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 .
Status of the Claims
Claims 4, 6, 8 and 15 are canceled.
Claims 11-13 and 18-23 are withdrawn.
Claims 1-3, 5, 7, 9-10, 14, 16-17 and 24-25 are prosecuted.
(2) Response to Argument
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
WITHDRAWN REJECTIONS
The following grounds of rejection are not presented for review on appeal because they have been withdrawn by the examiner: claims 1-3, 5, 7, 9-10, 14 and 16-17 rejected under 35 U.S.C. 103 as being unpatentable over Gabillet, Meador, evidenced by Doing, in view of Roberts with evidence from Guillaume; claims 24-25 rejected under 35 U.S.C. 103 as being unpatentable over Gabillet, Meador, in view of Roberts evidenced by Doing and Guillaume, further in view of Guillaume and Perva-Uzunalić.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 09/17/2025 follows the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
New Rejections
Applicants’ amendments have necessitated the following grounds of rejection:
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.
Claims 1, 2, 16, 17, and all dependent claims thereof are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites in lines 2-4, “the supplement comprising non-synthetic caffeine and a viscosity adjustor suspended in stable liquid form in the form of one or more thickening agents … and one or more second viscosity adjustment components.” It is not clear if the stable form is that of the supplement or only that of the components comprised by the supplement (i.e., non-synthetic caffeine and viscosity adjustor).
Line 2 of claim 1 recites "a dose of a naturally occurring source of caffeine.” Lines 8-9 of claim 1 recite “the naturally occurring caffeine.” Here the difference lies in that the claim limits a source of caffeine while the claim also recites caffeine. Thus there is insufficient antecedent basis for this limitation in the claim.
The recitation of “about” in the last lines of claim 1 and claim 17, i.e., “about 1-3% wt” renders the claims indefinite. Regarding the amount of caffeine, it remains unclear as to how far removed from the recited 1% or 3% one can be and still be within the realm of the term “about”. The instant disclosure does not provide a definition that describes how the term definitively modifies the 1-3%.
Similarly, claim 2 recites “about 500-650 cps” and for the same reason as discussed above, this claim is indefinite.
Claim 16 also recites “about” several times throughout the claim in disclosing the amount of the components, and viscosity (see lines 3-5). Please see above discussion.
Claim 1 and all dependent claims thereof are rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
The omitted steps that render the claim incomplete are a means by containing the supplement in order to facilitate the recited “squirting it into the mouth of the neonatal calf.”
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 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 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, 7, 9-10, 14, 16-17 and 24-25 are rejected under 35 U.S.C. § 103 as being unpatentable over Farber et al. (US 20070196496 A1) in view of Higgins et al. (US 20040086579 A1).
Farber discloses oral gel delivery systems that comprise an ingestible matrix within which one or more functional ingredients are substantially uniformly and completely dispersed and in which degradation of the functional ingredient(s) is minimized or eliminated (abstract, [0039]). The term "functional ingredients” are substances intended to improve the general health of an animal and substances that provide some degree of nutritional or therapeutic benefit to an animal when consumed ([0033]). The term “animal” includes, but is not limited to, mammals (including both humans and non-human mammals) ([0037]).
The oral gel delivery system for functional ingredients comprising an effective amount of one or more functional ingredients substantially uniformly dispersed throughout a semi-solid matrix, said semi-solid matrix formulated from: (a) between about 8% and about 60% by weight of one or more sugars, sugar syrups, or sugar alcohols, or a combination thereof; (b) between about 0.5% and about 15% by weight of a carbohydrate component comprising one or more starches or modified starches; (c) between about 0.1% to about 15% by weight of one or more hydrocolloids, and (d) between about 5% and about 50% by weight of a solvent component comprising glycerol, wherein said delivery system has a final moisture content of between about 10% and about 40% by weight ([0024-0025], claim 1).
Farber discloses that the nutritional supplements may include caffeine and green tea extract ([0143-0144]). The sugar component may be a corn syrup, hydrogenated glucose syrup, high fructose corn syrup ([0075]) to read on the species corn syrup of instant claim 5 and thereby reads on the one or more thickening agents of instant claim 1.
The total amount of sugar components present in the matrix is about 10% to about 60% by weight ([0079]). In one embodiment, the sugar component comprises a mixture of sugar syrup in a total amount of about 10% to about 60% by weight ([0080]). See also Farber disclosing that each delivery system prepared with 20%-60% w/w sugars, sugar alcohols and /or sugar syrups ([0265]). Here the prior art reads on the claimed thickening agents comprising about 50-60 % wt limitation of instant claim 1.
Particularly in Example 27 Farber teaches a composition comprising caffeine, thickening agents: glycerin, corn syrup, high fructose corn syrup, second viscosity agent: potato starch, antioxidant: vitamin C, and water. The reference suggests green tea extract, xanthan and/or guar gum and different viscosities of the composition. Specifically Example 27 entitled Delivery System for Vitamin C and Caffeine has caffeine at 0.83%, glycerol at 39.64% and a blend of corn syrup and HFCS at 41.09% ([0279]). In addition, Example 28 shows caffeine is at 0.39%, glycerol is at 33.83%, a blend of corn syrup and HFCS, i.e., high fructose corn syrup is at 21.97% to give a thickening agent component that is 55.8% of the formulation ([0280]). Also, Example 30 shows caffeine at 2.39%, glycerol at 45.02% and blend of corn syrup and HFCS at 32.08% ([0282]). Here the teachings of Farber read on the caffeine comprising 1-3% limitation of instant claim 1. As stated above both caffeine and green tea extract are taught ([0143-0144]).
The matrix of Farber further comprises one or more hydrocolloids which are typically animal derived, and carbohydrate-based hydrocolloids, such as polysaccharide gels, which are typically plant derived and examples of polysaccharide gels include but are not limited to guar gum and xanthan gum ([0082]). The total amount of hydrocolloid incorporated into the matrix is generally between about 0.1% and about 15% by weight ([0088]). This range of 0.1-15% falls within and overlaps with the claimed range of 0.05-0.20% wt of instant claim 1.
With respect to the viscosity (cps) range limitation of instant claim 1 (i.e., 400-800 cps at 21° C), Farber teaches properties of the matrix can be improved and viscosity of the delivery system can be increased by incorporating vegetable gums or modified or unmodified celluloses ([0102]). For instance, when the carbohydrate component of the matrix comprises a modified starch, a modified vegetable gum or cellulose may be included ([0102]). Advantageously vegetable gums or celluloses improve the stability of the system in the event the product is left in an excessively hot environment ([0102]). Temperature is taught as being important in order to obtain accurate viscosity readings; the samples are usually tempered to 21° C to 24° C prior to testing and reporting in centipoise (cps) ([0186]).
Farber is silent on an exact viscosity (cps).
However, Higgins discloses an improved method for administering a plant-based extract (i.e., parthenolide) as a dietary supplement wherein an oral dosage composition comprising an amount of the extract in a predetermined dosage amount is orally administered to a patient (abstract). The composition comprises green tea extract ([0023], claim 5). In some embodiments the patient may be an animal ([0039]).
Higgins teaches that preferred thickening agents for the composition include guar gum, potato starch, and xanthan gum ([0033]). The compositions have a viscosity that is from about 500 cP to about 5000 cP (approximately the viscosity of corn syrup), all measured at 25° C ([0034]). Here the range of teaching overlaps with the claimed ranges of 400-800 cps (i.e., instant claim 1) and 500-650 cps (i.e., instant claim 2). MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
It would have been prima facie obvious to one of ordinary skill in the art ahead of the effective filing date of the claimed invention to combine the teachings of Higgins and Farber with expected results. Both Farber and Higgins disclose caffeine and/or green tea extract to mammals to include non-human mammals. One would have been motivated to do so because Farber wants to improve absorption of the functional ingredients, noting problems of poor absorption of the supplements and overdosing of the active ingredients particularly with powders and capsule forms ([0006-0007]). Higgins provides a solution to these problems by teaching a composition wherein at least a portion of the administered oral dosage composition is retained by the patient in the oral cavity for a time sufficient to allow absorption of the active by oral mucosal tissues (abstract). With respect to the viscosity aspect, Higgins provides an oral delivery system with enhanced mucoadhesive properties having viscosities that include preferably a viscosity of 500 cps to fall within the claimed ranges. One skilled in the art would be motivated adjust such compositions to such viscosities as that claimed 400-800 cps in order to achieve advantageous mucoadhesive properties taught by Higgins to improve upon the delivery of functional ingredients of Farber, e.g., caffeine, green tea extract.
Further, the adjustment of particular conventional working conditions (e.g., adjustment of thickening agents to second viscosity adjustment components ratios) is deemed merely a matter of judicious selection well within the purview of the skilled artisan and is considered no more than an effort to optimize results. Criticality of the instantly claimed ranges have yet to be established. For example, a show of unexpected results relative to the prior art of record and a comparison of a sufficient number of tests both inside and outside the claimed range may support criticality. See MPEP 716.02.
Regarding claims 3, 10, and 24, both Farber and Higgins teach green tea extract (Farber [0144]; Higgins [0023]).
Regarding claim 5, Farber teaches high fructose and corn syrup (Example 27, claim 27).
Regarding claim 7, Farber teaches potato starch ([0282]).
Regarding claim 9, Farber teaches antioxidant ([0027], claim 16).
Regarding claim 14, Farber teaches sodium citrate in combination with other nutritional supplements ([0267] see Table 12).
Regarding claims 16 and 17, Farber teaches xanthan gum and guar gum; such use of hydrocolloids is well-known in the art and many hydrocolloids for use in products for human or animal consumption are available commercially ([0082]). Farber teaches 0.1% to about 15% by weight of one or more hydrocolloids ([0024]) to overlap with the claimed 0.05-0.20% range. Farber teaches the use of corn syrup at 50-60% wt ([0075], [0079]). And in view of Higgins teaching of a viscosity500 cps, as discussed above, one skilled in the art having known the information about viscosities of such components described in the art would be able to obtain a supplement with 400-800 cps.
Regarding claim 17 (i.e., green tea extract is 1-3%), as mentioned above Farber teaches green tea extract and caffeine as nutritional supplements in combination with other nutritional supplements ([0143-0144], see page 31 [0267] Table 12). The delivery systems of Farber comprise between about 0.01 and about 40% by weight of the one or more functional ingredients ([0146]). Examples 27 and 28 show caffeine delivered with other functional ingredients and Example 30 shows caffeine at 2.39%.
Regarding claim 25 (i.e., 100-400 mg caffeine), Farber teaches representative examples of types of delivery systems and suggested functional ingredients for incorporation that include caffeine (Table 1). In the above-mentioned Example 30 entitled Delivery System for Caffeine, the delivery system was formulated to deliver caffeine in a 5 g final product and comprises greater than 47% w/w of solvent ([0282]). Here the prior art teaches at least 100 mg of caffeine. Further, the prior art provides a basis for which one skilled in the art can adjust the amounts to obtain the desired percentage of green tea extract containing a concentrated amount of caffeine in the formulation. Such techniques are readily applied in the art and is well within the purview of one skilled in the art.
Conclusion
Claims 1-3, 5, 7, 9-10, 14, 16-17, and 24-25 are rejected.
Claims 11-13 and 18-23 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571) 270-5896. The examiner can normally be reached 900-500 ET.
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/Karen A Ketcham/Examiner, Art Unit 1614 /ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
