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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/12/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Claim Objections
Claim objected to because of the following informalities: The claims recite “MCT” and the abbreviation should be spelled out the first time it is being described. Appropriate correction is required.
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 18-32 are ejected under 35 U.S.C. 103 as being unpatentable over Hajime Sasaki et. al. (WO2015013932A1), and Yoshitaka Ando (JPH10203994A).
Sasaki teaches of a nutritional composition for inhibiting tumor growth (see abstract) and teaches the composition to contain a milk (whey) protein hydrolysate and a fermented milk protein as proteins; a oleic acid-containing oil and milk phospholipid and/or soybean lecithin as lipids; and isomaltulose as a carbohydrate (see claim 1). Sasaki teaches it is known in the prior art to use molecular weight peptides from cow milk that are within the range of 500-5000 in molecular weight and cites Japanese patent (JP10-203994) (see 0008).
Sasaki teaches a reduction in tumor growth, weight and volume (see 0098).
Sasaki also teaches “medium chain fatty acids such as caprylic acid, capric acid, or lauric acid may be added to adjust so that the ratio of saturated fatty acid : monounsaturated fatty acid : polyunsaturated fatty acid is close to 3 : 4 : 3” (see 0059-0060) and describes the formulation to comprise of MCT in amounts of 06g/100ml for liquid content or solid content 2.6 g/100g (see 0085 or table 3, page 29).
Sasaki teaches “Hydrolysis of peptide bonds increases the number of charged groups and hydrophobicity, decreases molecular weight, and modifies molecular configuration (J. Dairy Sci., 76: 311-320, 1993). Changes in functional properties depend greatly on the degree of hydrolysis” For example, the greatest changes commonly observed in whey protein functionality are increased solubility and decreased viscosity. Often when the degree of hydrolysis is high, hydrolysates will not precipitate, even upon heating, and are highly soluble at pH 3.5 to 4.0. Hydrolysates also have far lower viscosity than intact proteins . This difference is especially prominent when protein concentration is high other effects include altered gelation properties, enhanced thermostability, increased emulsifying and foaming abilities, and decreased emulsion and foam stabilities (Int. Dairy journal , 6: 13-31, 1996a; Dairy Chemistry 4 , pp .347-376, 1989; J. Dairy Sci. , 79: 782-790, 1996) .
[0029] Various bioactive oligopeptides derived from milk proteins are known. For example, A cancer metastasis inhibitor containing a treated material obtained by incubating a protein digestive enzyme, e.g. pepsine (JP62059220 (A) ).
[0030] For example, it is known that an autolysate of a protein digestive enzyme such as pepsin suppresses cancer metastasis via the platelet agglomeration induction activity of cancer cells (JPA62-059220).
[0031] Milk protein-derived various physiologically active peptides are known. For example, it is known that an autolysate of a protein digestive enzyme such as pepsin suppresses cancer metastasis via the platelet agglomeration induction activity of cancer cells. Further, it is also known that a lactoferrin hydrolysate enhances the cytotoxic activity of an antibody preparation in the antibody therapy.
Sasaki teaches the composition to have a carbohydrate component (see 0061, or claims 11 and 14) such as isomaltulose which can be used as a sweetener (see 0061), and also gives examples wherein the amount of carbohydrate in the composition is 14.5 g/100ml for liquid compositions 63.32 g/100g for solid compositions (see table 3, page 29).
Sasaki also teaches the composition to comprise of a lipid fraction and teaches the medium chain triglycerides at 30% wt of the lipid fraction (see table 3, page 29 under fat).
Sasaki’s invention specifically teaches obtaining molecular weights (for example 10,000: see claim 5) greater than what is claimed.
Sasaki teaches the composition to comprise of a protein content which provides 5 to 45% of the energy content (see table 3, page 29).
Ando is relied upon to show why one would be motivated to optimize the molecular weight of the whey protein hydrolysates to be at the instantly claimed range.
Ando teaches “a physiologically active composition comprising, as an active ingredient, a peptide having a molecular weight of 500 to 5,000 obtained by allowing a protease to act on one or more of proteins derived from milk, soybean and yeast. Stuff” (see claim 1), and teaches the properties of such molecular weight hydrolyzed milk proteins to be anticancer (see abstract and 0001).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to optimize the molecular weight of the whey protein hydrolysates to be within the instantly claimed range because the art recognizes that these sized hydrolysates have anticancer properties and indeed are used in methods for inhibiting cancer growth. Optimizing the amount of whey protein hydrolysates to be in the composition would help determine how concentrated the composition is since this is the active ingredient which is known to have the anticancer effect.
Optimizing the MCT to be in the amounts claimed appears to be a matter of judicious selection and one which any skilled artisan could do given the prior art. Sasaki teaches using the MCT’s to adjust the ratio of saturated, monounsaturated and polyunsaturated fatty acids to be at particular ratios, thus optimizing the MCT amount to 9-25% of the total energy content or at 40% of the lipid fraction is obvious as these do not appear to be critical to the invention and well within the purview of any skilled artisan, and for use in adjusting the ratios of the other saturated fatty acids. Optimizing the composition to have the protein hydrolysates having a degree of hydrolysis from 15-25% is obvious as this is the process for cleaving the peptide bonds to create smaller peptide fragments and it is apparent that it is the size and molecular weight of the peptides that allow the activity. Thus optimizing the degree of hydrolysis would help to optimize the amount of peptide fragments in the composition. It would have also been obvious to administer the composition to a subject undergoing cancer treatment as Sasaki teaches that lactoferrin hydrolysate enhances the cytotoxic activity of an antibody preparation in the antibody therapy. The activities recited in claim 27 would have been expected as these are merely mechanisms of action from which the whey protein hydrolysates appear to function and Sasaki teaches that the composition indeed reduced tumor volume and growth.
Given the prior art there would have been a reasonable expectation of success in arriving at the instant invention with some optimizations to reach the instantly claimed ranges, however those optimizations do not appear critical to the invention and would have been prima facie obvious to persons having ordinary skill in the art.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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