DETAILED ACTION
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 .
Specification
The disclosure is objected to because of the following informalities:
[0002] line 3: “roll” should be “role”
[0044] last line: “homogonous” should be “homogeneous”
[0061] line 6: “spray dried” is labeled 628 instead of 620, as on Figure 6
[0066] line 3: “matric” should be “matrix”
[0066] line 5: “bioactive molecules” is labeled 806 instead of 802, as on Figure 8
[0067] line 3: “430” and “630” do not correspond with any number labels present in the drawings
[0068] line 6: “bioactive molecules” is labeled 806 instead of 802, as on Figure 8
[0071] line 2: “805” does not correspond with any number label present in the drawings
[0072] line 2: “bioactive molecules” is labeled 806 instead of 802, as on Figure 8
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware of in the specification.
Claim Interpretation
Claims 3 and 8: “constructed of” is being interpreted to be a grammatical equivalent of “comprises”
Claim Rejections - 35 USC § 112
4. 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 13-14 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.
Regarding claims 13 and 14, they recite “the mammalian body” which lacks antecedent basis as they both depend from claim 11, which does not recite a mammalian body. See MPEP 2173.05(e).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 8, 15, 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2005/0261238 A1), published 11/24/2005.
Regarding claims 1 and 6: Lee teaches a method for preparing an ATP disodium salt composition wherein ATP disodium is agglomerated into granules using a seed crystal nucleus, upon which a mixture containing ATP and various excipients for binding are progressively loaded (reads on microencapsulation matrix) [0076]. Lee further teaches that the agglomeration yields granules with an active ATP drug load of about 10% to 30% [0082] and comprising microcrystalline cellulose [0078] and maltodextrin [0081] (reads on polysaccharide).
Regarding claim 8: Lee teaches the ATP loaded particle may be coated with about 15% to about 40% aqueous enteric coating comprising about 5% Triacetin [0082]. Thus, the triacetin is present in the amount of from about 0.75% to about 2% by weight of the composition (0.15x5 to 0.40x5 = 0.75% to 2%), which reads on the instant claim limitation of about 0.4% to about 3.5% surfactant matrix by weight.
Regarding claim 15: Lee teaches the ATP composition may be dried to yield a granule from about 100 microns to about 1000 microns in size [0082] (reads on dry powder form).
Regarding claim 18: Lee teaches that the dried granules of claim 15 may further may be coated with aqueous enteric coating (reads on configured to be disposed around the matrix) comprising triacetin (reads on surfactant) present in the amount of about 0.75% to about 2% by weight of the composition [0082] (see math above).
Regarding claim 19: Lee teaches the composition of claim 1 and further teaches that the microencapsulation matrix may comprise hydroxypropylmethylcellulose and microcrystalline cellulose [0082].
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1) as applied to claim 1 above, and further in view of Edman et al. (US 5505966), issued 4/9/1996.
Regarding claim 2: Lee discloses the composition of claim 1 (discussed above) wherein the composition further comprises an enteric coating (reads on shell disposed around the microencapsulation matrix) [0082]. However, Lee does not explicitly teach a composition wherein the shell disposed around the microencapsulation matrix forms a coacervation microencapsulate. Edman teaches a composition comprising a polysaccharide-based matrix containing a therapeutically active species with an outer coacervate cover layer [Abstract; column 2, line 49]. It would be obvious to one of ordinary skill in the art, before the filing date of the claimed invention, to modify the teachings of Lee with that of Edman, to include a shell disposed around a microencapsulation matrix to form a coacervation microencapsulate for the benefit of retaining the active substance within the microencapsulation matrix until a desired target location is reached, upon which time the active substance is quickly and efficiently released [column 1, lines 14-20; column 2 lines 49-52].
Regarding claim 3, modified Lee (discussed above) teaches that the shell may comprise triacetin (reads on surfactant) and hydroxypropylmethylcellulose (reads on polysaccharide) [0082].
Claims 4, 5, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1) as applied to claim 1 above, and further in view of CN 112136967A (hereinafter referred to as “Amorlife”), published 12/29/2020.
The Examiner has provided a copy of the machine translation of Amorlife being relied upon below.
Regarding claims 4 and 5, Lee discloses the composition of claim 1 (discussed above) wherein the composition is protected from degradation by gastric juices (i.e. aqueous environment) through enteric coating [0050; 0125] (reads on microencapsulation matrix that prevents at least a portion of the plurality of bioactive molecules from undergoing hydrolysis), but fails to explicitly teach a composition further comprising water in the amount of about 70% to about 90% by weight. Amorlife teaches an energy supplementing solution comprising an adenosine triphosphate and water [Abstract] in the amount of 78.51% to 89.57% water by weight [0011]. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Amorlife to include water in the composition in the amount taught for the purpose of formulating an energy-supplementing beverage as desired by Lee [0023].
Regarding claim 11, Lee discloses the composition of claim 1 wherein the microencapsulation matrix prevents at least a portion of the plurality of bioactive molecules from undergoing hydrolysis (discussed above), but fails to explicitly disclose one or more of a natural or artificial flavoring additive; a natural or artificial coloring additive; or a preservative. Amorlife teaches an energy supplementing solution comprising an adenosine triphosphate and further comprising yeast extract as a flavor additive [0028]. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Amorlife to include a flavor additive, such as yeast, to modify the flavor and make the composition more palatable [0028].
Regarding claim 12, modified Lee teaches the composition of claim 11 (discussed above). Lee further teaches that the composition may be administered in nutraceutical or functional food forms to a mammal [Abstract; 0028], or formulated for human consumption [0052] (reads on food-grade components such that the composition is prepared for consumption by a mammalian body).
Regarding claim 13, modified Lee teaches the composition of claim 11 (discussed above). Lee further teaches that the composition may be administered in an amount effective to improve muscle size and/or strength (reads on effective amount for increasing strength of muscle contractions in the mammalian body) [Abstract; 0028]. See also Figure 13.
Regarding claim 14, modified Lee teaches the composition of claim 11 (discussed above). Lee fails to explicitly disclose a composition wherein the plurality of bioactive molecules is present in an effective amount for increasing the speed of cellular metabolism in the mammalian body. Amorlife teaches an energy supplementing solution comprising ATP wherein the ATP participates in synthesis of protein, fat, sugar, and nucleotides, which can enhance cell metabolic activity [0027]. Amorlife discloses that experimental groups of cats fed the nutrient solution displayed improved activity [Table 1; 0067]. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Amorlife, to formulate a composition containing ATP in an amount effective to enhance cellular metabolism to form a nutrient solution to supplement energy and enhance the cell metabolic activity. [0027; 0067].
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1) as applied to claims 1 and 15 above, and further in view of CN 105832675B (hereinafter referred to as “Hubei”), published 10/26/2018.
The Examiner has provided a copy of the machine translation of Hubei being relied upon below.
Regarding claim 7, Lee discloses the composition of claim 1 (discussed above). Lee fails to explicitly teach a composition wherein the microencapsulation matrix comprises from about 0.5% to about 3.5% by weight of the composition. Hubei teaches a polysaccharide encapsulated composition [Abstract] wherein the composition is prepared from a 3% chitosan solution with an encapsulation rate of 75.82% [0030]. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Hubei to formulate an ATP loaded particle with a chitosan matrix to impart controlled and sustained release of ATP [Abstract].
Regarding claim 17, Lee discloses the composition of claims 1 and 15 (discussed above). Lee fails to explicitly teach a composition wherein the microencapsulation matrix comprises from about 2.5% to about 17.7% by weight of the composition. As discussed, Hubei teaches a polysaccharide encapsulated composition [Abstract] wherein the composition is prepared from a 3% chitosan solution with an encapsulation rate of 75.82% [0030]. Generally, differences in concentration 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). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Hubei to formulate an ATP loaded particle with a chitosan matrix in the claimed amounts in order to adjust the controlled rate of release of bioactive molecules disposed within the microencapsulation matrix [0002].
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1) as applied to claim 1 above, and further in view of WO 2019/214567 A1 (hereinafter referred to as “EPC”), published 11/14/2019.
Regarding claims 9 and 10, Lee discloses the composition of claim 1 (discussed above) but fails to explicitly disclose the composition further comprising from about .01% to about 1.0% by weight of inorganic mineral, wherein the effective amount of the inorganic mineral comprises one or more of calcium, magnesium, chloride, phosphate, potassium, or sodium. EPC teaches an encapsulated flavor composition [0006] that may comprise ATP additives [00771] and calcium, magnesium, potassium, sodium, phosphate, chloride or combinations thereof [00756; 00758; 00815]. EPC further teaches that minerals may be present in the composition in an amount effect to provide an amount from about 25 ppm to about 25,000 of the final composition (i.e. about 0.0025% to about 2.5% by weight) [00759]. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of EPC to add inorganic minerals to the composition as a nutrition supplement [00754] or as an electrolyte/hydration agent to help the body replenish fluids lost during exercise [00815].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1) as applied to claims 1 and 15 above, and further in view of Rapaport et al. (US 2004/0162264A1), published 8/19/2004.
Lee fails to explicitly disclose a composition wherein the plurality of bioactive molecules comprises ATP disodium salt and wherein the composition comprises from about 50% to about 90% by weight of the ATP disodium salt. Rapaport teaches an ingestible composition of ATP wherein ATP comprises 60.6% by weight of the composition (500 mg ATP tablet) [0017]. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Rapaport, to include ATP in the taught amount by Rapaport to provide an amount effective to stimulate lipolysis to impart weight loss in humans [0012].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1) as applied to claim 1 above, and further in view of CN 1233315C (hereinafter referred to as “Beijing”), published 12/28/2005.
The Examiner has provided a copy of the machine translation of Beijing being relied upon below.
Regarding claim 20, Lee teaches the composition of claim 1, further comprising a surfactant matrix configured to be disposed around the microencapsulation matrix [0082]. Lee fails to explicitly disclose a surfactant matrix wherein the surfactant matrix is constructed of one or more of polyethylene glycol; propylene glycol; propanediol; or a lecithin extracted from one or more of egg yolks, seafood, soybeans, milk, rapeseed, cottonseed, or sunflower oil. Beijing teaches a composition comprising a surfactant matrix wherein the surfactant is polyethylene glycol [Abstract]. It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Lee with that of Beijing, to improve bioavailability and facilitate quick drug release [Abstract; 0013].
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached M-F 730-5 ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613