Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments, and/or Claims
1. Claims 30-90 are pending and under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 11/10/2025 and 07/24/2024 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Claim Rejections--Nonstatutory Obviousness-Type Double Patenting
3. Basis for nonstatutory double patenting:
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
4. Claims 30-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of US Patent No. 11,926,670 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 30-90 of the instant application are drawn to a pharmaceutical formulation, a syringe or a delivery device or a comprising a pharmaceutical formulation comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 15 mg/ml to about 200 mg/ml, and wherein the antibody or antigen-binding fragment thereof comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2, and 3 (HCDR1, HCDR2, and HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2, and 3 (LCDR1, LCDR2, and LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) one or more buffers that can buffer from pH 5.6 to pH 6.2; (iii) a polysorbate at a concentration of from 0.2% w/v to 2% w/v; (iv) sucrose, mannitol, or trehalose at a concentration of about 2.5% w/v to about 10% w/v; and (v) arginine at a concentration of about 25 mM to about 100 mM; wherein the pharmaceutical formulation has a pH of from 5.6 to 6.2.
On the other hand, claims 1-23 of US Patent No. 11,926,670 B2 are drawn to a pharmaceutical formulation comprising: (i) a human antibody at a concentration of about 100 mg/ml to about 200 mg/ml that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2 and 3 (HCDR1-HCDR2-HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2 and 3 (LCDR1-LCDR2-LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) acetate at a concentration of about 2.5 mM to about 22.5 mM; (iii) histidine at a concentration of about 10 mM to about 30 mM; (iv) an organic cosolvent that is a nonionic polymer containing a polyoxyethylene moiety at a concentration of from 0.2% w/v to 1% w/v; (v) a sugar or sugar alcohol at a concentration of about 2.5% w/v to about 10% w/v, wherein the formulation has a pH of from 5.6 to 6.2, and wherein at least about 92% of the antibody is in its native conformation after two weeks of storage at about 45°C, as determined by size exclusion chromatography.
Claims 30-90 of the instant application and claims 1-23 of US Patent No. 11,926,670 B2 vary in scopes and are obvious over each other.
5.Claims 30-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of US Patent NO. 9, 238, 692 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 30-90 of the instant application are drawn to a pharmaceutical formulation, a syringe or a delivery device or a comprising a pharmaceutical formulation comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 15 mg/ml to about 200 mg/ml, and wherein the antibody or antigen-binding fragment thereof comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2, and 3 (HCDR1, HCDR2, and HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2, and 3 (LCDR1, LCDR2, and LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) one or more buffers that can buffer from pH 5.6 to pH 6.2; (iii) a polysorbate at a concentration of from 0.2% w/v to 2% w/v; (iv) sucrose, mannitol, or trehalose at a concentration of about 2.5% w/v to about 10% w/v; and (v) arginine at a concentration of about 25 mM to about 100 mM; wherein the pharmaceutical formulation has a pH of from 5.6 to 6.2.
On the other hand, claims 1-22 of US Patent NO. 9, 238, 692 are drawn to a pre-filled syringe composition comprising a liquid pharmaceutical formulation comprising 100±10 mg/ml to 200±20 mg/ml of an antibody or antigen-binding fragment thereof that specifically binds human interleukin-4 alpha (hIL-4Rα). Claims 30-90 of the instant application and claims 1-22 of US Patent NO. 9, 238, 692 vary in scopes and are obvious over each other.
6. Claims 30-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of US Patent NO. 8, 945, 559 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 30-90 of the instant application are drawn to a pharmaceutical formulation, a syringe or a delivery device or a comprising a pharmaceutical formulation comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 15 mg/ml to about 200 mg/ml, and wherein the antibody or antigen-binding fragment thereof comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2, and 3 (HCDR1, HCDR2, and HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2, and 3 (LCDR1, LCDR2, and LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) one or more buffers that can buffer from pH 5.6 to pH 6.2; (iii) a polysorbate at a concentration of from 0.2% w/v to 2% w/v; (iv) sucrose, mannitol, or trehalose at a concentration of about 2.5% w/v to about 10% w/v; and (v) arginine at a concentration of about 25 mM to about 100 mM; wherein the pharmaceutical formulation has a pH of from 5.6 to 6.2.
On the other hand, claims 1-25 of US Patent NO. 8,945,559 B2 are drawn to a stable pharmaceutical formulation comprising a human antibody at the concentration of 100 to 200 mg/ml, wherein the antibody specifically binds human interleukin-4 alpha (hIL-4Rα) and comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 5.
Claims 30-90 of the instant application and claims 1-25 of US Patent NO. 8,945,559 B2 vary in scopes and are obvious over each other.
7. Claims 30-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of US Patent NO. 10, 435,473 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 30-90 of the instant application are drawn to a pharmaceutical formulation, a syringe or a delivery device or a comprising a pharmaceutical formulation comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 15 mg/ml to about 200 mg/ml, and wherein the antibody or antigen-binding fragment thereof comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2, and 3 (HCDR1, HCDR2, and HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2, and 3 (LCDR1, LCDR2, and LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) one or more buffers that can buffer from pH 5.6 to pH 6.2; (iii) a polysorbate at a concentration of from 0.2% w/v to 2% w/v; (iv) sucrose, mannitol, or trehalose at a concentration of about 2.5% w/v to about 10% w/v; and (v) arginine at a concentration of about 25 mM to about 100 mM; wherein the pharmaceutical formulation has a pH of from 5.6 to 6.2.
On the other hand, claims 1-21 of US Patent NO. 10,435,473 B2 are drawn to a stable pharmaceutical formulation comprising a human antibody at the concentration of 15 mg/ml to 200 mg/ml, wherein the antibody specifically binds human interleukin-4 alpha (hIL-4Rα) and comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 1 and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 5 and a stable pharmaceutical formulation contained in a syringe, such as a low tungsten syringe, or a microinfusor. Claims 30-90 of the instant application and claims 1-21 of US Patent NO. 10,435,473 B2 vary in scopes and are obvious over each other.
8. Claims 30-90 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-45 of US Patent NO. 11,059,896 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 30-90 of the instant application are drawn to a pharmaceutical formulation, a syringe or a delivery device or a comprising a pharmaceutical formulation comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 15 mg/ml to about 200 mg/ml, and wherein the antibody or antigen-binding fragment thereof comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2, and 3 (HCDR1, HCDR2, and HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2, and 3 (LCDR1, LCDR2, and LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) one or more buffers that can buffer from pH 5.6 to pH 6.2; (iii) a polysorbate at a concentration of from 0.2% w/v to 2% w/v; (iv) sucrose, mannitol, or trehalose at a concentration of about 2.5% w/v to about 10% w/v; and (v) arginine at a concentration of about 25 mM to about 100 mM; wherein the pharmaceutical formulation has a pH of from 5.6 to 6.2.
On the other hand, claims 1-45 of US Patent NO. 11,059,896 B2 are drawn to a pen or autoinjector delivery device containing a stable liquid pharmaceutical formulation comprising (i) a human antibody at a concentration of from 15 mg/ml to 200 mg/ml, wherein the antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4Rα) and comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:1 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:5; (ii) acetate at a concentration of from 10 mM to 15 mM; (iii) histidine at a concentration of from 15 mM to 25 mM; (iv) sucrose at a concentration of from 2.5% w/v to 10% w/v; (v) polysorbate at a concentration of from 0.1% w/v to 0.3% w/v; and (vi) arginine at a concentration of from 20 mM to 100 mM; wherein the formulation has a pH of from 5.6 to 6.2.
Claims 30-90 of the instant application and claims 1-45 of US Patent NO. 11,059,896 B2 vary in scopes and are obvious over each other.
Claim Rejections[Symbol font/0xBE]35 USC § 112, 1st paragraph
9. The following is a quotation of the first paragraph of 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.
10. Claims 30-90 are rejected under 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. To provide adequate written description and evidence of possession of a claimed genus, 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.
Claims 30-90 are drawn to a pharmaceutical formulation, a syringe or a delivery device or a comprising a pharmaceutical formulation comprising (i) an antibody or antigen-binding fragment thereof that specifically binds to human interleukin-4 receptor alpha (hIL-4Ra), wherein the antibody or antigen-binding fragment thereof is present at a concentration of about 15 mg/ml to about 200 mg/ml, and wherein the antibody or antigen-binding fragment thereof comprises (a) a heavy chain variable region (HCVR) comprising heavy chain complementarity determining regions 1, 2, and 3 (HCDR1, HCDR2, and HCDR3) that comprise the amino acid sequences of SEQ ID NO:2, SEQ ID NO:3, and SEQ ID NO:4, respectively; and (b) a light chain variable region (LCVR) comprising light chain complementarity determining regions 1, 2, and 3 (LCDR1, LCDR2, and LCDR3) that comprise the amino acid sequences of SEQ ID NO:6, SEQ ID NO:7, and SEQ ID NO:8, respectively; (ii) one or more buffers that can buffer from pH 5.6 to pH 6.2; (iii) a polysorbate at a concentration of from 0.2% w/v to 2% w/v; (iv) sucrose, mannitol, or trehalose at a concentration of about 2.5% w/v to about 10% w/v; and (v) arginine at a concentration of about 25 mM to about 100 mM; wherein the pharmaceutical formulation has a pH of from 5.6 to 6.2. The claims do not require that the pharmaceutical composition possess a particular buffer agent nor a particular concentration of the buffer agent. Thus, the claims encompass a genus of pharmaceutical formulations comprising the anti-hIL-4Rα antibody.
The specification discloses various formulation comprising a human antibody that specifically binds to hIL-4Rα. However, all disclosed formulations comprise a particular cosolvent, a thermal stabilizer, a viscosity reducing agent or a particular buffer agent at a particular concentration (see Examples). Thus, the instant disclosure does not adequately support the scope of the claimed genus of formulations. Furthermore, the prior art does not provide compensatory teachings to enable one skilled in the art to identify the encompassed formulations. For instance, both Dix et al. and Andya et al teach an antibody formulation (Esue (WO 2010/102241 A1, US 8,372,396 B2). However, each stable antibody formulation requires a defined composition.
Vas-Cath Inc. v Mahurkar, 19 USPQ2d 1111 (Fed. Cir.1991), clearly states that “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 purpose of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Adequate written description requires more than a mere statement that it is part of the invention are reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir.1991).
An adequate written description of a chemical invention “requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir.2004); Regents of the Univ. of Cal. V. Eli Lilly & Co., Inc., 119 F.3d 1559, 1556 (Fed. Cir.1997); Fiers v. Revel, 984F.2d 1164, 1171 (Fed. Cir.1993). “A description of what a material does, rather than of what it is, usually does not suffice.” Rochester, 358F.3d at 923; Eli Lilly, 119 F.3d at 1568. In addition, possession of a genus “may be achieved by means of a recitation of a representative number of [compounds]…falling within the scope of the genus.” Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 f. 3d at 927.
Due to the breadth of the claimed pharmaceutical formulations, one skilled in the art would not recognize from the disclosure that the applicant was in possession of the invention.
Conclusion
11. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
June 17, 2026
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