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 .
Applicant’s response filed on 07/20/2026 is acknowledged.
Claims 1, 4, 7-25, 29 and 34 are pending.
4. Applicant’s election of
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with the linker GGGS which is present in DR465 and a pegylated molecule and IgG1 upper hinge domain for UH1 and UH2 in the reply filed on 07/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
5. Claims 10-11 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/20/2026.
6. Claims 1, 4, 7-9, 12-16, 18-25, 29 and 34 are under consideration as they read on SEQ ID NO:55.
7. Applicant’s IDS document filed on 07/07/2023, 03/19/2024, 09/23/2024, 11/20/2024 and 08/28/2025 have been considered.
Claim Objections
8. Claims 7, 14, 21, 25 and 29 are objected to because of the following informalities:
Claims 21, 25 and 29 do not end in a terminal period.
Claim 7 should recite IL2Rγ not IL10RΑα.
Claim 14 recites a sequence without its sequence identification number.
Appropriate correction is required.
Double Patenting
9. 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.
10. Claims 1, 4, 7-9, 12-16, 18-25, 29 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent 12,540,188 (Reference A). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-14 of U.S. Patent 12,540,188 are directed to an IL10Rα /IL2Rℽ binding molecule that specifically binds to IL10Rα and IL2Rℽ, wherein the binding molecule comprises a single-domain antibody (sdAb) that specifically binds to IL10Rα, wherein the anti- IL10Rα sdAb comprises a CDR1 comprising SEQ ID NO: 38, a CDR2 comprising a SEQ ID NO: 56 and a CDR 3 comprising SEQ ID NO: 74 and a sdAb that specifically binds to IL2Rℽ comprising a CDR1 comprising SEQ ID NO: 97, a CDR2 comprising a SEQ ID NO: 120 and a CDR3 comprising SEQ ID NO: 143, wherein the IL10Rα sdAb and IL2Rℽ sdAb are in stable association via a peptide bond, a peptide linker, or complementary knob and hole Fc domains of claim 1; wherein the anti-IL10Rα sdAb is a VHH antibody and/or the anti- IL2Rℽ sdAb is a VHH antibody of claim 2; wherein the anti-IL10Rα sdAb and the anti- IL2Rℽ sdAb are joined by a peptide linker of claim 3; wherein the peptide linker comprises between 1 and 50 amino acids of claim 4; wherein the peptide linker comprises a sequence of GGGS (SEQ ID NO: 9) of claim 5; wherein the binding molecule comprises the anti-IL10Rα sdAb linked to the N-terminus of a linker and the anti- IL2Rℽ sdAb linked to the C-terminus of the linker of claim 6; wherein the anti-IL10Rα sdAb comprises a sequence having at least 90% sequence identity to-SEQ ID NO: 206 of claim 7; wherein the anti-IL10Rα sdAb comprises SEQ ID NO: 206 or SEQ ID NO: 203 of claim 8; the anti-IL2Rℽ sdAb comprises a sequence having at least 90% sequence identity to SEQ ID NO: 229 of claim 9; wherein the anti- IL2Rℽ sdAb comprises SEQ ID NO: 229, SEQ ID NO: 213 or SEQ ID NO: 217 of claim 10; wherein the IL10Rα sdAb comprises a sequence having at least 90% sequence identity to SEQ ID NO: 206, and the anti- IL2Rℽ sdAb comprises a sequence having at least 90% sequence identity to SEQ ID NO: 229 of claim 11; wherein the anti-IL10Rα sdAb comprises SEQ ID NO: 206 or SEQ ID NO: 203, and the anti- IL2Rℽ sdAb comprises SEQ ID NO: 229, SEQ ID NO: 213 or SEQ ID NO: 217 of claim 12; wherein the binding molecule comprises the anti- IL2Rℽ sdAb linked to the N-terminus of a linker and the anti-IL10Rα sdAb linked to the C-terminus of the linker of claim 13; a pharmaceutical composition comprising the IL10Rα /IL2Rℽ binding molecule of claim 1 and a pharmaceutically acceptable carrier of claim 14.
Instant claim 1 is directed to an IL10Rα /IL2Rγ binding protein. Instant claim 1, part (A), is directed to the IL10Rα VHH having CDRs of SEQ ID NOS: 17 or 268/18/19. These CDRs correspond to instant VHH DR240 (SEQ ID NO: 20). Instant SEQ ID NO: 20 corresponds to reference SEQ ID NO: 206. Instant claim 1, part (A)(iii), is directed to the IL2Rγ VHH having CDRs of SEQ ID NOS: 33 or 272/34, 35. These CDRs correspond to instant VHH DR231 (SEQ ID NO: 36). Instant SEQ ID NO: 36 corresponds to reference SEQ ID NOs: 229.
Instant claim 1, part (A) with part (iii), matches CDRs for reference SEQ ID NO: 206 and instant SEQ ID NO: 229. Instant claim 1 also recites other embodiments within instant reference claims 1-2.
Instant SEQ ID NOs: 17, 18 and 19 correspond to reference SEQ ID NOs 38, 56 and 74. These CDRs correspond to the elected IL10RΑα VHH.
Instant SEQ ID NOS: 33, 34, and 35 correspond to reference SEQ ID NOS: 97, 120, and 143, respectively. These CDRs correspond to the elected IL2Rγ VHH.
Co-pending claims 6-7 reference VHH DR231.
Instant claims 8 and 10 recite the positional limitations corresponding to reference claims 9-10, respectively.
Instant claims 12-13 recite linkers corresponding to reference claims 3-4, respectively.
Instant claim 14 includes SEQ ID NO: 115 which is a fusion protein of reference SEQ ID NO: 229 and SEQ ID NO: 206 with a linker GGGS (see amino acids 122-125 of instant SEQ ID NO: 115). Reference SEQ ID NO: 229 corresponds to amino acids 1-161 of instant SEQ ID NO: 115. Reference SEQ ID NO: 206 corresponds to amino acids 126-251 of instant SEQ ID NO: 115.
Instant claim 24 is directed to pharmaceutical compositions meeting the limitations of reference claim 14.
Instant claim 20, part (E)(iii), is directed to a heterodimeric binding protein meeting the limitations of at least reference claims 1-2.
Reference binding proteins would put one of ordinary skill in the art in possession of instant claims 21-23 directed to nucleic acids, vector, and host cells that encoded the instant binding proteins.
Instant claim 25, 29 and 34 are directed to methods of treatment using the reference products.
The reference teachings anticipate the claimed invention.
11. Claims 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent 12,297,281 (PTO-892; Reference B) in view of U.S. Patent Application Publication 2014/0363426 (PTO-892; Reference C) and Delgoff et al. (IDS filed on 07/07/2023; Reference 15).
Claims 1-17 of U.S. Patent 12,297,281 are directed to the IL10Rα sdAb binding molecules of the instant claims and compositions thereof.
The claimed invention differs from the prior art in the recitation of the IL10RΑα/IL2Rγ binding proteins of the instant claims.
U.S. Patent Application Publication 2014/0363426 teaches heterodimeric proteins having the form shown in Figure 2S having a heterodimer of a two different Dab (single domain antibody) fused to an Fc. Paragraph [0197] discloses that bispecific antibodies of the invention can be any combination of the antigens listed which include IL10RΑα and IL2Rγ. Pharmaceutical compositions are disclosed. See at least paragraph [0299].
Delgoffe et al. teaches wherein IL10Rα activates STATS (IL10Rα activates STAT3; page 4, third para.), and wherein IL2Rγ likewise activates STAT3 (wherein the common γ chain also activate STAT3; page 4, third para.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce a binding molecule comprises a single-domain antibody (sdAb) that specifically binds to IL10Rα (an anti- IL10Rα sdAb) and a sdAb that specifically binds to IL2Rγ (an anti-IL2Rγ sdAb) based on the teaching of Delgoffe according to the method of U.S. Patent Application Publication 2014/0363426. It would have been obvious to use the IL10Rα sdAb of U.S. Patent 12,297,281. One would have been motivated to do so for the purpose of providing a single molecule capable of causing interaction of IL2Rγ and IL10Rα with STAT3, forming a multimer, in order to modulate immune cell activation in a subject in need thereof.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-8, 10-15, 18-27 of U.S. Patent 12,077,594 (PTO-892; Reference D) in view of U.S. Patent Application Publication 2014/0363426 (PTO-892; Reference C)) and Delgoff et al. (IDS filed on 07/07/2023; Reference 15).
Claims 1-22 of U.S. Patent 12,077,594 are directed to IL2Rg binding molecules that are sdAb and compositions thereof. The reference claims are directed to an IL2Rg binding molecule linked to a second binding molecule that specifically binds to the extracellular domain of a second cell surface molecule; a method of using the binding molecules; and nucleic acids, vectors, and host cells.
The claimed invention differs from the prior art in the recitation of the IL10Rα /IL2Rγ binding proteins of the instant claims.
U.S. Patent Application Publication 2014/0363426 teaches heterodimeric proteins having the form shown in Figure 2S having a heterodimer of a two different Dab (single domain antibody) fused to an Fc. Paragraph [0197] discloses that bispecific antibodies of the invention can be any combination of the antigens listed which include IL10Rα and IL2Rγ. Pharmaceutical compositions are disclosed. See at least paragraph [0299].
Delgoffe teaches wherein IL10Rα activates STATS (IL10Rα activates STAT3; page 4, third para.), and wherein IL2Rγ likewise activates STAT3 (wherein the common γ chain also activate STAT3; page 4, third para.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce a binding molecule comprising a single-domain antibody (sdAb) that specifically binds to IL10Rα (an anti- IL10Rα sdAb) and a sdAb that specifically binds to IL2Rγ (an anti-IL2Rγ sdAb) based on the teaching of Delgoffe according to the method of U.S. Patent Application Publication 2014/0363426. It would have been obvious to use the IL2Rγ sdAb of U.S. Patent 12,077,594. One would have been motivated to do so for the purpose of providing a single molecule capable of causing interaction of IL2Rγ and IL10Rα with STAT3, forming a multimer, in order to modulate immune cell activation in a subject in need thereof.
U.S. Patent 12,077,594 is directed to nucleic acids, vector, and host cells that would put one of ordinary skill in the art in possession of the instant IL10Rα binding proteins.
IL10Rα is directed to methods of using the IL10Rα products.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Improper Markush Grouping
13. Claims 1, 4, 7-9, 12-16, 18-25, 29 and 34 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings of claims 1, 4, 7-9, 12-16, 18-25, 29 and 34 are improper because the alternatives defined by the Markush groupings do not share both a single structural similarity and a common use for the following reasons: The binding molecules containing two sdAb antibodies recited in claims 1, 4, 7-9, 12-16, 18-25, 29 and 34 do not belong to an art recognized class. Each sdAb antibody has a structurally different set of three CDRs or sequence responsible for binding to IL10Rα and binding to IL2Rγ. Note that the claims are directed to various combinations of CDRs or sequences from the tables recited in the claims. There is no evidence of record that the sdAb for each antigen binds to the same epitope or have the substantially equivalent binding properties or that the different binding molecules have substantially equivalent binding properties. There is no expectation from the knowledge in the art that each of the antibodies will behave in the same way. That is, they are not interchangeable or functionally equivalent.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
14. 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.
15. Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 references tables 10-12. However, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See at least MPEP 21753.05(s).
16. 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.
17. Claim 20 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 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.
Claim 20 recites one or more CDRs in a row in various tables where each CDR independently comprises 0, 1, 2, or 3 amino acid changes relative to the sequence in the table. Note that the claim does not require that CDR1, CDR2, and CDR3 are in the same row of the table. In addition, the claims encompass combining human CDRs (Tables 10-11) with mouse CDRs (Table 12).
Antigen binding for each VHH sdAb in the tables requires the particular three CDRs disclosed. The CDRs responsible for antigen binding are not defined for claim 20. In the minimal embodiment of claim 20, a single CDR is defined and can further have up to three amino acid changes. Again, claim 20 as written encompasses combining different CDRs from different VHH sdAb in the tables. The genus of antibodies embraced by these claims is not adequately described.
The “at least 90% sequence identity” limitations in claims 20 permits unspecified changes in the CDRs.
The particular embodiments in the tables are not sufficient to describe all binding molecules embraced by the claims, particularly where the binding molecules must bind two different proteins and cause multimerization of the two proteins. In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification exemplifies particular sdAb VHH for IL10RΑα and IL2Rγ that could be linked as a fusion protein with a peptide linker having the properties recited in the claims; however, the structural variability of the claimed genus is large. No reasonable structure-function correlation has been established that is commensurate in scope with the claims, particularly for combining CDRs from human and mouse VHH and making unspecified mutations to the recited CDRs. The specification does not describe representative examples to support the full scope of the claims.
U.S. Court of Appeals for the Federal Circuit recently decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017) which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § l 12(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test, which had been based on an example in USPTO- issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § l 12(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. , the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional. Id.
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the ... claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 U.S.P.Q.2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the applicant had possession at the time of invention of the claimed invention. regarding description of the claimed invention, the specification does not provide an adequate written description of the invention claimed herein. See The Regents of the University of California v. Eli Lilly and Company, 43 USPQ2d 1398, 1404-7 (Fed. Cir. 1997). In University of California v. Eli Lilly and Co., 39 U.S.P.Q.2d 1225 (Fed. Cir. 1995) the inventors claimed a genus of DNA species encoding insulin in different vertebrates or mammals, but had only described a single species of cDNA which encoded rat insulin. The court held that only the nucleic acids species described
in the specification (i.e. nucleic acids encoding rat insulin) met the description
requirement and that the inventors were not entitled to a claim encompassing a genus
of nucleic acids encoding insulin from other vertebrates, mammals or humans, id. at
1240. The Federal Circuit has held that if an inventor is "unable to envision the detailed
constitution of a gene so as to distinguish it from other materials . . . conception has not
been achieved until reduction to practice has occurred", Amgen, Inc. v. Chugai
Pharmaceutical Co, Ltd., 18 U.S.P.Q.2d 016 (Fed. Cir. 1991). Attention is also directed
to the decision of The Regents of the University of California v. Eli Lilly and Company
(CAFC, July 1997) wherein is stated: "The description requirement of the patent statute
requires a description of an invention, not an indication of a result that one might
achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 222 USPQ 369,
372-373 (Fed. Cir. 1984) (affirming rejection because the specification does "little more
than outlin[ e] goals appellants hope the claimed invention achieves and the problems
the invention will hopefully ameliorate."). Accordingly, naming a type of material
generally known to exist, in the absence of knowledge as to what that material consists
of, is not a description of that material. Thus, as we have previously held, a cDNA is not
defined or described by the mere name "cDNA," even if accompanied by the name of
the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA." See Fiers, 984
F.2d at 1171, 25 USPQ2d at 1606.
The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or U.S.C 112, I 1 "Written Description" Requirement make clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical
and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus.
The claims are not supported by a description that satisfies 35 U.S.C. § 112(a) or 35 U.S.C. § 112, first paragraph. "[T]he test for sufficiency [of the written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Phanns., Inc. V. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane).
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." Id. at 1350. "[A]n adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials." Id.
"[F]unctional claim language can meet the written description requirement when the art has established a correlation between structure and function." Id. "But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species." Id.
"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) (emphasis added).
With respect to representative number of species, see AbbVic Deutschland GmbH & Co.V. Janssen Biotech, Inc. (Fed. Cir. 2014). Also, see MPEP 2163 II(A)(3)(a))(ii):
"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. 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 Abb Vie 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.")."
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., Koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
As such, there is insufficient written description of the required kind of structure
identifying information about the corresponding makeup of the binding proteins to demonstrate possession.
18. Claims 25, 29 and 34 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 IL10Rα /IL2Rℽ binding molecule comprising all 6 CDRs recited in the claims , does not reasonably provide enablement for : a method of treating a neoplastic disease in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of an IL10Ra/IL2Ry binding protein of claim 25; a method of treating an autoimmune or inflammatory disease, disorder, or condition in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of an IL10Ra/IL2Ry binding protein of claim 29; and a method to selectively induce activity in one or more of a first cell type over one or more of a second cell type, comprising contacting a population of cells comprising both the first and second cell types with an IL10Ra/IL2Ry binding protein of claim 1 thereby selectively inducing activity in one or more of the first cell type over one or more of the second cell type of claim 34. 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. The specification disclosure does not enable one skilled in the art to practice the invention without an undue amount of experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to practice the claimed invention.
The specification fails to provide guidance as to how to treat any disease using any of the recited agents. The art is highly unpredictable as to what will be a therapy forcancer or autoimmune disease, so it would require an undue amount of experimentation for one of ordinary skill in the art to practice the claimed invention commensurate in the scope with the claims.
Since no in vivo studies were used as model system to treat any disorder it is not clear that reliance on the in vitro data accurately reflects the relative animal efficacy of the claimed therapeutic strategy. The specification does not adequately teach how to effectively treat any disorders or reach any therapeutic endpoint in animals by administrating the composition, much less any disorder as encompassed by the instant claims. The specification does not teach how to extrapolate data obtained from the in vitro studies to the development of effective in vivo animal therapeutic treatment, commensurate in scope with the claimed invention.
Although, the specification describes in vitro experiments, there is no correlation on this record between the in vitro studies and the treating neoplastic or autoimmune disease in currently available form for humans or animals. It is not enough to rely on in vitro studies where, as here, a person having ordinary skill in the art has no basis for perceiving those studies as constituting recognized screening procedures with clear relevance to efficacy in humans or animals (emphasis added). Ex parte Maas, 9 USPQ2d 1746
In view of the absence of a specific and detailed description in Applicant's specification of how to effectively use the genus of compositions claimed, absence of working examples providing evidence which is reasonably predictive that the genus of claimed agents are effective for in vivo use for treatment of disease, and the lack of predictability in the art at the time the invention was made, an undue amount of experimentation would be required to practice the claimed vaccine compositions with a reasonable expectation of success.
Substantiating evidence may be in the form of animal tests, which constitute recognized screening procedures with clear relevance to efficacy in humans. See Ex parte Krepelka, 231 USPQ 746 (Board of Patent Appeals and Interferences 1986) and cases cited therein. Ex parteMaas, 9 USPQ2d 1746.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
Claim Rejections - 35 USC § 103
19. 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.
20. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
21. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2014/0302038 (PTO-892; Reference E) in view of Delgoffe et al. (IDS filed on 07/07/2023; Reference 15).
U.S. Patent Application Publication 2014/0302038 teaches bispecific binding proteins comprising Fc that can bind two or more cytokines. The cytokines disclosed include IL10Rα and IL2Rγ. See at least abstract, paragraphs [0003] and [0158]. The binding molecule subunits can comprise single-domain antibodies (sdAb) that specifically bind the cytokines (see paragraphs [0064] and [0158]). Pharmaceutical compositions are disclosed in paragraphs [0193-0194]. The reference teaches that the subunits can be joined by a peptide linker wherein the peptide linker comprises between 1 and 50 amino acids. The peptide linker can comprise a sequence of GGGGS. See at least paragraph [0132 and 0238].
The claimed invention differs from the prior art in the recitation of wherein the binding molecule comprises a single-domain antibody (sdAb) that specifically binds to IL10Rα (an anti- IL10Rα sdAb) and a sdAb that specifically binds to IL2Rγ (an anti-IL2Rγ sdAb).
Delgoffe teaches wherein IL10Rα activates STATS (IL10Rα activates STAT3; page 4, third para.), and wherein IL2Rγ likewise activates STAT3 (wherein the common γ chain also activate STAT3; page 4, third para.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce a binding molecule comprises a single-domain antibody (sdAb) that specifically binds to IL10Rα (an anti- IL10Rα sdAb) and a sdAb that specifically binds to IL2Rγ (an anti-IL2Rγ sdAb) based on the teaching of Delgoffe according to the method of U.S. Patent Application Publication 2014/0302038. One would have been motivated to do so for the purpose of providing a single molecule capable of causing interaction of IL2Rγ and IL10Rα with STAT3, forming a multimer, in order to modulate immune cell activation in a subject in need thereof.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
22. No claim is allowed.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 26, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
