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
The instant application is a 35 U.S.C. 371 national phase application and claims priority to International Application No. PCT/IN2021/051095 (filing date 11/24/2021), which claims the benefit of the prior-filed Indian Provisional Patent Application No. IN202041051228 (filing date 11/25/2020).
Status of Application/Claims
The amendment, filed 04/14/2026, is acknowledged. Claims 2, 6-8, and 11-13 are canceled. Claims 1 and 3 are currently amended. Claims 1, 3-5, and 9-10 are currently pending and are examined on the merits herein.
Information Disclosure Statement
No new IDS is submitted.
Withdrawn Objections & Rejections
Regarding the claim 3 objection for minor informalities, applicant amendment has addressed the issue. Thus, the objection is withdrawn.
Regarding the rejection for claims 6 and 8 under 35 U.S.C. 112(b) for indefiniteness: Applicant amendment has addressed the rejections. Claims 6 and 8 are canceled. Thus, the rejection for claims 6 and 8 is withdrawn.
Regarding the rejection for claims 11-13 under 35 U.S.C. 112(d) for failing to further limit: Applicant amendment has addressed the rejections. Claims 11-13 are canceled. Thus, the rejection for claims 11-13 is withdrawn.
Regarding the rejection for claims 1, 3-5, and 9-10 under 35 U.S.C. 103 for obviousness: Applicant amendment has overcome the rejection. Thus, the rejection for claims 1, 3-5, and 9-10 is withdrawn. Consideration of the amended claims has resulted in new prior art rejections (see below).
Regarding the rejection for claims 1-6, and 8-13 under 35 U.S.C. 103 for obviousness: Claims 2, 6, 8, and 11-13 are canceled and the rejection is withdrawn for these claims. Applicant arguments are were found to be persuasive. Thus, the rejection for claims 1, 3-5, 9-10 is also withdrawn. Applicant has amended claims 1 and 3. Applicant amendment and response has resulted in new prior art rejections (see below).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Huabo Biopharm. Co. LTD.—CN110585430A. Humanized anti-human IL-17A monoclonal antibody pharmaceutical composition. Published 12/20/2019 (herein referred to as Huabo); as evidenced by Zhang, et al. Formulation strategies in immunotherapeutic pharmaceutical products. World J. Clin. Oncol., May 24, 2020, 11:5, p.275-282 (herein referred to as Zhang).
Huabo teaches high-concentration anti-human IL-17A monoclonal antibody pharmaceutical compositions and aqueous (i.e., in water) liquid pharmaceutical formulations for improved stability under conditions of pressurization, acceleration and long-term refrigeration, and improved safety for clinical use (abstract; p.1-2, claims 1-2; p.13, [0085]; p.25, [0191-0193]); wherein the IL-17A antibody concentration can be within the range of 10 mb/mL to 200 mg/mL (p.2, claim 2). Huabo teaches compositions comprising pharmaceutically acceptable carriers, which includes a buffer, stabilizer, and surfactant; wherein the buffer can be a histidine-acetate buffer (i.e., an organic base/histidine-weak organic acid/acetate buffer; p.1-2, claims 1 and 3). Huabo teaches that the stabilizer is selected from sodium chloride, amino acids, sugar alcohols, or a combination thereof (p.2, claim 5). Huabo teaches, in a preferred example, compositions comprising the amino acid selected from the group consisting of proline, arginine, glycine, histidine, methionine, or a combination thereof (p.7, [0031]); and/or the sugar alcohol selected from the group consisting of Sucrose, Mannitol, Trehalose, Maltose, Sorbitol, or a combination thereof (p.7, [0032]). Huabo teaches that the composition comprises a pH within the range of 5.0 to 7 (p.3, claim 9). Huabo further teaches useful concentration ranges for the aforementioned stabilizers and excipients. Additionally, Huabo teaches the inclusion of a chelating agent selected from the group consisting of disodium ethylenediamine tetraacetate (EDTA), diethylenetriaminepentaacetic acid (DTPA), or a combination thereof. Huabo teaches pharmaceutical compositions devoid of methionine (see entire document).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to combine the teachings of Huabo by formulating a high-concentration aqueous pharmaceutical formulation comprising an anti-IL17 antibody at 150 mg/mL, a histidine organic base/acetate weak organic acid buffer, trehalose sugar and arginine amino acid stabilizers (i.e., excipients), and surfactant, that is devoid of the antioxidant methionine and that is within a pH range within 5.5-6.5, in order to arrive at the instantly claimed invention, because the combination of prior art elements according to known methods results in a predictable result of producing a high-concentration IL17 antibody formulation suitable for administration for the benefit of treating IL-17-mediated disease. Regarding Huabo’s formulations that are devoid of antioxidants but that contain chelating agents such as EDTA, DTPA, or a combination thereof (p.17, [0128]): It is noted that the instant specification defines methionine and cysteine as an “anti-oxidants” (see instant disclosure p.5, line 30—p.6, line2); whereas, EDTA and DTPA are defined in the disclosure as a “chelating agents” (see instant disclosure p.9, line 27—p.10, line5). Further, EDTA and DTPA are included in formulations of the instant invention; however, the claims stipulate that the claimed pharmaceutical formulation is “devoid of antioxidant.” Given the discrepancy between “antioxidants” and “chelating agents” provided in the disclosure, while EDTA is customarily understood in the art to indirectly serve as an “anti-oxidant” in addition to being a “chelating agent” (as evidenced by Zhang p.279, para.2), the examiner interprets EDTA as a “chelating agent” and not as an “anti-oxidant” as per applicant’s special meanings provided in the disclosure (see MPEP § 2111.01 and MPEP § 2173.05(a)). Thus, the instantly claimed formulation is determined as taught by the combination of Huabo’s teachings.
Response to Arguments
Regarding the rejection under 35 U.S.C. 103 for obviousness for claims 2, 6, 8, and 11-13 of the previous office action filed 01/14/2026: Applicant traverses in remarks filed 04/14/2026 on the basis that the DiPadova reference teaches non-analagous art that is focused on IL-17 antibody amino acid sequences, binding characteristics, recombinant production, and purification rather than formulation-related problems related to excipient selection, oxidation control, stability enhancement (see remarks, p.9-13). The examiner agrees and the rejection has been withdrawn. The examiner has provided new obviousness rejections over the amended claims above in this non-final action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jami M Gurley whose telephone number is (571)272-0117. The examiner can normally be reached Monday - Friday, 8am - 4pm.
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/JAMI MICHELLE GURLEY/Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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