‘869.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in a dependent claim 8 of ‘869 (see above) is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘869.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 22 of ‘869, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘869.
(7) Claims 45-49, 51-53 and 55-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No 12,540,197, issued 2/3/26 (cited on the 4/17/26 IDS), and which shares the same applicant and several inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The scope of the instant independent claim 45 is set forth above. Claim 1 of ‘197 encompasses a conjugate comprising an antibody that specifically binds to tissue factor defined by CDRs, the antibody being linked site-specifically to at least one payload moiety and comprising one or more non-natural amino acids. Dependent claim 12 of ‘197 further limits the non-natural amino acid to a site selected from a group including LC-K42. As such, instant claim 45 is not patentably distinct from the claims of ‘197.
Instant claims 46-47, 49, 51-53 and 55 depend from claim 45 and further limit the antibody conjugate to embodiments that correspond to the further limitations of the antibody conjugate of the claims of ‘197 as follows:
Instant Claim
Claim(s) of ‘197
46
19
47
1
49
13
51
15
52
15
53
15
55
1
As such, the antibody conjugate of each of these instant claims is also not patentably distinct from the claims of ‘197.
Claim 48 encompasses an antibody conjugate of claim 46 wherein the antibody is linked to the payload moiety via a linker that hydrolytically stable. The portion of the specification of ‘197 informing the claimed invention indicates that a primary form of the linkage of the antibody to the payload moiety (as recited in claim 1 of ‘197) is a hydrolytically stable linker (col 237, starting at line 51). As such, the claims of ‘197 are properly construed as encompassing an embodiment wherein the linker is hydrolytically stable. As such, claim 48 is also not patentably distinct from the claims of ‘197.
Claims 56-60 encompass an antibody conjugate of claim 45 that is an IgG antibody (claim 56), or humanized (claim 57), or aglycosylated (claim 58), or is antibody fragment (claim 59) that is an scFv fragment (claim 60). While these further features of the antibody of the conjugate are not expressly recited in the claims of ‘197, each is a primary feature of said antibody as disclosed in the portion of the specification informing the claimed invention of ‘197. See col 29, starting at line 43 (IgG); col 29, starting at line 53 (scFv fragments); col 243, starting at line 31 (elimination of glycosylation, which is equivalent to aglycosylated); and col 273, starting at line 42 (humanized). As such, the claims of ‘197 are properly construed as encompassing such embodiments, and claims 56-60 are therefore not patentably distinct from the claims of ‘197.
Instant claims 61-62 and 64 directed to a kit as described above. The term “kit” is not provided with a limiting definition in the instant specification, and furthermore the kit of the instant claims does not require any components beyond the antibody conjugate and instructions for use. As set forth above, such instructions are not sufficient to render the claims patentably distinct because they do not perform any function with respect to the antibody conjugate. Claim 2 of ‘197 is directed to a kit comprising the antibody conjugate of claim 1 and instructions for use of the antibody conjugate. As such, the kit of instant claims 61-62 and 64 is not patentably distinct from the kit of claim 2 of ‘197.
Instant claim 63 encompasses a kit of claim 62 wherein the antibody conjugate further comprises a detectable moiety. A payload moiety such as the hemiasterlin moiety recited in a dependent claim 15 of ‘197 (see above) is also detectable, and thus the kit of instant claim 63 is also not patentably distinct from the claims of ‘197.
Instant claim 65 is directed to a pharmaceutical composition comprising the antibody conjugate of claim 45 and a pharmaceutically acceptable carrier, which corresponds to claim 7 of ‘197, which is directed to a to a pharmaceutical composition comprising the antibody conjugate of claim 1 and a pharmaceutically acceptable carrier. Thus the pharmaceutically composition instant claim 65 is also not patentably distinct from the claims of ‘197.
Note
No prior art has been identified that teaches or suggests an antibody comprising a light chain with a non-natural amino acid at position lysine 42 of the light chain (LC-K42) according to the Kabat or Chothia numbering scheme, and thus no prior art has been identified that teaches or suggests an antibody conjugate with a payload moiety linked to such an antibody.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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