Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
2. The Preliminary Amendment filed 23 January 2024 has been entered in full. Claims 1-11 have been canceled, and claims 12-26 have been added. Therefore, claims 12-26 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 23 January 2024, 04 February 2025 and 20 February 2026 have been considered by the examiner.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
7. 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.
8. Claims 12-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dix et al. (WO 2011/085158 A2; published 14 July 2011; cited by Applicant), further in view of Correia et al. (WO 2010/062896 A1; published 03 June 2010; cited by Applicant).
9. Dix et al. disclose liquid formulations comprising an IL-6 receptor antibody, 25 mM histidine, a polyol, including sucrose and mannitol, a surfactant, including polysorbate 80, the free amino acid arginine, and the pH is adjusted to 6.0 (See Table 23; claim 1 and claim 10). Dix et al. does not teach the amino acid methionine or arginine, the IL-6R antibody tocilizumab, or the particular concentrations of the recited components of the composition. However Correia et al. also disclose stable liquid formulations comprising an IL-6 receptor antibody, a buffer system comprising histidine, a polyol, including mannitol, a surfactant, including polysorbate 80, the free amino acid methionine and arginine, and the pH is adjusted to 6.0 (See claims 54, 64, 69, 79-80 and 107). While neither Dix nor Correia disclose the use of a salt from of the free amino acid as the salt, it would have been obvious to do so since salt forms of amino acids, such as arginine hydrochloride were known in the art and further known to suppress protein aggregation and decrease viscosity of antibody formulations, as evidenced by Inoue et al. (Mol. Pharm. 11(6):1889-1896, published 2014).
10. It would have been obvious to utilize methionine as the free amino acid, as well as the recited IL-6R antibody tocilizumab. One would have been motivated to use methionine as the free amino acid as antibody compositions utilizing said amino acid are recognized in the art, as evidenced by Correia et al. cited supra, and the IL-6R antibody tocilizumab and compositions comprising the same were well-known in the art as evidenced by Yokota et al (Clinical Reviews in Allergy and Immunology. 28:231-237; cited by Applicant).
11. There would have been a reasonable expectation of success in utilizing methionine in the claimed composition and utilizing the IL-6R antibody tocilizumab, as antibody compositions comprising said elements were both known in the art. Regarding the specific concentrations or rations of the recited components of the composition, it is routine experimentation to optimize concentrations. The courts have determined that:
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955).
12. Therefore, the invention as a whole was prima facie obvious over the combined teachings of the art to one of ordinary skill in the art at the time the invention was filed.
Double Patenting
13. 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).
14. 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
15. The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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.
16. Claims 12-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,961,314. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-10 of the ‘314 patent are drawn to a genus of IL-6R antibody (including tocilizumab) formulations that encompasses the genus of tocilizumab antibody formulations recited in the instant claims. While the claims of the ‘314 Patent do not recite the specific concentrations or rations of the recited components of the composition, it is routine experimentation to optimize concentrations. The courts have determined that:
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955).
Therefore, the claims are overlapping in scope.
Summary
17. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JON M LOCKARD/
Examiner, Art Unit 1647
March 7, 2026
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