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 1, 3-6, and 10-32 are pending.
Claims 10 and 12-32 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 3-6, and 11 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants Claims are directed to compositions combining non-refined complex carbohydrates, proteins, fats including monounsaturated and polyunsaturated fats which must include omega-6 and omega-3 fatty acids each present in amounts contributing a defined range of calories to the total calorie content of the composition, and where the composition includes fish meal, fish oil, and olive oil in the form of a powder combined with water. Claim 3 specifies that the composition are to contain legumes and fish meal. Claim 4 indicates the composition non-refined complex carbohydrate is to include a component selected from a Markush-type listing of alternatives. Claim 5 incorporates a fat component selected from among a Markush-type listing of alternative fats which contribute a defined range of the total calorie amount provided in the composition. Claim 6 incorporates a “supplement component” selected from a Markush-type listing of alternative additives. Claim 11 indicates that the composition comprises a protein component selected from among a Markush-type listing of alternatives.
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, 3-6, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gillespie (U.S. PGPub. 2020/0383368), Bell (U.S. PGPub. 2021/0186050), Cho (J.H. Cho & I. H. Kim, Fish Meal – Nutritive Value, 95 J Anim. Physiol. Anim. Nutr. 685 (2011)), and Sargent (J. R. Sargent, Fish Oils and Human Diet, 78 Br. J Nut. S5 (1997)).
Gillespie describes food products containing, as a percentage of the total caloric content of the composition, between 20-80% fat, 10-45% protein, and 10-65% carbohydrate, ranges overlapping and therefore rendering obvious the limitations of Claim 1. (Abs.), See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Gillespie indicates that these compositions may take the form of a “soup” which adds the water of Claim 1 to the fat, carbohydrate, and protein, resulting in an aqueous suspension of these elements sufficient to address the “shake” language of Claim 1. [0009-23; 0048; 0058]. Gillespie indicates that the fats of the composition are to contain both omega-3 and omega-6 fatty acids from such sources as fish, optionally in a ratio of omega-6 to omega-3 fatty acids of 3:1, addressing the limitations of Claim 1. [0089-91]. Sources of medium chain triglycerides such as olive oil of Claim 1 may be incorporated as a source of the fats in these compositions. [0094]. The carbohydrates of the Gillespie compositions may be complex carbohydrates sourced from potatoes, [0104], and fiber from sources such as chard, spinach, and pumpkin of Claim 4. [0106-08]. Gillespie indicates that the various foods incorporated into the compositions may be blended, pureed or pulverized, addressing the “liquid” limitations of Claim 11. [0049]. Combinations of vitamins according to Claim 6 may also be included. [0117-30].
Despite this breadth of teaching, Gillespie does not specify the use of fish meal or fish oils as the omega-3 and omega-6 fatty acid source in addition to the olive oil as a source of “healthy” fats, nor is the use of legumes and fish meal as the protein source.
However, Bell indicates that oil seed meals such as soybeans may be used to generate protein concentrates to produce vegetable protein products. [0003-04]. Bell teaches that protein concentrates generated from soybean exhibit improved nutritional content compared to oil seed protein concentrates currently available, [0026], can be combined with additional ingredients to provide a plant protein concentrate, [0035], and that fish meal concentrates of Claims 1 and 3 were, at the time, known to be alternative sources of protein concentrate for incorporation into foodstuffs for consumption by any animal. [0053-54]. Cho goes further, indicating that fish meal carries large quantities of energy and is a source of high-quality protein and highly digestible essential amino and fatty acids, including each of omega-3 and omega-6 fatty acids. (Cho, Pg.685). An added benefit to fish meal in the diet is that most is made from small bony and oily fish that are otherwise not fit for human consumption, implying their use as a human foodstuff. (Pg.686).
Sargent indicates that omega-3 and omega-6 fatty acids are obtained from dietary sources such as oily fish and the oils obtained therefrom. (Abs.). The ratio of omega-3 to omega-6 fatty acids, as well as the protein content of these fish can be manipulated by alteration of their diet, such as supplementation by fish meal. (S6-7; S11).
It would have been prima facie obvious to have provided an aqueous suspension of carbohydrates obtained from potatoes, pumpkins, chard, or spinach representing 45-65% of the caloric content of the composition, soybeans and fish meal as protein sources representing between 7-18% of the total calories in the composition, and fish meal, fish oils, and olive oils representing between 20-40% of the caloric content of the composition where the ratio of omega-6 to omega-3 fatty acids in the fat component is 3, combined with various vitamins to provide a dietary supplement per the instant claims. One of ordinary skill in the art would have been motivated to do so because Gillespie describes food products containing, as a percentage of the total caloric content of the composition, between 20-80% fat, 10-45% protein, and 10-65% carbohydrate, indicating further that vitamins and water may be included, and that olive oil, potato, pumpkin, chard, spinach and fish may be utilized as sources of the macronutrients required. Bell, Cho, and Sargent establish that soy, a legume per Claim 3, as well as the fact that fish meals are sources of dietary protein and fatty acids, and that fish meal is used to provide healthy fats from fish oil. The presently claimed compositions therefore appear little more than the predictable use of prior art elements according to their established functions, and obvious thereby. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)) (indicating that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.”).
Response to Arguments
Applicant's arguments filed 24 August 2026 have been fully considered.
As a threshold matter, Applicants are reminded that it is not possible to establish the non-obviousness of an invention rendered obvious by the combined teachings of multiple prior art references by arguing that each of the references relied upon fails to teach the entirety of the invention which has been claimed; the absence of a single anticipatory reference is implied by both the reliance on the combined teachings of multiple references as well as the fact that the rejection being made is one of obviousness under 35 U.S.C. 103 rather than any of the subsections of 35 U.S.C. 102. MPEP § 2145(IV), see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references"). The piecemeal discussion of what each individual reference teaches, accompanied by assertions that the entirety of the invention claimed is not disclosed by each of the references considered in a vacuum, is unpersuasive.
Applicants argue, apparently earnestly, that Gillespie only asserts that the compositions should possess ratios of omega-3 to omega-6 fatty acids, and not any ratios of omega-6 to omega-3 fatty acids recited by the claims. Applicants are reminded of the symmetric property of mathematics, whereby if a > b, then by definition b < a. So, by disclosing a ratio of omega-3 to omega-6 fatty acids of “at least 1:3” then by the symmetric property of relations, Gillespie describes ratios of omega-6 to omega-3 fatty acids of at least 3:1, a value falling within and therefore rendering obvious the limitations of the instant claims. Applicants assertion that none of the working examples of Gillespie rely on such a ratio is irrelevant to a prima facie case of obviousness on the basis of the present record, because it has long been held that art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); see also In re Chapman, 357 F.2d 418, 148 USPQ 711 (C.C.P.A. 1966) (establishing that a reference is not limited to its working examples, but must be evaluated for what it teaches those of ordinary skill in the art).
Applicants next assert that Sargent simply reviews fish oils in the human diet and fails to describe any particular composition for such consumption, while also suggesting a preference for omega-6 to omega-3 fatty acid ratios outside of the ranges encompassed by the instant claims. Again, applicants are reminded that art is art for all that it teaches, see Merck, supra, but also that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981), see also In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). This does nothing to detract from the fact Sargent establishes fish oils as a source of omega-3 and omega-6 fatty acids for use in dietary supplementation which, when combined with the remaining art of record, provides a skilled artisan the information and rationale to arrive at applicants claimed compositions.
In a similar manner, Applicants arguments concerning the teachings of Bell misapprehend the reason Bell has been relied on. See Keller, supra. The Examiner’s rationale for combining the art of record to arrive at the invention claimed has been set forth previously and again above, and for that reason properly establishes a prima facie case of obviousness which has not been rebutted.
Applicants assertion that the “composition is a ‘powder-based shake’ in which the balance of the composition is water” distinct from the “soup” described by Gillespie is unpersuasive. This is because, as set forth previously and again above, all that the claims require is that the composition be provided as solid particulates which are suspended in water. Applicants description of this composition as a “shake” does nothing to impart physical limitations on the composition beyond the elements which are explicitly recited and represents, at best, a distinction without a difference from the “dispersion, solution, suspension, or colloid” which Gillespie indicates the “soup” is to take. See Gillespie [0058].
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614