DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 16 and 19-29 are pending upon entry of amendment filed on 12/22/23.
Upon further consideration, the election of species has been withdrawn.
3. Applicant’s IDS filed on 12/22/23, 1/19/24, 10/10/25 and 4/23/26 have been acknowledged.
The non-English foreign patent documents are considered to its English Abstract. Applicant is required to submit English translation for further consideration.
4. The oath filed on 12/22/23 has been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. 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.
7. Claims 24 and 26 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.
The use of the term “preferably” in claim 24 renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
Claim 26 is missing a conjunction between items (c ) and (d).
8. 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 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.
9. 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 of this title, 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.
10. Claims 16 and 19-29 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2012/095662 (IDS reference) in view of U.S.Pub.2015/0150979 (IDS reference).
The ‘662 publication teaches treatment of IL-17 mediated disorders comprising administering antibody formulation that binds IL-17A and IL-17F set forth in the SEQ ID NO:1-2 (see SEQ ID NO:7, 9, 11 and 15, see claims 1-8, 16-17, p. 24-27). The ‘662 publication further teaches inclusion of acetate buffer, amino acids, and/or polysorbate at pH of interest (p. 24-27) and the disorder comprises Crohn’s disease, rheumatoid arthritis, JIA or psoriasis. In addition, the ‘662 publication teaches use of antibody fragments (p. 10).
The disclosure of the ‘662 publication differs from the instant claimed invention in that it does not teach the use 80-200mg/ml of antibody, addition of glycine as in claim 1 and specific concentrations of excipients recited in claims 16-24 of the instant application.
The ‘979 publication teaches antibody formulations comprising about 200mg/ml of antibody with 20-150mM of acetate, 0.01-0.03% polyorbate with 100-500mM of glycine (claims 15-28). The ‘979 publication further teaches exemplary formulations comprising 40mM of sodium acetate, about 220mM of glycine, 200mg/ml of antibody 0.01% polysorbate at pH 5 (Example 1) and this formulation reduces viscosity and enhances overall stability.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known excipient concentrations taught by the ‘979 publication into the IL-17A/F antibody compositions taught by the ‘662 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known excipient concentration combinations taught by the ‘979 publication and reduces viscosity for higher concentration and enhances stability.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
11. Claims 16 and 19-29 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 8,580,265 (IDS reference) in view of U.S.Pub.2015/0150979 (IDS reference).
The ‘265 patent teaches treatment of IL-17 mediated disorders comprising administering antibody formulation that binds IL-17A and IL-17F set forth in the SEQ ID NO:1-2 (see SEQ ID NO:7, 9, 11 and 15, see col. 16-18). The ‘265 patent further teaches inclusion of acetate buffer, amino acids, and/or polysorbate at pH of interest (col. 14-15) in the formulation. In addition, the ‘265 patent teaches use of antibody fragments (p. 10).
The disclosure of the ‘265 patent differs from the instant claimed invention in that it does not teach the use 80-200mg/ml of antibody, addition of glycine as in claim 1 and specific concentrations of excipients recited in claims 16-24 of the instant application.
The ‘979 publication teaches antibody formulations comprising about 200mg/ml of antibody with 20-150mM of acetate, 0.01-0.03% polysorbate with 100-500mM of glycine (claims 15-28). The ‘979 publication further teaches exemplary formulations comprising 40mM of sodium acetate, about 220mM of glycine, 200mg/ml of antibody 0.01% polysorbate at pH 5 (Example 1) and this formulation reduces viscosity and enhances overall stability.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known excipient concentrations taught by the ‘979 publication into the IL-17A/F antibody compositions taught by the ‘265 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of known excipient concentration combinations taught by the ‘979 publication and reduces viscosity for higher concentration and enhances stability.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. No claims are allowable.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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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Yunsoo Kim
Patent Examiner
Technology Center 1600
October 6, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
