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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 09/24/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/24/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 08/04/2026 is acknowledged. The traversal is on the ground(s) that the applicant believes that since the special technical feature (hydrolysate of a non-animal origin) is made in a particular manner that this special technical feature is not disclosed in the art and is therefore novel. This is not found persuasive because the special technical feature has already been previously disclosed as pointed out in the previous restriction notice and is also made obvious considering the rejection below. Also, the art relied upon renders the method of arriving at the instantly disclosed hydrolysates, through the same method steps obvious, and teaches the special technical feature, therefore the special technical feature is made obvious by the prior art and unity of invention is brokem.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/04/2026.
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 4 and 7 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.
Claims 4 and 7 recite the term “preferably” and the phrase “more preferably” and it is unclear if the phrases/terms following those terms/phrases are to be considered limitations or merely suggestive. The claims are indefinite.
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 1-2, 4-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Jaouad Fichtali et. al. (US8048652B2).
Fichtali teaches methods of producing a biomass hydrolysate (see abstract).
Fichtali teaches “when oilseed plants are the source of LCPUFAs, the seeds can be harvested and processed to remove any impurities, debris or indigestible portions from the harvested seeds prior to Subjecting them to a step of hydrolyzing. Processing steps vary depending on the type of oilseed. Processing steps can include threshing (such as, for example, when soybean seeds are separated from the pods), dehulling (removing the dry outer covering, or husk, of a fruit, seed, or nut), drying, cleaning, grinding, milling and flaking. After the seeds have been processed to remove any impurities, debris or indigestible materials, they can be added to an aqueous solution, preferably water, and then mixed to produce a slurry” (see column 13, lines 31-34). Furthermore, Fichatali teaches “the biomass may optionally be washed in order to reduce extracellular components. In preferred embodiments, the biomass may have up to about 99% moisture by weight before being treated by any methods of the present invention” (see column 12, lines 9-10).
Fichtali teaches “in one embodiment, the biomass is separated from its culture media by a solid/liquid separation prior to treatment by methods of the present invention. Typical solid/liquid separation techniques include centrifugation, filtration, and membrane filter pressing (plate and frame filter press with Squeezing membranes)” (see column 11, lines 56-61).
Fichtali teaches high-pressure homogenization and enzyme treatment as a means for hydroylzing a biomass for cell disruption (see column 16, lines 27-39). For example, if a homogenization step is used to effect hydrolysis, the homogenization step will preferentially be conducted by a high-pressure homogenizer (see column 16, lines 43-45).
Fichtali teaches “a preferred method for emulsion comprises homogenization with a Panka2K homogenizer (Niro Inc., Hudson, Wis.), performing emulsification by passing hydrolysate through multiple passes at 1350 bar and 150 bar in the first and second stage, respectively” (see column 19, lines 36-41).
Fichtali teaches adding 500.0 g of water was added to 125 g dried Schizochytrium
Biomass (see example 3, column 27), which is directly outside of the 1:5 range claimed.
The inventors have found that surprisingly, such use of exogenous enzyme hydrolysis improves the taste qualities of the resultant product. For different biomass sources, different enzymes and reaction conditions can be employed. An important enzyme selection criterion is to select an enzyme that will attack and degrade a portion of the material in the membrane
(such as the proteins, polysaccharides, cell outer membrane, peptidoglycan layer, cellulose, chitin, hemicellulose, lignin, lignin-related compounds, and other cell wall components)” (see column 17, last para.).
The selection of reaction conditions, including enzyme type, enzyme concentration,
temperature, pH, water activity, other reagent concentration, reaction time, etc. will depend in part on the specific enzyme and material within the cell membrane” (see column 17, first para.).
Fichtali teaches concentration of the hydrolyzed biomass material (see column 18, lines 47-48).
Fichtali teaches typical solid/liquid separation techniques include centrifugation, filtration, and membrane filter pressing (plate and frame filter press with squeezing membranes) (see column 11, lines 59-61).
Fichtali teaches homogenization with two passes at 1350 bar and 150 bar (see column 28, line 5).
Fichtali teaches using cellulases, chitinases and proteases (see column 4, line 30-31) and teaches using alcalase (see example 9, column 30) and teaches endo-proteolytic enzymes such as trypsin and chymostrypsin (see column 17, line 6) and discusses pH adjustment to around 7 to 6.4 at temperatures allowed to reach 63°C. (see examples 1-3).
Fichtali teaches heating up to 95°C and adjusting the pH to inactivate the enzymes (see example 9, column 30).
Fichtali does not specifically teach the method of subjecting the biomass to water infusion at the ratio of 1:5-1:20 and at a temperature between 20°C and 45°C. However, Fichtali teaches that after the seeds (biomass) have been processed to remove any impurities, debris or indigestible materials, they can be added to an aqueous solution, preferably water, and then mixed to produce a slurry. Therefore, it would have been obvious to people having ordinary skill in the art before the effective filing date to make the instant method for obtaining hydrolysates. It would have been obvious in determining the amount of water to dry biomass to be in the instantly claimed ratios appears to be a matter of judicious selection and an optimization well within the purview of any skilled artisan. Keeping the temperature low would also help to preserve any heat sensitive components. It would have been obvious to combine back then hydrolysate with the liquid in step 1 as Fichtali teaches repeating the hydrolyzation steps more than a single time and this would assist in making sure that the process was fully complete. It would have also been obvious to recover the hydrolysates through decantation and subsequent filtration and/or centrifugation because Ficthali teaches typical solid/liquid separation techniques include centrifugation, filtration, and membrane filter pressing (plate and frame filter press with squeezing membranes).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Jaouad Fichtali et. al. (US8048652B2) as applied to claims 1-2, 4-6 and 8-10 above, and further in view of Angela Zinnai et. al. (Supercritical fluid extraction from microalgae with high content of LC-PUFAs. A case study: Sc-CO2 oil extraction form Schizochytrium sp, J. of Supercritical Fluids 116 (2016) 126-131).
Fichtali teaches the method for obtaining a hydrolysate from a biomass, however, is silent on the cold extraction.
Zinnai teaches “among the different kinds of marine sources, microalgae are a potential source of triacylglycerides which may contain high amounts of LC-PUFAs such as -3 fatty acids EPA and DHA. For the extraction of oil from microalgae, Sc-CO2is regarded with interest being safer than hexane and offering a negligible environmental impact, a short extraction time and a petroleum-free final product. In such a contest, a mathematical model able to describe the kinetics of an SFE process was applied to the extraction with Sc-CO2 of lipids from Schizochytrium sp., a marine microalga characterized by a particularly high content of LC-PUFAs, and a very high concentration of DHA” (see abstract).
Therefore, it would have been obvious to people who have ordinary skill in the art before the effective filing date to use supercritical CO2 extraction before the homogenization step taught by Fichtali, because this method would help to extract additional PUFAs from the biomass through a separate means thus making a method of obtaining hydrolyzed extracts which would be rich in PUFAs. It is prima facie obvious to combine equivalents known for the same purpose.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jaouad Fichtali et. al. (US8048652B2) as applied to claims 1-2, 4-6 and 8-10 above, and further in view of Florin Oancea et. al. (From IDS, RO135137A0).
Fichtali teaches the instantly claimed method for obtaining hydrolysates however is silent on adding exo-proteolytic enzymes.
Oancea teaches a process for obtaining spent yeast hydrolysates (see abstract and claim 1) through known methods of treating the spent yeast with a mixture of enzymes containing endo- and exo (1,3) -beta-D-glucanases and endo-chitinase, in a ratio of 75-100 beta-glucanase units and 320-400 endo-chitinase units per 1 kg of yeast substance dry, for 4 hours at 50 ° C; cell lysis by high pressure homogenization, 3 passes at 750 - 1200 bar; bringing the pH to 7.0 and enzymatic hydrolysis by treatment with microbial endo- and exo-proteases, in relation to 36-40 units of Anson endo-proteases and 5000 - 6000 units of amino-peptidase leucine per 1 kg of yeast, at a temperature of 65 ° C for 12 hours; inactivation of proteases by heating the hydrolyzate to 90-95 ° C for 10 min, followed by cooling to 60 ° C, adjusting the pH to 7.0 with concentrated sodium hydroxide or hydrochloric acid solutions and treating with peptidglutaminase, in ratio of 100-150 peptidglutaminase units per 1 kg of yeast at 60 ° C for 8 hours (see claim 1).
Therefore, it would have been obvious to people having ordinary skill in the art before the effective filing date to combine both endo- and exo- proteases within the instantly claimed temperatures and pH levels because this would indeed help to create hydrolysates from spent yeast. Ficthali teaches wherein the process can be used on yeast and Oancea teaches a process for obtaining hydrolysates from spent yeast in a manner which utilizes both endo- and exo- proteases for being able to cleave amino acids contained within the yeast.
There would have been a reasonable expectation of success in using endo- and exo- proteases in Ficthali’s invention to create hydrolysates as these enzymes are known for cleaving amino acids from spent yeast and other biomasses.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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