DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed April 23, 2026 has been entered. Claims 2-4, 6-19, 25 and 26 are pending examination.
The rejection of claims 2 and 4-15 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), claim 3 under 35 U.S.C. 103 as being unpatentable over Soto-Sierra et al. in view of Kadam et al. (US 2014/0242238) and claims 16-19, 25 and 26 under 35 U.S.C. 103 as being unpatentable over Soto-Sierra et al. in view of Tang (WO 2011/057406 A1) have been withdrawn in light of Applicant’s amendment and remarks filed April 23, 2026.
The claim objection of claim 12 and rejection of claims 5 and 16 under 35 U.S.C. 112 (b) have been withdrawn in light of Applicant’s amendment filed April 23, 2026.
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 2-4, 6-16, 18, 19, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Tang (W0 2011/057406).
Regarding claims 11-15, Tang discloses an edible microalgae protein hydrolysate having a protein content of about 30% to about 90% on a dry weight basis (i.e., g/100g powder -Abstract, p. 1/L15-19, p. 5/L17-21, p. 7/L21-24, p. 12/L5-14, p. 19/L18-19). Tang disclose the protein hydrolysate is dried in a vacuum dryer, fluidized be dryer, hot air dryer, ring dryer or spray dryer and milled into a powder (p. 14/L13-16, p. 19/L15-17, p. 51/L18-20).
Tang disclose the term microalgae refers to any aquatic photosynthetic organism (i.e., from freshwater or marine environments -p. 38/L8-21).
Tang discloses the microalgae protein is extracted from defatted microalgae (p. 37/L12-29). Tang discloses defatted microalgae refers to algae which has been treated to remove all of the oil contained within. Tang discloses that in one embodiment, to remove oil from the microalgae, the algae are dried, the dried microalgae are mixed with a solvent to make a slurry, the slurry is milled to break the cell walls of the algae and centrifuged to separate the oil in the solvent from the solids, the solids are desolventized and dried to produce defatted microalgae (i.e., dehydrated lipid extract microalgae -p. 37/L12-29). Given Tang discloses the protein hydrolysate is obtained from dried defatted microalgae, it necessarily follows the protein hydrolysate would comprise residue from the defatted microalgae.
Tang discloses in the process of recovering protein from the defatted microalgae, the soluble liquid extract is subjected to ultrafiltration and diafiltration to recover soluble protein and to remove ash (p. 107/L11-12). Tang discloses a protein hydrolysate with an ash content of 5.48% on a dry weight basis (p. 109/Table).
Given Tang discloses a protein concentrate from microalgae obtained by a method substantially similar to the present disclosure, inherently the protein hydrolysate would have essential amino acids in an amount of at least 30 g/100 g of powder, a branched chain amino acid content equal to or great than 15 g per 100 g product, and display an amino acid profile as claimed.
Regarding claims 2, 4, 9 and 10, Tang discloses all of the claim limitations as set forth above. Given Tang discloses a microalgae protein hydrolysate obtained by a method substantially similar to the present disclosure, inherently the protein hydrolysate would exhibit water solubility and protein digestibility scores as presently claimed.
Regarding claims 3 and 6, Tang discloses all of the claim limitations as set forth above. While Tang discloses the term microalgae refers to any aquatic photosynthetic organism, which produce a concentrate having a protein content of at least 30% (w/w)(p. 38/L , the reference is silent with respect to microalgae of the class Eustigmaticieae and genus Nannochloropsis.
Given Tang discloses protein products obtained from any macroalgae and/or microalgae (i.e., any aquatic photosynthetic organism), 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 used any microalgae, including one from the class Eustigmaticieae and genus Nannochloropsis, to obtain the protein hydrolysate of Tang with a reasonable expectation of success.
Regarding claims 7 and 8, Tang discloses all of the claim limitations as set forth above. Tang discloses an edible microalgae protein hydrolysate having a protein content of about 30% to about 90% on a dry weight basis (i.e., g/100g powder -Abstract, p. 1/L15-19, p. 5/L17-21, p. 7/L21-24, p. 12/L5-14, p. 19/L18-19).
Tang discloses a protein hydrolysate with an ash content of 5.48% on a dry weight basis (p. 109/Table). A prima facie case of obviousness exist where the claimed ranges or amounts do not overlap with the prior but a merely close. The ash content of Tang is so close to the claim range of less than 5 g per 100 g of powder, prima facie one skilled in the art would have expected them to have the same properties (MPEP §2144.05 I).
Regarding claim 16, Tang discloses all of the claim limitations as set forth above. Tang discloses a beverage comprising the edible microalgae protein hydrolysate (i.e., edible aqueous suspension or solution -p. 46/L7-17).
Regarding claims 18 and 26, Tang discloses all of the claim limitations as set forth above. Tang discloses a protein fortified soft drink comprising the edible microalgae protein hydrolysate (p. 46/L7-10). Given Tang discloses a soft drink, it necessarily follows the soft drink would comprise added flavors and have a pH less than 5.
Regarding claims 19 and 25, Tang discloses all of the claim limitations as set forth above. While Tang discloses a protein fortified soft drink comprising the edible microalgae protein hydrolysate, the reference is silent with respect to the protein content of the drink. However, the person of ordinary skill in the art would have been motivated to adjust, in routine processing, the protein content (i.e., added microalgae protein hydrolysate) in the soft drink to obtain a drink with a desired nutritional profile while maintaining the sensory profile.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tang (W0 2011/057406) as applied to claim 12, and further in view of Brzozowska (WO 20211021026 A).
Regarding claim 17, Tang discloses all of the claim limitations as set forth above. Tang discloses a beverage comprising the edible microalgae protein hydrolysate (i.e., edible aqueous suspension or solution -p. 46/L7-17). Tang et al. does not disclose the particles of the protein hydrolysate are encapsulated.
Brzozowska teaches encapsulated, water-dispersible solubilized protein product for us in food and beverage formulations (Abstract, p. 1/L5-9). Brzozowska teaches encapsulating protein-based powders in a water-soluble modified starch material (Abstract, p. 2/L15-30, p. 3/L14-18).
Tang and Brzozowska are combinable because they are concerned with the same field of endeavor, namely beverages comprising edible proteins. 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 encapsulated, as taught by Brzozowska, the microalgae protein hydrolysate of Tang to obtain a protein with improved solubility in beverage matrices.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim et al. (WO 2012/077874 A1) teaches peptide derived from hydrolysate of microalgae used to protect liver cells and suppressing hepatic fibrosis. The reference do not teach edible compositions.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759