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 .
Election/Restrictions
Applicant’s election without traverse of the composition of Claims 1-9 and 11 in the reply filed on 27 January 2026 is acknowledged.
Status of the Claims
Claims 1-32 are pending.
Claims 10 and 12-32 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-9 and 11 are presented for examination and rejected as set forth below.
Priority
The instant application is a National Stage entry of International application PCT/US2023/029604 filed 7 August 2023, which claims the benefit of Provisional U.S. application 63/400,090 filed 23 August 2022.
Claim Interpretation
Applicants Claims are directed to compositions combining non-refined complex carbohydrates, proteins, and “healthy fats,” each present in amounts contributing a defined range of calories to the total calorie content of the composition. Claim 2 indicates that the “healthy fats” are “at least partially” provided by the combination of fish meal, fish oil, and olive oil. As the claim does not specifically indicate that each of the fish meal, fish oil, and olive oil are actually present but rather are “provided by” each of the recited elements, art indicating that fish meal, fish oil, and olive oil has been utilized to provide the fatty portion containing a ratio of omega-6 to omega-3 from 2-4 will be considered sufficient to address the limitations of Claim 2. Claim 3 specifies that the proteins 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 7 incorporates a liquid carrier, with Claim 8 indicating the carrier is water. Claim 9 specifies that the composition is a “shake.” Claim 11 indicates that the composition comprises a protein component selected from among a Markush-type listing of alternatives.
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.
Claims 1-9 and 11 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.
The term “healthy fats” in claim 1 is a relative term which renders the claim indefinite. The term “healthy fats” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While applicants specification includes examples of healthy fats, no governing definition of the term can be found in the specification as originally filed, making the claim indefinite.
Claim 1 indicates “a calorie ratio of omega-6 to omega-3 is from 2 to 40,” without indicating that either “omega-6” or “omega-3” are either required as a portion of the composition, nor is any indication of what “omega-6” or “omega-3” modifies. The Examiner presumes this is an incomplete reference to omega-6 and omega-3 fatty acids, but requires applicants to clarify the scope of the invention by specifying precisely what is contemplated here.
From the language of Claim 2, especially when contrasted with Claim 5, it is unclear whether applicants intend for the healthy fats are to be “provided by” any one of the recited elements, or a combination of all three. Appropriate correction or clarification is required.
From the language of Claim 3, it is unclear whether applicants intend for the proteins are to be “provided by” either one of the recited elements, or a combination of the two. Appropriate correction or clarification is required.
The language of Claim 4 makes it unclear wither the members of the Markush-type listing of alternatives are included to satisfy the carbohydrate requirements of Claim 1, or are an additional component. The broadest reasonable interpretation of this language would be the narrowing of the limitations of Claim 1, which is the interpretation the Examiner will apply.
The language of Claim 5 makes it unclear wither the members of the Markush-type listing of alternatives are included to satisfy the carbohydrate requirements of Claim 1, or are an additional component. The broadest reasonable interpretation of this language would be the narrowing of the limitations of Claim 1, which is the interpretation the Examiner will apply.
Applicant’s Claim 9 indicates that the composition of Claim 8 is to take the form of a “shake.” The Examiner notes that applicants provide no guiding definition of what a “shake” is to represent. When a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention, or the claim remains indefinite under § 112. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel). Here, it is important to note that the term “shake” adopts different definitions depending on one’s geographic region: a “shake” in New York is a combination of flavor, milk, and ice cream, whereas in New England a “shake” is milk and flavoring. See Aimee Tucker, The Difference Between a Milkshake and a Frappe, available at https://newengland.com/yankee/history/milk-shakes-frappes-cabinets/ (12 Jul 2022). As applicants offer no controlling definition of “shake,” but instead indicate that an embodiment contains the powdered composition in water, any combination of solid ingredients and water yielding a suspension containing the required elements will be considered a “shake” within the context of the instant claim.
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 1-9 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), 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 Claims 7 and 8 to the fat, carbohydrate, and protein, resulting in an aqueous suspension of these elements sufficient to address the “shake” language of Claim 9. [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 5 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 Claim 3 were, at the time, known to be alternative sources of protein concentrate for incorporation into foodstuffs. [0054].
Sargent indicates that omega-3 and omega-6 fatty acids are obtained from dietary sources such as oily fish. (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, addressing the limitations of Claim 2. (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 oils from fish fed fish meals as well as 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 and Sargent establish that soy, a legume per Claim 3, as well as fish meals are sources of dietary protein, 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.”).
Conclusion
No Claims are allowable.
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
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614