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
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-18 and 23-24
Withdrawn claims: None
Previously canceled claims: 19-22
Newly canceled claims: None
Amended claims: 1-9, 11-18, and 23-24
New claims: None
Claims currently under consideration: 1-18 and 23-24
Currently rejected claims: 1-18 and 23-24
Allowed claims: None
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 10 and 12 are objected to because of the following informalities:
In claim 10, line 7, it appears that “gum arable” should read, “gum arabic”.
Claim 12, lines 8-9, recites, “L-Carnitine, taurine, leutein”. These are not proteins and should be removed from the list, which is directed toward proteins.
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 1-6, 9-18, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over López Pedrosa et al. (WO 2021/092209 A1) and Aprikian et al. (US 2012/0021977 A1, cited on the IDS filed on 18 November 2024).
Regarding claim 1, López Pedrosa teaches a method of lowering a risk of developing insulin resistance, prediabetes, or diabetes in a subject, comprising administering to a subject at risk of developing insulin resistance, prediabetes, or diabetes a nutritional composition comprising intact bovine milk-isolated exosomes ([0004] – [0008]). The nutritional composition further comprises protein, fat, and carbohydrate ([0007]), and the protein may include milk proteins including casein and whey protein ([0039]).
López Pedrosa does not specifically discuss administering the nutritional composition to a pediatric individual as a means of promoting healthy catch-up growth in the pediatric individual.
However, Aprikian teaches administering a nutritional composition comprising bovine casein proteins to an infant or young child (i.e., a pediatric individual) undergoing a period of catch-up growth following a period of growth restriction during or after the period of catch-up growth so as to reduce the risk of development of insulin resistance or Type 2 diabetes later in the life of the infant or young child and/or so as to promote healthy growth in infants and young children ([0011], [0028]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of López Pedrosa with the teachings of Aprikian to administer the nutritional composition of López Pedrosa to a pediatric individual to promote healthy catch-up growth in said pediatric individual. One of ordinary skill in the art would have done so with a reasonable expectation of success in arriving at the claimed invention because López Pedrosa teaches a nutritional composition comprising the required bovine casein protein that Aprikian teaches promotes healthy catch-up growth to avoid insulin resistance and diabetes, and López Pedrosa teaches that a nutritional composition comprising intact bovine milk-derived exosomes prevents insulin resistance and diabetes.
Claim 1 is therefore rendered obvious.
Regarding claims 2-4, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa does not discuss that the healthy catch-up growth comprises enhancing development of lean body mass (re: claim 2), reducing development of catch-up fat (re: claim 3), or increasing a growth rate of the individual (re: claim 4).
However, Aprikian teaches, “The term ‘unhealty [sic] or uncontrolled catch-up growth’ relates to excessive catch-up of body fat and excessive hyperinsulinemia that could constitute important mechanisms in the link between catch-up growth and susceptibility to later obesity and/or type 2 diabetes. On contrary ‘heathly [sic] catch up growth’ is a controlled growth not inducing detrimental effects or reducing the risk of detrimental effects” ([0028]). Aprikian teaches that it is important that catch up growth is not accompanied by excessive fat deposition and hyerinsulinemia ([0004]). Thus, this healthy catch-up growth wherein catch-up body fat is reduced would entail an increase in lean body mass, and by nature of being “catch-up” growth, entail an increased growth rate.
Where the method of López Pedrosa as modified by Aprikian teaches the method of claim 1, the limitations of claims 2-4 are also rendered obvious with the same motivation and expectation of success.
Moreover, the limitations of claims 2-4 are not a positively recited method step, and therefore do not carry patentable weight.
Regarding claim 5, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa does not discuss the age of the pediatric individual.
However, Aprikian teaches administering the nutritional composition to an infant or young child ([0011]). Aprikian defines “infant” as a child under the age of 12 months ([0024]) and “young child” as a child between the age of 1 and 12 years ([0027]).
Where the method of López Pedrosa as modified by Aprikian teaches the method of claim 1, the claimed ranges of at or under the age of about 15 years old, or at or under the age of about 10 years old, or at or under the age of about 5 years old, or at or under the age of about 1 year old, or at or under the age of about 6 months old, or at or under the age of about 3 months old are also rendered obvious with the same motivation and expectation of success. The claimed ranges of at or under the age of about 6 months old, or at or under the age of about 3 months old lie inside the disclosed range or under the age of 12 months. In a 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).
Claim 5 is therefore rendered obvious.
Regarding claim 6, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa does not discuss the age of the pediatric individual.
However, Aprikian teaches administering the nutritional composition to an infant or young child ([0011]). Aprikian defines “young child” as a child between the age of 1 and 12 years ([0027]).
Where the method of López Pedrosa as modified by Aprikian teaches the method of claim 1, the claimed range of about 5 years old to about 19 years old is also rendered obvious with the same motivation and expectation of success. The claimed range of about 5 years old to about 19 years old overlaps the disclosed range or under the age of between the age of 1 and 12 years. In a 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).
Claim 6 is therefore rendered obvious.
Regarding claim 9, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa also teaches that the nutritional composition comprising the exosome-enriched product comprising intact bovine milk-derived exosomes further comprises one or more of a carbohydrate, a protein and/or a fat ([0007]).
Claim 9 is therefore rendered obvious.
Regarding claim 10, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises one or more carbohydrates comprising fiber, human milk oligosaccharides (HMOs), maltodextrin, corn syrup, gellan gum, inositol, carrageenan, fructooligosaccharides, hydrolyzed starch, glucose polymers, corn syrup solids, rice-derived carbohydrates, sucrose, glucose, lactose, honey, sugar alcohols, isomaltulose, sucromalt, pullulan, potato starch, galactooligosaccharides, oat fiber, soy fiber, corn fiber, gum arable, sodium carboxymethylcellulose, methylcellulose, guar gum, locust bean gum, konjac flour, hydroxypropyl methylcellulose, tragacanth gum, karaya gum, gum acacia, chitosan, arabinoglactins, glucomannan, xanthan gum, alginate, pectin, low methoxy pectin, high methoxy pectin, cereal beta-glucans, psyllium, inulin, or combinations of two or more thereof ([0042]).
Claim 10 is therefore rendered obvious.
Regarding claim 11, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises one or more carbohydrates comprising sucrose, maltodextrin, fructooligosaccharides, or combinations of two or more thereof ([0042]).
Claim 11 is therefore rendered obvious.
Regarding claim 12, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises one or more proteins comprising whey protein concentrate, whey protein isolate, whey protein hydrolysate, acid casein, sodium caseinate, calcium caseinate, potassium caseinate, casein hydrolysate, milk protein concentrate, milk protein isolate, milk protein hydrolysate, nonfat dry milk, condensed skim milk, soy protein concentrate, isolated soy protein, soy protein hydrolysate, pea protein concentrate, pea protein isolate, pea protein hydrolysate, collagen protein, collagen protein isolate, potato proteins, earthworm protein, insect protein, one or more amino acids and/or metabolites thereof, or combinations of two or more thereof ([0039]).
Claim 12 is therefore rendered obvious.
Regarding claim 13, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises one or more proteins comprising milk protein concentrate, isolated soy protein, calcium caseinate, or combinations of two or more thereof ([0039]).
Claim 13 is therefore rendered obvious.
Regarding claim 14, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises milk protein and/or soy protein ([0039]).
Claim 14 is therefore rendered obvious.
Regarding claim 15, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises one or more fats comprising coconut oil, fractionated coconut oil, soy oil, corn oil, safflower oil, high oleic sunflower oil, palm olein, medium chain triglycerides, linoleic acid, alpha-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosahexaenoic acid, olive oil, medium chain triglyceride oil (MCT oil), high gamma linolenic (GLA) safflower oil, palm oil, palm kernel oil, canola oil, marine oils, fish oils, algal oils, borage oil, cottonseed oil, fungal oils, or combinations of two or more thereof ([0044]).
Claim 15 is therefore rendered obvious.
Regarding claim 16, López Pedrosa and Aprikian teach the method of claim 9.
López Pedrosa also teaches that the nutritional composition comprises one or more fats comprising canola oil, soy oil, medium chain triglyceride oil, and high oleic sunflower oil, or combinations of two or more thereof ([0044]).
Claim 16 is therefore rendered obvious.
Regarding claim 17, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa also teaches that the nutritional composition comprising the exosome-enriched product comprising intact bovine milk-derived exosomes is administered to the pediatric individual orally – “Such compositions in powder or liquid form can be easily orally administered to obtain the benefits of the bioactive agent(s) in the exosomes.” ([0035]).
Claim 17 is therefore rendered obvious.
Regarding claim 18, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa does not discuss that the nutritional composition comprising the exosome-enriched product comprising intact bovine milk-derived exosomes is administered as part of a catch-up diet.
However, Aprikian teaches that the “nutritional composition may be fed to an infant during a period of catch-up growth following a period of growth restriction as the sole source of nutrition from birth to the age of six months and subsequently as part of a mixed diet during the introduction of solid foods until weaning is complete at about the age of 12 months.” ([0049]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of López Pedrosa with the teachings of Aprikian to administer the nutritional composition of López Pedrosa as part of a catch-up diet. One of ordinary skill in the art would have done so with a reasonable expectation of success in arriving at the claimed invention because López Pedrosa teaches a nutritional composition comprising the required bovine casein protein that Aprikian teaches promotes healthy catch-up growth to avoid insulin resistance and diabetes, and López Pedrosa teaches that a nutritional composition comprising intact bovine milk-derived exosomes prevents insulin resistance and diabetes. Further, Aprikian teaches that the nutritional composition may be fed as part of a mixed diet during a period of catch-up growth.
Claim 18 is therefore rendered obvious.
Regarding claim 23, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa does not discuss that promoting healthy catch-up growth is achieved by at least one of increasing lean body mass, increasing weight, reducing fat mass accumulation, increasing growth rate, or any combinations thereof.
However, Aprikian teaches, “The term ‘unhealty [sic] or uncontrolled catch-up growth’ relates to excessive catch-up of body fat and excessive hyperinsulinemia that could constitute important mechanisms in the link between catch-up growth and susceptibility to later obesity and/or type 2 diabetes. On contrary ‘heathly [sic] catch up growth’ is a controlled growth not inducing detrimental effects or reducing the risk of detrimental effects” ([0028]). Aprikian teaches that it is important that catch up growth is not accompanied by excessive fat deposition and hyerinsulinemia ([0004]). Thus, this healthy catch-up growth wherein catch-up body fat is reduced would entail an increase in lean body mass, and by nature of being “catch-up” growth, entail an increased growth rate and weight.
Where the method of López Pedrosa as modified by Aprikian teaches the method of claim 1, claim 23 is also rendered obvious with the same motivation and expectation of success.
Moreover, the limitations of claim 23 are not a positively recited method step, and therefore do not carry patentable weight.
Regarding claim 24, López Pedrosa and Aprikian teach the method of claim 1.
López Pedrosa also teaches that the nutritional composition is administered to the subject from about 1 to about 6 times per day or per week ([0060]).
López Pedrosa does not discuss that the nutritional composition comprising an exosome-enriched-product comprising intact bovine milk-derived exosomes is administered chronically during a period of weight gain.
However, Aprikian teaches that the “nutritional composition may be fed to an infant during a period of catch-up growth following a period of growth restriction as the sole source of nutrition from birth to the age of six months and subsequently as part of a mixed diet during the introduction of solid foods until weaning is complete at about the age of 12 months.” ([0049]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of López Pedrosa with the teachings of Aprikian to administer the nutritional composition of López Pedrosa chronically during a period of weight gain. One of ordinary skill in the art would have done so with a reasonable expectation of success in arriving at the claimed invention because López Pedrosa teaches a nutritional composition comprising the required bovine casein protein that Aprikian teaches promotes healthy catch-up growth to avoid insulin resistance and diabetes, and López Pedrosa teaches that a nutritional composition comprising intact bovine milk-derived exosomes prevents insulin resistance and diabetes. Further, Aprikian teaches that the nutritional composition may be fed over a period of months during a period of catch-up growth.
Claim 24 is therefore rendered obvious.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over López Pedrosa et al. (WO 2021/092209 A1) and Aprikian et al. (US 2012/0021977 A1, cited on the IDS filed on 18 November 2024) as applied to claim 1 above, and further in view of Gat-Yablonski et al. (Gat-Yablonski, G., & Phillip, M. (2015). Nutritionally-induced catch-up growth. Nutrients, 7(1), 517–551. https://doi.org/10.3390/nu7010517).
Regarding claims 7-8, López Pedrosa and Aprikian teach the method of claim 1.
The cited prior art does not explicitly discuss that the pediatric individual is suffering from a condition comprising at least one of malnourishment, severe weight loss, wasting, under nutrition weight loss, underweight, growth stunt, or any combination thereof (re: claim 7) or that the pediatric individual is suffering from malnutrition (re: claim 8).
However, Gat-Yablonski teaches that malnutrition is considered a leading cause of growth attenuation in children, and when food is replenished, catch-up growth usually occurs (Abstract). Thus, Gat-Yablonski teaches that malnutrition is a reason for needing catch-up growth.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the composition of López Pedrosa to a pediatric individual who is suffering from malnutrition. One of ordinary skill in the art would have been motivated to do so and would have had a reasonable expectation of success in arriving at the claimed invention because, as discussed regarding claim 1, it would have been obvious to administer the composition of López Pedrosa to promote catch-up growth, and Gat-Yablonski teaches that children suffering from malnutrition need catch-up growth.
Claims 7-8 are therefore rendered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Shellhammer whose telephone number is (703) 756-5525. The examiner can normally be reached Monday - Thursday 7:30 am - 5:00 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
Prosecution Insights