DETAILED OFFICE ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s preliminary amendment filed on 07 November 2022 is acknowledged and entered. Following the amendment, the original claims 1-16 are canceled, and the new claims 17-28 are added.
Currently, claims 17-28 are pending and under consideration.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 10/11/2022 is acknowledged and has been considered. A signed copy is attached hereto.
Priority acknowledgement
This application claims benefit of U.S. applications 17/015,029 filed 09/08/2020; 16/053,564 filed 08/02/2018; 14/499,691 filed on 09/29/2014; and 13/521,999 filed 10/16/2012, which is a national stage entry (371) of PCT/US11/20985 with the international filing date of 01/12/2011, which claims benefit of U.S. provisional application 61/295,387 filed 01/15/2010, and 61/422,059, filed 12/10/2010, which is acknowledged.
Specification
The specification is objected to because the status of U.S. Application 17/015,029,
which has been issued as U.S. Patent No. 11,505,612, has not been updated yet.
Claims
Claims 18 and 19 are objected to for the following informalities, appropriate correction is required for each item:
Claim 18 recites “a heavy chain variable domain comprising amino acid sequence of SEQ ID NO: 3 and a light chain variable domain comprising amino acid sequence of SEQ ID NO: 4”; the following is suggested: “a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 3 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO: 4.”
Claim 19 recites “antibody comprises a heavy chain amino acid sequence comprising SEQ ID NO: 1 or SEQ ID NO: 12 and a light chain amino acid sequence comprising SEQ ID NO: 2”; the following is suggested: “antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 12 and a light chain comprising the amino acid sequence of SEQ ID NO: 2.”
Rejections under 35 U.S.C. §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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-28 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 pre-AIA the applicant regards as the invention.
Claim 17 is indefinite for the recitation “a formulation comprising (i) …, (ii) …, (iii) …, (iv) …, and (v) about 140 mg, or about 210 of a human monoclonal antibody” because it is unclear 1) whether “about 210” means “about 210 mg”; and 2) what the concentration of the antibody is in said formulation? For example, is it about 140 mg/ml, or about 210 mg/ml? The metes and bounds of the claim, therefore, cannot be determined.
Claim 25 is indefinite and confusing for the recitation “the patient is adult, juvenile, and/or pediatric patients” because it is unclear what “the patient is adult, juvenile, and pediatric patients” is meant, or how a patient can be adult, juvenile, and pediatric patient? The metes and bounds of the claim, therefore, cannot be determined. The following is suggested: “the patient is adult, juvenile, or pediatric patient”.
The remaining claims are included in this rejection because they are dependent from the specifically mentioned claims without resolving the indefiniteness issue belonging thereto.
Rejections Over Prior Art:
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 17-21, 23 and 25-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tocker et al. (US2008/0219979A1, 9/11/2008; provided by applicants), and Jacob et al. (US 2008/0213282 A1, 9/4/08; provided by applicants).
Tocker discloses monoclonal antibodies to IL-17RA, among which is monoclonal antibody AM-14, which six CDRs of SEQ ID NO:146-148 and 224-226 (page 11, 1st column, lines 15-18) are 100% identical to the present SEQ ID NO:5 and 7-11, respectively; its VH and VL of SEQ ID NO:14 and 40 (page 12, [0055]) are 100% identical to the present SEQ ID NO:3 and 4, respectively; and its heavy and light chains of SEQ ID NO:427 and 429 comprise the present SEQ ID NO:1 and 2, respectively, with 100% sequence identity. Additionally, Tocker teaches that the IL-17RA antibodies may be used in methods of treating IL-17RA associated diseases, including, among others, scleroderma, sclerosis, and multiple sclerosis (MS) (pages 28-29, [0194], for example). Further, Tocker teaches pharmaceutical formulations, and routes of administration, wherein a pharmaceutical formulation comprises the antibody and a pharmaceutically acceptable diluent, carrier, solubilizer, emulsifier, preservative, and/or adjuvant (page 30, [0209]; and the routes of administration include, among others, intravenous and intraarterial injection, intramuscular injection, and subcutaneous injection (page 37, [0265]). Furthermore, Tocker teaches that, in a pharmaceutical formulation, the concentration of the IL-17RA antibody may be between approximately 20 and 250 mg/ml or 20 and 150 mg/ml; and the pH is optionally between approximately 4.0 and 5.5 (page 33, [0228] and [0229); and lysine, proline, serine, and alanine can be used for stabilizing proteins in a formulation (page 35, [0251]); and that the optimal pharmaceutical composition will be determined by one skilled in the art depending upon, for example, the intended route of administration, delivery format and desired dosage; see, for example, REMINGTON'S PHARMACEUTICAL SCIENCES (page 31, [0215]). Furthermore, Tocker teaches that dosing frequency will depend upon the pharmacokinetic parameters of the particular IL-17RA antigen binding protein in the formulation used, typically, a clinician administers the composition until a dosage is reached that achieves the desired effect, and refinement of the appropriate dosage is routinely made by those of ordinary skill in the art and is within the ambit of tasks routinely performed by them; and appropriate dosages may be ascertained through use of appropriate dose-response data (page 37, [0272]). Furthermore, Tocker showed that the IL-17RA mAbs, including AM-14, inhibited binding of IL-17A to IL-17RA (page 42, [0298]; Table 8; and Example 9).
Tocker does not teach the specific pharmaceutical formulation as claimed.
Jacob teaches a formulation comprising a buffering solution, proline, and an effective amount of a biopharmaceutical, and a kit containing components of the formulation; wherein the buffering solution can comprise a glutamic acid buffer, and the biopharmaceutical can comprise a polypeptide, for example, an antibody such as a therapeutic antibody (page 2, [0014]). Additionally, Jacob teaches a formulation comprising between about 1-50 mM glutamic acid or aspartic acid with a pH from about 4.0 to about 6.0, about 2% to about 10% proline and a therapeutically effective amount an antibody; for example, 10 mM, 30 mM or 50 mM glutamic acid or aspartic acid and a pH of about 5 (page 16, [0167], [0170] and [173]); and page 7, [0084], for example). Additionally, Jacob teaches that a formulation of the invention can contain a desired concentration or amount of one or more biopharmaceuticals such as an antibody or antigen-binding fragment having a concentration from between about 40 to about 200 mg/ml, about 140 mg/ml, for example; that biopharmaceutical concentrations and/or amounts of formulations can be less than, greater than or in between these ranges described herein, for example, a formulation can contain a concentration of one or more biopharmaceuticals greater than about 200 mg/ml (page 13, [0141] and [0142]). Further, Jacob teaches that surfactants can be included in a formulation for a variety of purposes including, for example, to prevent or control aggregation, particle formation and/or surface adsorption in liquid formulations or to prevent or control these phenomena during the lyophilization and/or reconstitution process in lyophilized formulations, wherein surfactants include, among others, polysorbate 20 (page 4, [0056] and [0057]); and that a formulation can be produced that contains essentially any desired concentration or amount of one or more surfactants including, among others, a concentration of about 0.01% (page 8, [0098]).
Therefore, it would have been obvious to the person of ordinary skill in the art at the time the invention was made to prepare a pharmaceutical formulation of the IL-17RA antibody AM-14, and to use the pharmaceutical formulation for treating diseases such as scleroderma, sclerosis, and MS; wherein the formulation comprises, for example, 140 mg/ml of Tocker’s anti-IL-17RA monoclonal antibody in a 30 mM glutamic acid buffer containing about 3% L-proline, about 0.01% polysorbate 20, at pH 5, following the teachings of Tocker and Jacob. The person of ordinary skill in the art would have been motivated to do so for disease treatment, and reasonably would have expected success because Tocker has demonstrated that monoclonal antibody AM-14 is capable of inhibiting both IL-17A-IL-17RA binding and IL-17F-IL-17RA binding; and teaches that scleroderma, sclerosis, and MS are IL-17RA associated diseases. With respect to the limitations regarding osmolarity and viscosity in claims 20 and 21, they would be the inherent properties of the formulation taught by Jacob as these are dependent upon the ingredients/components of the formulation (excipient/diluent, pH, etc.).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Double Patenting Rejections:
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 claims at issue 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 17-21, 23 and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,883,151, in view of Jacob et al. (US 2008/ 0213282 A1, 9/4/08; provided by applicants).
Claims 1-6 of ‘151 patent are directed to a pharmaceutical formulation comprising an aqueous solution of a glutamic acid buffer and an anti-IL-17RA antibody, and a kit thereof; wherein the anti-IL17RA antibody comprises the same CDRs, VH/VL, and H/L chains (claims 1-3) as that recited in the present claims 17-19, respectively; wherein the formulation comprises 140+5% mg/ml antibody, and has a glutamic acid concentration of 10+0.2 mM, a pH of 4.8+0.2, 3+0.2% proline (w/v), 0.01+0.002% (w/v) polysorbate 20, a viscosity of 5 to 7 cP at 25 oC, and an osmolarity of 275 to 350 mOsm/L (claim 1), and an osmolarity of 275 to 325 osm (claim 4), which values are either the same or within the range of that in the formulation recited in the present claim 17, except the concentration of the glutamic acid concentration of 30 mM in the present invention. As such, the only difference between the two formulations (the present invention and the patent) is the glutamic acid concentration (30 mM vs 10 mM). Jacob teaches an antibody formulation comprising between about 1-50 mM glutamic acid or aspartic acid with a pH from about 4.0 to about 6.0, about 2% to about 10% proline and a therapeutically effective amount an antibody; for example, 10 mM, 30 mM or 50 mM glutamic acid or aspartic acid and a pH of about 5 (page 16, [0167], [0170] and [173]); for example); and that the formulation can be administered via parenteral routes of intravenous (IV), subcutaneous (SC) or intramuscular (IM) administration (page 7, [0091], for example). In addition, according to the ‘151 patent, the claimed antibody is antibody AM-14 (column 3, lines 46-61, for example); and can be used to treat diseases including, among others, scleroderma, sclerosis, and multiple sclerosis (MS) (column 17, lines 18-40, for example). Thus, it would have been obvious to the person of ordinary skill in the art to treat a human patient having scleroderma, sclerosis, or MS with the claimed formulation comprising antibody AM-14 by subcutaneous administration (for example) in view of the teachings of Jacob, and the ‘151 patent. Therefore, the conflicting claims are not patentably distinct from each other. See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010).
Claims 17-21 and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,808,033. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-6 of ‘033 patent are directed to a pharmaceutical formulation comprising 140 mg/ml of an anti-IL-17RA antibody or antigen-binding fragment thereof, and a kit thereof; wherein the anti-IL17RA antibody comprises the same CDRs, VH/VL, and H/L chains (claims 1-3) as that recited in the present claims 17-19, respectively; wherein the formulation comprises 140 mg/ml antibody, 30 mM glutamic acid, a pH of 4.55-4.93, 2-4% (w/v) proline, and 0.01+0.002% (w/v) polysorbate 20 (claim 1), which ingredients and their concentrations are either the same or encompass the range of that in the formulation recited in the present claim 17. In addition, according to the ‘033 patent, the claimed antibody is antibody AM-14 (column 3, line 53 to column 4, line 2, for example); and can be used to treat diseases including, among others, scleroderma, sclerosis, and multiple sclerosis (MS) (column 17, line 47 to column 18, line 2, for example). Thus, it would have been obvious to the person of ordinary skill in the art to treat a human patient having scleroderma, sclerosis, or MS with the claimed formulation comprising antibody AM-14 in view of the teachings of the ‘033 patent. Therefore, the conflicting claims are not patentably distinct from each other. See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010).
Claims 17, 18, 23 and 25-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 4 of U.S. Patent No. 10,208,122, in view of Jacob et al. (US 2008/ 0213282 A1, 9/4/08; provided by applicants).
Claims 1, 3 and 4 of ‘122 patent are directed to an isolated human monoclonal antibody that specifically binds IL-17RA, and comprises the LCDR1-3 of SEQ ID NO:224-226, respectively, and the HCDR1-3 of SEQ ID NO:146-148, respectively (claim 1); or the VL of SEQ ID NO: 40 and the VH of SEQ ID NO: 14 (claim 3); and a formulated pharmaceutical composition (claim 4), which sequences are 100% identical to those recited in the present claims 17 and 18. In addition, according to the ‘122 patent, the claimed antibody is antibody AM-14 (column 88, lines 46-49, for example), and the IL-17RA antigen binding proteins (the antibody) may be used in methods of treating IL-17RA associated diseases including, among others, scleroderma, sclerosis, and multiple sclerosis (MS) (column 101, lines 33-67, for example). Jacob teaches an antibody formulation comprising between about 1-50 mM glutamic acid or aspartic acid with a pH from about 4.0 to about 6.0, about 2% to about 10% proline and a therapeutically effective amount an antibody; for example, 10 mM, 30 mM or 50 mM glutamic acid or aspartic acid and a pH of about 5 (page 16, [0167], [0170] and [173]); for example); and that the formulation can be administered via parenteral routes of intravenous (IV), subcutaneous (SC) or intramuscular (IM) administration (page 7, [0091], for example). Thus, it would have been obvious to the person of ordinary skill in the art to treat a human patient having scleroderma, sclerosis, or MS with the claimed formulation comprising antibody AM-14 by subcutaneous administration (for example) in view of the teachings of Jacob, and the ‘122 patent. Therefore, the conflicting claims are not patentably distinct from each other. See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Company (Fed. Cir. July 28, 2010).
Claims 17, 18, 23 and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 4 of U.S. Patent No. 11/858,999, in view of Jacob et al. (US 2008/ 0213282 A1, 9/4/08; provided by applicants).
Claims 1, 3 and 4 of ‘999 patent are directed to a method of treating scleroderma with a human monoclonal antibody that specifically binds IL-17RA, and comprises the LCDR1-3 of SEQ ID NO:224-226, respectively, and the HCDR1-3 of SEQ ID NO:146-148, respectively; or the VL of SEQ ID NO: 40 and the VH of SEQ ID NO: 14 (claim 1); or a pharmaceutical composition thereof (claim 3), wherein the composition is administered to the patient subcutaneously, intramuscularly, or intravenously (claim 4). The sequences of the antibody recited in the patent are 100% identical to those recited in the present claims 17 and 18. The teachings of Jacob are reviewed above. It would have been obvious to the person of ordinary skill in the art to treat scleroderma with the claimed formulation comprising antibody AM-14 by subcutaneous administration (for example) in view of claims 1, 3 and 4 of the ‘999 patent and the teachings of Jacob. Therefore, the conflicting claims are not patentably distinct from each other.
Conclusion:
No claim is allowed.
Advisory Information:
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/DONG JIANG/
Primary Examiner, Art Unit 1674
11/28/25