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 .
Claim Status
Claims 1-11 are pending.
Claim 11 was withdrawn from further consideration (see below).
Claims 1-10 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 9/17/2025 is acknowledged.
Claim(s) 11 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/17/2025.
Claim Objections
Claim 8 is objected to because of the following informalities: “The liquid pharmaceutical composition claim 1” should read “The liquid pharmaceutical composition according to claim 1”. Appropriate correction is required.
Claim 8-9 are objected to because of the following informalities: “10 and 25 mM histidine” should read “10 to 25 mM histidine” because the concentration of histidine cannot be 10 mM and 25 mM at the same time. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “comprising a liquid pharmaceutical composition as claimed in claim 1” should read “comprising the liquid pharmaceutical composition as claimed in claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “(c) a stabilizer selected from lactic acid or salts thereof” and it seems that Applicant intends to recite Markush group of alternatives. Markush group is used to select one member from alternatives of the closed group. In instant claim, a stabilizer is selected from two members and the stabilizer is lactic acid or salt thereof. Therefore, claim 1 encompasses the liquid pharmaceutical composition comprising lactic acid, and another species liquid pharmaceutical composition comprising salt of lactic acid. However, it is well known in the art that the liquid pharmaceutical composition comprising weak acid like lactic acid will also comprise its conjugate base. The ratio between acid and base conjugate is determined by Henderson-Hasselbalch equation (pH = pKa + log([A-]/[]HA)). For example, in the instant case, pKa value of lactic acid is 3.86. Therefore, at pH 5.86 within pH range recited by instant claim 1, log(lactate/lactic acid) = pH – pKa = 5.86 – 3.86 = 2, and therefore lactate/lactic acid = 100. Therefore, about 99% of conjugate will exist as lactate and about 1% will exist as lactic acid. In sum, the composition comprises both lactic acid and lactate. Because, instant claim 1 recites Markush group, it is unclear whether Applicant intends to recite (i) the pharmaceutical composition comprising only one of lactic acid and lactate because Markush group is used to select only one from closed group; or (ii) the pharmaceutical composition comprising both lactic acid and lactate which is real situation in the real world.
In this case, one of ordinary skill in the art would recite most abundant conjugate form (e.g. sodium lactate in the instant case as disclosed by instant specification) because one of ordinary skill in the art would understand that there must be conjugate acid also in the liquid solution.
Same reasoning applies to instant claims 8-9.
Dependent claims are also rejected because they depend from claim 1 and therefore contain same claim limitation.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,291,725 (hereinafter patent’725; PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claims 1 and 3-4, claims 1 and 18 of patent’725 claim “A liquid pharmaceutical composition comprising: (a) 160 to 250 mg/ml of tocilizumab antibody; (b) 10-25 mM histidine buffer; (c) 5-15 mM lactic acid or salt thereof; (d) arginine; (e) a surfactant; (f) water for injection; and (g) optionally a salt, wherein the composition has a pH between 5.5 and 7.0.”
Regarding claim 2, claim 2 of patent’725 claims that the composition has a pH between 5.8 and 6.2.
Regarding claims 5-6, claims 4-5 of patent’725 claim that the surfactant is a polysorbate 80.
Regarding claim 7, claim 6 of patent’725 claims that the optional salt is sodium chloride.
Regarding claims 8-9, claim 9 of patent’725 claims “The liquid pharmaceutical composition according to claim 1, wherein the composition comprises: 160 to 200 mg/ml of tocilizumab antibody; 10 to 25 mM histidine; 5 to 15 mM sodium lactate or lactic acid; 50 to 150 mM arginine; 0.1 to 0.2 mM polysorbate 80; water for injection; and 5 to 50 mM sodium chloride.”
Regarding claim 10, claim 10 of patent’725 claims “A drug delivery device comprising a liquid pharmaceutical composition as claimed in claim 1.”
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674