DETAILED ACTION
Status of Application
Claims 1-20 are pending.
Claims 1-20 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claim 4 is 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 claim recited the inclusion of soybean oil, medium-chain triglyceride, olive oil, and fish oil which is indefinite as the independent claim recites the presence of caprylic acid and capric acid in triglyceride form which are medium chain triglycerides wherein the recitation for medium chain triglycerides is unclear. Is it the same triglycerides of caprylic acid and capric acid? Are they different? It does not allow one to ascertain the metes and bounds of the claim as written.
Claims 4-15, 18-20 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 phrase “preferably” renders the claims and its dependent claims indefinite because it is unclear whether the limitations(s) following the phrase are part of the claimed invention. It does not allow one to ascertain the metes and bounds of the claims as written.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 8, 11, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (WO 2020/159251) in view of Viola et al. (Virgin olive oil as a fundamental nutritional component and skin protector-Abstract only), Trouilly et al. (WO 2019/232044), Yin (L-Cysteine metabolism and its nutritional implications-Abstract only), and Abele et al. (U.S. Pat. Pub. 2013/0020226).
Rejection:
Cho et al. teaches pharmaceutical composition that is a 3 chamber bag where:
a chamber contains sugars including glucose,
another chamber contains amino acids and electrolytes,
another chamber with fats.
Sugars include glucose which is preferred, the amount of glucose can be 46.1-46.3g per 100ml; glucose monohydrate if an infusion preparation, and may be 14.2-14.4 per 100ml [61]. Carriers include saline , sterilized water, Ringer’s solution, buffered saline, dextrose solution, glycerol, maltodextrin solution, and a combination of at least one components, cand other conventional additives like antioxidants, buffers, bacteriostatic agents [33].
The amino acids include free amino acids and salt forms, and be at least one from the group consisting of L-alanine, L-arginine, glycine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, taurine, L-threonine, L-tryptophan, L-tyrosine, L-valine and L-glutamic acid. The amino acid salt forms may be at least one selected from the group consisting of inorganic acid salts such as L-arginine hydrochloride, L-histidine hydrochloride, L-lysine hydrochloride, etc.; L-lysine acetate; and L-lysine malate [55].
The preparation may contain 2.05-2.10 g of L-alanine, 1.10-1.20 g of L-arginine, 0.98-1.08 g of glycine, 0.45-0.50 g of L-histidine, 0.50-0.70 g of L-isoleucine, 0.68-0.78 g of L-leucine, 0.715-0.735 g of L-lysine hydrochloride, 0.30-0.50 g of L-methionine, 0.50-0.62 g of L-phenylalanine, 0.63-0.73 g of L-proline, 0.40-0.60 g of L-serine, 0.05-0.15 g of taurine, 0.37-0.47 g of L-threonine, 0.13-0.23 g of L-tryptophan, 0.03-0.05 g of L-tyrosine and 0.53-0.63 g of L-valine based on 100 mL of the chamber fluid [57].
Electrolytes including calcium, phosphorus, sodium, magnesium, potassium, zinc, chlorine; like calcium phosphate and magnesium phosphate and sodium chloride [52-54]
The chamber with fats Include omega-3 and omega-6 fatty acids may be 47-53mg/ml, omega -3 may be from 23-27mg/ml, omega-6 fatty acids from 20-30mg/ml, including linolenic acid, eicosapentaenoic acid and docosahexaenoic acid [18-20, 24]. The composition contains at least one oil including fish oil, soybean oil, olive oil, cottonseed oil, safflower il, sesame oil, coconut oil, and corn oil [38-39]. The oil can further contain a synthetic oil like medium chain triglyceride [40].
Particularly, the pharmaceutical composition may contain 3.0 g to 5.0 g of soybean oil, 3.5 g to 4.5 g of medium chain triglyceride, 5.0 g to 6.0 g of olive oil, and 6.0 g to 7.0 g of fish oil based on the total 100 ml of the composition, and more particularly may contain 4 g of soybean oil, 4 g of medium chain triglyceride, 5.5 g of olive oil, and 6.5 g of fish oil based on the total 100 ml of the composition, which may be appropriately adjusted in the range that maintains the weight ratio of omega-3 and omega-6 fatty acids [41].
Example 2 contains a chamber with amino acids and electrolytes- L-alanine, L-arginine, glycine, L-histidine, L-isoleucine, L-leucine, L-lysine hydrochloride, L-methionine, L-phenylalanine, L-proline, L-serine, taurine, L-threonine, L-tryptophan, L-tyrosine, L-valine, calcium chloride dihydrate, sodium glycerophosphate anhydrous, sodium acetate hydrate, magnesium sulfate heptahydrate, potassium chloride and zinc sulfate heptahydrate; another chamber with glucose monohydrate solution, and another with fats including soybean oil, medium chain triglyceride, olive oil, fish oil ([91-97], Tables 1-3).
The volume ratio of the amino acid to sugar/glucose to fats may be 2.66:1.59:1, 2.24:3.86:1 but the volume ratio is not limited and may be divided according to criteria for nutritional calories ([64], see full document specifically areas cited).
While Cho et al. does not teach the exact claimed values for some of the amino acids, glucose, and EPA/DHA; they are taught to be included and some have overlapping ranges wherein optimization of the component around the suggested ranges to attain the desired therapeutic/nutrition profile is prima facie obvious with a reasonable expectation of success.
Cho et al. does not expressly recite the presence of oleic acid, L-cysteine, caprylic acid, capric acid, and the dependent range for total amino acids; but does recite the inclusion of olive oil, amino acids, and medium chain triglycerides.
Viola et al. teaches that olive oil contains 98-99% fatty acid triglycerides which is mainly oleic (abstract).
Trouilly et al. teaches that parenteral compositions contain amino acids formulations typically include 2-10 grams of amino acids per 100ml includes cysteine, alanine, arginine, glycine, histidine, isoleucine, leucine, and lysine [135].
Yin et al. teaches that L-cysteine is a nutritionally semi-essential amino acid and plays an important role in cellular homeostasis (abstract).
Abele et al. teaches known medium chain triglycerides include caprylic acid and capric acid [65].
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate oleic acid, L-cysteine, caprylic acid, and capric acid as suggested by Viola et al, Trouilly et al., Yin et al. and Abele et al. and produce the claimed invention; as Cho et al. teaches the inclusion of olive oil which is primarily oleic acid as established by Viola, and teaches the inclusion of amino acids and medium chain triglycerides where the inclusion of additional amino acids like semi-essential amino acids like L-cysteine as addressed by Trouilly et al. Yin et al., and known medium chain triglycerides like caprylic acid and capric acid as established by Abele et al. for their known purpose is prima facie obvious with a reasonable expectation of success. It is also prima facie obvious to optimize the amount of amino acids within their known ranges and known types of medium chain triglyceride to attain the desired therapeutic/nutritional profile with a reasonable expectation of success absent evidence of criticality for the recited range. It is noted that the claims are composition/product claims, not method of use claims; and the prior art meets the structural components of the compositions in the 3-chambers wherein it is capable of the future intended use recited for its administration at the future combination ratios of the various contents of the different chambers.
Claims 6-7, 9-10, 12-15, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (WO 2020/159251) in view of Viola et al. (Virgin olive oil as a fundamental nutritional component and skin protector-Abstract only), Trouilly et al. (WO 2019/232044), Yin (L-Cysteine metabolism and its nutritional implications), and Abele et al. (U.S. Pat. Pub. 2013/0020226) as applied to claims 1-5, 8, 11, 16 above, further in view of Brandenburger et al. (WO 2020/038941).
U.S. Pat. Pub. 2021/0169739 is the national stage of WO 2020/038941 and will be used as the English translation. All references are to the U.S. Pat. Pub.
Rejection:
The teachings of Cho et al. in view of Viola et al., Trouilly et al., Yin, and Abele et al. are addressed above.
Cho et al. in view of Viola et al., Trouilly et al., Yin, and Abele et al. does not expressly teach the volume of the chambers, but is directed to infusion 3 chamber bag.
Brandenburger et al. teaches that infusion bags can be a multi-chamber bag such as a three chamber bag for parenteral nutrition where each chamber in each case contains a constituent (glucose, amino acids, lipids) [81] which can be a total capacity of up to 3000ml, and can have a storage capacity of 50-1000ml-in particular per chamber [27].
Wherein it would be obvious to one of ordinary skill in the art to optimize the volume of each chamber as suggested by Brandenburger et al. and produce the claimed invention; as it is prima facie obvious to one of skill in the art to optimize the volume of the chamber for each constituent (glucose, amino acids, lipids) around the known volumes for chambers for infusion bag to attain the desired therapeutic/nutritional profile with a reasonable expectation of success absent evidence of criticality for the claimed values.
Conclusion
Claims 1-20 are rejected.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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