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
Claims 1-20 are pending.
Election/Restrictions
Applicant’s election of the Invention of Group I, claims 1-15, drawn to an oral formulation in the reply filed on 2/2/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 are withdrawn as being drawn to a nonelected invention.
Claims 1-15 are under consideration.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 1/18/24. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 1-15 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 pre-AIA the applicant regards as the invention.
Claims 1-5 each recite an “an in vitro dissolution” of the first and/or second composition. The claims do not define how the dissolution is achieved. A dissolution of a composition depends upon the conditions under which it is tested, for example the type of dissolution medium, the pH, the temperature, if the composition is stirred or is static, etc. The same composition may have different dissolution profiles based on different testing conditions. The metes and bounds of the claims are unclear because the claims do not define the testing method or conditions. Claims 6-15 are rejected as depending from and not clarifying claim 1.
Claim 14 contains the trademark/trade name "145K290001". Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a mixture of hydroxypropyl methyl cellulose, triacetin and talc and, accordingly, the identification/description is indefinite.
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 of this title, 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 1-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vepuri et al. (US 2016/0128943; cited previously).
Vepuri et al. teach formulations comprising a combination of extended release components, rapid release components, immediate release components, and delayed release components which are combined to provide caffeine dosage forms having the desired release profile and/or pharmacokinetic parameters (e.g. paragraph 0024).
Vepuri et al. teach an oral tablet formulation, comprising:
a first component comprising caffeine (i.e. a xanthine derivative); and
a second component comprising caffeine and EUDRAGIT L100 (i.e. a xanthine derivative and an enteric excipient)(e.g. Examples, paragraph 0078; Claim 1).
Regarding the release profiles, see rejection under 112(b) above. Vepuri et al. teach that a dissolution of the composition releases 25-70% of the caffeine within about 30 minutes to about 3 hours post-administration, at least about 75% of the caffeine is released within about 4 hours post-administration, at least about 90% of the caffeine is released within about 5 hours post-administration, at least about 95% of the caffeine is released within about 6 hours post-administration, and about 100% of the caffeine is released within about 7 hours post-administration (e.g. Claim 7), and further that the first component provides for an immediate release of up to about 50% of the total caffeine within about one hour after administration under physiological conditions, and wherein the second component provides release of the remaining caffeine that is delayed until at least 3 hours after administration, and release occurs up to about 8 hours after administration under physiological conditions (e.g. claim 9). Vepuri otherwise does not distinguish between release from the first or second compositions versus release from the composition as a whole.
Regarding Claims 1-5, the profiles disclosed by Vepuri et al. overlap the claimed release profiles. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I). In addition, Vepuri et al. teach that one or more loading dosages can be prepared by creating coated or multilayer coated capsules or tablets, where the rate of dissolution will depend on a number of factors, in some cases including the particular nature of the film-forming polymer and the encapsulated material (e.g. paragraphs 0090). It would have been obvious to one of ordinary skill in the art at the time of filing to vary the tablet composition and therefore vary the rate of dissolution in order to optimize the resulting product to achieve a desired dissolution rate in order to provide caffeine dosage forms having the desired release profile and/or pharmacokinetic parameters. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 6, Vepuri et al. teach the composition may be a bilayered tablet (e.g. paragraphs 0067-0071, 0108).
Regarding Claim 7, Vepuri et al. exemplify a tablet comprising 320 mg of a first composition 312 mg of a second composition, resulting in a ratio of 1:1.03, which is within the claimed range (e.g. Example 1).
Regarding Claims 8 and 9, Vepuri et al. teach that the coating may comprise zein (e.g. paragraph 0086, 0097; Claim 17). Vepuri et al. do not teach an amount of zein, but they exemplify a second component comprising caffeine and Eudragit L-100 at 8 wt% (i.e. a xanthine derivative and an enteric excipient)(e.g. Example 6, Batches 176 and 177). It would have been obvious to one of ordinary skill in the art at the time of filing to replace the Eudragit L-100 of Batches 176 and 177 with zein, as Vepuri et al. teach them to be suitable polymers (e.g. paragraphs 0086 and 0097). In addition, as Vepuri et al. do not teach a general concentration range for polymers, it would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the zein concentration through routine experimentation to arrive at the concentration of 5.5-10% in order to optimize the resulting product.
Regarding Claims 10-12, Vepuri et al. teach a coated tablet form having two loading dosage layers and a total loading dosage of 250 mg of caffeine, the outermost/first-most loading dosage layer could contain 200 mg with the second loading dosage layer containing 50 mg (e.g. paragraph 0108).
Regarding Claim 15, Vepuri et al. teach the initial peak blood plasma concentration is reached within about one hour after administration (e.g. paragraph 0112, Claim 29).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Vepuri et al. (US 2016/0128943; cited previously), as applied to claims 1-12 and 15, and further in view of Dulloo et al. (Am J Clin Nutr. 1999 Dec;70(6):1040-5)) and Folger et al. (US 2013/0084332).
Regarding Claims 1-12 and 15, the teachings of Vepuri et al. are described supra. Vepuri et al. further teach that the compositions may comprise polyvinylpyrrolidone, microcrystalline cellulose, crospovidone, magnesium stearate and silicon dioxide (e.g. paragraphs 0086, 0088, 0090, 0092, 0094, 0099, 0100, 0101 and 0104; Examples). As evidenced by the instant Specification, coating 145K290001 is a mixture of hydroxypropyl methyl cellulose, triacetin and talc, which are taught as coating ingredients by Vepuri et al. (e.g. paragraphs 0076, 0084, 0086, 0088, 0092, 0094, 0097; Examples).
Vepuri et al. do not teach the inclusion of green tea extract, wherein the green tea extract includes the xanthine derivative, or the inclusion of medium chain triglyceride. This is made up for by the teachings of Dulloo et al. and Folger et al.
Dulloo et al. investigated whether a green tea extract, by virtue of its high content of caffeine and catechin polyphenols, could increase 24-h energy expenditure (EE) and fat oxidation in humans (e.g. abstract). Dulloo et al. investigated 3 treatments: green tea extract (50 mg caffeine and 90 mg epigallocatechin gallate), caffeine (50 mg), and placebo. Dulloo et al. concluded that green tea has thermogenic properties and promotes fat oxidation beyond that explained by its caffeine content per se. The green tea extract may play a role in the control of body composition via sympathetic activation of thermogenesis, fat oxidation, or both (e.g. abstract).
Folger et al. teach taste masked multi-layered particles an inert core, one or more coating layer(s) comprising a pharmaceutically active ingredient (e.g. abstract). Folger et al. teach that the active may be a xanthine derivative (e.g. paragraph 0007, 0138). Folger et al. teach that the composition comprises medium chain triglycerides as an additional ingredient (e.g. paragraph 0207; Claim 23). Folger et al. teach that the composition is a tablet (e.g. Claims 52 and 54).
It would have been obvious to one of ordinary skill in the art at the time of filing to select green tea extract as the source of caffeine for the tablets of Vepuri et al. One of ordinary skill in the art would have predicted success as green tea comprises caffeine, and would have been motivated to obtain the additional benefits of thermogenesis and fat oxidation. It further would have been obvious to one of ordinary skill in the art at the time of filing to include the medium chain triglycerides of Folger et al. for use in the composition of Vepuri et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as both Vepuri and Folger teach tablets comprising xanthine derivatives and overlapping excipients. Simple substitution of one known element for another to obtain predictable results is obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619