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
Status of Claims
Claims 14-16 are canceled. Claims 1-13 are pending and currently under examination and the subject matter of the present Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
“L-Arginine-L-Asparat” should not be capitalized, and is missing an “e” at the end of aspartate.
Appropriate correction is required.
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 1-12 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.
Claim 1 is rejected because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation in the same claim is considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In this case, Claim 1 recites “amino acids or salts thereof”, which is the broader limitation, and also recites “magnesium L-aspartate”, "L-arginine-L-aspartate", and “L-lysine acetate”, which are narrow salt limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. All claims depending from Claim 1 are also rejected.
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 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 1-5, 7, 10, and 12-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Schoemaker et al. (WO 2018/108931 A2), hereinafter Schoemaker.
Schoemaker discloses the administration to subjects of nutritional compositions comprising dietary butyrate or lactoferrin, a carbohydrate source, a protein source, and a fat source (Claim 1). In some embodiments, the dietary butyrate may be provided in an encapsulated or coated with inter alia hydrocolloids, such as starches, maltodextrins etc. for longer shelf-stability and improved organoleptic properties [0059].
Regarding Claim 1, Schoemaker teaches the protein source to comprise of extensively hydrolyzed protein such as casein [0156]-[0158]; the protein hydrolysate is stored at a liquid state [0155]. The nutritional composition also comprises a carbohydrate source such as maltodextrin and starch etc. [0166]. The composition comprising the protein can be administered in a liquid nutritional drink, or can be further processed, preferably by spray-drying with a carrier material such as maltodextrin [0115]—[0017]. As such, Claim 13 is also rendered obvious.
Regarding Claim 2, 4-5, and 7 Schoemaker teaches the protein source comprise about 5%-30% of nonfat milk powder and about 2wt% to about 20wt% of whey protein concentrate based on the total weight of the nutritional composition [0166]. In some embodiments, the nutritional composition comprises between about 1 g and about 7 g of a protein source per 100 Kcal, in some embodiment about 3.5 g and about 4.5g/100 Kcal [0165]. Schoemaker teaches carbohydrate sources for the nutritional composition includes maltodextrins, sucrose, starch etc. between 5-25g per 100 Kcal, in some embodiment about 12 g and about 14 g/100 Kcal [0166]. Schoemaker teaches embodiment wherein the nutritional composition comprises between about 1g/100 Kcal to about 10 g/100 Kcal of a fat or lipid source, in some embodiment about 3 g and about 4 g/100 Kcal [0169]. Table 17 of Schoemaker give an example composition listing the maximum and minimum amounts of the nutrients. By adding the weights of the nutrients, the Examiner calculates the nutrient ranges in the example to encompass from about 1.4% to 46.7% protein, at least 7% carbohydrate, and 1.4% to 66.7% fat, which overlap with the claimed ranges.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05. Furthermore, an improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). The idea that optimizing an ordinary variable does not by itself constitute a patentable advance was also stated in In re Geisler, 43 USPQ2d 1362: “…“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). Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
Regarding Claim 3, the amino acids are recited as optional, i.e. alternative to extensively hydrolyzed protein, which Schoemaker has already taught. Nevertheless, Schoemaker teaches that free amino acid as protein equivalent source, and may comprise leucine, isoleucine, valine, alanine, histidine etc. [0027].
Regarding Claim 10, Schoemaker teaches the nutritional composition is an infant formula [0177].
Regarding Claim 12, Schoemaker teaches spray drying the liquid phase with a carrier material e.g. maltodextrin, ([0117], [0133]). Regarding the recitation of “wherein the liquid concentrate and the solid carbohydrate particles form agglomerates during spray-drying”, the limitation is not related to subject matter eligibility issues. See MPEP 2106.05b. Additionally, what happens during spray-drying the same components taught by the prior art would have found obvious absent a persuasive evidence to the contrary. A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed._Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). Note MPEP 2111.04. In this case, the term "wherein" rather than "whereby" is used, but it is concluded that the terms should be treated the same, and the clause merely characterizes the results of the spray-drying step and does not distinguish the instantly claimed application from the application taught in the prior art.
Claims 6, 8-9, and 11-12 are rejected under 35 U.S.C. 103(a) as being unpatentable over Schoemaker, as applied to Claims 1-5, 7, 10, 12-13 above, and in view of Meister et al. (AU 2017201323 A1), hereinafter Meister.
Schoemaker does not teach the amount of solid carbohydrate particle, and that the liquid concentrate has a solid content of at least 35 wt.%.
Meister discloses a process for preparing a dehydrated carbohydrate-containing nutritional product by preparing a liquid concentrate with a reduced carbohydrate content, spraying the liquid concentrate into a spray-drier and incorporating the remainder of the carbohydrate content into the nutritional product by blowing solid carbohydrate particles into the spray dryer and removing the carbohydrate containing nutritional product from the spray-drier and, as such, reduces the fouling problem of the spray dryer (Abstract). Meister also teaches infant formula or healthcare formula, prepared from a protein source and a lipid source (p. 5, lines 8-11), which makes it compatible with Schoemaker.
Regarding Claims 6 and 8-9, Meister teaches evaporating the wet ingredients to produce a liquid concentrate with a solids content above about 20%; for example about 30 to about 40 %, preferably about 35 % (p. 4, lines 20-24). Meister expressly teaches a liquid milk mixed with milk powder, an added with oil, and evaporation to provide a liquid concentrate with a solids content of approximately 40% followed by further evaporation to reach a solids content of between 55 and 60% and is then spray-dried (Example 1). A powder mix made up of maltodextrin, sucrose, vitamins and minerals is blown into the spray-drier, ultimately giving a powder that has an agglomerated, homogeneous structure (Example 1). Depending upon the composition of the final product, the carbohydrate added by blowing a proportion of all the carbohydrates in the product, e.g. from 20 to 30% of the total carbohydrate in the composition may be added by blowing into the spray dryer (p. 3, lines 14-16). Suitable carbohydrates include sucrose, lactose, maltodextrin, starch etc. (p. 3, lines 17-18). Meister teaches the necessity to ensure that appropriate quantities of solid carbohydrate particles are blown into the spray dryer, for example, by monitoring the solids content of the liquid concentrate and the rate of entering the spray dryer to control the rate of introduction of the solid carbohydrate particles accordingly. In comparison with dry-mixing method, the structure of the powder of Meister’s inventive method is substantially more homogeneous, and the powder obtained has substantially improved wettability leading to improved solubility in both cold and warm water (p. 9, lines 14-27; Fig. 1a and 1b).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the method of Meister, starting with the solids content in the liquid concentrate and the solid carbohydrate content introduced at spraying in the amount taught by Meister to obtain a more homogeneous powder with substantially improved wettability and improved solubility. One would adjust the amount of solid content in the liquid concentrate as a matter of experimentation, depending on the observed rate and homogeneity.
One would also use any of the finite number of carbohydrates taught by Meister, and would substitute maltodextrin with starch depending on factors such as availability and cost. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Meister further teaches that the technique of introducing the solid carbohydrate particles into the spray dryer in the zone of turbulence of the spray dryer is a preferred technique to manage the risks of explosion in spray dryers (p. 3, last paragraph to p. 4, 1st paragraph). Once introduced into the spray-drier, the solid carbohydrate particles agglomerate with the drying particles of the liquid concentrate to produce a homogeneous final product (p. 4, 2nd paragraph). Furthermore, this technique reduce the cleaning down-time due to reduced fouling and caking in the spray-dryer while also improving efficiency (Example 1). As such, Claims 11-12 are rendered obvious by Meister, in the event that the agglomeration feature of Claim 12 is given patentable weight.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kwon et al. (Nutrients. 2020 Oct 21;12(10):3208) teaches the nutrient conversion values, i.e. 1 g carbohydrates = 4 kcal, 1 g protein = 4 kcal and 1 g fat = 9 kcal (Section 2.2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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