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 .
DETAILED ACTION
1. Claims 1-3,6-15,27, 29,31-37,44-47,49,50,53,54-64, 68-71 are pending.
2. Claims 44-47,49,50,53, 54-64 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-3,6 -15, 27, 29, 31-37, 68-71 read on an aqueous pharmaceutical composition comprising levilimab are under consideration in the instant application.
3. 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.
4. Claims 1-3,6 -15, 27, 29, 31-37, 68-71 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20240226235 , US Patent Application 20250221969 and US Patent Application 20240150479 for the same reasons set forth in the previous Office Action mailed on 10/01/25.
Applicant’s arguments filed on 12/30/25 have been fully considered but have not been found convincing.
Applicant asserts that : (i) US Patent Application’235 and US Patent Application ‘969 do not disclosed pharmaceutical composition comprising levilimab that provides long-term storage and can be used for treatment of IL-6R associated diseases ; (ii) US patent Application ‘479 teaches a composition comprising tocilizuman not levilimab.
As initial matter it is noted that the instant claims are drawn to a product, i.e. an aqueous pharmaceutical composition comprising levilimab, not a method of storage or treating IL-6R associated diseases.
Applicants have traversed the primary and the secondary references pointing to the differences between the claims and the disclosure in each reference. Applicant is respectfully reminded that the rejection is under 35 USC103 and that unobviousness cannot be established by attacking the references individually when the rejection is based on the combination of the references. see In re Keller, 642 F.2d 4B, 208 USPQ 871, 882 (CCPA 1981) See MPEP 2145. This applicant has not done, but rather argues the references individually and not their combination. One cannot show non-obviousness by attacking references individually where the rejections are based on a combination of references. In re Young 403 F.2d 759, 150 USPQ 725 (CCPA 1968).
Moreover, the Examiner disagrees with applicant’s interpretation of the teaching of prior art references. In particular, US Patent Application’ 235 explicitly teach pharmaceutical composition comprisng levilimab ( see paragraphs 0038 and 0039 in particular), US Patent Application’ 969 explicitly teach pharmaceutical composition comprisng levilimab ( see paragraph 0030)
The teaching of US Patent Application’479 was used to show that at the time the invention was made one skill in the art would know about a pharmaceutical composition comprising anti-IL-6R antibody, polyols and that pH of said aqueous composition can be adjusted accordingly with sodium acetate to 4.8.
Applicant provided no evidences or declaration of why it would not be obvious and conventional and within the skill of the art to make a pharmaceutical composition comprising instantly claimed concentration of levilimab, glycine, polyol and sodium acetate.
As has been stated previously, US Patent Application’235 teaches an aqueous pharmaceutical composition comprising anti-IL-6 R inhibitor levilimab (BCD-089) for treating patient. US Patent Application’235 further teaches that said composition comprises polyols and that pH of said aqueous composition can be adjusted accordingly with sodium acetate to 4.8 (( see entire document, paragraphs 0038,0039,0049, 0013, 0214, 0189 in particular).
US Patent Application’969 teaches an aqueous pharmaceutical composition comprising anti-IL-6 R inhibitor levilimab (BCD-089) for treating patient. US Patent Application’235 further teaches that said composition comprises polyols and that pH of said aqueous composition can be adjusted accordingly with sodium acetate to 4.8 (( see entire document, paragraphs 0030, 0039,0097, 0101, 0105, in particular).
US Patent Application’479 teaches an aqueous pharmaceutical composition comprising anti-IL-6 R antibody for treating patient. US Patent Application’479 further teaches that said composition comprises polyols and that pH of said aqueous composition can be adjusted accordingly with sodium acetate between 5.5 and 7.5. US Patent Application’479 further teaches the presence of glycine in said pharmaceutical composition as stabilizing agent. US Patent Application’479 teaches that in some embodiments said an aqueous pharmaceutical composition comprises arginine ( see entire document, paragraphs 0008, 0009, 0025, 0029, 0031, 0037 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
It is noted that US Patent Application 20240226235 , US Patent Application 20250221969 and US Patent Application 20240150479 do not explicitly recited the claimed concentrations of levilimab, glycine, polyol and sodium acetate.
However, it id the Examiner’s position that it would be conventional and within the skill of the art to : identify an optimal concentration of levilimab, glycine, polyol and sodium acetate to be present in an aqueous pharmaceutical composition. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
As concentrations of levilimab, glycine, polyol and sodium acetate were known to the ordinary artisan, it would have been obvious to optimize the dosing regimens to meet the needs of the patient at the time the invention was made.
"The test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
5. No claim is allowed.
6. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644