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
Claims 31-32,36,40 and 43-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/17/2025.
Applicant’s election without traverse of Group I, claims 1-4,6-8,10-13,18-19,22 and 24 in the reply filed on 12/17/2025 is acknowledged.
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 1-4, 6-8, 18-19, 22 and 24 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 claims are directed to a nutritional composition for human consumption comprising a whey protein concentrate from milk. The limitations of the whey protein concentrate are further defined, however, there is no limitation as to how much of the concentrate is present in the nutritional composition. While this is an issue of breadth, here, the metes and bounds of the claim are so broad as to render the claim indefinite and so broad that one of ordinary skill would not be reasonably appraised of the scope of the claim. The claim limitations regarding specific amounts are limited to a single part of the whole composition. There are no specifics of the composition and the concentrate is present in an unknown quantity in the whole composition. Thus, the limitations of the milk fat content of the overall composition are undefined and indeed, unlimited and cannot be clearly defined based upon the mere presence of the concentrate. One of ordinary skill would not be able to determine if the instant claims are infringed since the composition as a whole is undefined and the limitations of the milk fat content of a concentrate are not limiting on the overall composition. For example, a composition having any amount of milk fat (additional milk fats may be present in unlimited amounts) and having any amount of sphingomyelin (no limitations are placed on the content in the nutritional composition as a whole), and any amount of whey protein would be indiscernible from the instant claims. Thus, there is no clear way to determine the scope of the claimed nutritional composition based upon the concentrate limitations alone. See MPEP 2173.04 which states in part “a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear.”
In addition, the claim scope encompasses an interpretation where the composition IS the concentrate since there are no requirements for additional materials to be present and the concentrate could be reasonably considered “nutritional” inasmuch as the term is defined in the instant specification as a substance that satisfies at least a portion of a subject’s nutrient requirements. Thus, the claims are subject to more than one interpretation, one where additional material is present as part of a composition as a whole resulting in an indeterminate amount of milk fat, protein and sphingomyelin, and one where the composition is the concentration itself. The claims will be examined with both interpretations in mind.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-8, 18, 19, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) as anticipated by US 20080003330 (Rueda ‘330).
Under the interpretation where the claimed concentrate is present in an unidentified composition in an unidentified amount, Rueda ‘330 is seen to meet the claims under the broadest reasonable interpretation. Rueda ‘330 discloses infant formulas preferably comprising enriched concentrations of gangliosides, phospholipids, and sialic acid, all of which can be added separately or in varied combinations to the infant formula. It is preferred, however, that a combination of all three ingredients come from an enriched whey protein concentrate as described below [0027].
The enriched whey protein concentrates for use in the infant formulas of the present invention are those having a high concentration of milk fat globule membrane materials. Milk fat globule membrane materials are the membrane and membrane-associated materials that surround the triacylglycerol-rich milk fat globules in bovine or other mammalian milk. Many of the compounds identified in the milk fat globule membrane materials are present in much higher concentrations in human milk than in commercial infant formulas. By adding whey protein concentrates enriched in such materials to an infant formula, the resulting formula is more similar in composition to human milk, especially with respect to human milk concentrations of gangliosides, phospholipids, and sialic acid [0028].
The term "enriched whey protein concentrate" as used herein, unless otherwise specified, refers generally to any whey protein concentrate having at least about 3%, more typically at least about 5%, by weight of phospholipids, of which at least about 20% by weight of sphingomyelin; at least about 0.5%, typically at least about 1.2% by weight of a sialic acid; and at least about 0.05%, typically at least about 0.1%, by weight of gangliosides. At least about 2.5% by weight of the sialic acid from the concentrate is lipid-bound [0029]. Thus, a concentrate having 5wt% phospholipids, 20wt% of which is sphingomyelin (1wt%) would provide at least 7mg/g (0.7wt%) in the concentrate. Since the concentrate has a high concentration of MFGMs, the majority of sphingomyelin is sourced from the MFGMs.
Thus, the infant formula comprises a concentrate that comprises MFGMs (milk fat), sphingomyelin, and whey protein, thus meeting claims 1-4, 6-8, 19, and 22. Moreover, as noted above, the concentrate has at least about 1wt% sphingomyelin which meets claims 6-8 and 19 under either interpretation.
With regard to both interpretations, the limitations of the majority of the sphingomyelin provided by the MFGMs (components thereof) in claim 1 and greater than 90% in the total amount of sphingomyelin in claim 18 are not seen to further limit the final composition as the origin of sphingomyelin does not limit the structure thereof. Additional material may be present in the composition, thus sphingomyelin from other sources may be present. The origin of the sphingomyelin does not limit the sphingomyelin itself and does not set it apart from other sphingomyelin.
Regarding claim 24, Rueda discloses that the infant formulas of the present invention comprise at least about 5 mg/L of gangliosides, including from about 7 mg/L to 50 mg/L, also including from about 10 to about 30 mg/L. These ganglioside concentrations are similar to that found in human milk, which typically contains at least about 3 mg/L of gangliosides, more typically from about 3 mg/L to about 30 mg/L of gangliosides. These gangliosides for use in the infant formulas typically comprise one or more, more typically all, of the gangliosides GD3, O-Acetyl-GD3 and GM3. These gangliosides generally represent at least about 80%, more typically at least about 90%, by weight of the total gangliosides in the infant formula herein [0046].
Claim(s) 1-4, 6-8, 18, 19, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) as anticipated by NZ 599976 (Fletcher).
Under the interpretation that the composition is the concentrate itself claims 1, 2, 18, 19, and 24 are anticipated by Fletcher. Regarding claims 1, and 2, Fletcher discloses a process for producing a lipid enriched fraction and a lipid depleted fraction where the lipid depleted fraction contains all of the milk fat globule membrane proteins and therefore could be used in infant formulas to deliver health benefits that are more strongly associated with milk fat globule membrane protein components. The lipid depleted fraction is enriched in milk fat globule membrane proteins and may contain, on a powder basis, about 60-80% protein (TN x 6.38), 6-12% lactose, 5-11% fat including phospholipids (pages 6-7). In a fraction described but not claimed, the fraction comprises preferably about 72% protein (TN x 6.38), 9% lactose, 8% fat including phospholipids, 5% ash and 4% moisture (page 7). These values fall within the ranges claimed. The process of providing the lipid depleted fraction is seen to form a protein concentrate based upon the majority of protein present and concentration from the dairy starter material. Fletcher discloses that the lipid depleted fraction contains all of the milk fat globule membrane proteins, thus, the majority of sphingomyelin is reasonably expected to be sourced from these membrane components.
Under the interpretation of the claim where the concentrate is added to an unknown amount of other unidentified materials, Fletcher discloses the addition of the lipid-depleted fraction (concentrate) to infant formula. Thus, the formula with the concentrate would include milk fat, components of milk fat globule membranes, sphingomyelin and GD3. Since there is no limitation on the amounts of each of these materials, the claimed nutritional composition is considered met for claims 1-4, 6-8, 19, 22 and 24.
With regard to both interpretations, the limitations of the majority of the sphingomyelin provided by the MFGMs (components thereof) in claim 1 and greater than 90% in the total amount of sphingomyelin in claim 18 are not seen to further limit the final composition as the origin of sphingomyelin does not limit the structure thereof. Additional material may be present in the composition, thus sphingomyelin from other sources may be present. The origin of the sphingomyelin does not limit the sphingomyelin itself and does not set it apart from other sphingomyelin. Under the interpretation that the composition is the concentrate itself, Fletcher discloses that the lipid depleted fraction is enriched in milk fat globule membrane proteins (component of milk fat globule membranes) which is considered a protein concentrate and has protein, lactose and fat, including phospholipids. Due to the concentration of the MFGMs, the sphingomyelin present must be of MFGM origins and as Fletcher discloses that the lipid-depleted fraction contains all of the MFGM proteins, then all of the sphingomyelin is considered to be from the MFGM source, thus meeting claim 18.
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.
Claim(s) 3-4, 6-8, 10-13 are rejected under 35 U.S.C. 103 as obvious over NZ 599976 (Fletcher).
Under the interpretation that the composition is the concentrate itself, regarding claims 3 and 4, Fletcher discloses a range of milk fat of 5-11wt% fat which overlaps the instant range of 8.5-10wt% or 9.5-10wt%, presents a prima facie case of obviousness.
Regarding claims 6, 7, and 8 (under either interpretation), Fletcher discloses that increasing the amount of sphingomyelin is recognized as leading to enhanced gut maturation, decreased risk of infection and other benefits (paragraph bridging pages 2-3). Thus, one of ordinary skill would have found it obvious to optimize the amount of sphingomyelin in the composition of Fletcher to provide the optimum benefits to the recipients thereof. Notably, depending upon the intended recipient, the necessary amounts of sphingomyelin would reasonably be altered by one of ordinary skill to suit the particular recipient.
Regarding claims 10-13, Fletcher discloses the addition of 1-50wt% of the lipid depleted fraction may be added to an infant formula (see claims 23 and 27 of Fletcher). This range overlaps with the claimed ranges and presents a prima facie case of obviousness.
Claim(s) 22 are rejected under 35 U.S.C. 103 as obvious over NZ 599976 (Fletcher) in view of US 2008/0057178 (Rueda ‘178).
Fletcher discloses the MFGM enriched protein concentrate discussed above but does not disclose an amount of total phospholipids within the range claimed under an interpretation where the composition is the concentrate itself. Fletcher discloses an embodiment with 8% fat and 7% of the fraction is phospholipids (page 7). Rueda discloses an enriched whey protein concentrate having a high concentration of milk fat globule membrane materials [0036]. Rueda discloses that the enriched whey protein concentrate generally has at least 3wt%, more typically 5wt% of phospholipids, of which about 20wt% is sphingomyelin and typically at least about 0.1wt% gangliosides [0037]. The amount of 3-5wt% meets the claimed limitation of 2.5-5.0wt% (25-50 mg/g). It would have been obvious to one of ordinary skill to provide a known and acceptable amounts of phospholipids as disclosed by Rueda in the concentrate of Fletcher as both references disclose using the concentrates in formulas and Rueda discloses the range of general amounts thereof that are demonstrably known in the art.
Claim(s) 10-13 are rejected under 35 U.S.C. 103 as obvious over by US 20080003330 (Rueda ‘330).
Rueda ‘330 discloses adding the enriched whey concentrate to infant formula to provide desired levels of beneficial gangliosides, phospholipids, and other materials, but does not expressly disclose the amount of concentrate added (claims 2 and 15, 0012 and 0196). It would have been obvious to one of ordinary skill to provide the desired amount of the concentrate to a formula to reach the necessary final amounts of sphingomyelin, gangliosides and phospholipids in the formula to accelerate brain development, neural migration and cognitive development (abstract of Rueda ‘330).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793