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 10 and 12-28 are pending upon entry of amendment filed on 3/1/23.
Upon further consideration, the restriction requirement mailed on 12/3/25 has been withdrawn.
Claim 10, 12-28 are under consideration in the instant application.
The instant application comprises 2 independent claims and the claimed invention relates method of treating RA, Ps, GenPS, Pruritus, AS, PA, PPP, HS or MM comprising administering a bufferless composition comprising IL-17A set forth in SEQ ID NO:1-10 at concentration of 72-88mg/ml, sucrose at 211-257mM, surfactant at 0.005-0.005% +/- 10% at pH 5.2-6.5.
3. Applicant’s IDS filed on 3/1/23 and 1/28/25 have been acknowledged.
4. The oaths filed on 3/1/23 have 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. Claims 1 is objected in recitation of RA, Ps, GenPS, AS, PA, PPP, HS or MM. Applicant is advised to spell out such diseases at the first appearance.
7. 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.
8. Claims 23-24 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 phrase “substantially free” in claim 23-24 renders the claim indefinite because it is unclear as the metes and bounds of the claimed limitations are not defined.
9. 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.
10. 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.
11. Claims 10 and 12-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 9,376,491 (IDS reference) in view of Laursen et al (Basic and Clinical Pharmacology and toxicology 2006, vol. 98, p 218-221) and U.S. Pub 2016/0304599 (IDS reference).
The ‘491 patent teaches treatment of RA, Ps, AS, PA or MM comprising IL-17A antibody formulations at 80-150mg/ml in the presence of polysorbate 80 at about 0.03% in the presence of 230mM NaCl at pH about 5.7 (col. 2, claims 7-8). The claimed ixekizumab has SEQ ID Nos:7-10 and the prior art sequence SEQ ID NO:1-5 are identical. Also, given that the CDRs set forth in the claimed SEQ ID NO:1-6 are contained in the prior art SEQ ID NO:1-5, it meets the limitations of claim 10 of the instant application.
The disclosure of the ‘491 patent differs from the instant claimed invention in that it does not teach the use of sucrose at about 234mM or substantially free of amino acid or ionic tonicity excipient as in claims 10 and the dose regimen as recited in claims 12-13 of the instant application.
Laursen et al teaches that the citrate buffer causes more pain in subcutaneous administration and uses 5 point VRS system (p.219). The Laursen reference further teaches VRS is being used in pain perception. As less than 20mm of VAS in claim 19 is well controlled pain, VRS in Fig 2 is well controlled and meets the limitations of claim 19 (note discussion p.221).
Further, the ‘599 publication teaches adalimumab (TNF-α antibody) formulation is used in treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (p.35); dose of 10-80mg/dose is being administered subcutaneously and weekly administrations for several weeks ([306], p. 36) readable upon limitations of claim 16. Moreover, the antibody formulation may contain upto 160mg/ml (claims). The ‘599 publication teaches buffer-less formulation in lack of amino acid and stabilizer (claims 1-9) or addition of polyol including sucrose at about 200mM (e.g. inclusive of 234mM-10% as in claim 1) and stable at 40oC for a week.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete citrate buffer and utilize VRS as in Laursen reference and utilize regimen that is known to treat rheumatoid arthritis as in ‘599 publication into the IL-17A antibody formulation taught by the ‘491 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the antibody formulation comprising sucrose, polysorbate and buffer improve stability by reduction of aggregates and known regimen would facilitate RA therapy.
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. Claims 10 and 12-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat. 9,845,353 in view of Laursen et al (Basic and Clinical Pharmacology and toxicology 2006, vol. 98, p 218-221) and U.S. Pub 2016/0304599 (IDS reference).
The ‘353 patent teaches treatment of RA, Ps, AS, PA or MM comprising IL-17A antibody formulations at 80-150mg/ml in the presence of polysorbate 80 at about 0.03% in the presence of 230mM NaCl at pH about 5.7 (col. 2, claims 7-8). The claimed ixekizumab has SEQ ID Nos:7-10 and the prior art sequence SEQ ID NO:1-5 are identical. Also, given that the CDRs set forth in the claimed SEQ ID NO:1-6 are contained in the prior art SEQ ID NO:1-5, it meets the limitations of claim 10 of the instant application.
The disclosure of the ‘353 patent differs from the instant claimed invention in that it does not teach the use of sucrose at about 234mM or substantially free of amino acid or ionic tonicity excipient as in claims 10 and the dose regimen as recited in claims 12-13 of the instant application.
The teachings of the Laursen and the ‘599 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete citrate buffer and utilize VRS as in Laursen reference and utilize regimen that is known to treat rheumatoid arthritis as in ‘599 publication into the IL-17A antibody formulation taught by the ‘353 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the antibody formulation comprising sucrose, polysorbate and buffer improve stability by reduction of aggregates and known regimen would facilitate RA therapy.
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.
13. Claims 10 and 12-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub 2018/0057584 in view of Laursen et al (Basic and Clinical Pharmacology and toxicology 2006, vol. 98, p 218-221) and U.S. Pub 2016/0304599 (IDS reference).
The ‘584 publication teaches treatment of RA, Ps, AS, PA or MM comprising IL-17A antibody formulations at 80-150mg/ml in the presence of polysorbate 80 at about 0.03% in the presence of 230mM NaCl at pH about 5.7 (p. 2, claims 23-28). The claimed ixekizumab has SEQ ID Nos:7-10 and the prior art sequence SEQ ID NO:1-5 are identical. Also, given that the CDRs set forth in the claimed SEQ ID NO:1-6 are contained in the prior art SEQ ID NO:1-5, it meets the limitations of claim 10 of the instant application.
The disclosure of the ‘584 publication differs from the instant claimed invention in that it does not teach the use of sucrose at about 234mM or substantially free of amino acid or ionic tonicity excipient as in claims 10 and the dose regimen as recited in claims 12-13 of the instant application.
The teachings of the Laursen and the ‘599 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete citrate buffer and utilize VRS as in Laursen reference and utilize regimen that is known to treat rheumatoid arthritis as in ‘599 publication into the IL-17A antibody formulation taught by the ‘584 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the antibody formulation comprising sucrose, polysorbate and buffer improve stability by reduction of aggregates and known regimen would facilitate RA therapy.
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.
14. 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 §§ 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/patent/patents-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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
15. Claims 10 and 12-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-8 of U.S. Pat. 9,376,491 in view of Laursen et al (Basic and Clinical Pharmacology and toxicology 2006, vol. 98, p 218-221) and U.S. Pub 2016/0304599 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘491 patent recites a method of treating RA comprising IL-17A antibody set forth in SEQ ID NO:1-10 (note patented SEQ ID NO:4-5) at 80-150mg/ml, citric acid 20mM, 0.02-0.03% polysorbate 80 at pH about 5.7.
The claims of the ‘491 patent differs from the instant claimed invention in that it does not teach the use of sucrose at about 234mM or substantially free of amino acid or ionic tonicity excipient as in claims 10 and dose regimen as recited in claims 12-13 of the instant application.
The teachings of the Laursen and the ‘599 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete citrate buffer and utilize VRS as in Laursen reference and utilize regimen that is known to treat rheumatoid arthritis as in ‘599 publication into the IL-17A antibody formulation taught by the ‘491 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the antibody formulation comprising sucrose, polysorbate and buffer improve stability by reduction of aggregates and known regimen would facilitate RA therapy.
16. Claims 10 and 12-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6 of U.S. Pat. 9,845,353 in view of Laursen et al (Basic and Clinical Pharmacology and toxicology 2006, vol. 98, p 218-221) and U.S. Pub 2016/0304599 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘353 patent recites a method of treating RA comprising IL-17A antibody set forth in SEQ ID NO:1-10 (note patented SEQ ID NO:4-5) at 80-150mg/ml, citric acid 20mM, 0.02-0.03% polysorbate 80 at pH about 5.7.
The claims of the ‘353 patent differs from the instant claimed invention in that it does not teach the use of sucrose at about 234mM or substantially free of amino acid or ionic tonicity excipient as in claims 10 and dose regimen as recited in claims 12-13 of the instant application.
The teachings of the Laursen and the ‘599 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete citrate buffer and utilize VRS as in Laursen reference and utilize regimen that is known to treat rheumatoid arthritis as in ‘599 publication into the IL-17A antibody formulation taught by the ‘353 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the antibody formulation comprising sucrose, polysorbate and buffer improve stability by reduction of aggregates and known regimen would facilitate RA therapy.
17. Claims 10 and 12-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6 of U.S. Pat. 10,472,416 in view of Laursen et al (Basic and Clinical Pharmacology and toxicology 2006, vol. 98, p 218-221) and U.S. Pub 2016/0304599 (IDS reference).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘416 patent recites a method of treating RA comprising IL-17A antibody set forth in SEQ ID NO:1-10 (note patented SEQ ID NO:4-5) at 80-150mg/ml, citric acid 20mM, 0.02-0.03% polysorbate 80 at pH about 5.7.
The claims of the ‘416 patent differs from the instant claimed invention in that it does not teach the use of sucrose at about 234mM or substantially free of amino acid or ionic tonicity excipient as in claims 10 and dose regimen as recited in claims 12-13 of the instant application.
The teachings of the Laursen and the ‘599 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to delete citrate buffer and utilize VRS as in Laursen reference and utilize regimen that is known to treat rheumatoid arthritis as in ‘599 publication into the IL-17A antibody formulation taught by the ‘416 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the antibody formulation comprising sucrose, polysorbate and buffer improve stability by reduction of aggregates and known regimen would facilitate RA therapy.
18. No claims are allowable.
19. 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.
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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
February 26, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641