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 .
Claims 1, 2, 48, 14, 15, 17 and 32 are presented for examination.
The amendments and remarks filed on 07/27/2027 have been received and entered.
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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.
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.
Claim(s) 1, 2, 4-8, 14, 15, 17 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shang et al. (US 20190241530) in view of Timmins et al. (Formulation technology can enable Oral Delivery of New Generation Medicines For Inflammatory Bowel Disease) and further in view of yang et al. (US 20160287525), Liu (US 20200241009) and Chow et al. (WO 2007117314 Submitted by the applicant)).
Claims 1, 2, 4-8, 14, 15 and 32 are drawn to a delayed-release pharmaceutical composition comprising ozanimod or a pharmaceutically acceptable salt thereof, one or more controlled release substances, and one or more pharmaceutically acceptable excipients, wherein the controlled release substance comprises one or more of pH dependent polymers and pH independent polymers. Claim 17 is drawn to a method of treating irritable bowel disease using the composition of claim 1.
Regarding claim 1, Shang teaches Ozanimod is a selective sphingosine-1-phosphate (S1P) receptor modulator, used for treatment for autoimmune diseases. See Para [0002]. The treatment of ulcerative colitis is taught in claim 18. Shang does not teach a controlled release ozanimod composition. However, Yang teaches the hydrophilic polymer are cellulose derivatives, such as hydroxypropyl methyl cellulose, hydroxypropyl cellulose and methacrylate copolymer in a delayed release composition for delivery of active ingredients to the colon. See Claims 15 and 19. Chow teaches that Acrylate and methacrylate are taught to be pH dependent. See Para [0022]. It would have been obvious to a person skilled in the art to add a pH dependent and a pH independent polymer to ozanimod, motivated by the teachings of Yang and chow, which make clear that the claimed polymers have been previously used in a delayed release composition for delivering active ingredients to the colon.
Regarding claim 2, Shang does not teach the release rate of ozanimod at the pH of 5-7.5. However, Yang et al. teach a controlled release oral pharmaceutical composition for delivering active pharmaceutical ingredients to the colon. See Par [0002]. Yang teaches that dissolution rate of less than about 2% to about 20% dissolution at pH 1.2 after about 60 minutes to about 300 minutes; less than about 2% to about 20% dissolution at pH 4.5 after about 60 minutes to about 300 minutes; or at least about a 50% in vitro dissolution rate at pH 7.2 after about 60 minutes to about 480 minutes. See Para [0021].
Regarding claim 4, Yang teaches the hydrophilic polymer are cellulose derivatives, such as hydroxypropyl methyl cellulose, hydroxypropyl cellulose and methacrylate copolymer in a delayed release composition for delivery of active ingredients to the colon. See Claims 15 and 19. Chow teaches that Acrylate and methacrylate are taught to be pH dependent. See Para [0022].
Regarding claim 5, Yang teaches the use of polyvinylpyrrolidone and polyvinyl acetate in a delayed release composition for delivery of active ingredients to the colon. See claim 18. Chow teaches that that Polyvinyl acetate is pH independent. See Para [0036].
Regarding claim 6, Yang teaches the use of the excipient in the delayed release composition. See Para [0116]. Shang teaches the specific excipients, such as lubricants and disintegrants. See Para [0105]. Regarding claim 7, Shang teaches the use of ozanimod in the form of tablets, capsules and powder. See Para [0106]. The addition of delayed release polymers is taught by Yang and Chow. It would have been obvious to a person skilled in the art to add a pH dependent and a pH independent polymer to ozanimod, motivated by the teachings of Yang and chow, which make clear that the claimed polymers have been previously used in a delayed release composition for delivering active ingredients to the colon.
Regarding Claim 8, Yang teaches a controlled release matrix for delivering drugs used for treating irritable bowel disease. See the abstract, claims 1 and 40.
Regarding claim 14, Shang teaches Ozanimod is a selective sphingosine-1-phosphate (S1P) receptor modulator, used for treatment for autoimmune diseases. See Para [0002]. The treatment of ulcerative colitis is taught in claim 18. Liu teaches a composition for the treatment of irritable bowel disease with a sphingosine-1-phosphate receptor agonist agent. See the abstract. The use of ozanimod as sphingosine-1-phosphate receptor agonist agent is taught in claim 13. Shang does not teach a controlled release ozanimod composition. Shang does not teach the release rate of ozanimod at the pH of 5-7.5. However, Yang et al. teach a controlled release oral pharmaceutical composition for delivering active pharmaceutical ingredients to the colon. See Par [0002]. Yang teaches that dissolution rate of less than about 2% to about 20% dissolution at pH 1.2 after about 60 minutes to about 300 minutes; less than about 2% to about 20% dissolution at pH 4.5 after about 60 minutes to about 300 minutes; or at least about a 50% in vitro dissolution rate at pH 7.2 after about 60 minutes to about 480 minutes. See Para [0021].
Regarding Claim 15, Yang teaches the hydrophilic polymer are cellulose derivatives, such as hydroxypropyl methyl cellulose, hydroxypropyl cellulose and methacrylate copolymer. See Claims 15 and 19. Yang also teaches the use of polyvinylpyrrolidone and polyvinyl acetate in claim 18.
Regarding claim 17, Liu teaches a composition for the treatment of irritable bowel disease with a sphingosine-1-phosphate receptor agonist agent. See the abstract. The use of ozanimod as sphingosine-1-phosphate receptor agonist agent is taught in claim 13.
Regarding Claim 32, Sheng does not teach, wherein the delayed release composition is coated on a core. However, Chow teaches long-lasting sustained dosage compositions, and carriers and active ingredients in the compositions thereof, such as controlled release and extended release drug compositions for oral controlled release dosage formulations containing a drug and a carrier material. See Para [0001]. pharmaceutical composition includes one or more aqueous polymeric colloidal dispersions adapted to coat a drug-containing core. See Para [0007]. Chow teaches The coating may include a surfactant and an aqueous dispersion of one or more insoluble pharmaceutical acceptable polymers, which may be one or more pH-independent and pH-dependent polymers. See Para [0008]. Acrylate and methacrylate are taught to be pH dependent. See Para [0022]. Polyvinyl acetate is taught as pH independent. See Para [0036]. Hydroxypropyl methyl cellulose acetate succinate is taught in claim 12. Chow makes clear that the use a core and polymers in a pharmaceutical delayed release composition is old and well know.
Response to arguments
Applicant in his response argues that “Timmins et. al. discloses various formulation technologies which may be useful for delivering new generation medicines for the treatment of inflammatory bowel disease. In case of Ozanimod, Timmins et al. disclosed that Ozanimod is potent, orally bioavailable S1P receptor antagonist. While discussing mechanism of action of Ozanimod, Timmins et. al. disclosed that Ozanimod has greater affinity for S1P1 receptors, rapidly induces a reversible reduction in circulating lymphocytes. The reduction in circulating lymphocytes leads to anti-inflammatory activity by inhibiting migration of pathogenic lymphocytes to site of inflammation. Timmins et. al. teaches that Ozanimod is a good candidate for a novel rapid-release formulation because Ozanimod is an anti-inflammatory agent that requires good systemic availability and thus, sustained plasma level is not required [emphasis added] (SEE Page 9). Thus, by studying Timmins a person skilled in the art will be motivated to develop an immediate-release composition of Ozanimod with reasonable expectation that such immediate-release composition will provide better treatment benefit”. It is the examiner’s position that Timmis is not relied upon in the instant Office Action. Furthermore, the remaining Yang and Chow teach the use of the claimed carriers in combination with other compounds being used in a delayed release composition in treating IBD. Therefore, it would have been obvious to a person skilled in the art to use such carriers with ozanimod. Additionally, there is no evidence of record commensurate in scope with the claimed language to show the advantages of delayed release ozanimod over immediate release in terms of treating inflammatory conditions, such IBD.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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