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 .
Response to Arguments
Applicant's arguments filed 5/4/2026 have been fully considered but they are not persuasive.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
The 112(b) rejections of claims 13-14 are withdrawn in light of amendment.
The 102(a) rejections of claims 1, 6, 8, 15 and 18-19 are withdrawn in light of amendment.
The following rejections and/or objections are either reiterated or newly applied.
New/modified 103 rejections of claims 1, 3-20 and 41 are presented as necessitated by amendment.
A New 112(b) rejection of claim 3 is presented as necessitated by amendment.
103 Rejection over Lee in view of Edman
Applicant argues the combination of Lee and Edman changes the principal operation of Lee, rendering Lee unsatisfactory for its purpose of protecting ATP from gastric juices. This argument is not persuasive. Lee teaches an enteric coating surrounding a granule comprising ATP disodium salt and various excipients loaded onto a crystal seed nucleus [0076]. The enteric coating serves to protect the granules from degradation by gastric juices (i.e. stomach acid) [0028]. As evidenced by Maderuelo, enteric coatings prevent the delivery of a drug in the stomach but permit release and absorption in distal portions of the gastrointestinal tract [Introduction], including the colon [pg. 6, right column, bottom].
Edman teaches an outer coacervate coating layer surrounding a polysaccharide-based matrix core containing a therapeutically active species [col 2 line 49-52]. The outer coacervate layer of Edman is selectively degraded by colonic enzymes to facilitate drug release in the colon [col 1 line 14-20]. Edman discloses that an aspect of their invention is the provision of a drug-free cover layer that is selectively enzymatically degradable in the colon, but is also resistant to the conditions prevailing in the stomach [col 1 line 60 - col 2 line 5]. Edman also teaches a method of treating the coacervate composition with hydrogen cations to induce carboxylate (COO-) groups in the polysaccharide chains to react with ions and form coupling points [col 4 line 57- col 5 line 6]. This causes the polysaccharide chains to become interconnected to a higher degree, thus allowing the outer coacervate layer to better withstand passing through the stomach [col 4 line 57- col 5 line 6]. Thus, the enteric coating of Lee and the coacervate layer of Edman serve compatible functions wherein both protect the drug-containing portion of the composition from gastric conditions as to allow for drug release at a desired target site. Consequently, Applicant's argument that Edman renders Lee unsatisfactory for its purpose of protecting ATP from degradation in the stomach is not persuasive.
New Claim Rejections - 35 USC § 112(b)
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.
Claim 3 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.
Claim 3 is written as depending from canceled claim 2. This renders the scope of the claim unclear. For purposes of compact prosecution, claim 3 is being interpreted as depending from claim 1.
New/Modified 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.
Claims 1, 3-4, 6, 8, 15, 18-19 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996).
Regarding claims 1 and 3, 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]. The base granulation formula may comprise of microcrystalline cellulose [0078] and maltodextrin [0081] (reads on polysaccharide matrix). Lee does not explicitly teach a composition comprising a shell disposed around the microencapsulation matrix to form 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]. Edman further teaches that the coacervate layer may comprise of polysaccharide [column 3 para. 2]. 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 polysaccharide 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 4, the composition of Lee may further comprise an enteric coating (reads on shell disposed around the microencapsulation matrix) [0082]. The coating protects the composition from by gastric juices (i.e. aqueous environment) [0050; 0125] (reads on microencapsulation matrix that prevents at least a portion of the plurality of bioactive molecules from undergoing hydrolysis). Similarly, the outer coacervate layer of Edman protects the drug-loaded matrix core from the conditions of the stomach [col line 57- col 5 line 6].
Regarding claim 6, Lee teaches that the agglomeration yields granules with an active ATP drug load of about 10% to 30% [0082].
Regarding claims 8 and 18, Lee teaches the ATP loaded particle may be coated with about 15% to about 40% aqueous enteric coating comprising about 5% Triacetin (reads on surfactant) by weight of the composition [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%). The claimed ranges overlap or lie inside ranges disclosed by the prior art, thus a prima facie case of obviousness exists. MPEP 2144.05
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 19, Lee teaches that the microencapsulation matrix may comprise hydroxypropylmethylcellulose and microcrystalline cellulose [0082].
Regarding claim 41, this claim recites limitations that have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein. (See rejections for claims 1 and 3-4.) Claim 41 recites the additional limitation wherein the composition comprises “a shell disposed around the microencapsulation matrix to form a coacervation microencapsulate wherein the shell comprises a surfactant and a polysaccharide.” Examiner would like to note that coacervation is a method producing a microencapsulate and the instant invention is directed to a product. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113 I. As discussed, Lee teaches that the ATP-loaded granules may comprise an outer shell/enteric coating [0082]. The shell comprises of triacetin (surfactant) and hydroxypropyl methylcellulose (polysaccharide) [0082]. Thus, even though Lee does not explicitly state the method by which its ATP-loaded granules are encapsulated, the enteric coating can be considered to read on the instant claim limitation of “coacervation microencapsulate wherein the shell comprises a surfactant and a polysaccharide.”
Claims 5 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996) as applied to claim 1 above, and further in view of CN 112136967A (hereinafter referred to as “Amorlife”, published 12/29/2020).
Regarding claim 5, Lee and Edman fail 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 and Edman 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 and Edman disclose 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 fail 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 and Edman 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 in a mamma(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). Modified 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, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996) as applied to claims 1 and 15 above, and further in view of CN 105832675B (hereinafter referred to as “Hubei”), published 10/26/2018.
Regarding claim 7, Lee and Edman make obvious the composition of claim 1 (discussed but fail 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 and Edman make obvious the composition of claims 1 and 15 (discussed above) but fail 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, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996) 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 and Edman make obvious the composition of claim 1 (discussed above) but fail to explicitly disclose a composition further comprising about 0.1% 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, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996) as applied to claims 1 and 15 above, and further in view of Rapaport et al. (US 2004/0162264A1, published 8/19/2004).
Regarding claim 16, Lee and Edman fail 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 and Edman 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, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996) as applied to claim 1 above, and further in view of CN 1233315C (hereinafter referred to as “Beijing”), published 12/28/2005.
Regarding claim 20, Lee and Edman make obvious 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].
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2005/0261238 A1, published 11/24/2005), in view of Edman et al. (US 5505966, issued 4/9/1996), and further in view of Kiekens et al. (US 2019/0321302 A1, published 10/24/2019), as evidenced by Mohamed et al. (2025).
Regarding claim 41, this claim recites limitations that have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein. (See rejections for claims 1 and 3.) Claim 41 recites the additional limitation wherein the composition comprises “a shell disposed around the microencapsulation matrix to form a coacervation microencapsulate wherein the shell comprises a surfactant and a polysaccharide.” The composition made obvious by Lee and Edman does not explicitly teach a coacervation microencapsulate shell comprising a surfactant and a polysaccharide.
Kiekens teaches a microencapsulated probiotic formulation [Abstract] wherein the outer shell may comprise of gum Arabic (surfactant) and chitosan (polysaccharide) [0018]. As evidenced by Mohamed, gum Arabic is commonly used in the food and pharmaceutical industries as an emulsifier (i.e. surfactant) [Abstract] (see also section 4.1.1). The microencapsulate may be produced using coacervation-phase separation (reads on coacervate microencapsulate) [0053]. Kiekens further teaches that the combination of gum Arabic with chitosan allows for cross-linking that may enhance the durability of the microcapsules, allowing for greater protection of the encapsulated contents against water and air [0056-0057]. It would be obvious to one of ordinary skill, before the effective filing date of the claimed invention, to modify the teachings of Lee and Edman with that of Kiekens, to formulate the instantly claimed microencapsulate composition with an outer coacervate shell comprising gum Arabic and chitosan to allow for great durability and improved long-term storage.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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