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
Priority and Status of the Claims
1. This application is a CON of 18395225 12/22/2023 PAT 12042484, which is a CIP of 17/918,130 10/11/2022, which is a 371 of PCT/CN2022/091371 05/07/2022, which claim benefit of foreign application: CHINA CN202110577512.4 05/26/2021.
2. Claims 1-20 are pending in the application.
3. 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.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) 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.
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(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-20 are rejected under 35 U.S.C. 103(a) as being obvious over Aung-
Din’s US 8,883,830.
Applicants claim liquid pharmaceutical composition, comprising a) about 0.1-2 mg/mL of tizanidine hydrochloride; b) water, and a pharmaceutically acceptable excipient, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.1 as adjusted by one or more pH buffering agents, see claim 1. Dependent claims 2-9 and 18-20 further limit the scope of compounds, i.e., specific excipient and amount of tizanidine.
Applicants claim of administering tizanidine to a subject in need thereof for muscle relaxation, comprising administering a liquid pharmaceutical composition orally to said subject, wherein the pharmaceutical composition comprises a) about 0.1-2 mg/mL of tizanidine hydrochloride; b) water, and a pharmaceutically acceptable excipient, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.1 as adjusted by one or more pH buffering agents, see claim 10. Dependent claims 11-17
further limit the scope of methods, i.e., specific excipient and amount of tizanidine, and buffering agents.
Determination of the scope and content of the prior art (MPEP §2141.01)
Aung-Din’s ‘830 discloses a liquid composition comprising 0.2 mg to 8 mg of
tizanidine hydrochloride, tetrasodium EDTA, and aqueous-based excipients, and it is
used for treating muscle pain, migraines, or cluster headaches, see claims 1, 4, 9, 14, 16
and 20 in columns 26-28.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Aung-Din’s ‘830 is that the instant claims are embraced within the scope of Aung-Din’s ‘830.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the 1-20 prima facie obvious because one would be motivated to employ the compositions and methods of use of Aung-Din’s ‘830 to obtain instant invention.
The motivation to claim instant compositions and methods of use derived from the known compositions and methods of use of Aung-Din’s ‘830 would possess similar activity to that which is claimed in the reference.
Double Patenting
5. 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. See 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).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 10 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 and 16 of Chen et al. US 12,042,484, and over claims 1 and 13 of Chen et al. US 12,263,158 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim liquid pharmaceutical composition, comprising a) about 0.1-2 mg/mL of tizanidine hydrochloride; b) water, and a pharmaceutically acceptable excipient, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.1 as adjusted by one or more pH buffering agents, see claim 1. Dependent claims 2-9 and 18-20 further limit the scope of compounds, i.e., specific excipient and amount of tizanidine.
Applicants claim of administering tizanidine to a subject in need thereof for muscle relaxation, comprising administering a liquid pharmaceutical composition orally to said subject, wherein the pharmaceutical composition comprises a) about 0.1-2 mg/mL of tizanidine hydrochloride; b) water, and a pharmaceutically acceptable excipient, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.1 as adjusted by one or more pH buffering agents, see claim 10.
Chen et al. ‘484 claims a liquid pharmaceutical composition, comprising a) about 0.1-2 mg/mL of tizanidine hydrochloride; b) about 0.5-5 mM of EDTA; c) water, d) about 2-6 mM citric acid, e) about 0.5-3 mM sodium citrate, and a pharmaceutically acceptable excipient, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.1, and wherein the liquid pharmaceutical composition retains at least 99% tizanidine concentration as measured by USP assay when stored at room temperature for at least 30 days, see claim 1 in column 35.
Chen et al. ‘484 claims a method of administering tizanidine to a subject in need thereof for muscle relaxation, comprising administering a liquid pharmaceutical composition orally to said subject, wherein the pharmaceutical composition comprises a) about 0.1-2 mg/mL of tizanidine hydrochloride; b) about 0.5-5 mM of EDTA; and c) water, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.1, and wherein the liquid pharmaceutical composition retains at least 99% tizanidine concentration as measured by USP assay when stored at room temperature for at least 30 days, see claim 16 in column 37.
Chen et al. ‘158 claims liquid oral pharmaceutical composition, comprising a) about 0.2-10 mg/mL of tizanidine hydrochloride; b) a chelating agent; c) water, and a pharmaceutically acceptable excipient, wherein pH of the liquid pharmaceutical composition is between 3.5 and 6.5, see claim 1 in column 29.
Chen et al. ‘158 claims a method of administering tizanidine to a subject in need thereof for muscle relaxation, comprising administering a liquid oral pharmaceutical composition orally to said subject, wherein the pharmaceutical composition comprises a) about 0.2-10 mg/mL of tizanidine hydrochloride; b) a chelating agent; c) water, and a pharmaceutically acceptable excipient, wherein pH of the liquid oral pharmaceutical composition is between 3.5 and 6.5, see claim 13 in column 31.
The difference between instant claims and Chen et al. ‘484 and ‘158 is that the instant claims are embraced within the scope of Chen et al. ‘484 and ‘158. It is noted that the instant claims are silent an agent EDTA and buffering agents.
One having ordinary skill in the art would find the claims 1 and 10 prima facie obvious because one would be motivated to employ the compositions and methods of use of Chen et al. ‘484 and ‘158 to obtain instant invention.
The motivation to make the claimed compositions and methods of use derived from the known compositions and methods of use of Chen et al. ‘484 and ‘158 would possess similar activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 13, 2026
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