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 .
DETAILED ACTION
Claims 16-32 are pending. Claims 16-32 are examined on the merits.
Claim Rejections –35 USC § 112, 2nd
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.
Claim 25 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 25 (at line 3) recites parenthetical expression "(increased)". The metes and bounds of Claim 25 are rendered vague and indefinite by the parenthetical recitation of because it is unclear as to whether the limitation is part of the instantly claimed subject matter.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 16-32 are rejected under 35 U.S.C. 103(a) as being unpatentable over Neal et al (WO 2013148685 A1).
Neal et al teach in some embodiments, the protein component of the nutritional composition includes intact pea protein (thus claim 23 is met) in combination with soy protein isolate (thus essentially free from animal protein, thus claim 16 is met). In these specific embodiments, the intact pea protein provides from about 20% to about 50% (thus overlaps with 32-58% in claim 16; 36-54% in claim 18; 41-50% in claim 19; 43-47% in clam 20; ), including from about 20%> to about 40%, including from about 25% to about 40%, including from about 30%> to about 40%>, and including from about 30%> to about 35% by weight of the protein component and the soy protein provides from about 50%) to about 80%> (thus claims 16, and 18 are met) including from about 60%> to about 80%>, including from about 60%) to about 75%, including from about 60%> to about 70%>, and also including from about 65% to about 70% by weight of the protein component. In one specific embodiment, the intact pea protein provides about 34% by weight of the protein component and the soy protein provides about 66%> by weight of the protein component [0036].
Neal et al teach the nutritional composition of claim 8 wherein the functional amino acid is selected from the group consisting of leucine (thus claims 20, 21 and 24 are met), valine, isoleucine, and combinations thereof (see claim 9).
Neal et al teach the non-therapeutical use of a nutritional composition of claim 19 for building and/or maintaining muscle in an individual, wherein the individual is a human adult (see claim 20).
Neal et al teach non-therapeutical use of a nutritional composition according to any one of claims 1-12 for increasing nitrogen accretion in muscle, or for increasing protein synthesis (thus claim 26 is met) and/or preventing protein degradation (see claim 21).
Neal et al teach these benefits may be useful for adults interested in building and/or maintaining muscle, older adults (50 years old and older) (claims 17 and 25 are met), individuals suffering from (or at risk of or susceptible to) muscle degeneration, and/or wasting disease (cachexia and the like) [0113].
Neal et al teach the functional amino acids and branched chain amino acids used in
combination with the intact pea protein may be in the form of free amino acids, salt
form (e.g., L-arginine hydrochloride), peptide-bound form (e.g., L-alanyl-Lglutamine),
and protein-bound form (e.g., bovine beta-lactoglobulin, which includes
2/85 wt% arginine, 7.18 wt% glutamine and 15.76 wt% leucine) (thus claim 16 is met).
Neal et al teach the products may further comprise vitamins or related nutrients, nonlimiting examples of which include vitamin A, vitamin D (thus claim 32 is met), vitamin E, vitamin K, thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid,
pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof,
and combinations thereof [0104].
Neal et al teach this emulsion can then be further diluted, heat-treated, and
packaged to form a ready-to-feed or concentrated liquid [0110] (thus claim 28 is met).
Neal et al do not explicitly teach combination of the three claimed components in one composition at claimed amount, neither do Neal et al teach dosage in claims 27, 30, and 31 or tube feeding in claim 29.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the three claimed components in one composition since Neal et al teach the nutritional composition of claim 8 wherein the functional amino acid is selected from the group consisting of leucine, etc. (see claim 9).
It would also have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use tube feeding since the composition is a “a ready-to-feed or concentrated liquid” (see [0110]), it is a general practice to use a straw to drink a liquid, thus the limitation of claim 29 is met.
Regarding to claimed percentage of each component or the dosages of the composition, determining an appropriate amount of the components within the composition or the dosage of the composition is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. For example, when the subject is in older age or suffering from severe muscle degeneration, the dosage may increase.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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