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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/US2021/023030 filed March 18, 2021, which claims the benefit of US Provisional Application No. 62/991,388 filed March 18, 2020. All claims have been given an effective filing date of March 18, 2020.
Election/Restriction
Applicant's election with traverse of Group I (Claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48) and species:
An anti-PDL-1 binding domain
An IL-15 domain
An IL-15 domain
An IL-15 domain enhancer
in the reply filed on September 17, 2025 is acknowledged. Applicant makes the election “with traverse” as recited on page 1, last paragraph of the remarks filed 09/17/2025. Applicant does not distinctly point out the supposed errors in the restriction requirement. The restriction is proper because Groups I through VIII lack unity of invention as no technical feature is shared between all the groups (see page 4 of the restriction requirement filed 06/17/2025). As such, the requirement is still deemed proper and is therefore made FINAL. Please note that after a final requirement for restriction, the Applicants, in addition to making any response due on the remainder of the action, may petition the Commissioner to review the requirement. Petition may be deferred until after final action on or allowance of claims to the invention elected, but must be filed not later than appeal. A petition will not be considered if reconsideration of the requirement was not requested (See § 1.181.).
Claims 49-50, 53-54, 56, 62, and 66-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on September 17, 2025.
Claim Status
Claim listing filed on September 17, 2025 is pending. Claims 7-15, 17-20, 22-27, 29-30, 32, 35, 37-43, 45-47, 51-52, 55, 57-61, and 63-65 are canceled. Claims 56, 62, 66-70, and 73 are amended. Claims 49-50, 53-54, 56, 62, and 66-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species. Claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on 11/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: There is a missing quotation mark at the beginning of paragraph [0066]. Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, there is a hyperlink in paragraph [0041]. 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.
The disclosure is objected to because Table 6, Figure 10, and Figure 10 descriptions recite the melting temperatures of various IL2-Fab complexes. However, the species listed (1215-1045, 1215-1046, 1215-1047, 1215-1048) are defined as IL-15-Fab complexes in Table 3. It is unclear whether the listed species are IL2-Fab complexes or IL-15-Fab complexes. Appropriate action is required to correct this discrepancy.
Claim Objections
Claim 31 is objected to because of the following informalities: “anti PDL-1 binding domain” and “anti L1CAM binding domain” should recite “anti-PDL-1 binding domain” and “anti-L1CAM binding domain” with hyphens after “anti.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 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.
Claims 1-2 recite “first ligand binding domain,” “second ligand binding domain,” and “second ligand binding domain enhancer.” Claims 3-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 are dependent on Claims 1 or 2 and do not further define both claimed ligand binding domains and the ligand binding domain enhancer. The specification defines “ligand binding domain” as a peptide domain capable of selectively binding to a target ligand (paragraph [0102]). The specification defines “ligand binding domain enhancer” as positively affecting the biological function of the ligand binding domain (paragraph [0095]). These phrases are considered functional language because the feature (the ligand binding domain/the ligand binding domain enhancer) are defined by what they do (binding a target ligand/positively affecting the biological function of the ligand binding domain) rather than by what they are (MPEP § 2173.05(g)). Note, Claim 31 continues the indefinite functional language by reciting “an anti-PDL-1 binding domain” wherein the binding domain is defined by what it does (binds PDL-1) instead of the structural limitations of what it is. Similarly, an “interleukin domain enhancer” as recited in Claim 36 defines the enhancer by what it does (enhances an interleukin domain) rather than by what it is. To determine if functional language is ambiguous, the following factors are considered: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting (MPEP § 2173.05(g)). The claims are directed to a result obtained without any structural limitations. The metes about bounds of the “first ligand binding domain,” “second ligand binding domain,” and “second ligand binding domain enhancer” cannot be readily determined. Therefore, Claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 are rejected as being indefinite.
Claim 5 recites wherein said second ligand binding domain comprises a cysteine at a position corresponding to position 45, 87, or 90 of said second ligand binding domain. Claim 6 recites wherein said second ligand binding domain enhancer comprises a cysteine at a position corresponding to position 37, 38, 68, or 67 of said second ligand binding domain enhancer. These claims are indefinite because there is no reference sequence that defines positions 45, 87, 90, 37, 38, 68, or 67. Different proteins have different amino acids at these positions, and some proteins may not comprise up to 90 amino acids. Therefore, it is unclear what these positions represent. Claims 5-6 are rejected for indefiniteness.
Claim 44 recites wherein said first chemical linker and said second chemical linker are independently a protease cleavable linker. This claim can be interpreted in two ways: (1) both the first and second chemical linkers are protease cleavable linkers or (2) either the first or the second chemical linker is a protease cleavable linker. Based on specification Figures 1A and 1C, it is interpreted that (2) either the first or the second chemical linker is a protease cleavable linker (not both) but appropriate clarification is required. Claim 44 is rejected for indefiniteness.
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 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 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 claims contain 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.
Claims 1-2 are directed to a multivalent ligand binding complex comprising a first ligand binding domain comprising a first protein dimerizing domain non-covalently bound to a second protein dimerizing domain wherein the first protein dimerizing domain is covalently bound to a second ligand binding domain by a first chemical linker and wherein the first protein dimerizing domain is covalently bound to a second ligand binding domain enhancer by a second chemical linker. It is interpreted that the first and second ligand binding domains and the ligand binding domain enhancer can comprise any protein. Note, “dimerizing domain” is not defined in the specification and is interpreted as a protein domain that forms a dimer with a second protein domain. Claims 16, 21, and 28 are directed to the first protein dimerizing domain comprising any antibody and the first ligand binding domain comprising any Fab domain. Claim 31 encompasses wherein the first ligand binding domain is any binding domain that binds PDL-1. Claim 34 recites wherein the second ligand binding domain is an IL-15 domain but fails to define the first ligand binding domain or the second ligand binding domain enhancer. Claim 36 encompasses wherein the second ligand binding domain enhancer is any protein that enhances the biological function of an interleukin domain. Thus, the claims are directed to a genus of possible multivalent ligand binding complexes.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. In order to provide adequate written description and evidence of possession of this claimed genus of complexes, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In the instant case, the specification teaches two species of multivalent ligand binging complexes: (1) wherein the first ligand binding domain is an anti-PDL-1 Fab, the second ligand binding domain is an IL-2 domain, and the second ligand binding domain enhancer is an IL-2Rα (with various linkers and N- to C- terminal orientations) (paragraph [0252] and Tables 1-2) and (2) wherein the first ligand binding domain is an anti-PDL-1 Fab, the second ligand binding domain is an IL-15 domain, and the second ligand binding domain enhancer is an IL-15Rα (with various linkers and N- to C- terminal orientations) (paragraph [0252] and Tables 3-5).
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) (MPEP § 2163.05.Ib). In the absence of sufficient recitation of distinguishing identifying characteristics or structure-to-function attributes for the entire genus of multivalent ligand binding complexes wherein the ligand binding domains and the enhancer can comprise any protein, the specification does not provide adequate written description of the claimed genus. Therefore, in view of the case law directed to an appropriate number of representative species, claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 are rejected for insufficient written description.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 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 the two specific species of multivalent ligand binding complexes taught in Tables 1-5, does not reasonably provide enablement for the genus of complexes encompassed by the claims. 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.
MPEP § 2164.01(a) states that there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure
does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include, but are not limited to:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and nature of the invention:
The nature of the invention is complex. As understood with the broadest reasonable interpretation, Claims 1-2 are directed to a multivalent ligand binding complex comprising a first ligand binding domain comprising a first protein dimerizing domain non-covalently bound to a second protein dimerizing domain wherein the first protein dimerizing domain is covalently bound to a second ligand binding domain by a first chemical linker and wherein the first protein dimerizing domain is covalently bound to a second ligand binding domain enhancer by a second chemical linker. It is interpreted that the first and second ligand binding domains and the ligand binding domain enhancer can comprise any protein. Claims 16, 21, and 28 are directed to the first protein dimerizing domain comprising any antibody and the first ligand binding domain comprising any Fab domain. Claim 31 encompasses wherein the first ligand binding domain is any binding domain that binds PDL-1. Claim 34 recites wherein the second ligand binding domain is an IL-15 domain but fails to define the first ligand binding domain or the second ligand binding domain enhancer. Claim 36 encompasses wherein the second ligand binding domain enhancer is any protein that enhances the biological function of an interleukin domain. Thus, the claims are directed to a genus of possible multivalent ligand binding complexes.
When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. The case law applies to the instant claims which encompass a genus of multivalent ligand binding complexes comprising any proteins that bind different ligands and enhance ligand binding, yet the inventors have only disclosed two species: (1) IL2_linker1_LCFab_linker2_IL2Rα and HC Fab (with various linkers and orientations; Tables 1-2) and (2) IL-15_linker1_HCFab_linker2_IL-15Rα and LC Fab (with various linkers and orientations; Tables 3-5).
In Amgen, the Supreme Court has stated that despite recent advances, aspects of antibody science remain unpredictable. For example, scientists understand that changing even one amino acid in the sequence can alter an antibody's structure and function. See id., at 14. But scientists cannot always accurately predict exactly how trading one amino acid for another will affect an antibody's structure and function. Ibid. The unpredictability of antibody structure and function extends to the ligand binding domains and the ligand binding domain enhancer in the instant application. The domains are required to have binding function, but the domains can broadly comprise any type of protein structure.
The case law shows a continued lack of predictability even after the effective filing date of the instant invention, and there is no support in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability in the genus of complexes claimed. The specification provides no guidance or direction for structure that must be maintained such that the functional properties of the invention are preserved (binding target ligands and positively affecting the biological function of the ligand binding domain).
Level of skill in the art:
The level of skill would be high encompassing protein science, antibodies, immunology, binding assays, etc.
Amount of direction provided by inventor and the existence of working examples:
The specification teaches two species of multivalent ligand binging complexes: (1) wherein the first ligand binding domain is an anti-PDL-1 Fab, the second ligand binding domain is an IL-2 domain, and the second ligand binding domain enhancer is an IL-2Rα (with various linkers and N- to C- terminal orientations) (paragraph [0252] and Tables 1-2) and (2) wherein the first ligand binding domain is an anti-PDL-1 Fab, the second ligand binding domain is an IL-15 domain, and the second ligand binding domain enhancer is an IL-15Rα (with various linkers and N- to C- terminal orientations) (paragraph [0252] and Tables 3-5).
However, two species do not adequately represent the scope of multivalent ligand binding complexes that could encompass thousands of variations. A person having ordinary skill in the art would have to make a substantial inventive contribution in order to make and characterize a representative number of multivalent ligand binding complexes to encompass the claimed genus.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In light of the unpredictability surrounding the claimed subject matter, the undue breadth of the claimed invention’s intended use, and the lack of adequate guidance, one wishing to make and practice the presently claimed invention would be unable to do so without engaging in undue experimentation. Given that structure is essential to function, a person having ordinary skill in the art would have to perform further experimentation to make the complexes encompassed by the claims and screen their characteristics in order to practice the invention commensurate with the scope of the claims.
The instant specification does not enable the invention to make and use the entire genus of multivalent ligand binding complexes; therefore, Claims 1-6, 16, 21, 28, 31, 33-34, 36, 44, and 48 are rejected.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 16, 21, 28, 31, 33-34, 36, 44, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Andresen WO 2019/010219 (of record in IDS) in view of Winston WO 2019/222295.
In regard to Claims 1-3, 16, 21, 28, 33-34, 36, Andresen teaches immunostimulatory fusion molecules comprising an immune cell targeting moiety and a cytokine molecule (abstract). The immune cell targeting moiety can comprise a Fab fragment wherein the cytokine molecule is operably linked to the Fab fragment at a C-terminus of the light chain, a N-terminus of the light chain, a C-terminus of the heavy chain, or a N-terminus of the heavy chain (page 2 line 24 to page 3 line 2). Note, it is understood that Fab fragments comprise both covalent and non-covalent bonds which reads on the first ligand binding domain. The cytokine molecule can be an IL-15 molecule non-covalently linked to IL-15Rα (page 18 line 12 to page 19 line 2) wherein IL-15 reads on the second ligand binding domain and IL-15Rα reads on the second ligand binding domain enhancer. The IL-15 can be linked to the Fab (Fig. 3B) or the IL-15Rα can be linked to the Fab (Fig. 3D).
In regard to Claim 31, Andresen teaches that the immune cell targeting moiety binds to an immune checkpoint inhibitor such as PD-L1 (page 10 lines 11-12) wherein anti-PD-L1 antibodies are known in the art such as atezolizumab, avelumab, and durvalumab (page 73 lines 8-18).
In regard to Claim 44, Andresen teaches that the cytokine is operably linked to the Fab by a linker wherein the linker can be a cleavable linker (page 3 lines 3-5) wherein the cleavable linker is configured for cleavage by a protease (page 83 lines 23-27).
In regard to Claim 48, Andresen teaches pharmaceutical compositions comprising the immunostimulatory fusion molecules and a pharmaceutically acceptable excipient such as salts or buffering agents (page 121 lines 18-24).
Andresen fails to teach wherein there is a second chemical linker that can be cleavable between either IL-15 and Fab or IL-15Ra and Fab. This difference can be visualized by comparing instant Fig. 1A (left) to Andresen Figs. 3B and 3D (right).
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However, Winston teaches activatable cytokine fusion proteins (abstract) wherein the fusion protein can comprise in N- to C- terminal orientation a cytokine, a protease cleavable linker, a half-life extension moiety, a protease cleavable linker, and a blocking moiety (Fig. 2). Alternatively, the fusion protein can comprise in N- to C- terminal orientation a cytokine, a protease cleavable linker, a targeting domain, a protease cleavable linker, a half-life extension moiety, a protease cleavable linker, and a blocking moiety (Fig. 4A). The blocking moiety binds to the cytokine and can comprise a cytokine receptor (paragraph [94]). The half-life extension element can comprise an Fc fragment (paragraph [6]). The targeting domain can comprise an scFv that binds to a tumor antigen or immune checkpoint protein such as PD-L1 (paragraph [10] and [113]).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to adapt the immunostimulatory fusion molecule taught by Andresen to include a second chemical linker as taught by Winston. In the scenario wherein the IL-15 is bound to the N-terminus of the Fab and IL-15Rα is bound to the IL-15, it would be obvious to add a second chemical linker that binds the IL-15Rα to the C-terminus of the Fab based on the teachings of Winston. Winston teaches that cytokines and cytokine receptors that are separated by Fc fragments and/or scFv targeting domains can still bind to one another with sufficiently long protease cleavable linkers. Upon activation by cleaving the second chemical linker, the instant multivalent ligand binding complex becomes identical to the immunostimulatory fusion molecule taught by Andresen (see figures above). The motivation to add a second chemical linker that is a protease cleavable linker is because the linker can be cleaved by the protease present in the tumor microenvironment which activates the therapeutic complex at the desired treatment site to avoid off-target effects and to reduce overall toxicity (Winston paragraphs [4]-[5]).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Andresen WO 2019/010219 (of record in IDS) in view of Winston WO 2019/222295 as applied to Claims 1-3, 16, 21, 28, 31, 33-34, 36, 44, and 48 above, and further in view of Qu US 2019/0070264 (of record in IDS).
The teachings of Andresen and Winston as they apply to Claims 1-3, 16, 21, 28, 31, 33-34, 36, 44, and 48 are outlined in the rejection above. Andresen and Winston fail to teach wherein the second ligand binding domain is covalently bound to the second ligand binding domain enhancer though one or more disulfide linkages (Claim 4); wherein the second ligand binding domain comprises a cysteine at position 45 (Claim 5); and wherein the second ligand binding domain enhancer comprises a cysteine at position 37 (Claim 6).
Qu teaches an IL-15 protein complex wherein IL-15 has at least one amino acid residue mutated to a cysteine which pairs with a corresponding mutated cysteine residue on IL-15Rα to form one or more disulfide bonds (abstract). The IL-15 can comprise a L45C mutation and the IL-15Rα can comprise an A37C mutation (paragraph [0072] and combination #2 in Table 4).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the immunostimulatory fusion molecule taught by Andresen and Winston to include cysteine mutations in the IL-15 and IL-15Rα domains to form covalent disulfide linkages as taught by Qu. Qu teaches a therapeutic IL-15 protein complex wherein the IL-15 comprises L45C that can form a disulfide linkage with IL-15Rα A37C. The motivation to apply these mutations to form disulfide linkages between the IL-15 and IL-15Rα domains is because introducing a disulfide bond between IL-15 and IL-15Ra can increase the molecular stability and bioactivity as well as simplify the manufacturing process (Qu paragraph [0007]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675