DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Claim Interpretation
Regarding claims 1-15, the claimed formulation is drawn to product claims and therefore the intended use of the formulation, “for use with a pressurized metered dose inhaler (MDI)” does not carry patentable weight over the teachings of the prior art.
Claim Rejections - 35 USC §103
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
on sale or otherwise available to the public before the effective filing date of the claimed
invention.
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 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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US20170281666A1) hereinafter Chang in view of Balwani et al. (WO2008109018A1) hereinafter Balwani.
Regarding claims 1-20, Chang is drawn to compositions for oral administration and processes of preparing the same are described. In particular, compositions in the form of bilayer tablets including B vitamins for modified delivery are described. The bilayer multi-B vitamin tablets offer immediate release of a first set of B vitamins, such as riboflavin (B2) and cyanocobalamin (B12) followed by controlled release of a second set of B vitamins, such as folic acid, biotin, niacinamide (B3), pyridoxine (B6), pantothenic acid (B5) and thiamine (B1) (abstract).
Chang discloses a bilayer multi-active formulation comprising a first layer comprising basic yeast and a first set of active components, the first layer providing immediate release of the first set of active components at a first location in the gastrointestinal tract; a second layer comprising basic yeast and a second set of active components, the second layer providing a modified release of the second set of active components at a second location in the gastrointestinal tract; wherein the basic yeast from the first layer contributes to the modified release of the second set of active components from the second layer; and optionally, a film coating that covers the first layer and the second layer [0009]
Chang discloses the immediate release layer may also include bulking agents, such as lactose, microcrystalline cellulose, wood cellulose, corn starch, modified corn starch [0062]. The immediate release and modified release layers each comprise abutting substantially planar layers, which form the bilayer tablet [0069]
the bilayer tablet may also include an outer protective coating layer that may comprise from 0 to about 15% by weight of the bilayer tablet [0071].
Chang discloses the delivery system may also include other non-vitamin B components, including other vitamins or minerals, or trace elements that are to be released at the first and or the second location(s). Specifically, in certain further embodiments, the immediate and or modified release layers may include other vitamins, such as A, C, E, D and K. In addition, one or more minerals and trace elements, including, but not limited to chromium, calcium, zinc, magnesium, molybdenum, selenium, copper and iodine, may be included in immediate and or modified release layers. Furthermore, other actives, such as phytonutrients (e.g., cartoneoids like betacarotene, lycopene, lutein, zeaxanthin, etc.), or flavonoids (e.g., catechins, hesperidin, quercetin, etc.), or ellagic acids (e.g., resveratrol), glucosinolates, phytoestrogens, or active pharmaceutical ingredients may be included. The components of the modified release layer will be released after the components of the immediate release layer, and at the same point and or a point downstream from the release of the components of the immediate release layer [0059].
Chang discloses in forming the bilayer tablet, both layers may be prepared by conventional wet granulation or dry granulation (compaction) techniques. The layers may then be compressed and combined to form a bilayer tablet employing conventional bilayer tableting equipment. In certain embodiments, the immediate release and modified release layers each comprise abutting substantially planar layers, which form the bilayer tablet [0067-0069].
Chang discloses in carrying out the method of the present invention, the bilayer multi-B formulations containing a first set of vitamin B components comprising riboflavin (B2) and cyanocobalamin (B12) and a second set of vitamin B components comprising folic acid, biotin, niacinamide (B3), pyridoxine (B6), pantothenic acid (B5) and thiamine (B1) may be administered to mammalian species, such as monkeys, dogs, cats, rats, humans, etc. as a dietary supplement, and, as described hereinbefore, may be incorporated in tablet [0073].
Chang does not explicitly disclose wherein the starch is a modified tapioca starch.
However, Balwani discloses the pharmaceutical composition provides controlled release consisting of rapid initial release and extended release of carisoprodol with or without the one or more additional active agents for about 6 hours to about 24 hours, preferably a period greater than 12 hours in the form of a bilayer tablet, where one layer comprises the immediate release formulation and the other layer provides the extended release formulation [0082].
Balwani discloses examples of modified starches for use in the practice of the present invention include, but are not limited to, modified tapioca starches, hydroxypropylated tapioca starches [0168].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings as previously disclosed by Chang, wherein the starch is modified tapioca, as previously disclosed by Balwani, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Chang and Balwani are both in the field of bilayer tablets, and Balwani discloses immediate release and extended release bilayer tablets [0082], comprising hydroxypropylated tapioca starches [0168], thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
From the teachings of the references, it is 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 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
Prosecution Insights