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 .
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 (i.e., changing from AIA to pre-AIA ) 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kong et al. (CN 114365841 A; April 19, 2022) in view of Vurma et al. (US 2016/0278419 A1; Sep. 29, 2016) and Fan et al. (CN 116369513 A; July 4, 2023).
Regarding claims 1-3, Kong discloses a total nutrition formula emulsion comprising carbohydrates, casein, fiber, compound vitamins, compound minerals, compound oil, phospholipid, and colloids (page 3, para 13) as shown in the Table below.
Ingredient
Invention
Kong
Carbohydrates
10-14
20-30
Calcium caseinate
4-5
3-5 casein
Dietary Fiber
1.3-2
1.2-2
Sodium Chloride
0.1-0.15
-
Sodium Citrate
0.1-0.12
-
Potassium Citrate
0.1-0.15
-
Magnesium Chloride
0.15-0.2
-
Dipotassium Hydrogen Phosphate
0.1-0.15
-
Vitamins
0.05-0.1
0.1-1
Minerals
0.05-0.1
0.5-2.5
Oil
2.5-3.6
4-8
Phospholipid
0.3-0.5
0.2-0.4
MCT
0.2-0.5
-
Colloids
0.04-0.08
0.02-0.04
As shown above, Kong teaches amounts of dietary fiber, vitamins, phospholipid, and colloids overlapping 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. (MPEP 2144.05 I)
With respect to the amount of carbohydrates, Kong teaches a slightly higher amount of 20 than the claimed amount of 14 (page 3). With respect to the amount of minerals and oil, Kong teaches minerals in a slightly higher amount of 0.5 than the claimed amount of 0.1 and oil in a slightly higher amount of 4 than the claims amount of 3.6 (page 3).
However, as stated in MPEP 2144.05: 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. "Where 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)
It would have been obvious to one of ordinary skill in the art to vary the amount of carbohydrate, minerals, and oil depending on the targeted nutrition of the formula, which is well understood, routine and convention in the art.
With respect to the amount of calcium caseinate, Kong teaches casein in an amount overlapping the claimed range (page 3), but fails to specifically teach calcium caseinate.
Kong further fails to teach sodium chloride, sodium citrate, potassium citrate, magnesium chloride, dipotassium hydrogen phosphate and MCT.
Vurma discloses total nutrition formulas comprising similar ingredients as Kong. Vurma teaches that the formula can include carbohydrates in an amount of 5-40 parts ([0043]), thus overlapping the claimed range of 10-14 parts. As it is well known in the art for a nutrition formula to include a lower amount of carbohydrates, it would have been obvious to decrease the amount of carbohydrates in the formula of Kong depending on the targeted nutrition.
Vurma further teaches the use of calcium caseinate as a suitable protein source, wherein the protein is included in an amount of 0.5-30 parts ([0041]-[0042]), thus overlapping the claimed range of 4-5 parts. Vurma teaches the inclusion of sodium chloride as a flavor agent ([0054]) as well as the minerals sodium citrate, potassium citrate, magnesium chloride ([0056], See Examples and Tables). Vurma also teaches the inclusion of MCT as a suitable fat source, wherein it can be combined with other fats, including oil, in an amount from 1-30 parts ([0045][0047]).
With respect to the claimed amounts of sodium chloride, sodium citrate, potassium citrate, magnesium chloride and MCT, Vurma clearly teaches that such ingredients are well known in the art for nutrition formulas and therefore it would have been obvious to one of ordinary skill in the art to determine the optimum amount of each depending on the target taste and nutrition for the formula. Again, as stated in MPEP 2144.05: 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. "Where 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)
As Vurma teaches that is it well known in the art for a nutrition formula to comprise calcium caseinate as a suitable protein source in an amount overlapping the claimed range, sodium chloride, sodium citrate, potassium citrate, magnesium chloride and MCT, it would have been obvious to one of ordinary skill in the art to include such components in the formula of Kong in order to provide suitable protein, fat, and mineral sources to the formula of Kong, thus providing Kong with desired taste and nutrition. Further, Vurma teaches overlapping ranges of oil and calcium caseinate and therefore would have been obvious for the formula of Kong to have similar amounts as such amounts are known to be suitable for a total nutrition formula.
Kong and Vurma render obvious a formula as described above, but fail to further teach the inclusion of dipotassium hydrogen phosphate.
Fan discloses a nutritional formula emulsion comprising carbohydrates, oil, vitamins and minerals. Fan further teaches that the formula includes dipotassium hydrogen phosphate as a mineral component in an amount of 0.307 parts by weight (page 2, last para), which is higher than the claimed amount of 0.1-0.15.
However, as stated in MPEP 2144.05: 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. "Where 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)
It would have been obvious to one of ordinary skill in the art to vary the amount of dipotassium hydrogen phosphate depending on the targeted nutrition of the formula, which is well understood, routine and convention in the art.
It would have been obvious to further include dipotassium hydrogen phosphate in the formula of Kong in a desired amount in order to provide the formula of Kong with suitable and well-known mineral sources.
Kong, Vurma and Fan are all directed towards total nutrition formulas comprising carbohydrate, fat, protein, vitamins and minerals. All the specifically claimed components are taught in the prior art as suitable ingredients in the nutrition formulas as described above. Therefore, with respect to the exact amount of each, including the more specific amounts recited in claims 2 and 3, it is well within the ordinary skill in the art to determine the optimum amount based upon the teachings and suggestion of the prior art.
With respect to the total nutrition formula emulsion being low GI, the examiner notes that such language is solely recited in the preamble. When reading the preamble in the context of the entire claim, the recitation “low GI” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Furthermore, the instant specification described low GI as being related to specific carbohydrates. The instant invention uses cassava dextrin as the carbohydrate source. As Kong teaches that the carbohydrate can be cassava dextrin, which is the same as the instant invention, the composition of Kong is considered to be low GI as it uses the same ingredients as the instant invention.
Regarding claim 4, Kong teaches that the carbohydrate can be a mixture of maltodextrin and cassava dextrin (page 3, para. 8-13).
Regarding claim 5, Kong teaches that the maltodextrin can be in an amount of 12-26 g and the cassava dextrin can be in an amount of 0-20 g (page 3, para. 13). Therefore, for example, Kong teaches that cassava dextrin can be present in an amount of 20 and the maltodextrin can be in an amount of 12, thus resulting in a ratio of 10:6. Kong, therefore teaches a ratio of cassava dextrin to maltodextrin that can overlap the claimed ratio of (12-6):(0-6). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Further, it would have been obvious to one of ordinary skill in the art determine the optimum amount of each of the cassava dextrin and the maltodextrin depending on the targeted nutrition and desired properties of the formula. As stated in MPEP 2144.05: 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. "Where 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, Kong teaches that the dietary fiber can be at least one of resistant dextrin and inulin (page 3, para. 10). It would have been obvious to use both resistant dextrin and inulin as the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07)
As stated in MPEP 2144.06 ““It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.)”
Kong further teaches that the colloids can be carrageenan (page 3, para 13).
Regarding claim 7, as stated above, Kong teaches the nutrition formula comprising dietary fiber, minerals and oil. Kong further teaches that the fiber is present in an amount of 1.2-2, the minerals are present in an amount of 0.5-2.5, and the oil is present in an amount of 4-8 (page 3).
With respect to the ratio of dietary fiber to minerals to oil, Kong teaches a ratio of (1.2-2):(0.5-2.5):(4-8), which is different than the claimed ratio as Kong teaches higher amounts of minerals and oil, however, it would have been obvious to vary the amount of each components to arrive as a desired ratio depending on the target nutrition. This is merely routine experimentation that is well within the ordinary skill in the art.
Conclusion
No claims are allowed.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791