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, 3-9, 12, 13, 15, 21, 23-27, 32 and 41-42 are presented for examination.
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 and 21 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.
Claims 1 and 21 are rejected as to the term “UPLC”. Such phrase fails to set forth the intended meaning.
The claims depending on claims 1 and 21 are also rejected, since they have all the limitations of the rejected claims.
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, 3-9, 12, 13, 15, 21, 23-27, 32 and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ostrow et al. (US 20160339007).
The claims are drawn to A method of manufacturing a multi-dose ophthalmic consumer product, comprising:
providing a sterile ophthalmic composition comprising a therapeutic agent, wherein the therapeutic agent is atropine or a pharmaceutically acceptable salt thereof, and further comprising a viscosity modifier that generates a dynamic viscosity of between 5 and 50 cP (centipoise); aseptically filling the sterile ophthalmic composition into a sterilized container; wherein the container is prepared from a polymer and is sterilized in a process that post- sterilization and after storage of the ophthalmic composition at 40 °C for at least 6 months (a) limits loss of dynamic viscosity to equal or less than 5 cP, and (b) limits total impurities leached from the container to equal or less than 6.5 wt.% as determined by reverse phase UPLC.
Regarding claim 1, Ostrow teaches an ophthalmic composition comprising atropine. See Para [0003]. The use of a viscosity modifier, such as cellulose is taught in para [0022]. The use of polymer containers, such as polyethylene glycol and propylene glycol for storing the ophthalmic formulation is taught in Para [0115]. Ostrow teaches that the composition stored in a plastic container has a potency of at least 99% after extended period of time under storage condition. In some instances, the storage condition comprises a temperature of about 25° C., about 40° C., or about 60° C. In some instances, the extended period of time is at least 1 week, at least 2 weeks, at least 3 weeks, at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 18 months, or at least 24 months. See Para [0117]. The sterilization by filtration is taught in Para [0185]. The concentration of atropine is taught in Para [0010]. The sterilization by autoclaving is taught in Para [0186} and [0189]. Ostrow teaches that the composition comprises less than 5% of major degradant based on the concentration of the ophthalmic agent after extended period of time under storage condition. See Para [0012]. The use of HPLC for measuring the amount of atropine or impurities is taught in Para [0167]. Ostrow, teaches the viscosity of 10-50,000 cps, which encompasses the claimed viscosity. See Para [0169]. Ostrow does not teach the viscosity of between 5 and 50 cP. However, Ostrow teaches the viscosity of 10-50000 cP, which encompasses the claimed viscosity. It would have been obvious to a person skilled in the art to select the claimed viscosity which is within the range of Ostrow’s viscosity in the absence of evidence to the contrary. The limit loss of the dynamic viscosity is the inherent property of Ostrow’s composition. In terms of the total impurities, Ostrow teaches the composition comprises less than 5% of major degradant based on the concentration of the ophthalmic agent after extended period of time under storage condition. See Para [0012]. The use of reversed phase HPLC for measuring the concentration of atropine and the determination of degradation as a result is taught in Para [0167].
Regarding claim 3, Ostrow teaches the muscarinic antagonist is present in the composition at a concentration of: from about 0.001 wt. % to about 0.04 wt. %, from about 0.001 wt. % to about 0.03 wt. %, from about 0.001 wt. % to about 0.025 wt. %, from about 0.001 wt. % to about 0.02 wt. %, from about 0.001 wt. % to about 0.01 wt. %, from about 0.001 wt. % to about 0.008 wt. %, or from about 0.001 wt. % to about 0.005 wt. %. See Para [0057], [0010] and [0206]. The concentration of 0.001-0.05% is taught in Para [0047] and [0057].
Regarding claim 4, Ostrow teaches the use of a cellulosic material as a viscosity modifier. See Para [0022].
Regarding claim 5, Ostrow teaches the use of cellulose such as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, nitro celluloses, hydroxypropyl cellulose, carboxymethyl cellulose in Para [0205].
Regarding claim 6, Ostrow teaches the use of viscosity enhancing agents other than cellulose. See Para [0022].
Regarding claim 7, Ostrow teaches the use of polysaccharide, such as dextran as a viscosity enhancing agent. See Para [0022].
Regarding claim 8, Ostrow teaches filtering and autoclaving as means for sterilizing the ophthalmic solution. See Paras [0185], [0186] and [0189].
Regarding claim 9, Ostrow, teaches the viscosity of 10-50,000 cps, which encompasses the claimed viscosity. See Para [0169]. It would have been obvious to a person skilled in the art to select a viscosity within the scope of the claimed viscosity in the absence of evidence to the contrary.
Regarding claim 12, Ostrow teaches the containers being polypropylene and low density polyethylene. See Para [0115].
Regarding claim 13, Ostrow teaches the use of ethylene oxide as a mean of sterilization, which reads on the gaseous sterilization. See Para [0197].
Regarding claim 15, Ostrow teaches the impurities of less than 5% impurities leached from the container, but does not teach the viscosity of less than 4cP. See Para [0012]. The determination of optimum viscosity is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 21, Ostrow teaches an ophthalmic composition comprising atropine. See Para [0003]. The use of a viscosity modifier, such as cellulose is taught in para [0022]. The use of polymer containers, such as polyethylene glycol and propylene glycol for storing the ophthalmic formulation is taught in Para [0115]. Ostrow teaches that the composition stored in a plastic container has a potency of at least 99% after extended period of time under storage condition. In some instances, the storage condition comprises a temperature of about 25° C., about 40° C., or about 60° C. In some instances, the extended period of time is at least 1 week, at least 2 weeks, at least 3 weeks, at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 8 months, at least 10 months, at least 12 months, at least 18 months, or at least 24 months. See Para [0117]. The sterilization by filtration is taught in Para [0185]. The concentration of atropine is taught in Para [0010]. The sterilization by autoclaving is taught in Para [0186} and [0189]. . It would have been obvious to a person skilled in the art to select the claimed viscosity which is within the scope of Ostrow’s viscosity in the absence of evidence to the contrary. Ostrow teaches that the composition comprises less than 5% of major degradant based on the concentration of the ophthalmic agent after extended period of time under storage condition. See Para [0012]. The concentration and purity of atropine was determined by reverse phase HPLC. See Para [0167].
Regarding claim 23, Ostrow teaches the muscarinic antagonist is present in the composition at a concentration of one of: from about 0.001 wt. % to about 0.04 wt. %, from about 0.001 wt. % to about 0.03 wt. %, from about 0.001 wt. % to about 0.025 wt. %, from about 0.001 wt. % to about 0.02 wt. %, from about 0.001 wt. % to about 0.01 wt. %, from about 0.001 wt. % to about 0.008 wt. %, or from about 0.001 wt. % to about 0.005 wt. %. See Para [0057], [0010] and [0206]. The concentration of 0.001-0.05% is taught in Para [0047] and [0057].
Regarding claim 24, Ostrow teaches the use of a cellulosic material as a viscosity modifier. See Para [0022].
Regarding claim 25, Ostrow teaches the use of celluloses such as alkyl celluloses, hydroxyalkyl celluloses, cellulose ethers, cellulose esters, nitro celluloses, hydroxypropyl cellulose, carboxymethyl cellulose in Para [0205].
Regarding claim 26, Ostrow teaches the use of viscosity enhancing agents other than cellulose. See Para [0022].
Regarding claim 27, Ostrow teaches the use of polysaccharide, such as dextran as a viscosity enhancing agent. See Para [0022].
Regarding claim 32, Ostrow teaches the containers being polypropylene and low density polyethylene. See Para [0115]. The sterilization of the containers by ethylene oxide would have been obvious to a person skilled in the art, considering that Ostrow teaches ethylene oxide is a mean of sterilizing containers. See Para [0197].
Regarding claim 41, Ostrow teaches the muscarinic antagonist is present in the composition at a concentration of one of: from about 0.001 wt. % to about 0.04 wt. %, from about 0.001 wt. % to about 0.03 wt. %, from about 0.001 wt. % to about 0.025 wt. %, from about 0.001 wt. % to about 0.02 wt. %, from about 0.001 wt. % to about 0.01 wt. %, from about 0.001 wt. % to about 0.008 wt. %, or from about 0.001 wt. % to about 0.005 wt. %. See Para [0057], [0010] and [0206]. The concentration of 0.001-0.05% is taught in Para [0047] and [0057]. Ostrow teaches the containers being polypropylene and low density polyethylene. See Para [0115]. The sterilization of the containers by ethylene oxide would have been obvious to a person skilled in the art, considering that Ostrow teaches ethylene oxide is a mean of sterilizing containers. See Para [0197]. The determination of the volume of a container is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 42, Ostrow teaches the use of hydroxypropyl methylcellulose a phosphate buffer. See Para [02050, [0103] and [0105]. The use of ethylene oxide for sterilization of containers is also taught by Ostrow. See Para [0197].
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