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 .
Claim Objections
Claim 12 objected to because of the following informalities: In line 9, the phrase “(g/100 of powder)” should read “(g/100 g of powder)”. Appropriate correction is required.
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 5 and 16 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.
Regarding claim 5, the recitation “wherein a viscosity of a solution of the protein does not increase after the liquid after heat induced gelation” renders the claim indefinite. It is not clear after what step the viscosity of the solution does not increase. Does the viscosity of the solution, a liquid, not increase after heat induced gelation? Moreover, at what concentration of protein does the solution exhibit not increase in viscosity?
Regarding claim 16, the recitation “A food composition comprising the powder of claim 12, in an aqueous medium, forming an edible aqueous suspension or solution” renders the claim indefinite. It is not clear if Applicant’s intend to claim a step of “forming an edible aqueous suspension or solution” or “wherein the food composition is and edible aqueous suspension or solution.”
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.
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 2 and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over Soto-Sierra et al. (“Process development of enzymatically-generated algal protein hydrolysates for specialty food applications”, Algal Research, 55 (2021), pp. 1-10).
Regarding claims 6, 7, 11-15, Sota-Sierra et al. disclose a hydrolyzed microalgal protein product comprising 72 ± 3% (w/w) protein, 1.5% histidine, 4.8% lysine, 2.7% methionine, 6.0% phenylalanine, 6.2% threonine, 5.3% isoleucine, 9.9% leucine and 6.2% valine (i.e. essential amino acids in an amount equal to or more than 30 g/100 g-p. 8/Table 2, p. 9/Table 3) and dried (i.e., powder – p. 4/2.4.4 Purity). Sota -Sierra et al. disclose the hydrolyzed microalgal protein product has a branched-chain amino acid content (leucine, isoleucine and valine) of 21.4 g./100 g. product (p. 9/Table 3). Sota-Sierra et al. disclose the protein hydrolysates are purified from lipid-extract microalgae of Nannochloropsis sp. biomass grown in open ponds (Abstract, p. 2/2.1 Substrate preparation). While Sota-Sierra et al. disclose microalgal material from Nannochloropsis sp. biomass, the reference is silent with respect to a marine microalgal. The fact that the microalgal material from Nannochloropsis sp. biomass is obtained from a different environment, i.e., ponds v. sea, the determination of patentability is based on the claimed product and not how is was obtained.
While Sota-Sierra et al. disclose a microalgal protein product comprising a protein content of 72 ± 3 g/100 g. product, the reference is silent with respect to algae residue and ash content. Given Sota-Sierra et al. disclose a microalgal protein product obtained from a lipid extracted algae of the Nannochloropsis sp. comprising protein in an amount of 72 ± 3 g/100 g. product, inherently the product would comprise algae residue. Moreover, Sota-Sierra et al. disclose a removing excess salt to a level of less than 10% by weight (i.e., ash content- p. 7-8/Section 3.2, Figure 6).
While Sota-Sierra et al. does not disclose the precisely claimed amounts of the essential amino acids, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (MPEP §2144.05 I). The proportions of the essential amino acids are so close that prima facie one skilled in the art would have expected them to have the same properties in a hydrolyzed protein composition intended for foodstuff.
Sota-Sierra et al. is silent with respect to tryptophan. However, given Sota-Sierra et al. disclose a microalgal protein product obtained from a lipid extracted algae of the Nannochloropsis sp. and substantially similar to that presently claimed, inherently the microalgal protein product would comprise tryptophan in amount overlapping the claimed range of 0.9 to 3.1 g/100 g of powder).
Sota-Sierra et al. is also silent with respect to the non-essential amino acids, alanine, arginine, asparagine + aspartic acid, cysteine, glutamine + glutamic acid, glycine, proline, serine and tyrosine. However, given Sota-Sierra et al. disclose a microalgal protein product obtained from a lipid extracted algae of the Nannochloropsis sp. substantially similar to that presently claimed, inherently the microalgal protein product would comprise the non-essential amino acids in the claimed ranges.
Regarding claims 2 and 4, Sota-Sierra et al. disclose all of the claim limitations as set forth above. Sota-Sierra et al. is silent with respect to solubility of the microalgal protein product. However, given Sota-Sierra disclose a lipid extracted algae of the Nannochloropsis sp. substantially similar to that presently claimed, inherently the microalgal protein product exhibit the claimed solubility index at a pH of 7 and 3.5.
Regarding claim 5, Sota-Sierra et al. disclose all of the claim limitations as set forth above. Sota-Sierra et al. is silent with respect to no viscosity change after a solution of the product has been heated. However, given Sota-Sierra disclose a lipid extracted algae of the Nannochloropsis sp. substantially similar to that presently claimed, inherently the microalgal protein product would exhibit the claimed viscosity change after a solution of the product has been heated.
Regarding claim 8, Sota-Sierra et al. disclose all of the claim limitations as set forth above. While Sota-Sierra et al. disclose a microalgal protein product comprising a protein content of 72 ± 3 g/100 g. product, the reference is silent with respect to a protein content of greater than 85 g per 100 g. powder. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have modified the fractionation and depth filtration processes of Sota-Sierra et al. to make a product with higher protein concentration (i.e., increase the purity of the product). One of ordinary skill in the art would have been motivated to make a product with higher protein concentration in order to utilize the products in producing high protein foodstuff.
Regarding claims 9 and 10, Sota-Sierra et al. disclose all of the claim limitations as set forth above. Sota-Sierra et al. is silent with respect to true protein digestibility and protein digestibility corrected amino acid score. However, given Sota-Sierra disclose a lipid extracted algae of the Nannochloropsis sp. substantially similar to that presently claimed, inherently the microalgal protein product would exhibit the claimed true protein digestibility and PDCAAS.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Soto-Sierra et al. (“Process development of enzymatically-generated algal protein hydrolysates for specialty food applications”, Algal Research, 55 (2021), pp. 1-10) as applied to claim 12, and further in view of Kadam et al. (US 2014/0242238).
Regarding claim 3, Sota-Sierra et al. disclose all of the claim limitations as set forth above. While Sota-Sierra et al. disclose a microalgal protein product obtained from Nannochloropsis sp., the reference is silent with respect to Eustigmaticicae sp.
Kadam et al. teach a method of extracting oil from microalgae (Abstract). Kadam et al. disclose the microalgae used for the invention are members of the class Eustigmatophyceae (i.e. Eustigmaticicae) or the genera Nannochloropsis.
Given Sota-Sierra et al. disclose preparing protein from lipid-extracted microalgae of the genera Nannochloropsis, since Kadam et al. teach extracting oil from microalgae of the class Eustigmaticicae or the genera Nannochloropsis, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used lipid-extracted microalgae of the class Eustigmaticicae as the source of microalgae in the product of Sota-Sierra et al.
Claims 16-19, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Soto-Sierra et al. (“Process development of enzymatically-generated algal protein hydrolysates for specialty food applications”, Algal Research, 55 (2021), pp. 1-10) as applied to claim 12, and further in view of Tang (WO 2011/057406 A1).
Regarding claim 16, Sota-Sierra et al. disclose all of the claim limitations as set forth above. Sota-Sierra et al. is silent with respect to a food composition.
Tang teaches a hydrolyzed microalgae protein product having a protein content of about 75% to about 90% (protein concentrate or isolate) (Abstract, [0022]-[0023]). Tang teaches the protein product is useful as a protein ingredient in nutritional beverages such as protein fortified soft drinks, sports drinks, fruit juices and other high protein drinks (p. 45/L23-27). Here, a beverage is considered an edible aqueous solution.
Sota-Sierra et al. and Tang are combinable because they are concerned with the same field of endeavor, namely hydrolyzed microalgae protein products. It would have been obvious to one of ordinary skill in the art to have used the hydrolyzed microalgal protein product of Sota-Sierra et al. in a beverage, as taught by Tang to make a protein fortified beverage.
Regarding claim 17, modified Sota-Sierra et al. disclose all of the claim limitations as set forth above. Tang teaches beverages, for example high protein drinks. Given the microalgal protein product of Sota-Sierra et al., a powder, would be added to the ingredients of a protein drink and mixed, inherently particles of powder would be encapsulated to some extent by the matrix of the ingredients.
Regarding claim 18, modified Sota-Sierra et al. disclose all of the claim limitations as set forth above. Given Tang teaches beverages, including soft drinks, sports drink and fruit juices, inherently the juices would comprise some type of added flavor.
Regarding claims 19 and 25, modified Sota-Sierra et al. disclose all of the claim limitations as set forth above. Given Tang teaches nutritional beverages such as protein fortified soft drinks, sports drinks, fruit juices and other high protein drinks, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have adjusted, in routine processing, the protein content of a specific beverage to obtained the desired nutritional benefit while maintaining a desired sensory profile.
Regarding claim 26, modified Sota-Sierra et al. disclose all of the claim limitations as set forth above. Tang et al. disclose using microalgae protein products in soft drinks (i.e., aqueous beverages having a pH less than 5- p. 45/L23-27).
Conclusion
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759